Six-Month Outcomes of a Web-Based Intervention for Users of Amphetamine-Type Stimulants: Randomized Controlled Trial

Background

The use of amphetamine-type stimulants (ATS) places a large burden on health services.

Objective

The aim was to evaluate the effectiveness of a self-guided Web-based intervention (“breakingtheice”) for ATS users over 6 months via a free-to-access site.

Methods

We conducted a randomized trial comparing a waitlist control with a fully automated intervention containing 3 modules derived from cognitive behavioral therapy and motivation enhancement. The main outcome was self-reported ATS use in the past 3 months assessed at 3- and 6-month follow-ups using the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). Secondary outcomes were help-seeking intentions (general help-seeking questionnaire), actual help seeking (actual help-seeking questionnaire), psychological distress (Kessler 10), polydrug use (ASSIST), quality of life (European Health Interview Survey), days out of role, and readiness to change. Follow-up data were evaluated using an intention-to-treat (ITT) analysis with a group by time interaction.

Results

We randomized 160 people (intervention: n=81; control: n=79). At 6 months, 38 of 81 (47%) intervention and 41 of 79 (52%) control participants provided data. ATS scores significantly declined for both groups, but the interaction effect was not significant. There were significant ITT time by group interactions for actual help seeking (rate ratio [RR] 2.16; d=0.45) and help-seeking intentions (RR 1.17; d=0.32), with help seeking increasing for the intervention group and declining for the control group. There were also significant interactions for days completely (RR 0.50) and partially (RR 0.74) out of role favoring the intervention group. However, 37% (30/81) of the intervention group did not complete even 1 module.

Conclusions

This self-guided Web-based intervention encouraged help seeking associated with ATS use and reduced days out of role, but it did not reduce ATS use. Thus, this program provides a means of engaging with some sections of a difficult-to-reach group to encourage treatment, but a substantial minority remained disengaged.

Trial Registration

Australian and New Zealand Clinical Trials Registry: ACTRN12611000947909; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=343307 (Archived by WebCite at http://www.webcitation.org/6Y0PGGp8q).     

Web-Based Nursing Intervention for Self-Management of Pain After Cardiac Surgery: Pilot Randomized Controlled Trial

Background

Most adults undergoing cardiac surgery suffer from moderate to severe pain for up to 6 days after surgery. Individual barriers and attitudes regarding pain and its relief make patients reluctant to report their pain and ask for analgesic medication, which results in inadequate pain management. More innovative educational interventions for postoperative pain relief are needed. We developed a Web-based nursing intervention to influence patient’s involvement in postoperative pain management. The intervention (SOULAGE-TAVIE) includes a preoperative 30-minute Web-based session and 2 brief face-to-face postoperative booster sessions. The Web application generates reflective activities and tailored educational messages according to patients’ beliefs and attitudes. The messages are transmitted through videos of a virtual nurse, animations, stories, and texts.

Objective

The aim of this single-blinded pilot randomized trial was to investigate the preliminary effects of a virtual nursing intervention (SOULAGE-TAVIE) to improve pain relief in patients undergoing cardiac surgery.

Methods

Participants (N = 60) were adults scheduled for their first cardiac surgery. They were randomly assigned to the experimental group using SOULAGE-TAVIE (n = 30) or the control group using usual care, including an educational pamphlet and postoperative follow-up (n = 30). Data were collected through questionnaires at the time of admission and from day 1 to day 7 after surgery with the help of a blinded research assistant. Outcomes were pain intensity, pain interference with daily activities, patients’ pain barriers, tendency to catastrophize in face of pain, and analgesic consumption.

Results

The two groups were comparable at baseline across all demographic measures. Results revealed that patients in the experimental group did not experience less intense pain, but they reported significantly less pain interference when breathing/coughing (P = .04). A severe pain interference with breathing/coughing (pain ranked ≥ 7/10) was reported on day 3 after surgery by 15% of the patients in the experimental group (4/27), as compared to 44% (7/16) in the control group. On day 7 after surgery, participants in the experimental group also exhibited fewer pain-related barriers as measured by the Barriers Questionnaire-II (mean 10.6, SD 8.3) than patients in the control group (mean 15.8, SD 7.3, P = .02). No difference was found for pain catastrophizing. However, in both groups, means revealed a lower tendency to catastrophize pain before surgery as measured by the Pain Catastrophizing Scale (control group mean 1.04, SD 0.74; experimental group mean 1.10, SD 0.95) and after surgery (control group mean score 1.19, SD 0.94; experimental group mean score 1.08, SD 0.99). Finally, the experimental group consumed more opioid medication (mean 31.2 mg, SD 23.2) than the control group (mean 18.8 mg, SD 15.3, P  = .001).

Conclusions

This pilot study provides promising results to support the benefits of this new Web-tailored approach that can increase accessibility to health education and promote pain relief without generating more costs.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01084018","term_id":"NCT01084018"}}NCT01084018; http://www.clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT01084018","term_id":"NCT01084018"}}NCT01084018 (Archived by WebCite® at http://www.webcitation.org/6CoTBkIoT)     

Effectiveness of a Web-Based,Computer-Tailored,Pedometer-Based Physical Activity Intervention for Adults: A Cluster Randomized Controlled Trial

Background

Computer-tailored physical activity (PA) interventions delivered through the Internet represent a promising and appealing method to promote PA at a population level. However, personalized advice is mostly provided based on subjectively measured PA, which is not very accurate and might result in the delivery of advice that is not credible or effective. Therefore, an innovative computer-tailored PA advice was developed, based on objectively pedometer-measured PA.

Objective

The study aim was to evaluate the effectiveness of a computer-tailored, pedometer-based PA intervention in working adults.

Methods

Participants (≥18 years) were recruited between May and December 2012 from eight Flemish workplaces. These workplaces were allocated randomly to an intervention or control group. Intervention group participants (n=137) received (1) a booklet with information on how to increase their steps, (2) a non-blinded pedometer, and (3) an Internet link to request computer-tailored step advice. Control group participants (n=137) did not receive any of the intervention components. Self-reported and pedometer-based PA were assessed at baseline (T0), and 1 month (T1) and 3 months (T2) months post baseline. Repeated measures analyses of covariance were used to examine intervention effects for both the total sample and the at-risk sample (ie, adults not reaching 10,000 steps a day at baseline).

Results

The recruitment process resulted in 274 respondents (response rate of 15.1%) who agreed to participate, of whom 190 (69.3%) belonged to the at-risk sample. Between T0 and T1 (1-month post baseline), significant intervention effects were found for participants’ daily step counts in both the total sample (P=.004) and the at-risk sample (P=.001). In the at-risk sample, the intervention effects showed a daily step count increase of 1056 steps in the intervention group, compared to a decrease of 258 steps in the control group. Comparison of participants’ self-reported PA revealed a significant intervention effect for time spent walking in the at-risk sample (P=.02). Intervention effects were still significant 3 months post baseline for participants’ daily step counts in both the total sample (P=.03) and the at-risk sample (P=.02); however, self-reported PA differences were no longer significant.

Conclusions

A computer-tailored, pedometer-based PA intervention was effective in increasing both pedometer-based and self-reported PA levels, mainly in the at-risk participants. However, more effort should be devoted to recruit and retain participants in order to improve the public health impact of the intervention.

Trial Registration

ClinicalTrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT02080585","term_id":"NCT02080585"}}NCT02080585; https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT02080585","term_id":"NCT02080585"}}NCT02080585 (Archived by WebCite at http://www.webcitation.org/6VvQnRQSy).     

Efficacy of a Web-Based Computer-Tailored Smoking Prevention Intervention for Dutch Adolescents: Randomized Controlled Trial

Background

Preventing smoking initiation among adolescents is crucial to reducing tobacco-caused death and disease. This study focuses on the effectiveness of a Web-based computer-tailored smoking prevention intervention aimed at adolescents.

Objective

The intent of the study was to describe the intervention characteristics and to show the effectiveness and results of a randomized controlled trial. We hypothesized that the intervention would prevent smoking initiation among Dutch secondary school students aged 10-20 years and would have the largest smoking prevention effect among the age cohort of 14-16 years, as smoking uptake in that period is highest.

Methods

The intervention consisted of a questionnaire and fully automated computer-tailored feedback on intention to start smoking and motivational determinants. A total of 89 secondary schools were recruited via postal mail and randomized into either the computer-tailored intervention condition or the control condition. Participants had to complete a Web-based questionnaire at baseline and at 6-month follow-up. Data on smoking initiation were collected from 897 students from these schools. To identify intervention effects, multilevel logistic regression analyses were conducted using multiple imputation.

Results

Smoking initiation among students aged 10-20 years was borderline significantly lower in the experimental condition as compared to the control condition 6 months after baseline (OR 0.25, 95% CI 0.05-1.21, P=.09). Additional analyses of the data for the 14-16 year age group showed a significant effect, with 11.5% (24/209) of the students in the control condition reporting initiation compared to 5.7% (10/176) in the experimental condition (OR 0.22, 95% CI 0.05-1.02, P=.05). No moderation effects were found regarding gender and educational level.

Conclusions

The findings of this study suggest that computer-tailored smoking prevention programs are a promising way of preventing smoking initiation among adolescents for at least 6 months, in particular among the age cohort of 14-16 years. Further research is needed to focus on long-term effects.

Trial Registration

International Standard Randomized Controlled Trial Number (ISRCTN): 77864351; http://www.controlled-trials.com/ISRCTN77864351 (Archived by WebCite at http://www.webcitation.org/6BSLKSTm5).     

Efficacy of Standard Versus Enhanced Features in a Web-Based Commercial Weight-Loss Program for Obese Adults,Part 2: Randomized Controlled Trial

Background

Commercial Web-based weight-loss programs are becoming more popular and increasingly refined through the addition of enhanced features, yet few randomized controlled trials (RCTs) have independently and rigorously evaluated the efficacy of these commercial programs or additional features.

Objective

To determine whether overweight and obese adults randomized to an online weight-loss program with additional support features (enhanced) experienced a greater reduction in body mass index (BMI) and increased usage of program features after 12 and 24 weeks compared to those randomized to a standard online version (basic).

Methods

An assessor-blinded RCT comparing 301 adults (male: n=125, 41.5%; mean age: 41.9 years, SD 10.2; mean BMI: 32.2 kg/m², SD 3.9) who were recruited and enrolled offline, and randomly allocated to basic or enhanced versions of a commercially available Web-based weight-loss program for 24 weeks.

Results

Retention at 24 weeks was greater in the enhanced group versus the basic group (basic 68.5%, enhanced 81.0%; P=.01). In the intention-to-treat analysis of covariance with imputation using last observation carried forward, after 24 weeks both intervention groups had reductions in key outcomes with no difference between groups: BMI (basic mean –1.1 kg/m², SD 1.5; enhanced mean –1.3 kg/m², SD 2.0; P=.29), weight (basic mean –3.3 kg, SD 4.7; enhanced mean –4.0 kg, SD 6.2; P=.27), waist circumference (basic mean –3.1 cm, SD 4.6; enhanced mean –4.0 cm, SD 6.2; P=.15), and waist-to-height ratio (basic mean –0.02, SD 0.03; enhanced mean –0.02, SD 0.04, P=.21). The enhanced group logged in more often at both 12 and 24 weeks, respectively (enhanced 12-week mean 34.1, SD 28.1 and 24-week mean 43.1, SD 34.0 vs basic 12-week mean 24.6, SD 25.5 and 24-week mean 31.8, SD 33.9; P=.002).

Conclusions

The addition of personalized e-feedback in the enhanced program provided limited additional benefits compared to a standard commercial Web-based weight-loss program. However, it does support greater retention in the program and greater usage, which was related to weight loss. Further research is required to develop and examine Web-based features that may enhance engagement and outcomes and identify optimal usage patterns to enhance weight loss using Web-based programs.

Trial Registration

Australian New Zealand Clinical Trials Registry (ANZCTR) trial number: ACTRN12610000197033; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=335159 (Archived by WebCite at http://www.webcitation.org/6HoOMGb8j).     

Changes in Physical Activity Following a Genetic-Based Internet-Delivered Personalized Intervention: Randomized Controlled Trial (Food4Me)

Background

There is evidence that physical activity (PA) can attenuate the influence of the fat mass- and obesity-associated (FTO) genotype on the risk to develop obesity. However, whether providing personalized information on FTO genotype leads to changes in PA is unknown.

Objective

The purpose of this study was to determine if disclosing FTO risk had an impact on change in PA following a 6-month intervention.

Methods

The single nucleotide polymorphism (SNP) rs9939609 in the FTO gene was genotyped in 1279 participants of the Food4Me study, a four-arm, Web-based randomized controlled trial (RCT) in 7 European countries on the effects of personalized advice on nutrition and PA. PA was measured objectively using a TracmorD accelerometer and was self-reported using the Baecke questionnaire at baseline and 6 months. Differences in baseline PA variables between risk (AA and AT genotypes) and nonrisk (TT genotype) carriers were tested using multiple linear regression. Impact of FTO risk disclosure on PA change at 6 months was assessed among participants with inadequate PA, by including an interaction term in the model: disclosure (yes/no) × FTO risk (yes/no).

Results

At baseline, data on PA were available for 874 and 405 participants with the risk and nonrisk FTO genotypes, respectively. There were no significant differences in objectively measured or self-reported baseline PA between risk and nonrisk carriers. A total of 807 (72.05%) of the participants out of 1120 in the personalized groups were encouraged to increase PA at baseline. Knowledge of FTO risk had no impact on PA in either risk or nonrisk carriers after the 6-month intervention. Attrition was higher in nonrisk participants for whom genotype was disclosed (P=.01) compared with their at-risk counterparts.

Conclusions

No association between baseline PA and FTO risk genotype was observed. There was no added benefit of disclosing FTO risk on changes in PA in this personalized intervention. Further RCT studies are warranted to confirm whether disclosure of nonrisk genetic test results has adverse effects on engagement in behavior change.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01530139","term_id":"NCT01530139"}}NCT01530139; http://clinicaltrials.gov/show/{"type":"clinical-trial","attrs":{"text":"NCT01530139","term_id":"NCT01530139"}}NCT01530139 (Archived by WebCite at: http://www.webcitation.org/6XII1QwHz)     

Effectiveness of a Blended Web-Based Intervention on Return to Work for Sick-Listed Employees With Common Mental Disorders: Results of a Cluster Randomized Controlled Trial

Background

Common mental disorders are strongly associated with long-term sickness absence, which has negative consequences for the individual employee’s quality of life and leads to substantial costs for society. It is important to focus on return to work (RTW) during treatment of sick-listed employees with common mental disorders. Factors such as self-efficacy and the intention to resume work despite having symptoms are important in the RTW process. We developed “E-health module embedded in Collaborative Occupational health care” (ECO) as a blended Web-based intervention with 2 parts: an eHealth module (Return@Work) for the employee aimed at changing cognitions of the employee regarding RTW and a decision aid via email supporting the occupational physician with advice regarding treatment and referral options based on monitoring the employee’s progress during treatment.

Objective

This study evaluated the effect of a blended eHealth intervention (ECO) versus care as usual on time to RTW of sick-listed employees with common mental disorders.

Methods

The study was a 2-armed cluster randomized controlled trial. Employees sick-listed between 4 and 26 weeks with common mental disorder symptoms were recruited by their occupational health service or employer. The employees were followed up to 12 months. The primary outcome measures were time to first RTW (partial or full) and time to full RTW. Secondary outcomes were response and remission of the common mental disorder symptoms (self-assessed).

Results

A total of 220 employees were included: 131 participants were randomized to the ECO intervention and 89 to care as usual (CAU). The duration until first RTW differed significantly between the groups. The median duration was 77.0 (IQR 29.0-152.3) days in the CAU group and 50.0 (IQR 20.8-99.0) days in the ECO group (hazard ratio [HR] 1.390, 95% CI 1.034-1.870, P=.03). No significant difference was found for duration until full RTW. Treatment response of common mental disorder symptoms did not differ significantly between the groups, but at 9 months after baseline significantly more participants in the ECO group achieved remission than in the CAU group (OR 2.228, 95% CI 1.115-4.453, P=.02).

Conclusions

The results of this study showed that in a group of sick-listed employees with common mental disorders, applying the blended eHealth ECO intervention led to faster first RTW and more remission of common mental disorder symptoms than CAU.

Trial Registration

Netherlands Trial Register NTR2108; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2108. (Archived by WebCite at http://www.webcitation.org/6YBSnNx3P).     

Development of Alive! (A Lifestyle Intervention Via Email), and Its Effect on Health-related Quality of Life,Presenteeism, and Other Behavioral Outcomes: Randomized Controlled Trial

Background

Cost-effective interventions to improve diet and physical activity are a public health priority. Alive! is an email-based intervention to increase physical activity, reduce saturated and trans fats and added sugars, and increase fruit and vegetable consumption. It was shown to improve these behaviors in a large randomized controlled trial.

Objective

(1) To describe the components and behavioral principles underlying Alive!, and (2) to report effects of the intervention on the secondary outcomes: health-related quality of life, presenteeism, self-efficacy, and stage of change.

Methods

The Alive! behavior change model is designed to elicit healthy behaviors and promote their maintenance. Behavioral strategies include assessments followed by individualized feedback, weekly goal-setting, individually tailored goals and tips, reminders, and promotion of social support. Alive! was tested among non-medical employees of Kaiser Permanente of Northern California, who were randomized to either the intervention group or the wait-list control group. After randomization, intervention group participants chose one topic to undertake for the intervention period: increasing physical activity, increasing fruits and vegetables, or decreasing saturated and trans fats and added sugars. Pre-post questionnaires assessed changes in SF-8 health-related quality of life, presenteeism, self-efficacy, and stage of change. Mixed effects multiple linear regression and ordinal logistic regression models were used, with department as a random effect factor. Analyses were by intention to treat: the 30% (238/787) who did not respond to the follow-up questionnaires were assigned change scores of zero.

Results

Participants were 19 to 65 years (mean 44.0 +/- 10.6), and 74.3% (585/787) were female. Mean SF-8 Physical quality of life score increased significantly more in the intervention group than in the control group, 1.84 (95% CI 0.96-2.72) vs 0.72 (95% CI -0.15-1.58) respectively, P = .02. SF8 Mental score also improved significantly more in the intervention group than in the control group (P = .02). The odds ratio for improvement in self-assessed health status was 1.57 (95% CI 1.21-2.04, P < .001) for the intervention group compared to the control group. The odds ratio for having a reduction in difficulty accomplishing work tasks because of physical or emotional problems, a measure of presenteeism, was 1.47 (95% CI 1.05-2.05, P = .02) for the intervention group compared to the control group. The odds of having an improvement in self-efficacy for changing diet was 2.05 (95% CI 1.44-2.93) for the intervention vs the control group (P < .001). Greater improvement in stage of change for physical activity (P = .05), fats (P = .06), and fruits/vegetables (P = .006) was seen in the intervention group compared to the control group. Significant effects on diet and physical activity behavior change are reported elsewhere.

Conclusions

Cost-effective methods that can reach large populations with science-based interventions are urgently needed. Alive! is a fully automated low-cost intervention shown to effect significant improvements in important health parameters.

Trial Registration

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00607009","term_id":"NCT00607009"}}NCT00607009; http://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00607009","term_id":"NCT00607009"}}NCT00607009 (Archived by WebCite at http://www.webcitation.org/5cLpCWcT6)     

Monotherapy with Lopinavir/Ritonavir as Maintenance After HIV-1 Viral Suppression: Results of a 96-Week Randomized,Controlled, Open-Label,Pilot Trial (KalMo Study)

Abstract

Background: Long-term adverse events and expenses associated with HAART have led to an interest in simplified therapy. Lopinavir/ritonavir monotherapy is attractive due to its potency and high genetic barrier. Methods: This is a 96-week, open-label, randomized study to assess the feasibility of using LPV/r monotherapy in patients with undetectable viral load after being on successful HAART for at least 6 months. Subjects were randomized (1:1) to either switch from HAART to LPV/r monotherapy or to maintain their previous regimen. Results: 60 patients were enrolled. Baseline characteristics were similar in both groups. At Week 96, by intention-to-treat analysis, 24/30 (80.0%) subjects in monotherapy group and 26/30(86.6%) in the control group had a plasma viral load of <80 copies/mL. There was one virologic failure (defined as VL > 500 copies/mL) in each arm. Genotyping testing identified no resistance-associated mutations. The patient on the monotherapy arm was successfully resuppressed to <80 copies/mL after intensification with tenofovir and lamivudine. No statistically significant differences were found with regard to changes in CD4 counts. One subject in the monotherapy group discontinued due to diarrhea. Five subjects in the control group underwent regimen changes due to drug-related toxicities. Viral load from semen samples collected at the end of follow-up was undetectable on 14/15 patients randomized to monotherapy. Conclusions: Switching from various HAART regimens to LPV/r monotherapy in patients who were virologically suppressed and without a history of previous virologic failure was effective, safe, and well tolerated through 96 weeks.