Effectiveness and cost-effectiveness of a web-based routine assessment with integrated recommendations for action for depression and anxiety (RehaCAT+): protocol for a cluster randomised controlled trial for patients with elevated depressive symptoms in rehabilitation facilities
Introduction The integration of a web-based computer-adaptive patient-reported outcome test (CAT) platform with persuasive design optimised features including recommendations for action into routine healthcare could provide a promising way to translate reliable diagnostic results into action. This s...
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| Format: | Article |
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e061259.full |
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| author | Reinhold Kilian Harald Baumeister Yannik Terhorst Johannes Knauer Paula Philippi Selina Kallinger Sandro Eiler Tamara Waldmann Morten Moshagen Martina Bader |
| author_facet | Reinhold Kilian Harald Baumeister Yannik Terhorst Johannes Knauer Paula Philippi Selina Kallinger Sandro Eiler Tamara Waldmann Morten Moshagen Martina Bader |
| author_sort | Reinhold Kilian |
| collection | DOAJ |
| description | Introduction The integration of a web-based computer-adaptive patient-reported outcome test (CAT) platform with persuasive design optimised features including recommendations for action into routine healthcare could provide a promising way to translate reliable diagnostic results into action. This study aims to evaluate the effectiveness and cost-effectiveness of such a platform for depression and anxiety (RehaCAT+) compared with the standard diagnostic system (RehaCAT) in cardiological and orthopaedic health clinics in routine care.Methods and analysis A two-arm, pragmatic, cluster-randomised controlled trial will be conducted. Twelve participating rehabilitation clinics in Germany will be randomly assigned to a control (RehaCAT) or experimental group (RehaCAT+) in a 1:1 design. A total sample of 1848 participants will be recruited across all clinics. The primary outcome, depression severity at 12 months follow-up (T3), will be assessed using the CAT Patient-Reported Outcome Measurement Information System Emotional Distress-Depression Item set. Secondary outcomes are depression at discharge (T1) and 6 months follow-up (T2) as well as anxiety, satisfaction with participation in social roles and activities, pain impairment, fatigue, sleep, health-related quality of life, self-efficacy, physical functioning, alcohol, personality and health economic-specific general quality of life and socioeconomic cost and benefits at T1-3. User behaviour, acceptance, facilitating and hindering factors will be assessed with semistructured qualitative interviews. Additionally, a smart sensing substudy will be conducted, with daily ecological momentary assessments and passive collection of smartphone usage variables. Data analysis will follow the intention-to-treat principle with additional per-protocol analyses. Cost-effectiveness analyses will be conducted from a societal perspective and the perspective of the statutory pension insurance.Ethics and dissemination The study will be conducted according to the Declaration of Helsinki. The Ethics Committee of Ulm University, has approved the study (on 24 February 2021 ref. 509/20). Written informed consent will be obtained for all participants. Results will be published via peer-reviewed journals.Trial registration number DRKS00027447 |
| format | Article |
| id | doaj-art-63f53f151a584ed392798afc65b76a5b |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-63f53f151a584ed392798afc65b76a5b2025-01-27T16:50:10ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2022-061259Effectiveness and cost-effectiveness of a web-based routine assessment with integrated recommendations for action for depression and anxiety (RehaCAT+): protocol for a cluster randomised controlled trial for patients with elevated depressive symptoms in rehabilitation facilitiesReinhold Kilian0Harald Baumeister1Yannik Terhorst2Johannes Knauer3Paula Philippi4Selina Kallinger5Sandro Eiler6Tamara Waldmann7Morten Moshagen8Martina Bader9Department of Psychiatry and Psychotherapy II, Ulm University, Ulm, GermanyDepartment of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, GermanyResearch Methods, Ulm University, Ulm, Baden-Württemberg, GermanyDepartment of Clinical Psychology and Psychotherapy, Ulm University, Ulm, GermanyDepartment of Clinical Psychology and Psychotherapy, Ulm University, Ulm, GermanyDepartment of Clinical Psychology and Psychotherapy, Ulm University, Ulm, GermanyDepartment of Clinical Psychology and Psychotherapy, Ulm University, Ulm, GermanyDepartment of Psychiatry and Psychotherapy II, Ulm University, Ulm, GermanyDepartment of Research Methods, Institute of Psychology and Education, University of Ulm, Ulm, GermanyDepartment of Psychological Research Methods, Ulm University, Ulm, GermanyIntroduction The integration of a web-based computer-adaptive patient-reported outcome test (CAT) platform with persuasive design optimised features including recommendations for action into routine healthcare could provide a promising way to translate reliable diagnostic results into action. This study aims to evaluate the effectiveness and cost-effectiveness of such a platform for depression and anxiety (RehaCAT+) compared with the standard diagnostic system (RehaCAT) in cardiological and orthopaedic health clinics in routine care.Methods and analysis A two-arm, pragmatic, cluster-randomised controlled trial will be conducted. Twelve participating rehabilitation clinics in Germany will be randomly assigned to a control (RehaCAT) or experimental group (RehaCAT+) in a 1:1 design. A total sample of 1848 participants will be recruited across all clinics. The primary outcome, depression severity at 12 months follow-up (T3), will be assessed using the CAT Patient-Reported Outcome Measurement Information System Emotional Distress-Depression Item set. Secondary outcomes are depression at discharge (T1) and 6 months follow-up (T2) as well as anxiety, satisfaction with participation in social roles and activities, pain impairment, fatigue, sleep, health-related quality of life, self-efficacy, physical functioning, alcohol, personality and health economic-specific general quality of life and socioeconomic cost and benefits at T1-3. User behaviour, acceptance, facilitating and hindering factors will be assessed with semistructured qualitative interviews. Additionally, a smart sensing substudy will be conducted, with daily ecological momentary assessments and passive collection of smartphone usage variables. Data analysis will follow the intention-to-treat principle with additional per-protocol analyses. Cost-effectiveness analyses will be conducted from a societal perspective and the perspective of the statutory pension insurance.Ethics and dissemination The study will be conducted according to the Declaration of Helsinki. The Ethics Committee of Ulm University, has approved the study (on 24 February 2021 ref. 509/20). Written informed consent will be obtained for all participants. Results will be published via peer-reviewed journals.Trial registration number DRKS00027447https://bmjopen.bmj.com/content/12/6/e061259.full |
| spellingShingle | Reinhold Kilian Harald Baumeister Yannik Terhorst Johannes Knauer Paula Philippi Selina Kallinger Sandro Eiler Tamara Waldmann Morten Moshagen Martina Bader Effectiveness and cost-effectiveness of a web-based routine assessment with integrated recommendations for action for depression and anxiety (RehaCAT+): protocol for a cluster randomised controlled trial for patients with elevated depressive symptoms in rehabilitation facilities BMJ Open |
| title | Effectiveness and cost-effectiveness of a web-based routine assessment with integrated recommendations for action for depression and anxiety (RehaCAT+): protocol for a cluster randomised controlled trial for patients with elevated depressive symptoms in rehabilitation facilities |
| title_full | Effectiveness and cost-effectiveness of a web-based routine assessment with integrated recommendations for action for depression and anxiety (RehaCAT+): protocol for a cluster randomised controlled trial for patients with elevated depressive symptoms in rehabilitation facilities |
| title_fullStr | Effectiveness and cost-effectiveness of a web-based routine assessment with integrated recommendations for action for depression and anxiety (RehaCAT+): protocol for a cluster randomised controlled trial for patients with elevated depressive symptoms in rehabilitation facilities |
| title_full_unstemmed | Effectiveness and cost-effectiveness of a web-based routine assessment with integrated recommendations for action for depression and anxiety (RehaCAT+): protocol for a cluster randomised controlled trial for patients with elevated depressive symptoms in rehabilitation facilities |
| title_short | Effectiveness and cost-effectiveness of a web-based routine assessment with integrated recommendations for action for depression and anxiety (RehaCAT+): protocol for a cluster randomised controlled trial for patients with elevated depressive symptoms in rehabilitation facilities |
| title_sort | effectiveness and cost effectiveness of a web based routine assessment with integrated recommendations for action for depression and anxiety rehacat protocol for a cluster randomised controlled trial for patients with elevated depressive symptoms in rehabilitation facilities |
| url | https://bmjopen.bmj.com/content/12/6/e061259.full |
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