Asthma Management Using the Mobile Asthma Evaluation and Management System in China

PurposeAs stated in the Global Initiative for Asthma, there are still some asthmatic patients who have not achieved asthma control. Mobile is a useful tool for asthma management. We aimed to compare the advantages of mobile management with traditional management in improving adherence and control of asthma.MethodsIn this prospective, multicentre, randomized, controlled and parallel-group study, we enrolled patients with poor adherence and uncontrolled asthma at 32 hospitals in 28 provinces in China. Patients were randomly assigned to the mobile management or traditional management groups for 12 months. The primary endpoint was the proportion of patients with good adherence (Medication Adherence Report Scale for Asthma [MARS-A] score ≥ 45) for 6 months. This study is registered at ClinicalTrials.gov ({"type":"clinical-trial","attrs":{"text":"NCT02917174","term_id":"NCT02917174"}}NCT02917174).ResultsBetween April 2017 and April 2018, 923 patients were eligible for randomization (mobile group, n = 461; traditional group, n = 462). Dropout was 84 (18.2%) in the mobile management group and 113 (24.4%) patients in the traditional management group. The proportion of patients with good adherence was significantly higher in the mobile management group than in the traditional management group (66.0% vs. 58.99%, P = 0.048). The mobile management group showed higher mean MARS-A score (at 1, 6, 9, and 12 months) and asthma control test scores (at 6 and 9 months), and lower total lost rate to follow-up within 12 months than the traditional management group.ConclusionsMobile asthma management can improve adherence and asthma control compared to traditional management.Trial RegistrationClinicalTrials.gov Identifier: {"type":"clinical-trial","attrs":{"text":"NCT02917174","term_id":"NCT02917174"}}NCT02917174     

Sequential Allocation to Balance Prognostic Factors in a Psychiatric Clinical Trial

OBJECTIVE:

This paper aims to describe and discuss a minimization procedure specifically designed for a clinical trial that evaluates treatment efficacy for OCD patients.

METHOD:

Aitchison’s compositional distance was used to calculate vectors for each possibility of allocation in a covariate adaptive method. Two different procedures were designed to allocate patients in small blocks or sequentially one-by-one.

RESULTS:

We present partial results of this allocation procedure as well as simulated data. In the clinical trial for which this procedure was developed, successful balancing between treatment arms was achieved. Separately, in an exploratory analysis, we found that if the arrival order of patients was altered, most patients were allocated to a different treatment arm than their original assignment.

CONCLUSION:

Our results show that the random arrival order of patients determine different assignments and therefore maintains the unpredictability of the allocation method. We conclude that our proposed procedure allows for the use of a large number of prognostic factors in a given allocation decision. Our method seems adequate for the design of the psychiatric trials used as models. Trial registrations are available at clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00466609","term_id":"NCT00466609"}}NCT00466609 and {"type":"clinical-trial","attrs":{"text":"NCT00680602","term_id":"NCT00680602"}}NCT00680602.     

Chemotherapy-Induced Intestinal Mucosal Barrier Damage: a Cause of Falsely Elevated Serum 1,3-Beta-d-Glucan Levels?

Blood citrulline and intestinal fatty acid binding protein were determined as biomarkers for intestinal mucositis. Biomarker levels were correlated with corresponding serum 1,3-beta-d-glucan levels in 56 samples obtained from 33 cases with underlying hematological malignancies receiving induction chemotherapy. No correlation between biomarkers of intestinal mucositis and BDG levels was observed. (This study has been registered at ClinicalTrials.gov under registration no. {"type":"clinical-trial","attrs":{"text":"NCT01576653","term_id":"NCT01576653"}}NCT01576653.)     

Results of External Quality Assessment for Proviral DNA Testing of HIV Tropism in the Maraviroc Switch Collaborative Study

The Maraviroc Switch collaborative study (MARCH) is a study in aviremic patients on stable antiretroviral therapy and utilizes population-based sequencing of proviral DNA to determine HIV tropism and susceptibility to maraviroc. An external quality assessment (EQA) program was implemented to ensure competency in assessing the tropism of clinical samples conducted by MARCH laboratories (n = 14). The MARCH EQA has three prestudy phases assessing V3 loop sequencing and tropism determination using the bioinformatic algorithm geno2pheno, which generates a false-positive rate (FPR). DNA sequences with low FPRs are more likely to be from CXCR4-using (X4) viruses. Phase 1 of the EQA involved chromatogram interpretation. Phases 2, 2/3, and 3 involved patient and clonal samples. Clinical samples used in these phases were from treatment-experienced HIV-infected volunteers; 18/20 had viral loads of <50 copies/ml, and 10/15 were CXCR4-tropic on prior phenotyping. All samples were tested in triplicate, and any replicate with a geno2pheno FPR of <10% was designated X4. Performance was deemed adequate if ≤2 R5 and ≤1 X4 specimens were miscalled. For several clinical samples in the EQA, triplicate testing revealed marked DNA variability (FPR range, 0 to 96.7%). Therefore, a consensus-based approach was employed for each sample, i.e., a median FPR across laboratories was used to define sample tropism. Further sequencing analysis showed mixed viral populations in the clinical samples, explaining the differences in tropism predictions. All laboratories passed the EQA after achieving predefined competence thresholds in either of the phase 2 rounds. The use of clinical samples from patients resembling those who were likely to be screened in the MARCH, coupled with triplicate testing, revealed inherent DNA variability that might have been missed if single or duplicate testing and/or clonal samples alone were used. These data highlight the importance of intensive EQA of tropism laboratories before embarking on clinical studies. (This study has been registered at ClinicalTrials.gov under registration no. {"type":"clinical-trial","attrs":{"text":"NCT01384682","term_id":"NCT01384682"}}NCT01384682 [http://www.clinicaltrials.gov/ct2/show/study/{"type":"clinical-trial","attrs":{"text":"NCT01384682","term_id":"NCT01384682"}}NCT01384682?term={"type":"clinical-trial","attrs":{"text":"NCT01384682","term_id":"NCT01384682"}}NCT01384682&rank=1].)     

Internet delivered support for tobacco control in dental practice: randomized controlled trial

Background

The dental visit is a unique opportunity for tobacco control. Despite evidence of effectiveness in dental settings, brief provider-delivered cessation advice is underutilized.

Objective

To evaluate an Internet-delivered intervention designed to increase implementation of brief provider advice for tobacco cessation in dental practice settings.

Methods

Dental practices (N = 190) were randomized to the intervention website or wait-list control. Pre-intervention and after 8 months of follow-up, each practice distributed exit cards (brief patient surveys assessing provider performance, completed immediately after the dental visit) to 100 patients. Based on these exit cards, we assessed: whether patients were asked about tobacco use (ASK) and, among tobacco users, whether they were advised to quit tobacco (ADVISE). All intervention practices with follow-up exit card data were analyzed as randomized regardless of whether they participated in the Internet-delivered intervention.

Results

Of the 190 practices randomized, 143 (75%) dental practices provided follow-up data. Intervention practices’ mean performance improved post-intervention by 4% on ASK (29% baseline, adjusted odds ratio = 1.29 [95% CI 1.17-1.42]), and by 11% on ADVISE (44% baseline, OR = 1.55 [95% CI 1.28-1.87]). Control practices improved by 3% on ASK (Adj. OR 1.18 [95% CI 1.07-1.29]) and did not significantly improve in ADVISE. A significant group-by-time interaction effect indicated that intervention practices improved more over the study period than control practices for ADVISE (P = 0.042) but not for ASK.

Conclusion

This low-intensity, easily disseminated intervention was successful in improving provider performance on advice to quit.

Trial Registration

clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00627185","term_id":"NCT00627185"}}NCT00627185; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00627185","term_id":"NCT00627185"}}NCT00627185 (Archived by WebCite at http://www.webcitation.org/5c5Kugvzj)     

Collecting Maternal Health Information From HIV-Positive Pregnant Women Using Mobile Phone-Assisted Face-to-Face Interviews in Southern Africa

Background

Most of the world’s women living with human immunodeficiency virus (HIV) reside in sub-Saharan Africa. Although efforts to reduce mother-to-child transmission are underway, obtaining complete and accurate data from rural clinical sites to track progress presents a major challenge.

Objective

To describe the acceptability and feasibility of mobile phones as a tool for clinic-based face-to-face data collection with pregnant women living with HIV in South Africa.

Methods

As part of a larger clinic-based trial, 16 interviewers were trained to conduct mobile phone–assisted personal interviews (MPAPI). These interviewers (participant group 1) completed the same short questionnaire based on items from the Technology Acceptance Model at 3 different time points. Questions were asked before training, after training, and 3 months after deployment to clinic facilities. In addition, before the start of the primary intervention trial in which this substudy was undertaken, 12 mothers living with HIV (MLH) took part in a focus group discussion exploring the acceptability of MPAPI (participant group 2). Finally, a sample of MLH (n=512) enrolled in the primary trial were asked to assess their experience of being interviewed by MPAPI (participant group 3).

Results

Acceptability of the method was found to be high among the 16 interviewers in group 1. Perceived usefulness was reported to be slightly higher than perceived ease of use across the 3 time points. After 3 months of field use, interviewer perceptions of both perceived ease of use and perceived usefulness were found to be higher than before training. The feasibility of conducting MPAPI interviews in this setting was found to be high. Network coverage was available in all clinics and hardware, software, cost, and secure transmission to the data center presented no significant challenges over the 21-month period. For the 12 MHL participants in group 2, anxiety about the multimedia capabilities of the phone was evident. Their concern centered on the possibility that their privacy may be invaded by interviewers using the mobile phone camera to photograph them. For participants in group 3, having the interviewer sit beside vs across from the interviewee during the MPAPI interview was received positively by 94.7% of MHL. Privacy (6.3%) and confidentiality (5.3%) concerns were low for group 3 MHL.

Conclusions

Mobile phones were found both to be acceptable and feasible in the collection of maternal and child health data from women living with HIV in South Africa.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00972699","term_id":"NCT00972699"}}NCT00972699; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00972699","term_id":"NCT00972699"}}NCT00972699 (Archived by WebCite at http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00972699","term_id":"NCT00972699"}}NCT00972699)     

Leveraging Text Messaging and Mobile Technology to Support Pediatric Obesity-Related Behavior Change: A Qualitative Study Using Parent Focus Groups and Interviews

Background

Text messaging (short message service, SMS) is a widely accessible and potentially cost-effective medium for encouraging behavior change. Few studies have examined text messaging interventions to influence child health behaviors or explored parental perceptions of mobile technologies to support behavior change among children.

Objective

Our aim was to examine parental acceptability and preferences for text messaging to support pediatric obesity-related behavior change.

Methods

We conducted focus groups and follow-up interviews with parents of overweight and obese children, aged 6-12 years, seen for “well-child” care in eastern Massachusetts. A professional moderator used a semistructured discussion guide and sample text messages to catalyze group discussions. Seven participants then received 3 weeks of text messages before a follow-up one-on-one telephone interview. All focus groups and interviews were recorded and transcribed verbatim. Using a framework analysis approach, we systematically coded and analyzed group and interview data to identify salient and convergent themes.

Results

We reached thematic saturation after five focus groups and seven follow-up interviews with a total of 31 parents of diverse race/ethnicity and education levels. Parents were generally enthusiastic about receiving text messages to support healthy behaviors for their children and preferred them to paper or email communication because they are brief and difficult to ignore. Participants anticipated high responsiveness to messaging endorsed by their child’s doctor and indicated they would appreciate messages 2-3 times/week or more as long as content remains relevant. Suggestions for maintaining message relevance included providing specific strategies for implementation and personalizing information. Most felt the negative features of text messaging (eg, limited message size) could be overcome by providing links within messages to other media including email or websites.

Conclusions

Text messaging is a promising medium for supporting pediatric obesity-related behavior change. Parent perspectives could assist in the design of text-based interventions.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01565161","term_id":"NCT01565161"}}NCT01565161; http://clinicaltrials.gov/show/{"type":"clinical-trial","attrs":{"text":"NCT01565161","term_id":"NCT01565161"}}NCT01565161 (Archived by WebCite at http://www.webcitation.org/6LSaqFyPP).     

An internet-based virtual coach to promote physical activity adherence in overweight adults: randomized controlled trial

Background

Addressing the obesity epidemic requires the development of effective, scalable interventions. Pedometers and Web-based programs are beneficial in increasing activity levels but might be enhanced by the addition of nonhuman coaching.

Objectives

We hypothesized that a virtual coach would increase activity levels, via step count, in overweight or obese individuals beyond the effect observed using a pedometer and website alone.

Methods

We recruited 70 participants with a body mass index (BMI) between 25 and 35 kg/m² from the Boston metropolitan area. Participants were assigned to one of two study arms and asked to wear a pedometer and access a website to view step counts. Intervention participants also met with a virtual coach, an automated, animated computer agent that ran on their home computers, set goals, and provided personalized feedback. Data were collected and analyzed in 2008. The primary outcome measure was change in activity level (percentage change in step count) over the 12-week study, split into four 3-week time periods. Major secondary outcomes were change in BMI and participants’ satisfaction.

Results

The mean age of participants was 42 years; the majority of participants were female (59/70, 84%), white (53/70, 76%), and college educated (68/70, 97%). Of the initial 70 participants, 62 completed the study. Step counts were maintained in intervention participants but declined in controls. The percentage change in step count between those in the intervention and control arms, from the start to the end, did not reach the threshold for significance (2.9% vs –12.8% respectively, P = .07). However, repeated measures analysis showed a significant difference when comparing percentage changes in step counts between control and intervention participants over all time points (analysis of variance, P = .02). There were no significant changes in secondary outcome measures.

Conclusions

The virtual coach was beneficial in maintaining activity level. The long-term benefits and additional applications of this technology warrant further study.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00792207","term_id":"NCT00792207"}}NCT00792207; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00792207","term_id":"NCT00792207"}}NCT00792207 (Archived by WebCite at http://www.webcitation.org/63sm9mXUD)     

Staying vigilant during recurrent sleep restriction: dose-response effects of time-in-bed and benefits of daytime napping

Study ObjectivesWe characterized vigilance deterioration with increasing time-on-task (ToT) during recurrent sleep restriction of different extents on simulated weekdays and recovery sleep on weekends, and tested the effectiveness of afternoon napping in ameliorating ToT-related deficits.MethodsIn the Need for Sleep studies, 194 adolescents (age = 15–19 years) underwent two baseline nights of 9-h time-in-bed (TIB), followed by two cycles of weekday manipulation nights and weekend recovery nights (9-h TIB). They were allocated 9 h, 8 h, 6.5 h, or 5 h of TIB for nocturnal sleep on weekdays. Three additional groups with 5 h or 6.5 h TIB were given an afternoon nap opportunity (5 h + 1 h, 5 h + 1.5 h, and 6.5 h + 1.5 h). ToT effects were quantified by performance change from the first 2 min to the last 2 min in a 10-min Psychomotor Vigilance Task administered daily.ResultsThe 9 h and the 8 h groups showed comparable ToT effects that remained at baseline levels throughout the protocol. ToT-related deficits were greater among the 5 h and the 6.5 h groups, increased prominently in the second week of sleep restriction despite partial recuperation during the intervening recovery period and diverged between these two groups from the fifth sleep-restricted night. Daytime napping attenuated ToT effects when nocturnal sleep restriction was severe (i.e. 5-h TIB/night), and held steady at baseline levels for a milder dose of nocturnal sleep restriction when total TIB across 24 h was within the age-specific recommended sleep duration (i.e. 6.5 h + 1.5 h).ConclusionsReducing TIB beyond the recommended duration significantly increases ToT-associated vigilance impairment, particularly during recurrent periods of sleep restriction. Daytime napping is effective in ameliorating such decrement.Clinical Trial Registration{"type":"clinical-trial","attrs":{"text":"NCT02838095","term_id":"NCT02838095"}}NCT02838095, {"type":"clinical-trial","attrs":{"text":"NCT03333512","term_id":"NCT03333512"}}NCT03333512, and {"type":"clinical-trial","attrs":{"text":"NCT04044885","term_id":"NCT04044885"}}NCT04044885.     

Interpreting the outcomes of automated internet-based randomized trials: example of an International Smoking Cessation Study

Background

Smoking is one of the largest contributors to the global burden of disease. Internet interventions have been shown to reduce smoking rates successfully. However, improved methods of evaluating effectiveness need to be developed for large-scale Internet intervention trials.

Objective

To illustrate a method to interpret outcomes of large-scale, fully automated, worldwide Internet intervention trials.

Methods

A fully automated, international, Internet-based smoking cessation randomized controlled trial was conducted in Spanish and English, with 16,430 smokers from 165 countries. The randomized controlled trial replicated a published efficacy trial in which, to reduce follow-up attrition, 1000 smokers were followed up by phone if they did not provide online follow-up data.

Results

The 7-day self-reported abstinence rates ranged from 36.18% (2239/6189) at 1 month to 41.34% (1361/3292) at 12 months based on observed data. Given high rates of attrition in this fully automated trial, when participants unreachable at follow-up were presumed to be smoking, the abstinence rates ranged from 13.63% (2239/16.430) at 1 month to 8.28% (1361/16,430) at 12 months. We address the problem of interpreting results with high follow-up attrition rates and propose a solution based on a smaller study with intensive phone follow-up.

Conclusions

Internet-based smoking cessation interventions can help large numbers of smokers quit. Large-scale international outcome studies can be successfully implemented using automated Internet sites. Interpretation of the studies’ results can be aided by extrapolating from results obtained from subsamples that are followed up by phone or similar cohort maintenance methods.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00721786","term_id":"NCT00721786"}}NCT00721786; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00721786","term_id":"NCT00721786"}}NCT00721786 (Archived by WebCite at http://www.webcitation.org/63mhoXYPw)     

Using Videogame Apps to Assess Gains in Adolescents’ Substance Use Knowledge: New Opportunities for Evaluating Intervention Exposure and Content Mastery

BackgroundVideogame interventions are becoming increasingly popular as a means to engage people in behavioral interventions; however, strategies for examining data from such interventions have not been developed.ObjectiveThe objective of this study was to describe how a technology-based intervention can yield meaningful, objective evidence of intervention exposure within a behavioral intervention. This study demonstrates the analysis of automatic log files, created by software from a videogame intervention, that catalog game play and, as proof of concept, the association of these data with changes in substance use knowledge as documented with standardized assessments.MethodsWe analyzed 3- and 6-month follow-up data from 166 participants enrolled in a randomized controlled trial evaluating a videogame intervention, PlayForward: Elm City Stories (PlayForward). PlayForward is a videogame developed as a risk reduction and prevention program targeting HIV risk behaviors (substance use and sex) in young minority adolescents. Log files were analyzed to extract the total amount of time spent playing the videogame intervention and the total number of game levels completed and beaten by each player.ResultsCompleting and beating more of the game levels, and not total game play time, was related to higher substance use knowledge scores at the 3- (P=.001) and 6-month (P=.001) follow-ups.ConclusionsOur findings highlight the potential contributions a videogame intervention can make to the study of health behavior change. Specifically, the use of objective data collected during game play can address challenges in traditional human-delivered behavioral interventions.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01666496","term_id":"NCT01666496"}}NCT01666496; https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01666496","term_id":"NCT01666496"}}NCT01666496 (Archived by WebCite at http://www.webcitation.org/6cV9fxsOg)     

Patients’ Reported Reasons for Non-Use of an Internet-Based Patient-Provider Communication Service: Qualitative Interview Study

Background

The adoption of Internet-based patient–provider communication services (IPPC) in health care has been slow. Patients want electronic communication, and the quality of health care can be improved by offering such IPPCs. However, the rate of enrollment in such services remains low, and the reasons for this are unclear. Knowledge about the barriers to use is valuable during implementation of IPPCs in the health care services, and it can help timing, targeting, and tailoring IPPCs to different groups of patients.

Objective

The goal of our study was to investigate patients’ views of an IPPC that they could use from home to pose questions to nurses and physicians at their treatment facility, and their reported reasons for non-use of the service.

Methods

This qualitative study was based on individual interviews with 22 patients who signed up for, but did not use, the IPPC.

Results

Patients appreciated the availability and the possibility of using the IPPC as needed, even if they did not use it. Their reported reasons for not using the IPPC fell into three main categories: (1) they felt that they did not need the IPPC and had sufficient access to information elsewhere, (2) they preferred other types of communication such as telephone or face-to-face contact, or (3) they were hindered by IPPC attributes such as login problems.

Conclusions

Patients were satisfied with having the opportunity to send messages to health care providers through an IPPC, even if they did not use the service. IPPCs should be offered to the patients at an appropriate time in the illness trajectory, both when they need the service and when they are receptive to information about the service. A live demonstration of the IPPC at the point of enrollment might have increased its use.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00971139","term_id":"NCT00971139"}}NCT00971139; http://clinicaltrial.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00971139","term_id":"NCT00971139"}}NCT00971139 (Archived by WebCite at http://www.webcitation.org/6KlOiYJrW).     

Individually tailored internet-based treatment for young adults and adults with panic attacks: randomized controlled trial

Background

Previous studies on Internet-based treatment with minimal therapist guidance have shown promising results for several specific diagnoses.

Objective

To (1) investigate the effects of a tailored, therapist-guided, Internet-based treatment for individuals with reoccurring panic attacks, and (2) to examine whether people in different age groups (18–30 years and 31–45 years) would respond differently to the treatment.

Methods

We recruited 149 participants from an online list of individuals having expressed an interest in Internet treatment. Screening consisted of online questionnaires followed by a telephone interview. A total of 57 participants were included after a semistructured diagnostic interview, and they were randomly assigned to an 8-week treatment program (n = 29) or to a control condition (n = 28). Treatment consisted of individually prescribed cognitive behavior therapy text modules in conjunction with online therapist guidance. The control group consisted of people on a waitlist who later received treatment.

Results

All dependent measures improved significantly immediately following treatment and at the 12-month follow-up. The between-group effect size on the primary outcome measure, the Panic Disorder Severity Scale, was d = 1.41 (95% confidence interval 0.81–1.95) at posttreatment. The within-group effect size from pretreatment to 12-month follow-up was d = 1.66 (95% confidence interval 1.14–2.35). Age group had no effect, suggesting that age did not influence the outcome.

Conclusions

Tailoring an Internet-based treatment can be a feasible approach in the treatment of panic symptoms and comorbid anxiety and depressive symptoms. Younger adults benefit as much as adults over 30 years and up to 45 years of age.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01296321","term_id":"NCT01296321"}}NCT01296321; http://www.clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01296321","term_id":"NCT01296321"}}NCT01296321 (Archived by WebCite at http://www.webcitation.org/65wddsqlL)     

A sleep schedule incorporating naps benefits the transformation of hierarchical knowledge

Study ObjectivesThe learning brain establishes schemas (knowledge structures) that benefit subsequent learning. We investigated how sleep and having a schema might benefit initial learning followed by rearranged and expanded memoranda. We concurrently examined the contributions of sleep spindles and slow-wave sleep to learning outcomes.MethodsFifty-three adolescents were randomly assigned to an 8 h Nap schedule (6.5 h nocturnal sleep with a 90-minute daytime nap) or an 8 h No-Nap, nocturnal-only sleep schedule. The study spanned 14 nights, simulating successive school weeks. We utilized a transitive inference task involving hierarchically ordered faces. Initial learning to set up the schema was followed by rearrangement of the hierarchy (accommodation) and hierarchy expansion (assimilation). The expanded sequence was restudied. Recall of hierarchical knowledge was tested after initial learning and at multiple points for all subsequent phases. As a control, both groups underwent a No-schema condition where the hierarchy was introduced and modified without opportunity to set up a schema. Electroencephalography accompanied the multiple sleep opportunities.ResultsThere were main effects of Nap schedule and Schema condition evidenced by superior recall of initial learning, reordered and expanded memoranda. Improved recall was consistently associated with higher fast spindle density but not slow-wave measures. This was true for both nocturnal sleep and daytime naps.ConclusionA sleep schedule incorporating regular nap opportunities compared to one that only had nocturnal sleep benefited building of robust and flexible schemas, facilitating recall of the subsequently rearranged and expanded structured knowledge. These benefits appear to be strongly associated with fast spindles.Clinical Trial registration{"type":"clinical-trial","attrs":{"text":"NCT04044885","term_id":"NCT04044885"}}NCT04044885 (https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT04044885","term_id":"NCT04044885"}}NCT04044885).     

A 5-Year follow-up of internet-based cognitive behavior therapy for social anxiety disorder

Background

Internet-based cognitive behavior therapy (CBT) has been shown to be a promising method to disseminate cognitive behavior therapy for social anxiety disorder (SAD). Several trials have demonstrated that Internet-based CBT can be effective for SAD in the shorter term. However, the long-term effects of Internet-based CBT for SAD are less well known.

Objective

Our objective was to investigate the effect of Internet-based CBT for SAD 5 years after completed treatment.

Method

We conducted a 5-year follow-up study of 80 persons with SAD who had undergone Internet-based CBT. The assessment comprised a diagnostic interview and self-report questionnaires. The main outcome measure was the Liebowitz Social Anxiety Scale-Self-Report (LSAS-SR). Additional measures of social anxiety were the Social Interaction Anxiety Scale (SIAS) and the Social Phobia Scale (SPS). Attrition rates were low: 89% (71/80) of the participants completed the diagnostic interview and 80% (64/80) responded to the questionnaires.

Results

Mixed-effect models analysis showed a significant effect of time on the three social anxiety measures, LSAS-SR, SIAS, and SPS (F _{3,98 -102} = 16.05 - 29.20, P < .001) indicating improvement. From baseline to 5-year follow-up, participants’ mean scores on the LSAS-SR were reduced from 71.3 (95% confidence interval [CI] 66.1-76.5) to 40.3 (95% CI 35.2 - 45.3). The effect sizes of the LSAS-SR were large (Cohen’s d range 1.30 - 1.40, 95% CI 0.77 - 1.90). Improvements gained at the 1-year follow-up were sustained 5 years after completed treatment.

Conclusions

Internet-based CBT for SAD is a treatment that can result in large and enduring effects.

Trial registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01145690","term_id":"NCT01145690"}}NCT01145690; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01145690","term_id":"NCT01145690"}}NCT01145690 (Archived by WebCite at http://www.webcitation.org/5ygRxDLfK)     

Development of an interactive, Web-delivered system to increase provider-patient engagement in smoking cessation

Background

Patient self-management interventions for smoking cessation are effective but underused. Health care providers do not routinely refer smokers to these interventions.

Objective

The objective of our study was to uncover barriers and facilitators to the use of an e-referral system that will be evaluated in a community-based randomized trial. The e-referral system will allow providers to refer smokers to an online smoking intervention during routine clinical care.

Methods

We devised a four-step development and pilot testing process: (1) system conceptualization using Delphi to identify key functionalities that would overcome barriers in provider referrals for smoking cessation, (2) Web system programming using agile software development and best programming practices with usability refinement using think-aloud testing, (3) implementation planning using the nominal group technique for the effective integration of the system into the workflow of practices, and (4) pilot testing to identify practice recruitment and system-use barriers in real-world settings.

Results

Our Delphi process (step 1) conceptualized three key e-referral functions: (1) Refer Your Smokers, allowing providers to e-refer patients at the point of care by entering their emails directly into the system, (2) practice reports, providing feedback regarding referrals and impact of smoking-cessation counseling, and (3) secure messaging, facilitating provider–patient communication. Usability testing (step 2) suggested the system was easy to use, but implementation planning (step 3) suggested several important approaches to encourage use (eg, proactive email cues to encourage practices to participate). Pilot testing (step 4) in 5 practices had limited success, with only 2 patients referred; we uncovered important recruitment and system-use barriers (eg, lack of study champion, training, and motivation, registration difficulties, and forgetting to refer).

Conclusions

Implementing a system to be used in a clinical setting is complex, as several issues can affect system use. In our ongoing large randomized trial, preliminary analysis with the first 50 practices using the system for 3 months demonstrated that our rigorous preimplementation evaluation helped us successfully identify and overcome these barriers before the main trial.

Trial

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00797628","term_id":"NCT00797628"}}NCT00797628; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00797628","term_id":"NCT00797628"}}NCT00797628 (Archived by WebCite at http://www.webcitation.org/61feCfjCy)     

Pedometer-Based Internet-Mediated Intervention For Adults With Chronic Low Back Pain: Randomized Controlled Trial

Background

Chronic pain, especially back pain, is a prevalent condition that is associated with disability, poor health status, anxiety and depression, decreased quality of life, and increased health services use and costs. Current evidence suggests that exercise is an effective strategy for managing chronic pain. However, there are few clinical programs that use generally available tools and a relatively low-cost approach to help patients with chronic back pain initiate and maintain an exercise program.

Objective

The objective of the study was to determine whether a pedometer-based, Internet-mediated intervention can reduce chronic back pain-related disability.

Methods

A parallel group randomized controlled trial was conducted with 1:1 allocation to the intervention or usual care group. 229 veterans with nonspecific chronic back pain were recruited from one Department of Veterans Affairs (VA) health care system. Participants randomized to the intervention received an uploading pedometer and had access to a website that provided automated walking goals, feedback, motivational messages, and social support through an e-community (n=111). Usual care participants (n=118) also received the uploading pedometer but did not receive the automated feedback or have access to the website. The primary outcome was measured using the Roland Morris Disability Questionnaire (RDQ) at 6 months (secondary) and 12 months (primary) with a difference in mean scores of at least 2 considered clinically meaningful. Both a complete case and all case analysis, using linear mixed effects models, were conducted to assess differences between study groups at both time points.

Results

Baseline mean RDQ scores were greater than 9 in both groups. Primary outcome data were provided by approximately 90% of intervention and usual care participants at both 6 and 12 months. At 6 months, average RDQ scores were 7.2 for intervention participants compared to 9.2 for usual care, an adjusted difference of 1.6 (95% CI 0.3-2.8, P=.02) for the complete case analysis and 1.2 (95% CI -0.09 to 2.5, P=.07) for the all case analysis. A post hoc analysis of patients with baseline RDQ scores ≥4 revealed even larger adjusted differences between groups at 6 months but at 12 months the differences were no longer statistically significant.

Conclusions

Intervention participants, compared with those receiving usual care, reported a greater decrease in back pain-related disability in the 6 months following study enrollment. Between-group differences were especially prominent for patients reporting greater baseline levels of disability but did not persist over 12 months. Primarily, automated interventions may be an efficient way to assist patients with managing chronic back pain; additional support may be needed to ensure continuing improvements.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00694018","term_id":"NCT00694018"}}NCT00694018; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00694018","term_id":"NCT00694018"}}NCT00694018 (Archived by WebCite at http://www.webcitation.org/6IsG4Y90E).     

Partnership for Health-2, A Web-Based Versus Print Smoking Cessation Intervention for Childhood and Young Adult Cancer Survivors: Randomized Comparative Effectiveness Study

Background

Smoking among cancer survivors increases the risk of late effects and second cancers. This article reports on Partnership for Health-2 (PFH-2)—an effort to develop an effective and scalable version of Partnership for Health (PFH), which was a previously tested peer-delivered telephone counseling program that doubled smoking cessation rates among childhood cancer survivors who smoke.

Objective

This paper presents results from a randomized controlled trial evaluating the effectiveness of PFH-2 in targeted and tailored Web-based versus print formats. The overall goal was to determine whether the intervention outcomes in these self-guided scalable formats approximate what was found in a more intensive telephone counseling program.

Methods

This study was a randomized controlled trial with a 15-month follow-up that included 374 smokers who were survivors of childhood or young adult cancers, recruited from five survivorship clinics. Participants were randomly assigned to a Web-based or print format of the PFH intervention; all had access to free pharmacotherapy. The website was designed to provide new content at each log-on, and a peer counselor moderated a forum/chat feature. The primary outcome was smoking status at 15 months post randomization.

Results

In total, 58.3% (77/132) of Web participants logged on at least once (mean visits 3.25). Using multiple imputation methods for missing data, there were similar rates of cessation in the two arms (print: 20/128, 15.6%; Web: 33/201, 6.4%), and no differences in quit attempts or readiness to quit. The quit rates were equivalent to those found in our previous telephone counseling intervention. There were high rates of satisfaction with both of the PFH-2 interventions.

Conclusions

The print and Web formats yielded equivalent levels of success to those found with our telephone-delivered intervention and are comparable to other Internet treatment studies. This study provides important options for survivorship programs that may not have resources for interpersonal forms of cessation counseling. Efforts to increase patient use of the interventions may result in higher cessation rates.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00588107","term_id":"NCT00588107"}}NCT00588107; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00588107","term_id":"NCT00588107"}}NCT00588107 (Archived by WebCite at http://www.webcitation.org/6K1gJtFEC).     

Serodiagnosis of Mycobacterium avium Complex and Mycobacterium abscessus Complex Pulmonary Disease by Use of IgA Antibodies to Glycopeptidolipid Core Antigen

An enzyme immunoassay kit that detects serum IgA antibody reacting to glycopeptidolipid core antigen derived from Mycobacterium avium complex (MAC) was not useful for differentiating MAC pulmonary disease (PD) from Mycobacterium abscessus complex PD (MAB-PD). However, this assay could be useful for differentiating MAC- and MAB-PD from pulmonary tuberculosis. (This study has been registered at ClinicalTrials.gov under registration no. {"type":"clinical-trial","attrs":{"text":"NCT00970801","term_id":"NCT00970801"}}NCT00970801.)     

Urine Galactomannan-to-Creatinine Ratio for Detection of Invasive Aspergillosis in Patients with Hematological Malignancies

Galactomannan (GM) testing of urine specimens may provide important advantages, compared to serum testing, such as easy noninvasive sample collection. We evaluated a total of 632 serial urine samples from 71 patients with underlying hematological malignancies and found that the urine GM/creatinine ratio, i.e., (urine GM level × 100)/urine creatinine level, which takes urine dilution into account, reliably detected invasive aspergillosis and may be a promising diagnostic tool for patients with hematological malignancies. (This study has been registered at ClinicalTrials.gov under registration no. {"type":"clinical-trial","attrs":{"text":"NCT01576653","term_id":"NCT01576653"}}NCT01576653.)