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

Uwe Konerding^{1

2}, Marcus Redaèlli³, Karolin Ackermann⁴, Sibel Altin⁵, Sebastian Appelbaum^{6

7}, Bianca Biallas⁸, August-Wilhelm Bödecker⁹, Suzan Botzenhardt¹⁰, Chloé Chermette¹¹, Martin Cichocki¹², Iris Dapper⁹, Katja Dehnen¹⁰, Christian Funke¹³, Angeli Gawlik¹¹, Lisa Giesen³, Johannes Goetz³, Christian Graf¹⁴, Bernd Hagen¹⁵, Martina Heßbrügge¹⁰, Phillip Hendrick Höhne⁵, Jens Kleinert¹¹, Helene Könnecke³, Lucas Küppers¹⁶, Nicole Kuth¹⁷, Lion Lehmann⁹, Claas Lendt⁸, Khalid Majjouti¹⁶, Yeliz Nacak⁴, Aliza Neuhausen⁴, Larisa Pilic⁹, Lara Schneider⁴, Maximilian Scholl⁸, Dusan Simic³, Andreas Sönnichsen¹², Anika Thielmann¹⁶, Ines Van der Arend¹⁷, Frank Vitinius⁴, Birgitta Weltermann¹⁶, Dorothea Wild¹⁶, Stefan Wilm¹³, Stephanie Stock³

Affiliations

¹ Trimberg Research Academy, University of Bamberg, D-96045, Bamberg, Germany. uwe.konerding@uni-bamberg.de.
² Department of Psychology and Psychotherapy, Witten/Herdecke University, Alfred-Herrhausen-Straße 50, D-58448, Witten, Germany. uwe.konerding@uni-bamberg.de.
³ Institute of Health Economics and Clinical Epidemiology, University Hospital Cologne (Institut für Gesundheitsökonomie und Klinische Epidemiologie, Universitätsklinikum Köln), D-50924, Köln, Germany.
⁴ Department of Psychosomatics and Psychotherapy, University Hospital Cologne (Klinik und Poliklinik für Psychosomatik und Psychotherapie, Universitätsklinikum Köln), Weyertal 76, 50931, Köln, Germany.
⁵ General Local Health Insurance, Rheinland/Hamburg (Allgemeine Ortskrankenkasse, Rheinland/Hamburg), Kasernenstraße 61, D-40213, Düsseldorf, Germany.
⁶ Trimberg Research Academy, University of Bamberg, D-96045, Bamberg, Germany.
⁷ Department of Psychology and Psychotherapy, Witten/Herdecke University, Alfred-Herrhausen-Straße 50, D-58448, Witten, Germany.
⁸ 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.
⁹ Teaching Unit of General Practice, University Hospital Cologne (Schwerpunkt Allgemeinmedizin, Universitätsklinikum Köln), D-50924, Köln, Germany.
¹⁰ Institute of General Practice, University Duisburg-Essen (Institut für Allgemeinmedizin, Universität Duisburg-Essen), Hufelandstr. 55, D-45122, Essen, Germany.
¹¹ Institute of Psychology, German Sport University Cologne (Institut für Psychologie, Deutsche Sporthochschule Köln), Am Sportpark Müngersdorf 6, D-50933, Köln, Germany.
¹² 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.
¹³ 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 Barmer Health Insurance (Barmer Krankenversicherung), BARMER, Heerdter Lohweg 35, D-40549, Düsseldorf, Germany.
¹⁵ Central Research Institute of Ambulatory Health Care in Germany (Zentralinstitut für die Kassenärztliche Versorgung in Deutschland), Salzufer 8, D-10587, Berlin, Germany.
¹⁶ Institute of Family Medicine and General Practice, University of Bonn (Institut für Hausarztmedizin, Universität Bonn), Venusberg-Campus 1, D-53127, Bonn, Germany.
¹⁷ Teaching Area of General Practice, University Hospital RWTH Aachen (Lehrgebiet für Allgemeinmedizin Uniklinik RWTH Aachen), Pauwelsstraße 30, D-52074, Aachen, Germany.

PMID: 34579783
PMCID: PMC8475316
DOI: 10.1186/s13063-021-05636-4

Randomized Controlled Trial

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

Uwe Konerding et al. Trials. 2021.

. 2021 Sep 27;22(1):659.

doi: 10.1186/s13063-021-05636-4.

Authors

Affiliations

¹ Trimberg Research Academy, University of Bamberg, D-96045, Bamberg, Germany. uwe.konerding@uni-bamberg.de.
² Department of Psychology and Psychotherapy, Witten/Herdecke University, Alfred-Herrhausen-Straße 50, D-58448, Witten, Germany. uwe.konerding@uni-bamberg.de.
³ Institute of Health Economics and Clinical Epidemiology, University Hospital Cologne (Institut für Gesundheitsökonomie und Klinische Epidemiologie, Universitätsklinikum Köln), D-50924, Köln, Germany.
⁴ Department of Psychosomatics and Psychotherapy, University Hospital Cologne (Klinik und Poliklinik für Psychosomatik und Psychotherapie, Universitätsklinikum Köln), Weyertal 76, 50931, Köln, Germany.
⁵ General Local Health Insurance, Rheinland/Hamburg (Allgemeine Ortskrankenkasse, Rheinland/Hamburg), Kasernenstraße 61, D-40213, Düsseldorf, Germany.
⁶ Trimberg Research Academy, University of Bamberg, D-96045, Bamberg, Germany.
⁷ Department of Psychology and Psychotherapy, Witten/Herdecke University, Alfred-Herrhausen-Straße 50, D-58448, Witten, Germany.
⁸ 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.
⁹ Teaching Unit of General Practice, University Hospital Cologne (Schwerpunkt Allgemeinmedizin, Universitätsklinikum Köln), D-50924, Köln, Germany.
¹⁰ Institute of General Practice, University Duisburg-Essen (Institut für Allgemeinmedizin, Universität Duisburg-Essen), Hufelandstr. 55, D-45122, Essen, Germany.
¹¹ Institute of Psychology, German Sport University Cologne (Institut für Psychologie, Deutsche Sporthochschule Köln), Am Sportpark Müngersdorf 6, D-50933, Köln, Germany.
¹² 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.
¹³ 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 Barmer Health Insurance (Barmer Krankenversicherung), BARMER, Heerdter Lohweg 35, D-40549, Düsseldorf, Germany.
¹⁵ Central Research Institute of Ambulatory Health Care in Germany (Zentralinstitut für die Kassenärztliche Versorgung in Deutschland), Salzufer 8, D-10587, Berlin, Germany.
¹⁶ Institute of Family Medicine and General Practice, University of Bonn (Institut für Hausarztmedizin, Universität Bonn), Venusberg-Campus 1, D-53127, Bonn, Germany.
¹⁷ Teaching Area of General Practice, University Hospital RWTH Aachen (Lehrgebiet für Allgemeinmedizin Uniklinik RWTH Aachen), Pauwelsstraße 30, D-52074, Aachen, Germany.

PMID: 34579783
PMCID: PMC8475316
DOI: 10.1186/s13063-021-05636-4

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.

Keywords: Coronary heart disease; Health services research; Peer support group; Pragmatic RCT; Pragmatic randomised controlled trial; Self-management; Study protocol; Type 2 diabetes mellitus.

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Conflict of interest statement

The authors declare that they have no competing interests.

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References

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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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Grants and funding