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September 27, 2021 article Open access Aachen paper

A pragmatic randomised controlled trial referring to a Personalised Self-management SUPport Programme (P-SUP) for persons enrolled in a disease management programme for type 2 diabetes mellitus and/or for coronary heart disease

Trials, vol. 22, pp. 659

DOI: 10.1186/s13063-021-05636-4 Full text (OA) OpenAlex

Abstract

BACKGROUND: Type 2 diabetes mellitus (T2DM) and coronary heart disease (CHD) are two chronic diseases that cause a tremendous burden. To reduce this burden, several programmes for optimising the care for these diseases have been developed. In Germany, so-called disease management programmes (DMPs), which combine components of Disease Management and the Chronic Care Model, are applied. These DMPs have proven effective. Nevertheless, there are opportunities for improvement. Current DMPs rarely address self-management of the disease, make no use of peer support, and provide no special assistance for persons with low health literacy and/or low patient activation. The study protocol presented here is for the evaluation of a programme that addresses these possible shortcomings and can be combined with current German DMPs for T2DM and CHD. This programme consists of four components: 1) Meetings of peer support groups 2) Personalised telephone-based health coaching for patients with low literacy and/or low patient activation 3) Personalised patient feedback 4) A browser-based web portal METHODS: Study participants will be adults enrolled in a DMP for T2DM and/or CHD and living in North Rhine-Westphalia, a state of the Federal Republic of Germany. Study participants will be recruited with the assistance of their general practitioners by the end of June 2021. Evaluation will be performed as a pragmatic randomised controlled trial with one intervention group and one waiting control group. The intervention group will receive the intervention for 18 months. During this time, the waiting control group will continue with usual care and the usual measures of their DMPs. After 18 months, the waiting control group will also receive a shortened intervention. The primary outcome is number of hospital days. In addition, the effects on self-reported health-state, physical activity, nutrition, and eight different psychological variables will be investigated. Differences between values at month 18 and at the beginning will be compared to judge the effectiveness of the intervention. DISCUSSION: If the intervention proves effective, it may be included into the DMPs for T2DM and CHD. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Registry (Deutsches Register Klinischer Studien (DRKS)) in early 2019 under the number 00020592. This registry has been affiliated with the WHO Clinical Trials Network ( https://www.drks.de/drks_web/setLocale_EN.do ) since 2008. It is based on the WHO template, but contains some additional categories for which information has to be given ( https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields ). A release and subsequent number assignment only take place when information for all categories has been given.

Authors 40

  1. Uwe Konerding corresponding

    Witten/Herdecke University · University of Bamberg

    Affiliation as printed

    Department of Psychology and Psychotherapy, Witten/Herdecke University, Alfred-Herrhausen-Straße 50, D-58448, Witten, Germany. uwe.konerding@uni-bamberg.de

    Trimberg Research Academy, University of Bamberg, D-96045, Bamberg, Germany. uwe.konerding@uni-bamberg.de

    Trimberg Research Academy, University of Bamberg, D-96045, Bamberg, Germany

  2. Marcus Redaèlli

    University of Cologne · University Hospital Cologne

    Affiliation as printed

    Institute of Health Economics and Clinical Epidemiology, University Hospital Cologne (Institut für Gesundheitsökonomie und Klinische Epidemiologie, Universitätsklinikum Köln), D-50924, Köln, Germany

  3. Karolin Ackermann

    University Hospital Cologne · Klinik und Poliklinik für Psychosomatik und Psychotherapie

    Affiliation as printed

    Department of Psychosomatics and Psychotherapy, University Hospital Cologne (Klinik und Poliklinik für Psychosomatik und Psychotherapie, Universitätsklinikum Köln), Weyertal 76, 50931, Köln, Germany

  4. Sibel Vildan Altin
    Affiliation as printed

    General Local Health Insurance, Rheinland/Hamburg (Allgemeine Ortskrankenkasse, Rheinland/Hamburg), Kasernenstraße 61, D-40213, Düsseldorf, Germany

  5. Sebastian Appelbaum

    Witten/Herdecke University · University of Bamberg

    Affiliation as printed

    Department of Psychology and Psychotherapy, Witten/Herdecke University, Alfred-Herrhausen-Straße 50, D-58448, Witten, Germany

    Trimberg Research Academy, University of Bamberg, D-96045, Bamberg, Germany

  6. Bianca Biallas

    German Sport University Cologne

    Affiliation as printed

    Institute of Movement Therapy and Movement-oriented Prevention and Rehabilitation, German Sport University Cologne (Institut für Bewegungstherapie und bewegungsorientierte Prävention und Rehabilitation, Deutsche Sporthochschule Köln), Am Sportpark Müngersdorf 6, D-50933, Köln, Germany

  7. August-Wilhelm Bödecker

    University Hospital Cologne

    Affiliation as printed

    Teaching Unit of General Practice, University Hospital Cologne (Schwerpunkt Allgemeinmedizin, Universitätsklinikum Köln), D-50924, Köln, Germany

  8. Suzan Botzenhardt

    University of Duisburg-Essen

    Affiliation as printed

    Institute of General Practice, University Duisburg-Essen (Institut für Allgemeinmedizin, Universität Duisburg-Essen), Hufelandstr. 55, D-45122, Essen, Germany

  9. Chloé Chermette

    German Sport University Cologne

    Affiliation as printed

    Institute of Psychology, German Sport University Cologne (Institut für Psychologie, Deutsche Sporthochschule Köln), Am Sportpark Müngersdorf 6, D-50933, Köln, Germany

  10. Martin Cichocki

    Medical University of Vienna

    Affiliation as printed

    Department of General Practice and Family Medicine, Medical University of Vienna (Abteilung für Allgemeinmedizin und Familienmedizin, Medizinischen Universität Wien), Kinderspitalgasse 15/1.Stock, A-1090, Wien, Austria

  11. Iris Dapper

    University Hospital Cologne

    Affiliation as printed

    Teaching Unit of General Practice, University Hospital Cologne (Schwerpunkt Allgemeinmedizin, Universitätsklinikum Köln), D-50924, Köln, Germany

  12. Katja Dehnen

    University of Duisburg-Essen

    Affiliation as printed

    Institute of General Practice, University Duisburg-Essen (Institut für Allgemeinmedizin, Universität Duisburg-Essen), Hufelandstr. 55, D-45122, Essen, Germany

  13. Christian Funke

    Heinrich Heine University Düsseldorf

    Affiliation as printed

    Institute of General Practice, Heinrich Heine University Düsseldorf (Institut für Allgemeinmedizin, Heinrich-Heine-Universität Düsseldorf), Post Office Box 10 10 07, D-40001, Düsseldorf, Germany

  14. Angeli Gawlik

    German Sport University Cologne

    Affiliation as printed

    Institute of Psychology, German Sport University Cologne (Institut für Psychologie, Deutsche Sporthochschule Köln), Am Sportpark Müngersdorf 6, D-50933, Köln, Germany

  15. Lisa Giesen

    University of Cologne · University Hospital Cologne

    Affiliation as printed

    Institute of Health Economics and Clinical Epidemiology, University Hospital Cologne (Institut für Gesundheitsökonomie und Klinische Epidemiologie, Universitätsklinikum Köln), D-50924, Köln, Germany

  16. Johannes Goetz

    University of Cologne · University Hospital Cologne

    Affiliation as printed

    Institute of Health Economics and Clinical Epidemiology, University Hospital Cologne (Institut für Gesundheitsökonomie und Klinische Epidemiologie, Universitätsklinikum Köln), D-50924, Köln, Germany

  17. Christian A. Graf
    Affiliation as printed

    Barmer Health Insurance (Barmer Krankenversicherung), BARMER, Heerdter Lohweg 35, D-40549, Düsseldorf, Germany

  18. Bernd Hagen

    Zentralinstitut für die Kassenärztliche Versorgung in der Bundesrepublik Deutschland

    Affiliation as printed

    Central Research Institute of Ambulatory Health Care in Germany (Zentralinstitut für die Kassenärztliche Versorgung in Deutschland), Salzufer 8, D-10587, Berlin, Germany

  19. Martina Heßbrügge

    University of Duisburg-Essen

    Affiliation as printed

    Institute of General Practice, University Duisburg-Essen (Institut für Allgemeinmedizin, Universität Duisburg-Essen), Hufelandstr. 55, D-45122, Essen, Germany

  20. Phillip Hendrick Höhne
    Affiliation as printed

    General Local Health Insurance, Rheinland/Hamburg (Allgemeine Ortskrankenkasse, Rheinland/Hamburg), Kasernenstraße 61, D-40213, Düsseldorf, Germany

  21. Jens Kleinert

    German Sport University Cologne

    Affiliation as printed

    Institute of Psychology, German Sport University Cologne (Institut für Psychologie, Deutsche Sporthochschule Köln), Am Sportpark Müngersdorf 6, D-50933, Köln, Germany

  22. Helene Könnecke

    University of Cologne · University Hospital Cologne

    Affiliation as printed

    Institute of Health Economics and Clinical Epidemiology, University Hospital Cologne (Institut für Gesundheitsökonomie und Klinische Epidemiologie, Universitätsklinikum Köln), D-50924, Köln, Germany

  23. Lucas Küppers

    University of Bonn

    Affiliation as printed

    Institute of Family Medicine and General Practice, University of Bonn (Institut für Hausarztmedizin, Universität Bonn), Venusberg-Campus 1, D-53127, Bonn, Germany

  24. N. Kuth Aachen Teaching Area of General Practice

    RWTH Aachen University · Universitätsklinikum Aachen

    Affiliation as printed

    Teaching Area of General Practice, University Hospital RWTH Aachen (Lehrgebiet für Allgemeinmedizin Uniklinik RWTH Aachen), Pauwelsstraße 30, D-52074, Aachen, Germany

  25. Lion Lehmann

    University Hospital Cologne

    Affiliation as printed

    Teaching Unit of General Practice, University Hospital Cologne (Schwerpunkt Allgemeinmedizin, Universitätsklinikum Köln), D-50924, Köln, Germany

  26. Claas Lendt

    German Sport University Cologne

    Affiliation as printed

    Institute of Movement Therapy and Movement-oriented Prevention and Rehabilitation, German Sport University Cologne (Institut für Bewegungstherapie und bewegungsorientierte Prävention und Rehabilitation, Deutsche Sporthochschule Köln), Am Sportpark Müngersdorf 6, D-50933, Köln, Germany

  27. Khalid Majjouti

    University of Bonn

    Affiliation as printed

    Institute of Family Medicine and General Practice, University of Bonn (Institut für Hausarztmedizin, Universität Bonn), Venusberg-Campus 1, D-53127, Bonn, Germany

  28. Yeliz Nacak

    University Hospital Cologne · Klinik und Poliklinik für Psychosomatik und Psychotherapie

    Affiliation as printed

    Department of Psychosomatics and Psychotherapy, University Hospital Cologne (Klinik und Poliklinik für Psychosomatik und Psychotherapie, Universitätsklinikum Köln), Weyertal 76, 50931, Köln, Germany

  29. Aliza Neuhausen

    University Hospital Cologne · Klinik und Poliklinik für Psychosomatik und Psychotherapie

    Affiliation as printed

    Department of Psychosomatics and Psychotherapy, University Hospital Cologne (Klinik und Poliklinik für Psychosomatik und Psychotherapie, Universitätsklinikum Köln), Weyertal 76, 50931, Köln, Germany

  30. Larisa Pilic

    University Hospital Cologne

    Affiliation as printed

    Teaching Unit of General Practice, University Hospital Cologne (Schwerpunkt Allgemeinmedizin, Universitätsklinikum Köln), D-50924, Köln, Germany

  31. Maximilian Scholl

    German Sport University Cologne

    Affiliation as printed

    Institute of Movement Therapy and Movement-oriented Prevention and Rehabilitation, German Sport University Cologne (Institut für Bewegungstherapie und bewegungsorientierte Prävention und Rehabilitation, Deutsche Sporthochschule Köln), Am Sportpark Müngersdorf 6, D-50933, Köln, Germany

  32. Dušan Simić

    University of Cologne · University Hospital Cologne

    Affiliation as printed

    Institute of Health Economics and Clinical Epidemiology, University Hospital Cologne (Institut für Gesundheitsökonomie und Klinische Epidemiologie, Universitätsklinikum Köln), D-50924, Köln, Germany

  33. Andreas C. Sönnichsen

    Medical University of Vienna

    Affiliation as printed

    Department of General Practice and Family Medicine, Medical University of Vienna (Abteilung für Allgemeinmedizin und Familienmedizin, Medizinischen Universität Wien), Kinderspitalgasse 15/1.Stock, A-1090, Wien, Austria

  34. Anika Thielmann

    University of Bonn

    Affiliation as printed

    Institute of Family Medicine and General Practice, University of Bonn (Institut für Hausarztmedizin, Universität Bonn), Venusberg-Campus 1, D-53127, Bonn, Germany

  35. I van der Arend Aachen Teaching Area of General Practice

    RWTH Aachen University · Universitätsklinikum Aachen

    Affiliation as printed

    Teaching Area of General Practice, University Hospital RWTH Aachen (Lehrgebiet für Allgemeinmedizin Uniklinik RWTH Aachen), Pauwelsstraße 30, D-52074, Aachen, Germany

  36. Frank Vitinius

    University Hospital Cologne · Klinik und Poliklinik für Psychosomatik und Psychotherapie

    Affiliation as printed

    Department of Psychosomatics and Psychotherapy, University Hospital Cologne (Klinik und Poliklinik für Psychosomatik und Psychotherapie, Universitätsklinikum Köln), Weyertal 76, 50931, Köln, Germany

  37. Birgitta Weltermann

    University of Bonn

    Affiliation as printed

    Institute of Family Medicine and General Practice, University of Bonn (Institut für Hausarztmedizin, Universität Bonn), Venusberg-Campus 1, D-53127, Bonn, Germany

  38. Dorothea M. G. Wild

    University of Bonn

    Affiliation as printed

    Institute of Family Medicine and General Practice, University of Bonn (Institut für Hausarztmedizin, Universität Bonn), Venusberg-Campus 1, D-53127, Bonn, Germany

  39. Stefan Wilm

    Heinrich Heine University Düsseldorf

    Affiliation as printed

    Institute of General Practice, Heinrich Heine University Düsseldorf (Institut für Allgemeinmedizin, Heinrich-Heine-Universität Düsseldorf), Post Office Box 10 10 07, D-40001, Düsseldorf, Germany

  40. Stephanie Stock

    University of Cologne · University Hospital Cologne

    Affiliation as printed

    Institute of Health Economics and Clinical Epidemiology, University Hospital Cologne (Institut für Gesundheitsökonomie und Klinische Epidemiologie, Universitätsklinikum Köln), D-50924, Köln, Germany

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References 39