Impacts of A Web-Based Social-Norms Edutainment Program on Sexually Violent Behavior and Bystander Behavior among University Men in Vietnam: The GlobalConsent Randomized Controlled Trial (Preprint)

BACKGROUND Sexual violence against women occurs worldwide. Prevention programs that treat men as “allies” and integrate a bystander framework are emerging in lower-income settings but evidence of effectiveness is conflicting. OBJECTIVE We tested the impact of GlobalConsent on sexually violent behavior and prosocial bystander behavior among university men in Vietnam. METHODS We applied a double-blind, parallel intervention-versus-control-group design with 1:1 randomization in two universities. Consenting heterosexual or bisexual men 18-24 years and matriculating in September 2019 (n=793) were enrolled and assigned randomly to GlobalConsent or AHEAD. GlobalConsent is an adapted, theory-based, six-module web-based intervention with diverse behavioral-change techniques and a locally produced serial drama. AHEAD is a customized, six-module attention-control program on adolescent health. Both programs were delivered to computers and smartphones over 12 weeks. Sexually violent behaviors toward women in the prior six months and prosocial bystander behaviors in the prior year were measured at zero, six, and 12 months. RESULTS Over 91% of men in both study arms completed at least one program module, and over 88% completed all six modules. At baseline, notable percentages of men reported any sexually violent behavior (GlobalConsent: 31.06%, n=396, AHEAD: 25.94%, n=397) in the prior six months. At endline (posttests 1 and 2 combined) compared to baseline, men receiving GlobalConsent had 1.26 times the odds of reporting a high level (at least two acts) of sexually violent behavior, and 0.67 times the odds of reporting any bystander behavior. The corresponding odds ratios for the AHEAD peers were less favorable, 2.67 and 0.45. CONCLUSIONS Compared to a health attention-control condition, GlobalConsent has sustained favorable impacts on sexually violent behavior and prosocial bystander behavior among matriculating university men in Vietnam, who otherwise would face increasing risks of sexually violent behavior. GlobalConsent shows promise for national scale-up and regional adaptation. CLINICALTRIAL ClinicalTrials.gov NCT04147455

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Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

10.21203/rs.3.rs-36678/v1 ◽

2020 ◽

Author(s):

Ricard Carrillo Muñoz ◽

Jose Luis Ballve Moreno ◽

Ivan Villar Balboa ◽

Yolanda Rando Matos ◽

Oriol Cunillera Puertolas ◽

...

Keyword(s):

Primary Care ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Double Blind ◽

Perceived Disability ◽

Randomised Controlled ◽

The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

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Tailored Web-Based Smoking Interventions and Reduced Attrition: Systematic Review and Meta-Analysis

Journal of Medical Internet Research ◽

10.2196/16255 ◽

2020 ◽

Vol 22 (10) ◽

pp. e16255

Author(s):

Amika Shah ◽

Michael Chaiton ◽

Dolly Baliunas ◽

Robert Schwartz

Keyword(s):

Systematic Review ◽

Smoking Cessation ◽

Passive Control ◽

Controlled Trial ◽

Meta Analysis ◽

Intervention Group ◽

Control Group ◽

Web Based ◽

The Impact

Background The increasing number of internet users presents an opportunity to deliver health interventions to large populations. Despite their potential, many web-based interventions, including those for smoking cessation, face high rates of attrition. Further consideration of how intervention features impact attrition is needed. Objective The aim of this systematic review is to investigate whether tailored web-based smoking cessation interventions for smokers are associated with reduced rates of attrition compared with active or passive untailored web-based interventions. The outcomes of interest were dropout attrition at 1-, 3-, 6-, and 12-month follow-ups. Methods Literature searches were conducted in May 2018 and updated in May 2020 on MEDLINE (Medical Literature Analysis and Retrieval System Online), PsycINFO (Psychological Information), EMBASE (Excerpta Medica dataBASE), CINAHL (Cumulated Index to Nursing and Allied Health Literature), Scopus, and the Cochrane Tobacco Addiction Group Specialized Register with the following search terms: smoking cessation, tailored, or web- or internet-based. Included studies were published in English before or in May 2020 using a randomized controlled trial design. Studies were restricted to those with web-based delivery, a tailored intervention group, an untailored control group, and a reported outcome of smoking cessation. Studies were assessed for methodological quality using the Cochrane Risk of Bias tool. Two reviewers independently extracted the study characteristics and the number of participants lost to follow-up for each treatment group. Results A total of 13 studies were included in the systematic review, of which 11 (85%) were included in the meta-analysis. Tailoring had no statistically significant effect on dropout attrition at 1-month (risk ratio [RR]=1.02, 95% CI 0.95-1.09; P=.58; I2=78%), 3-month (RR=0.99, 95% CI 0.95-1.04; P=.80; I2=73%), 6-month (RR=1.00, 95% CI 0.95-1.05; P=.90; I2=43%), or 12-month (RR=0.97, 95% CI 0.92-1.02; P=.26; I2=28%) follow-ups. Subgroup analyses suggested that there was a statistically significant effect of tailoring between the active and passive subgroups at 1-month (P=.03), 3-month (P<.001), and 6-month (P=.02) follow-ups but not at 12-month follow-up (P=.25). Conclusions The results suggest that tailoring of web-based smoking cessation interventions may not be associated with reduced rates of dropout attrition at 1-, 3-, 6-, or 12-month follow-ups. Significant differences between studies that include untailored active and passive control groups suggest that the role of tailoring may be more prominent when studies include a passive control group. These findings may be because of variability in the presence of additional features, the definition of smokers used, and the duration of smoking abstinence measured. Future studies should incorporate active web-based controls, compare the impact of different tailoring strategies, and include populations outside of the Western countries.

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Intravenous Esmolol Infusion Improves Surgical Fields during Sevoflurane-Anesthetized Endoscopic Sinus Surgery: A Double-Blind, Randomized, Placebo-Controlled Trial

American Journal of Rhinology and Allergy ◽

10.2500/ajra.2011.25.3701 ◽

2011 ◽

Vol 25 (6) ◽

pp. e208-e211 ◽

Cited By ~ 16

Author(s):

Ping-Hung Shen ◽

Erik Kent Weitzel ◽

Jen-Tsung Lai ◽

Peter-John Wormald ◽

Chee-Sang Ho

Keyword(s):

Blood Pressure ◽

Blood Loss ◽

Endoscopic Sinus Surgery ◽

Controlled Trial ◽

Sinus Surgery ◽

Constant Infusion ◽

Saline Control ◽

Control Group ◽

Double Blind ◽

The Impact

Background There is increasing evidence to support the use of anesthetics to affect operative fields during endoscopic sinus surgery and thus the speed, thoroughness, and safety of the surgery itself. Previous research has suggested preoperative beta-blockers improve surgical fields (SFs); our study is novel in showing the impact of a beta-blocker infusion on SFs during sinus surgery. Methods A prospective, randomized, double-blind, placebo-controlled trial was conducted in 40 patients. Patients undergoing endoscopic sinus surgery for chronic rhinosinusitis received a constant infusion of i.v. esmolol or saline in addition to a standard inhaled anesthetic protocol. At regular 15-minutes intervals, the quality of SF, heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) were assessed. Total blood loss was also recorded. Results Average vital sign parameters (HR/SBP/DBP) were significantly lower in the esmolol group (69.1/90.2/55.1 versus 77.2/99.5/63.5; p < 0.01). The esmolol infusion improved SFs relative to control (2.3 versus 2.6; p = 0.045). Esmolol infusion resulted in good SFs (grades 1 and 2) more often than poor fields (grades 3 and 4); on the contrary, the control group showed more poor than good SFs (chi-square; p = 0.04). A correlation between increasing HR and worsening SFs was identified (r = 0.259; p = 0.002). The control group had significantly higher average blood loss (1.3 versus 0.8 mL/min; p = 0.037). Conclusion Esmolol-induced relative hypotension and bradycardia during endoscopic sinus surgery achieves significantly improved SFs relative to saline control.

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Tailored Web-Based Smoking Interventions and Reduced Attrition: Systematic Review and Meta-Analysis (Preprint)

10.2196/preprints.16255 ◽

2019 ◽

Author(s):

Amika Shah ◽

Michael Chaiton ◽

Dolly Baliunas ◽

Robert Schwartz

Keyword(s):

Systematic Review ◽

Smoking Cessation ◽

Passive Control ◽

Controlled Trial ◽

Meta Analysis ◽

Intervention Group ◽

Control Group ◽

Web Based ◽

The Impact

BACKGROUND The increasing number of internet users presents an opportunity to deliver health interventions to large populations. Despite their potential, many web-based interventions, including those for smoking cessation, face high rates of attrition. Further consideration of how intervention features impact attrition is needed. OBJECTIVE The aim of this systematic review is to investigate whether tailored web-based smoking cessation interventions for smokers are associated with reduced rates of attrition compared with active or passive untailored web-based interventions. The outcomes of interest were dropout attrition at 1-, 3-, 6-, and 12-month follow-ups. METHODS Literature searches were conducted in May 2018 and updated in May 2020 on MEDLINE (Medical Literature Analysis and Retrieval System Online), PsycINFO (Psychological Information), EMBASE (Excerpta Medica dataBASE), CINAHL (Cumulated Index to Nursing and Allied Health Literature), Scopus, and the Cochrane Tobacco Addiction Group Specialized Register with the following search terms: smoking cessation, tailored, or web- or internet-based. Included studies were published in English before or in May 2020 using a randomized controlled trial design. Studies were restricted to those with web-based delivery, a tailored intervention group, an untailored control group, and a reported outcome of smoking cessation. Studies were assessed for methodological quality using the Cochrane Risk of Bias tool. Two reviewers independently extracted the study characteristics and the number of participants lost to follow-up for each treatment group. RESULTS A total of 13 studies were included in the systematic review, of which 11 (85%) were included in the meta-analysis. Tailoring had no statistically significant effect on dropout attrition at 1-month (risk ratio [RR]=1.02, 95% CI 0.95-1.09; P=.58; I2=78%), 3-month (RR=0.99, 95% CI 0.95-1.04; P=.80; I2=73%), 6-month (RR=1.00, 95% CI 0.95-1.05; P=.90; I2=43%), or 12-month (RR=0.97, 95% CI 0.92-1.02; P=.26; I2=28%) follow-ups. Subgroup analyses suggested that there was a statistically significant effect of tailoring between the active and passive subgroups at 1-month (P=.03), 3-month (P<.001), and 6-month (P=.02) follow-ups but not at 12-month follow-up (P=.25). CONCLUSIONS The results suggest that tailoring of web-based smoking cessation interventions may not be associated with reduced rates of dropout attrition at 1-, 3-, 6-, or 12-month follow-ups. Significant differences between studies that include untailored active and passive control groups suggest that the role of tailoring may be more prominent when studies include a passive control group. These findings may be because of variability in the presence of additional features, the definition of smokers used, and the duration of smoking abstinence measured. Future studies should incorporate active web-based controls, compare the impact of different tailoring strategies, and include populations outside of the Western countries.

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Chlorhexidine Gluconate Reduces Transmission of Methicillin-ResistantStaphylococcus aureusUSA300 among Marine Recruits

Infection Control and Hospital Epidemiology ◽

10.1086/666631 ◽

2012 ◽

Vol 33 (8) ◽

pp. 809-816 ◽

Cited By ~ 15

Author(s):

Timothy J. Whitman ◽

Carey D. Schlett ◽

Greg A. Grandits ◽

Eugene V. Millar ◽

Katrin Mende ◽

...

Keyword(s):

Molecular Epidemiology ◽

Controlled Trial ◽

Chlorhexidine Gluconate ◽

Control Group ◽

Entire Body ◽

Double Blind ◽

Pulsed Field ◽

Military Recruits ◽

The Impact ◽

Mrsa Colonization

Background.Methicillin-resistantStaphylococcus aureus(MRSA) pulsed-field type (PFT) USA300 causes skin and soft tissue infections in military recruits and invasive disease in hospitals. Chlorhexidine gluconate (CHG) is used to reduce MRSA colonization and infection. The impact of CHG on the molecular epidemiology of MRSA is not known.Objective.To evaluate the impact of 2% CHG—impregnated cloths on the molecular epidemiology of MRSA colonization.Design.Cluster-randomized, double-blind, controlled trial.Setting.Marine Officer Candidate School, Quantico, Virginia, in 2007.Participants.Military recruits.Intervention.Thrice-weekly application of CHG-impregnated or control (Comfort Bath; Sage) cloths over the entire body.Measurements.Baseline and serial (every 2 weeks) nasal and/or axillary swab samples were assessed for MRSA colonization. Molecular analysis was performed with pulsed-field gel electrophoresis.Results.During training, 77 subjects (4.9%) acquired MRSA, 26 (3.3%) in the CHG group and 51 (6.5%) in the control group (P= .004). When analyzed for PFT, 24 subjects (3.1%) in the control group but only 6 subjects (0.8%) in the CHG group (P= .001) had USA300. Of the 167 colonizing isolates recovered from 77 subjects, 99 were recovered from the control group, including USA300 (40.4%), USA800 (38.4%), USA1000 (12.1%), and USA100 (6.1%), and 68 were recovered from the CHG group, including USA800 (51.5%), USA100 (23.5%), and USA300 (13.2%).Conclusions.CHG decreased the transmission of MRSA—more specifically, USA300—among military recruits. In addition, USA300 and USA800 outcompeted other MRSA PFTs at incident colonization. Future studies should evaluate the broad-based use of CHG to decrease transmission of USA300 in hospital settings.

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Acute Effects of Ketamine Infusion on Postoperative Mood Scores in Patients Undergoing Dilation and Curettage: A Randomized Double-Blind Controlled Study

Anesthesiology Research and Practice ◽

10.1155/2021/6674658 ◽

2021 ◽

Vol 2021 ◽

pp. 1-10

Author(s):

Raham Hasan Mostafa ◽

Ahmed Mohamed Khamis ◽

Ashraf Nabil Saleh ◽

Yehia Mamdouh Hassan Mekki ◽

Mohamed Mohamed Kamal ◽

...

Keyword(s):

Low Dose ◽

Controlled Trial ◽

Acute Effect ◽

Controlled Study ◽

Control Group ◽

Double Blind ◽

Ketamine Infusion ◽

Dilation And Curettage ◽

Post Infusion ◽

The Impact

Background. Emotional and psychological effects following abortion are more common than physical side effects and can range from mild regret to more serious complications such as depression. In the last decade, it has been suggested that low dose of ketamine is a fast-acting antidepressant. Purpose. The aim of this study was to investigate the impact of intraoperative ketamine infusion on postoperative mood score in patients undergoing Dilation and Curettage (D&C) under spinal anesthesia. We hypothesized that a single low-dose administration of ketamine infusion during D&C surgery can improve mood scores in the immediate postoperative period. Methods. A prospective, randomized, double-blind, parallel-group, placebo-controlled trial. The study included a total of 60 patients, ≥18 years, physical status ASA II, with up to 12-week gestation undergoing elective D&C surgery. Patients were divided randomly into a ketamine group (group K) and a control group (group C). In group K, 0.4 mg/kg ketamine was given as a continuous infusion over 20 min intraoperatively. Main Outcome Measure. Profile of Mood States (POMS) was recorded preoperatively and 2 hours postoperatively. Results. There were no differences in preoperative POMS between the two groups. Mean postoperative POMS of group K was lower than that of group C indicating mood improvement. Ketamine group patients showed higher sedation score and increased, although self-limiting, psychedelic phenomena than the control group. Conclusion. Observed data here support an acute effect of ketamine on mood but any further claim will be speculative. Further future studies exploring postoperative mood scores after 24 hours post-infusion are needed. This trial is registered with PACTR201907779292947.

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Impact of Althaea Officinalis extract in patients with atopic eczema: a double-blind randomized controlled trial

Clinical Phytoscience ◽

10.1186/s40816-021-00306-z ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Negar Khalighi ◽

Farahzad Jabbari-Azad ◽

Maral Barzegar-Amini ◽

Jalil Tavakkol-Afshari ◽

Pouran Layegh ◽

...

Keyword(s):

Atopic Eczema ◽

Controlled Trial ◽

Similar Efficacy ◽

The Body ◽

Control Group ◽

Double Blind ◽

Prick Test ◽

Flower Extract ◽

Althaea Officinalis ◽

The Impact

Abstract Background Althaea Officinalis introduced as an emerging anti-inflammatory agent with immunomodulatory effects that may suppress the symptoms of atopic eczema. In this study, we aimed to investigate the impact of liposomal formulation of Althaea Officinalis flower extract compared with steroids for atopic eczema treatment. Methods In this randomized, double-blind controlled trial phase II, forty patients with moderate to severe allergic atopic eczema confirmed by skin prick test were enrolled in the study from October 2018 to January 2019. Steroids on the lesions of the left side of the body and topical Althaea Officinalis extract (intervention) or eucerin as a topical placebo on the lesions of the right side of the body were tested. SCORAD (SCORing Atopic Dermatitis) was assessed at the baseline, and two, and four weeks after completing the trial. Data were analyzed by SPSS version 22. Results In the active treatment group, after two weeks, the SCORAD was significantly lower in the left side (recovery with steroid treatment) (p < 0.001), and after 4 weeks the SCORAD was lower on both sides, and there were no significant differences between two sides (similarity between Althaea Officinalis and steroid effects). In the control group, the SCORAD score was significantly lower on the left side (steroid) after two and four weeks (p < 0.001). There was no side effect and reaction to drugs. Conclusions Considering the potential side effects of steroids, and the similar efficacy of Althaea Officinalis flower extract, using this component may be accompanied by higher benefits in patients with atopic eczema. Trial registration IRCT2016102323235N5.

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Reducing the Social Stigma Associated with Obsessive Compulsive Disorder: A Controlled Trial of an Intervention Program in a Turkish Community Sample

Journal of Evidence-Based Psychotherapies ◽

10.24193/jebp.2020.2.14 ◽

2020 ◽

Vol 20 (2) ◽

pp. 101-120

Author(s):

Ayça Aktaç Gürbüz ◽

Orçun YORULMAZ ◽

Gülşah DURNA

Keyword(s):

Obsessive Compulsive Disorder ◽

Intervention Program ◽

Controlled Trial ◽

Community Sample ◽

Case Vignette ◽

Control Group ◽

Obsessive Compulsive ◽

Compulsive Disorder ◽

Significant Difference ◽

The Impact

Scientific research into the reduction of stigmatization, particularly related to specific problems such as Obsessive-Compulsive Disorder (OCD), is scarce. In the present study, we examine the impact of a video-based antistigma intervention program for OCD in a pretest-posttest control group research. After being randomly assigned to either an intervention (n= 101) or control group (n= 96), the participants reported their attitudes on a hypothetical case vignette before and after OCD vs. Multiple Sclerosis (MS) videos, and again six months later as a follow up assessment. The mixed design analyses for the group comparisons indicated that although there was no significant difference in the measures of the control group, the participants watching the anti-stigma OCD video, in which the focus was psychoeducation and interaction strategies, reported significantly lower scores on social distances and negative beliefs for the case vignettes they read, and this difference was maintained six months later. Then, the present results indicate the effectiveness of our anti-stigma intervention program for OCD. Interventions to reduce stigmatization can also be viewed as effective tools for changing the attitudes of people toward OCD, although further research and applications are needed related to specific disorders if a longlasting impact is to be achieved.

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Impact of an Amaranth-Sorghum Grains Product on Nutrient Intake of Children Aged 6-23 Months in Kiandutu Slums, Thika, Kenya

10.37512/700 ◽

2020 ◽

Keyword(s):

Nutrition Education ◽

Nutrient Intake ◽

Controlled Trial ◽

Poor Quality ◽

Control Group ◽

Composite Flour ◽

Monthly Basis ◽

Sorghum Flour ◽

Baseline Characteristics ◽

The Impact

Poor quality complementary foods contribute to undernutrition in children aged 6-23 months. Therefore, there is need to explore foods that will provide adequate nutrients for this age group. This study aimed at determining the impact of a sorghum-amaranth composite flour porridge on nutrient intake of children aged 6-23 months. A randomized controlled trial was conducted at Kiandutu slum, Thika, Kenya. Children in the control group (CG), received a maize-sorghum flour while those in the treatment group (TG) received an amaranth-sorghum flour. The sample size per study group was 73 mother-child pairs. The children in the TG received Kcal 1000 worth of porridge/day while those in the CG received Kcal 266.8/day. Mothers of children in both groups were given nutrition education at baseline, and monthly, for six months. Food intake data was taken at baseline, then monthly for six months. Descriptive statistics were used to describe nutrient intake. Chi square and Mann Whitney U test were was used to compare the baseline characteristics of the two groups and their nutrient intake, respectively. At baseline characteristics of the two groups were similar. On a monthly basis, nutrient intake in the TG was significantly higher for a majority of the nutrients than in the CG. The product can contribute to preventing under-nutrition in children aged 6-23 months.

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Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

10.2196/preprints.16141 ◽

2019 ◽

Author(s):

Jan van Lieshout ◽

Joyca Lacroix ◽

Aart van Halteren ◽

Martina Teichert

Keyword(s):

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Community Pharmacies ◽

Web Based ◽

Randomized Controlled ◽

Tailored Interventions ◽

Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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