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: Konerding Uwe , Redaèlli Marcus , Ackermann Karolin , Altin Sibel , Appelbaum Sebastian , Biallas Bianca , Bödecker August-Wilhelm , Botzenhardt Suzan , Chermette Chloé , Cichocki Martin , Dapper Iris , Dehnen Katja , Funke Christian , Gawlik Angeli , Giesen Lisa , Goetz Johannes , Graf Christian , Hagen Bernd , Heßbrügge Martina , Höhne Phillip Hendrick , Kleinert Jens , Könnecke Helene , Küppers Lucas , Kuth Nicole , Lehmann Lion , Lendt Claas , Majjouti Khalid , Nacak Yeliz , Neuhausen Aliza , Pilic Larisa , Schneider Lara , Scholl Maximilian , Simic Dusan , Sönnichsen Andreas , Thielmann Anika , Van der Arend Ines , Vitinius Frank , Weltermann Birgitta , Wild Dorothea , Wilm Stefan , Stock Stephanie 
Published: September 2021

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:

Meetings of peer support groups

Personalised telephone-based health coaching for patients with low literacy and/or low patient activation

Personalised patient feedback

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.