PMID- 34579783
OWN - NLM
STAT- MEDLINE
DCOM- 20210929
LR  - 20231107
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 22
IP  - 1
DP  - 2021 Sep 27
TI  - 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.
PG  - 659
LID - 10.1186/s13063-021-05636-4 [doi]
LID - 659
AB  - 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.
CI  - (c) 2021. The Author(s).
FAU - Konerding, Uwe
AU  - Konerding U
AUID- ORCID: 0000-0002-6993-5977
AD  - Trimberg Research Academy, University of Bamberg, D-96045, Bamberg, Germany. 
      uwe.konerding@uni-bamberg.de.
AD  - Department of Psychology and Psychotherapy, Witten/Herdecke University, 
      Alfred-Herrhausen-Strasse 50, D-58448, Witten, Germany. 
      uwe.konerding@uni-bamberg.de.
FAU - Redaelli, Marcus
AU  - Redaelli M
AD  - Institute of Health Economics and Clinical Epidemiology, University Hospital 
      Cologne (Institut fur Gesundheitsokonomie und Klinische Epidemiologie, 
      Universitatsklinikum Koln), D-50924, Koln, Germany.
FAU - Ackermann, Karolin
AU  - Ackermann K
AD  - Department of Psychosomatics and Psychotherapy, University Hospital Cologne 
      (Klinik und Poliklinik fur Psychosomatik und Psychotherapie, Universitatsklinikum 
      Koln), Weyertal 76, 50931, Koln, Germany.
FAU - Altin, Sibel
AU  - Altin S
AD  - General Local Health Insurance, Rheinland/Hamburg (Allgemeine Ortskrankenkasse, 
      Rheinland/Hamburg), Kasernenstrasse 61, D-40213, Dusseldorf, Germany.
FAU - Appelbaum, Sebastian
AU  - Appelbaum S
AD  - Trimberg Research Academy, University of Bamberg, D-96045, Bamberg, Germany.
AD  - Department of Psychology and Psychotherapy, Witten/Herdecke University, 
      Alfred-Herrhausen-Strasse 50, D-58448, Witten, Germany.
FAU - Biallas, Bianca
AU  - Biallas B
AD  - Institute of Movement Therapy and Movement-oriented Prevention and 
      Rehabilitation, German Sport University Cologne (Institut fur Bewegungstherapie 
      und bewegungsorientierte Pravention und Rehabilitation, Deutsche Sporthochschule 
      Koln), Am Sportpark Mungersdorf 6, D-50933, Koln, Germany.
FAU - Bodecker, August-Wilhelm
AU  - Bodecker AW
AD  - Teaching Unit of General Practice, University Hospital Cologne (Schwerpunkt 
      Allgemeinmedizin, Universitatsklinikum Koln), D-50924, Koln, Germany.
FAU - Botzenhardt, Suzan
AU  - Botzenhardt S
AD  - Institute of General Practice, University Duisburg-Essen (Institut fur 
      Allgemeinmedizin, Universitat Duisburg-Essen), Hufelandstr. 55, D-45122, Essen, 
      Germany.
FAU - Chermette, Chloe
AU  - Chermette C
AD  - Institute of Psychology, German Sport University Cologne (Institut fur 
      Psychologie, Deutsche Sporthochschule Koln), Am Sportpark Mungersdorf 6, D-50933, 
      Koln, Germany.
FAU - Cichocki, Martin
AU  - Cichocki M
AD  - Department of General Practice and Family Medicine, Medical University of Vienna 
      (Abteilung fur Allgemeinmedizin und Familienmedizin, Medizinischen Universitat 
      Wien), Kinderspitalgasse 15/1.Stock, A-1090, Wien, Austria.
FAU - Dapper, Iris
AU  - Dapper I
AD  - Teaching Unit of General Practice, University Hospital Cologne (Schwerpunkt 
      Allgemeinmedizin, Universitatsklinikum Koln), D-50924, Koln, Germany.
FAU - Dehnen, Katja
AU  - Dehnen K
AD  - Institute of General Practice, University Duisburg-Essen (Institut fur 
      Allgemeinmedizin, Universitat Duisburg-Essen), Hufelandstr. 55, D-45122, Essen, 
      Germany.
FAU - Funke, Christian
AU  - Funke C
AD  - Institute of General Practice, Heinrich Heine University Dusseldorf (Institut fur 
      Allgemeinmedizin, Heinrich-Heine-Universitat Dusseldorf), Post Office Box 10 10 
      07, D-40001, Dusseldorf, Germany.
FAU - Gawlik, Angeli
AU  - Gawlik A
AD  - Institute of Psychology, German Sport University Cologne (Institut fur 
      Psychologie, Deutsche Sporthochschule Koln), Am Sportpark Mungersdorf 6, D-50933, 
      Koln, Germany.
FAU - Giesen, Lisa
AU  - Giesen L
AD  - Institute of Health Economics and Clinical Epidemiology, University Hospital 
      Cologne (Institut fur Gesundheitsokonomie und Klinische Epidemiologie, 
      Universitatsklinikum Koln), D-50924, Koln, Germany.
FAU - Goetz, Johannes
AU  - Goetz J
AD  - Institute of Health Economics and Clinical Epidemiology, University Hospital 
      Cologne (Institut fur Gesundheitsokonomie und Klinische Epidemiologie, 
      Universitatsklinikum Koln), D-50924, Koln, Germany.
FAU - Graf, Christian
AU  - Graf C
AD  - Barmer Health Insurance (Barmer Krankenversicherung), BARMER, Heerdter Lohweg 35, 
      D-40549, Dusseldorf, Germany.
FAU - Hagen, Bernd
AU  - Hagen B
AD  - Central Research Institute of Ambulatory Health Care in Germany (Zentralinstitut 
      fur die Kassenarztliche Versorgung in Deutschland), Salzufer 8, D-10587, Berlin, 
      Germany.
FAU - Hessbrugge, Martina
AU  - Hessbrugge M
AD  - Institute of General Practice, University Duisburg-Essen (Institut fur 
      Allgemeinmedizin, Universitat Duisburg-Essen), Hufelandstr. 55, D-45122, Essen, 
      Germany.
FAU - Hohne, Phillip Hendrick
AU  - Hohne PH
AD  - General Local Health Insurance, Rheinland/Hamburg (Allgemeine Ortskrankenkasse, 
      Rheinland/Hamburg), Kasernenstrasse 61, D-40213, Dusseldorf, Germany.
FAU - Kleinert, Jens
AU  - Kleinert J
AD  - Institute of Psychology, German Sport University Cologne (Institut fur 
      Psychologie, Deutsche Sporthochschule Koln), Am Sportpark Mungersdorf 6, D-50933, 
      Koln, Germany.
FAU - Konnecke, Helene
AU  - Konnecke H
AD  - Institute of Health Economics and Clinical Epidemiology, University Hospital 
      Cologne (Institut fur Gesundheitsokonomie und Klinische Epidemiologie, 
      Universitatsklinikum Koln), D-50924, Koln, Germany.
FAU - Kuppers, Lucas
AU  - Kuppers L
AD  - Institute of Family Medicine and General Practice, University of Bonn (Institut 
      fur Hausarztmedizin, Universitat Bonn), Venusberg-Campus 1, D-53127, Bonn, 
      Germany.
FAU - Kuth, Nicole
AU  - Kuth N
AD  - Teaching Area of General Practice, University Hospital RWTH Aachen (Lehrgebiet 
      fur Allgemeinmedizin Uniklinik RWTH Aachen), Pauwelsstrasse 30, D-52074, Aachen, 
      Germany.
FAU - Lehmann, Lion
AU  - Lehmann L
AD  - Teaching Unit of General Practice, University Hospital Cologne (Schwerpunkt 
      Allgemeinmedizin, Universitatsklinikum Koln), D-50924, Koln, Germany.
FAU - Lendt, Claas
AU  - Lendt C
AD  - Institute of Movement Therapy and Movement-oriented Prevention and 
      Rehabilitation, German Sport University Cologne (Institut fur Bewegungstherapie 
      und bewegungsorientierte Pravention und Rehabilitation, Deutsche Sporthochschule 
      Koln), Am Sportpark Mungersdorf 6, D-50933, Koln, Germany.
FAU - Majjouti, Khalid
AU  - Majjouti K
AD  - Institute of Family Medicine and General Practice, University of Bonn (Institut 
      fur Hausarztmedizin, Universitat Bonn), Venusberg-Campus 1, D-53127, Bonn, 
      Germany.
FAU - Nacak, Yeliz
AU  - Nacak Y
AD  - Department of Psychosomatics and Psychotherapy, University Hospital Cologne 
      (Klinik und Poliklinik fur Psychosomatik und Psychotherapie, Universitatsklinikum 
      Koln), Weyertal 76, 50931, Koln, Germany.
FAU - Neuhausen, Aliza
AU  - Neuhausen A
AD  - Department of Psychosomatics and Psychotherapy, University Hospital Cologne 
      (Klinik und Poliklinik fur Psychosomatik und Psychotherapie, Universitatsklinikum 
      Koln), Weyertal 76, 50931, Koln, Germany.
FAU - Pilic, Larisa
AU  - Pilic L
AD  - Teaching Unit of General Practice, University Hospital Cologne (Schwerpunkt 
      Allgemeinmedizin, Universitatsklinikum Koln), D-50924, Koln, Germany.
FAU - Schneider, Lara
AU  - Schneider L
AD  - Department of Psychosomatics and Psychotherapy, University Hospital Cologne 
      (Klinik und Poliklinik fur Psychosomatik und Psychotherapie, Universitatsklinikum 
      Koln), Weyertal 76, 50931, Koln, Germany.
FAU - Scholl, Maximilian
AU  - Scholl M
AD  - Institute of Movement Therapy and Movement-oriented Prevention and 
      Rehabilitation, German Sport University Cologne (Institut fur Bewegungstherapie 
      und bewegungsorientierte Pravention und Rehabilitation, Deutsche Sporthochschule 
      Koln), Am Sportpark Mungersdorf 6, D-50933, Koln, Germany.
FAU - Simic, Dusan
AU  - Simic D
AD  - Institute of Health Economics and Clinical Epidemiology, University Hospital 
      Cologne (Institut fur Gesundheitsokonomie und Klinische Epidemiologie, 
      Universitatsklinikum Koln), D-50924, Koln, Germany.
FAU - Sonnichsen, Andreas
AU  - Sonnichsen A
AD  - Department of General Practice and Family Medicine, Medical University of Vienna 
      (Abteilung fur Allgemeinmedizin und Familienmedizin, Medizinischen Universitat 
      Wien), Kinderspitalgasse 15/1.Stock, A-1090, Wien, Austria.
FAU - Thielmann, Anika
AU  - Thielmann A
AD  - Institute of Family Medicine and General Practice, University of Bonn (Institut 
      fur Hausarztmedizin, Universitat Bonn), Venusberg-Campus 1, D-53127, Bonn, 
      Germany.
FAU - Van der Arend, Ines
AU  - Van der Arend I
AD  - Teaching Area of General Practice, University Hospital RWTH Aachen (Lehrgebiet 
      fur Allgemeinmedizin Uniklinik RWTH Aachen), Pauwelsstrasse 30, D-52074, Aachen, 
      Germany.
FAU - Vitinius, Frank
AU  - Vitinius F
AD  - Department of Psychosomatics and Psychotherapy, University Hospital Cologne 
      (Klinik und Poliklinik fur Psychosomatik und Psychotherapie, Universitatsklinikum 
      Koln), Weyertal 76, 50931, Koln, Germany.
FAU - Weltermann, Birgitta
AU  - Weltermann B
AD  - Institute of Family Medicine and General Practice, University of Bonn (Institut 
      fur Hausarztmedizin, Universitat Bonn), Venusberg-Campus 1, D-53127, Bonn, 
      Germany.
FAU - Wild, Dorothea
AU  - Wild D
AD  - Institute of Family Medicine and General Practice, University of Bonn (Institut 
      fur Hausarztmedizin, Universitat Bonn), Venusberg-Campus 1, D-53127, Bonn, 
      Germany.
FAU - Wilm, Stefan
AU  - Wilm S
AD  - Institute of General Practice, Heinrich Heine University Dusseldorf (Institut fur 
      Allgemeinmedizin, Heinrich-Heine-Universitat Dusseldorf), Post Office Box 10 10 
      07, D-40001, Dusseldorf, Germany.
FAU - Stock, Stephanie
AU  - Stock S
AD  - Institute of Health Economics and Clinical Epidemiology, University Hospital 
      Cologne (Institut fur Gesundheitsokonomie und Klinische Epidemiologie, 
      Universitatsklinikum Koln), D-50924, Koln, Germany.
LA  - eng
GR  - 01NVF18033/G-BA/
PT  - Journal Article
PT  - Pragmatic Clinical Trial
PT  - Randomized Controlled Trial
DEP - 20210927
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
SB  - IM
MH  - Adult
MH  - *Coronary Disease/diagnosis/therapy
MH  - *Diabetes Mellitus, Type 2/diagnosis/therapy
MH  - Disease Management
MH  - Germany
MH  - Humans
MH  - *Self-Management
PMC - PMC8475316
OTO - NOTNLM
OT  - Coronary heart disease
OT  - Health services research
OT  - Peer support group
OT  - Pragmatic RCT
OT  - Pragmatic randomised controlled trial
OT  - Self-management
OT  - Study protocol
OT  - Type 2 diabetes mellitus
COIS- The authors declare that they have no competing interests.
EDAT- 2021/09/29 06:00
MHDA- 2021/09/30 06:00
PMCR- 2021/09/27
CRDT- 2021/09/28 05:39
PHST- 2021/04/02 00:00 [received]
PHST- 2021/09/15 00:00 [accepted]
PHST- 2021/09/28 05:39 [entrez]
PHST- 2021/09/29 06:00 [pubmed]
PHST- 2021/09/30 06:00 [medline]
PHST- 2021/09/27 00:00 [pmc-release]
AID - 10.1186/s13063-021-05636-4 [pii]
AID - 5636 [pii]
AID - 10.1186/s13063-021-05636-4 [doi]
PST - epublish
SO  - Trials. 2021 Sep 27;22(1):659. doi: 10.1186/s13063-021-05636-4.