Targeted Melanoma Prevention Intervention: A Cluster Randomized Controlled Trial

PURPOSE

Targeted interventions to reduce the risk and increase the early detection of melanoma have the potential to save lives. We aimed to assess the effect of such an intervention on patient prevention behavior.

METHODS

We conducted a pilot clustered randomized controlled trial, comparing a targeted screening and education intervention with a conventional information-based campaign in 20 private surgeries in western France. In the intervention group, 10 general practitioners identified patients at elevated risk for melanoma with a validated assessment tool, the Self-Assessment Melanoma Risk Score (SAMScore), examined their skin, and counseled them using information leaflets. In the control group, 10 general practitioners displayed a poster and the leaflets in their waiting room and examined patients’ skin at their own discretion. The main outcome measures were sunbathing and skin self-examinations among patients at elevated risk, assessed 5 months later with a questionnaire.

RESULTS

Analyses were based on 173 patients. Compared with control patients, intervention patients were more likely to remember the campaign (81.4% vs 50.0%, P = .0001) and to correctly identify their elevated risk of melanoma (71.1% vs 42.1%, P = .001). Furthermore, intervention patients had higher levels of prevention behaviors: they were less likely to sunbathe in the summer (24.7% vs 40.8%, P = .048) and more likely to have performed skin self-examinations in the past year (52.6% vs 36.8%, P = .029). The intervention was not associated with any clear adverse effects, although there were trends whereby intervention patients were more likely to worry about melanoma and to consult their general practitioner again about the disease.

CONCLUSIONS

The combination of use of the SAMScore and general practitioner examination and counseling during consultations is an efficient way to promote patient behaviors that may reduce melanoma risk. Extending the duration of follow-up and demonstrating an impact on morbidity and mortality remain major issues for further research.     

Seven-Valent Pneumococcal Conjugate Vaccine and Nasopharyngeal Microbiota in Healthy Children

Seven-valent pneumococcal conjugate vaccine (PCV-7) is effective against vaccine serotype disease and carriage. Nevertheless, shifts in colonization and disease toward nonvaccine serotypes and other potential pathogens have been described. To understand the extent of these shifts, we analyzed nasopharyngeal microbial profiles of 97 PCV-7–vaccinated infants and 103 control infants participating in a randomized controlled trial in the Netherlands. PCV-7 immunization resulted in a temporary shift in microbial community composition and increased bacterial diversity. Immunization also resulted in decreased presence of the pneumococcal vaccine serotype and an increase in the relative abundance and presence of nonpneumococcal streptococci and anaerobic bacteria. Furthermore, the abundance of Haemophilus and Staphylococcus bacteria in vaccinees was increased over that in controls. This study illustrates the much broader effect of vaccination with PCV-7 on the microbial community than currently assumed, and highlights the need for careful monitoring when implementing vaccines directed against common colonizers.     

A Theoretically Based Behavioral Nutrition Intervention for Community Elders at High Risk: The B-NICE Randomized Controlled Clinical Trial

We conducted a study designed to evaluate the efficacy and feasibility of a multilevel self-management intervention to improve nutritional intake in a group of older adults receiving Medicare home health services who were at especially high risk for experiencing undernutrition. The Behavioral Nutrition Intervention for Community Elders (B-NICE) trial used a prospective randomized controlled design to determine whether individually tailored counseling focused on social and behavioral aspects of eating resulted in increased caloric intake and improved nutrition-related health outcomes in a high-risk population of older adults. The study was guided by the theoretical approaches of the Ecological Model and Social Cognitive Theory. The development and implementation of the B-NICE protocol, including the theoretical framework, methodology, specific elements of the behavioral intervention, and assurances of the treatment fidelity, as well as the health policy implications of the trial results, are presented in this article.     

Feasibility and Acceptability of a Healthy Nordic Diet Intervention for the Treatment of Depression: A Randomized Controlled Pilot Trial

Healthy diet interventions have been shown to improve depressive symptoms, but there is a need for randomized controlled trials (RCTs) that are double blind and investigate biological mechanisms. The primary objectives of this randomized controlled pilot trial were to test the palatability of the meals and the acceptability of the intervention in preparation for an 8-week RCT in the future, which will investigate whether a healthy Nordic diet improves depressive symptoms in individuals with major depressive disorder, and associated biological mechanisms. Depressed (n = 10) and non-depressed (n = 6) women and men were randomized to receive either a healthy Nordic diet (ND) or a control diet (CD) for 8 days. Participants were blinded to their diet allocation and the study hypotheses. Health questionnaires were completed before and after the intervention and, throughout the study, questionnaires assessed participants’ liking for the meals, their sensory properties, adherence, and open-ended feedback. In the ND group, 75% of participants consumed only the provided foods, as instructed, compared to 50% of CD participants. The meals of both diets, on average, received good ratings for liking and sensory properties, though the ND ratings were somewhat higher. Overall, results were positive and informative, indicating that the planned RCT will be feasible and well-accepted, with some proposed modifications.     

Effect of Flaxseed Intervention on Inflammatory Marker C-Reactive Protein: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Functional food-flaxseed and its derivatives (flaxseed oil or lignans) are beneficial for human health, possibly because of their anti-inflammatory effects. C-reactive protein (CRP), a sensitive marker of inflammation was chosen to evaluate the anti-inflammatory effects of flaxseed. We searched randomized controlled trials from PubMed and the Cochrane Library in October 2015 and conducted a meta-analysis to evaluate the effectiveness of flaxseed and its derivatives on CRP. The mean differences (net change) in CRP (mg/L) concentrations were pooled with a random- or a fixed-effects model depending on the results of heterogeneity tests. Overall, flaxseed interventions had no effects on reduction of CRP (p = 0.428). The null effects were consistent in the subgroup analysis with multiple studies and population characteristics. Significant heterogeneity was observed in most of the analyses. Meta-regression identified baseline body mass index (BMI) as a significant source of heterogeneity (P-interaction = 0.032), with a significant reduction in CRP of 0.83 mg/L (95% confidence interval −1.34 to −0.31; p = 0.002) among subjects with a BMI of ≥30 kg/m². In conclusion, our meta-analysis did not find sufficient evidence that flaxseed and its derivatives have a beneficial effect on reducing circulating CRP. However, they may significantly reduce CRP in obese populations.     

Sociopsychological Tailoring to Address Colorectal Cancer Screening Disparities: A Randomized Controlled Trial

PURPOSE

Interventions tailored to sociopsychological factors associated with health behaviors have promise for reducing colorectal cancer screening disparities, but limited research has assessed their impact in multiethnic populations. We examined whether an interactive multimedia computer program (IMCP) tailored to expanded health belief model sociopsychological factors could promote colorectal cancer screening in a multiethnic sample.

METHODS

We undertook a randomized controlled trial, comparing an IMCP tailored to colorectal cancer screening self-efficacy, knowledge, barriers, readiness, test preference, and experiences with a nontailored informational program, both delivered before office visits. The primary outcome was record-documented colorectal cancer screening during a 12-month follow-up period. Secondary outcomes included postvisit sociopsychological factor status and discussion, as well as clinician recommendation of screening during office visits. We enrolled 1,164 patients stratified by ethnicity and language (49.3% non-Hispanic, 27.2% Hispanic/English, 23.4% Hispanic/Spanish) from 26 offices around 5 centers (Sacramento, California; Rochester and the Bronx, New York; Denver, Colorado; and San Antonio, Texas).

RESULTS

Adjusting for ethnicity/language, study center, and the previsit value of the dependent variable, compared with control patients, the IMCP led to significantly greater colorectal cancer screening knowledge, self-efficacy, readiness, test preference specificity, discussion, and recommendation. During the followup period, 132 (23%) IMCP and 123 (22%) control patients received screening (adjusted difference = 0.5 percentage points, 95% CI −4.3 to 5.3). IMCP effects did not differ significantly by ethnicity/language.

CONCLUSIONS

Sociopsychological factor tailoring was no more effective than nontailored information in encouraging colorectal cancer screening in a multiethnic sample, despite enhancing sociopsychological factors and visit behaviors associated with screening. The utility of sociopsychological tailoring in addressing screening disparities remains uncertain.     

Annals Journal Club: Physician Satisfaction with Chronic Care Processes: A Cluster-Randomized Trial of Guided Care

PURPOSE Chronically ill older patients with multiple conditions are challenging to care for, and new models of care for this population are needed. This study evaluates the effect of the Guided Care model on primary care physicians’ impressions of processes of care for chronically ill older patients.METHODS In Guided Care a specially educated registered nurse works at the practice with 2 to 5 primary care physicians, performing 8 clinical activities for 50 to 60 chronically ill older patients. The care model was tested in a cluster-randomized controlled trial between 2006 and 2009. All eligible primary care physicians in 14 pods (teams of physicians and their chronically ill older patients) agreed to participate (n = 49). Pods were randomly assigned to provide either Guided Care or usual care. Physicians were surveyed at baseline and 1 year later. We assessed the effects of Guided Care using responses from 38 physicians who completed both survey questionnaires. We measured physicians’ satisfaction with chronic care processes, time spent on chronic care, knowledge of their chronically ill older patients, and care coordination provided by physicians and office staff.RESULTS Compared with the physicians in the control group, those in the Guided Care group rated their satisfaction with patient/family communication and their knowledge of the clinical characteristics of their chronically ill older patients significantly higher (ρ<0.05 in linear regression models). Other differences did not reach statistical significance.CONCLUSIONS Based on physician report, Guided Care provides important benefits to physicians by improving communication with chronically ill older patients and their families and in physicians’ knowledge of their patients’ clinical conditions.     

Pneumococcal Vaccination: Perceptions of Primary Care Physicians

Background.Little is known about barriers to pneumococcal vaccination in the primary care setting.Methods.Mail survey to 405 randomly selected Massachusetts primary care physicians (response rate 68%).Results.Seventy-nine percent considered themselves knowledgeable about current vaccination guidelines, and 75% said vaccination is an important clinical priority. Respondents answered a mean of five of six knowledge questions about vaccination “correctly,” that is, consistent with current scientific evidence or expert opinion. Physicians reported high immunization rates: 51% thought over half their eligible patients were vaccinated; however, only 27% thought their colleagues immunized a similar number of patients. Physician attitude was the strongest independent predictor of high reported immunization rates (odds ratio of 4.7,P= 0.0001). Twenty-four percent of respondents thought physician oversight due to the need to attend to other active medical problems greatly reduces the number of patients they immunize. None of eight other financial, administrative, and clinical barriers were felt to be important by more than 7% of physicians. Sixty-six percent of physicians favored a standing order policy to immunize their eligible patients.Conclusions.Oversight and overestimation of immunization rates appear to be important barriers to pneumococcal vaccination. The literature suggests that reminder and performance feedback systems directed toward eliminating these barriers have had some success; interventions such as standing order policies may yield further improvements and appear to be acceptable to most physicians.     

Cluster randomized controlled trials in primary care: An introduction

Background: Cluster randomized trials occur when groups or clusters of individuals, rather than the individuals themselves, are randomized to intervention and control groups and outcomes are measured on individuals within those clusters. Within primary care, between 1997 and 2000, there has been a virtual doubling in the number of published cluster randomized trials. A recent systematic review, specifically within primary care, found study quality to be both generally lower than that reported elsewhere and not to have shown any recent quality improvement. Objective: To discuss the design, conduct and analysis of cluster randomized trials within primary care in terms of the appropriate expertise required, potential bias, ethical considerations and expense. Discussion: Compared with trials that involve the randomization of individual participants, cluster randomized trials are more complex to design and analyse and, for a given sample size, have decreased power and a broadening of confidence intervals. Cluster randomized trials are specifically prone to potential bias at two levels—the cluster and individual. Regarding the former, it is recommended that cluster allocation be undertaken by a party independent to the research team and careful consideration be given to ensure minimal cluster attrition. Bias at the individual level can be overcome by identifying trial participants before randomization and at this time obtaining consent for intervention, data collection or both. A unique ethical aspect to cluster randomized trials is that cluster leaders may consent to the trial on behalf of potential cluster members. Additional costs of cluster randomized trials include the increased number of patients required, the complexity in their design and conduct and, usually, the need to recruit clusters de novo.

Conclusion: Cluster randomized trials are a powerful and increasingly popular research tool. They are uniquely placed for the conduct of research within primary-care clusters where intracluster contamination can occur. Associated methodological issues are straightforward and surmountable and just need careful consideration and management.     

Randomized Trial of a Program to Increase Staff Influenza Vaccination in Primary Care Clinics

PURPOSE Although vaccination of health care workers against influenza is widely recommended, vaccination uptake is low. Data on interventions to increase staff immunization in primary care are lacking. We examine the effect of a promotional and educational intervention program, not addressing vaccine availability, to raise the influenza vaccination rate among staff in primary care clinics.METHODS The study included all 344 staff members with direct patient contact (physicians, nurses, pharmacists, and administrative and ancillary staff) in 27 primary care community clinics in the Jerusalem area during the 2007–2008 influenza season. Thirteen clinics were randomly selected for an intervention that consisted of a lecture session given by a family physician, e-mail-distributed literature and reminders, and a key figure from the local staff who personally approached each staff member.RESULTS Influenza immunization rate was 52.8% (86 of 163) in the intervention group compared with 26.5% (48 of 181) in the control group (P<.001). When compared with the rate of immunization for the previous season, the absolute increase in immunization rate was 25.8% in the intervention clinics and 6.6% in the control clinics. Multivariate analysis showed a highly significant (P<.001) independent association between intervention and immunization, with an odds ratio of 3.51 (95% confidence interval, 2.03–6.09).CONCLUSION We have developed an effective intervention program to increase previously low vaccination rates among primary health care workers. This simple intervention could be reproduced easily in other clinics and organizations with an expected substantial increase in influenza immunization rates.     

Effects of Individual Dietary Intervention on Nutrient Intake in Postpartum Japanese Women: A Randomized Controlled Trial

No dietary intervention that focuses on the diet quality of postpartum women has been developed in Japan, although most postpartum women experience an insufficient intake of vitamins and minerals. We aimed to examine whether dietary intervention, based on the health belief model, at both 1 and 3 months postpartum affects nutrient intake and food group consumption at 6 months postpartum. A randomized controlled trial was conducted at a university hospital in Tokyo between 2015 and 2016. Healthy women at 1 month postpartum were randomly allocated to either an intervention group (n = 100) or a control group (n = 94). Dietary intervention included dietary assessment, individual feedback, and dietary guidance. The dietary intakes between the two groups were compared using the Mann-Whitney U test. At 6 months postpartum, the energy-adjusted intakes of protein, total dietary fiber, potassium, magnesium, phosphorus, zinc, vitamin B₆, and β-carotene were significantly higher in the intervention group than in the control group. The changes in energy-adjusted intakes of total dietary fiber and iron from 1 month postpartum to 6 months postpartum were significantly different between the two groups. Dietary intervention based on the health belief model improved nutrition at 6 months postpartum, although the impact was limited.     

应用扩展版CONSORT声明提高非药物治疗随机对照研究的质量

介绍针对非药物治疗随机研究（NPT）的扩展版CONSORT声明，分析其与标准CONSORT的区别，为提高NPT的报告质量提供帮助。     

Changes in Dietary Patterns through a Nutritional Intervention with a Traditional Atlantic Diet: The Galiat Randomized Controlled Trial

Unhealthy dietary patterns (DPs) can lead to cardiovascular and other chronic diseases. We assessed the effects of a community-focused intervention with a traditional Atlantic diet on changes in DPs in families and the associations of these changes with weight loss. The Galiat study is a randomized, controlled trial conducted in 250 families (720 adults and children) and performed at a primary care setting with the cooperation of multiple society sectors. Over 6 months, families randomized to the intervention group received educational sessions, cooking classes, written supporting material, and foods that form part of the Atlantic diet, whereas those randomized to the control group followed their habitual lifestyle. At baseline, five DPs that explained 30.1% of variance were identified: “Caloric”, “Frieds”, “Fruits, vegetables, and dairy products”, “Alcohol”, and “Fish and boiled meals.” Compared to the controls, the intervention group showed significant improvements in “Fruits, vegetables, and dairy products” and “Fish and boiled meals” and reductions in the “Caloric” and “Frieds”. Changes in bodyweight per unit increment of “Frieds” and “Fruits, vegetables, and dairy products” scores were 0.240 kg (95% CI, 0.050–0.429) and −0.184 kg (95% CI, −0.379–0.012), respectively. We found that a culturally appropriate diet improved DPs associated with weight loss.     

Healthcare Costs for Pneumococcal Disease in the Era of Infant Immunization With 13-Valent Pneumococcal Conjugate Vaccine: A Population-Based Study

ObjectivesInvasive pneumococcal disease (IPD) and a variety of clinical syndromes caused by pneumococci, such as acute otitis media (AOM), acute sinusitis (AS), and community-acquired pneumonia (CAP), cause a substantial burden on healthcare systems. Few studies have explored the short-term financial burden of pneumococcal disease after the 13-valent pneumococcal conjugate vaccine (PCV13) introduction in the infant immunization programs. This population-based study evaluated changes in costs associated with healthcare utilization for pneumococcal disease after the PCV13 introduction in the infant immunization program in British Columbia, Canada.MethodsIndividuals with pneumococcal disease were identified using provincial administrative data for the 2000 to 2018 period. Total direct healthcare costs were determined using case-mix methodology for hospitalization and fee-for-service codes for outpatient visits and medications dispensed. Costs were adjusted to 2018 Canadian dollars. Changes in the annual healthcare costs were evaluated across vaccine eras (pre-PCV13, 2000-2010; PCV13, 2011-2018) using generalized linear models, adjusting for the 7-valent pneumococcal conjugate vaccine program (2004-2010).ResultsDuring the 19-year study period, pneumococcal disease resulted in 6.3 million cases among 85 million total patient-years, resulting in total healthcare costs of $7.9 billion. More than 6.2 million cases were treated in outpatient setting, costing $0.65 billion (8% of total costs associated with pneumococcal disease treatment), whereas 370 000 hospitalized cases were 3% of all cases, which accrued $7.25 billion (92% of total costs) in costs. Healthcare costs for all studied infections nearly doubled over the study period from $248 million in 2000 to $476 million in 2018 (P = .003). In contrast, there were large declines in total annual costs in the PCV13 era for IPD (adjusted relative rate (aRR) 0.73; 95% confidence interval [CI] 0.56-0.95; P = .032), AOM (aRR 0.70; 95% CI 0.59-0.83; P = .001), and AS (aRR 0.68; 95% CI 0.54-0.85; P = .004) compared with the pre-PCV13 era. Total costs increased marginally in the PCV13 era for all-cause CAP (aRR 1.04; 95% CI 0.94-1.15; P = .484).ConclusionsThis study confirms a temporal association in declining economic burden for IPD, AOM, and AS after the PCV13 introduction. Nevertheless, the total economic burden continues to be high in the PCV13 era, mainly driven by increasing CAP costs.     

Differences in Patient-Reported Outcomes That Are Most Frequently Detected in Randomized Controlled Trials in Patients With Solid Tumors: A Pooled Analysis of 229 Trials

ObjectivesPatient-reported outcome (PRO) measurements used in cancer research can assess a number of health domains. Our primary objective was to investigate which broad types of PRO domains (namely, functional health, symptoms, and global quality of life [QoL]) most frequently yielded significant differences between treatments in randomized controlled trials (RCTs).MethodsA total of 229 RCTs published between January 2004 and February 2019, conducted on patients diagnosed with the most common solid malignancies and assessed using the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, were considered. Studies were identified systematically using literature searches in key electronic databases. Unlike other PRO measurements typically used in RCTs, the scoring algorithm of the multidimensional EORTC QLQ-C30 allowed us to clearly distinguish the 3 broad types of PRO domains.ResultsIn total, 134 RCTs (58.5%) reported statistically significant differences between treatment arms for at least 1 of the QLQ-C30 domains. Most frequently, differences were reported for 2 or all 3 broad types of PRO domains (78 of 134 trials; 58.2%). In particular, 35 trials (26.1%) found significant differences for symptoms, functional health, and global QoL, 24 trials (17.9%) for symptoms and functional health, 11 trials (8.2%) for functional health and global QoL, and 8 trials (6.0%) for symptoms and global QoL. The likelihood of finding a statistically significant difference between treatment arms was not associated with key study characteristics, such as study design (ie, open-label vs blinded trials) and industry support.ConclusionsOur findings emphasize the importance of a multidimensional PRO assessment to most comprehensively capture the overall burden of therapy from the patients’ standpoint.     

Effects of a Multicomponent Frailty Prevention Program in Prefrail Community-Dwelling Older Persons: A Randomized Controlled Trial

ObjectiveTo examine the effects of a multicomponent frailty prevention program in community-dwelling older persons with prefrailty.DesignA randomized controlled trial.SettingA community elderly center in Hong Kong.ParticipantsPersons aged ≥50 years who scored 1-2 on a simple frailty questionnaire (FRAIL)MethodsParticipants (n = 127) were randomly assigned to a 12-week multicomponent frailty prevention program (exercise, cognitive training, board game activities) or to a wait-list control group. The primary outcomes were FRAIL scores, frailty status, and a combined frailty measure including subjective (FRAIL total score) and objective (grip strength, muscle endurance, balance, gait speed) measures. The secondary outcomes were verbal fluency assessed by dual-task gait speed, attention and memory assessed by digit span task, executive function assessed by the Frontal Assessment Battery, self-rated health, and life satisfaction. Assessments were conducted at baseline and at week 12.ResultsThe mean age of the participants was 62.2 years, and 88.2% were women. At week 12, the FRAIL score had decreased in the intervention group (−1.3, P < .001) but had increased in the control group (0.3, P < .01) (between-group differences P < .001). In addition, 83.3% and 1.6% of the intervention and control groups, respectively, had reversed from prefrailty to robust phenotype (between-group differences P < .001). Participants in the intervention group also had a greater reduction in the combined frailty score and greater improvements in muscle endurance, balance, verbal fluency, attention and memory, executive function, and self-rated health than those in the control group (all P < .05). There were no significant differences between the groups with respect to grip strength, gait speed, and life satisfaction.Conclusions and implicationsThe multicomponent frailty prevention program reduced frailty and improved physical and cognitive functions, and self-rated health in community-dwelling older persons with prefrailty. Findings can provide insights into the consideration of incorporating frailty prevention programs into the routine practice of community elderly services.     

Non-pharmacological Interventions in Hypertension: A Community-based Cross-over Randomized Controlled Trial

Background:

Hypertension is the most prevalent non-communicable disease causing significant morbidity/mortality through cardiovascular, cerebrovascular, and renal complications.

Objectives:

This community-based study tested the efficacy of non-pharmacological interventions in preventing/controlling hypertension.

Materials and Methods:

This is a cross-over randomized controlled trial (RCT) of the earlier RCT (2007) of non-pharmacological interventions in hypertension, conducted in the urban service area of our Institute. The subjects, prehypertensive and hypertensive young adults (98 subjects: 25, 23, 25, 25 in four groups) were randomly allotted into a group that he/she had not belonged to in the earlier RCT: Control (New Group I), Physical Exercise (NG II)-brisk walking for 50 to 60 minutes, three to four days/week, Salt Intake Reduction (NG III) to at least half of their previous intake, Yoga (NG IV) for 30 to 45 minutes/day, five days/week. Blood pressure was measured before and after eight weeks of intervention. Analysis was by ANOVA with a Games-Howell post hoc test.

Results:

Ninety-four participants (25, 23, 21, 25) completed the study. All three intervention groups showed significant reduction in BP (SBP/DBP mmHg: 5.3/6.0 in NG II, 2.5/2.0 in NG III, and 2.3/2.4 in NG IV, respectively), while the Control Group showed no significant difference. Persistence of significant reduction in BP in the three intervention groups after cross-over confirmed the biological plausibility of these non-pharmacological interventions. This study reconfirmed that physical exercise was more effective than Salt Reduction or Yoga. Salt Reduction, and Yoga were equally effective.

Conclusion:

Physical exercise, salt intake reduction, and yoga are effective non-pharmacological methods for reducing blood pressure in young pre-hypertensive and hypertensive adults.     

The Efficacy of a Brief,Altruism-Eliciting Video Intervention in Enhancing COVID-19 Vaccination Intentions Among a Population-Based Sample of Younger Adults: Randomized Controlled Trial

BackgroundHigh COVID-19 vaccine uptake is crucial to containing the pandemic and reducing hospitalizations and deaths. Younger adults (aged 20-39 years) have demonstrated lower levels of vaccine uptake compared to older adults, while being more likely to transmit the virus due to a higher number of social contacts. Consequently, this age group has been identified by public health authorities as a key target for vaccine uptake. Previous research has demonstrated that altruistic messaging and motivation is associated with vaccine acceptance.ObjectiveThis study had 2 objectives: (1) to evaluate the within-group efficacy of an altruism-eliciting short, animated video intervention in increasing COVID-19 vaccination intentions amongst unvaccinated Canadian younger adults and (2) to examine the video’s efficacy compared to a text-based intervention focused exclusively on non-vaccine-related COVID-19 preventive health measures.MethodsUsing a web-based survey in a pre-post randomized control trial (RCT) design, we recruited Canadians aged 20-39 years who were not yet vaccinated against COVID-19 and randomized them in a 1:1 ratio to receive either the video intervention or an active text control. The video intervention was developed by our team in collaboration with a digital media company. The measurement of COVID-19 vaccination intentions before and after completing their assigned intervention was informed by the multistage Precaution Adoption Process Model (PAPM). The McNemar chi-square test was performed to evaluate within-group changes of vaccine intentions. Exact tests of symmetry using pairwise McNemar tests were applied to evaluate changes in multistaged intentions. Between-group vaccine intentions were assessed using the Pearson chi-square test postintervention.ResultsAnalyses were performed on 1373 participants (n=686, 50%, in the video arm, n=687, 50%, in the text arm). Within-group results for the video intervention arm showed that there was a significant change in the intention to receive the vaccine (χ²₁=20.55, P<.001). The between-group difference in postintervention intentions (χ²₃=1.70, P=.64) was not significant. When administered the video intervention, we found that participants who had not thought about or were undecided about receiving a COVID-19 vaccine were more amenable to change than participants who had already decided not to vaccinate.ConclusionsAlthough the video intervention was limited in its effect on those who had firmly decided not to vaccinate, our study demonstrates that prosocial and altruistic messages could increase COVID-19 vaccine uptake, especially when targeted to younger adults who are undecided or unengaged regarding vaccination. This might indicate that altruistic messaging provides a “push” for those who are tentative toward, or removed from, the decision to receive the vaccine. The results of our study could also be applied to more current COVID-19 vaccination recommendations (eg, booster shots) and for other vaccine-preventable diseases.Trial RegistrationClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT04960228","term_id":"NCT04960228"}}NCT04960228; https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT04960228","term_id":"NCT04960228"}}NCT04960228     

Home-Based,Peer-Led Chronic Illness Self-Management Training: Findings From a 1-Year Randomized Controlled Trial

PURPOSE Studies suggest peer-led self-management training improves chronic illness outcomes by enhancing illness management self-efficacy. Limitations of most studies, however, include use of multiple outcome measures without predesignated primary outcomes and lack of randomized follow-up beyond 6 months. We conducted a 1-year randomized controlled trial of Homing in on Health (HIOH), a Chronic Disease Self-Management Program variant, addressing these limitations.METHODS We randomized outpatients (N = 415) aged 40 years and older and who had 1 or more of 6 common chronic illnesses, plus functional impairment, to HIOH delivered in homes or by telephone for 6 weeks or to usual care. Primary outcomes were the Medical Outcomes Study 36-ltem short-form health survey‘s physical component (PCS-36) and mental component (MCS-36) summary scores. Secondary outcomes included the EuroQol EQ-5D and visual analog scale (EQ VAS), hospitalizations, and health care expenditures.RESULTS Compared with usual care, HIOH delivered in the home led to significantly higher illness management self-efficacy at 6 weeks (effect size = 0.27; 95% CI, 0.10–0.43) and at 6 months (0.17; 95% CI, 0.01–0.33), but not at 1 year. In-home HIOH had no significant effects on PCS-36 or MCS-36 scores and led to improvement in only 1 secondary outcome, the EQ VAS (1-year effect size = 0.40; CI, 0.14–0.66). HIOH delivered by telephone had no significant effects on any outcomes.CONCLUSIONS Despite leading to improvements in self-efficacy comparable to those in other CDSMP studies, in-home HIOH had a limited sustained effect on only 1 secondary health status measure and no effect on utilization. These findings question the cost-effectiveness of peer-led illness self-management training from the health system perspective.