Promoting Return to Work After Vocational Rehabilitation Using a Work-Related Fitness App: Protocol for a Cluster-Randomized Controlled Trial.

BACKGROUND: Retraining programs in vocational rehabilitation are often characterized by a low level of physical activity, even when targeting jobs with primarily physical demands. They might therefore be accompanied by a decline in functional capacity if the lack of physical activity is not compensated by increased activity during leisure time. The implementation of a work-related exercise app might be a promising approach to promoting a return to work in vocational rehabilitation. We developed the "WORKout-app" which provides exercise plans based on a comparison of the physical demands of the retraining profession and the current functional capacity. OBJECTIVE: The aim of this study is to examine the effects of app-based exercise during vocational rehabilitation on perceived work ability (primary outcome), occupational self-efficacy, days of sick leave, and return to work (secondary outcomes). METHODS: We conducted a cluster-randomized controlled trial with 2 arms (intervention: WORKout-app vs control: treatment as usual) in 4 cohorts of 5 vocational rehabilitation centers in Germany. Participants are nested within retraining classes per vocational rehabilitation center and per cohort assigned to either the intervention condition or the control condition. The target sample size at the participant level is 598. Measurement time points include baseline, the end of rehabilitation, 3 months after the end of rehabilitation, and 6 months after the end of rehabilitation. Linear and generalized linear mixed-effects models are performed to test for treatment differences in outcomes. RESULTS: This study is funded by the German Federal Pension Insurance. The trial is registered with the German Clinical Trials Register (DRKS00030775) and approved by the Ethics Committee of the German Sport University Cologne (145/2022). CONCLUSIONS: The findings of the study will inform researchers and practitioners about the effectiveness of an exercise app developed to counteract the effects of physical inactivity during vocational rehabilitation. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/50200.

Development and usability of a web-based patient-tailored tool to support adherence to urate-lowering therapy in gout.

BACKGROUND: The aim of this study is to develop and assess usability of a web-based patient-tailored tool to support adherence to urate-lowering therapy (ULT) among gout patients in a clinical setting. METHODS: The content of the tool was based on the Integrated Change (I-Change) model. This model combines various socio-cognitive theories and assumes behavioral change is a result of becoming aware of the necessity of change by integrating pre-motivational, motivational, and post-motivational factors. An expert group (five gout experts, three health services researchers, and one health behavior expert) was assembled that decided in three meetings on the tool's specific content (assessments and personalized feedback) using information from preparatory qualitative studies and literature reviews. Usability was tested by a think aloud approach and validated usability questionnaires. RESULTS: The I-Change Gout tool contains three consecutive sessions comprising 80 questions, 66 tailored textual feedback messages, and 40 tailored animated videos. Navigation through the sessions was determined by the patients' intention to adapt suboptimal ULT adherence. After the sessions, patients receive an overview of the personalized advices and plans to support ULT adherence. Usability testing among 20 gout patients that (ever) used ULT and seven healthcare professionals revealed an overall score for the tool of 8.4 ± 0.9 and 7.7 ± 1.0 (scale 1-10). Furthermore, participants reported a high intention to use and/or recommend the tool to others. Participants identified some issues for further improvement (e.g. redundant questions, technical issues, and text readability). If relevant, these were subsequently implemented in the I-Change Gout tool, to allow further testing among the following participants. CONCLUSION: This study provides initial support for the usability by patients and healthcare professionals of the I-Change Gout tool to support ULT adherence behavior.

Effects of Providing Tailored Information About e-Cigarettes in a Web-Based Smoking Cessation Intervention: Protocol for a Randomized Controlled Trial.

BACKGROUND: There is an ongoing debate whether electronic cigarettes (e-cigarettes) should be advocated for smoking cessation. Because of this uncertainty, information about the use of e-cigarettes for smoking cessation is usually not provided in governmental smoking cessation communications. However, there is an information need among smokers because despite this uncertainty, e-cigarettes are used by many smokers to reduce and quit tobacco smoking. OBJECTIVE: The aim of this study is to describe the protocol of a randomized controlled trial that assesses the effect of providing tailored information about e-cigarettes compared to not providing this information on determinants of decision making and smoking reduction and abstinence. This information is provided in the context of a digital smoking cessation intervention. METHODS: A randomized controlled trial with a 6-month follow-up period will be conducted among adult smokers motivated to quit smoking within 5 years. Participants will be 1:1 randomized into either the intervention condition or control condition. In this trial, which is grounded on the I-Change model, participants in both conditions will receive tailored feedback on attitude, social influence, preparatory plans, self-efficacy, and coping plans. Information on 6 clusters of smoking cessation methods (face-to-face counselling, eHealth interventions, telephone counselling, group-based programs, nicotine replacement therapy, and prescription medication) will be provided in both conditions. Smokers in the intervention condition will also receive detailed tailored information on e-cigarettes, while smokers in the control condition will not receive this information. The primary outcome measure will be the number of tobacco cigarettes smoked in the past 7 days. Secondary outcome measures will include 7-day point prevalence tobacco abstinence, 7-day point prevalence e-cigarette abstinence, and determinants of decision making (ie, knowledge and attitude regarding e-cigarettes). All outcomes will be self-assessed through web-based questionnaires. RESULTS: This project is supported by a research grant of the National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu). Ethical approval was granted by the Ethics Review Committee Health, Medicine and Life Sciences at Maastricht University (FHML-REC/2019/072). Recruitment began in March 2020 and was completed by July 2020. We enrolled 492 smokers in this study. The results are expected to be published in June 2021. CONCLUSIONS: The experimental design of this study allows conclusions to be formed regarding the effects of tailored information about e-cigarettes on decision making and smoking behavior. Our findings can inform the development of future smoking cessation interventions. TRIAL REGISTRATION: Dutch Trial Register Trial NL8330; https://www.trialregister.nl/trial/8330. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27088.