Evidence map›Paper›PMID 34579783›Full record

Trial reportTrials2021

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, Marcus Redaèlli, Karolin Ackermann, Sibel Altin, Sebastian Appelbaum, Bianca Biallas, August-Wilhelm Bödecker, Suzan Botzenhardt, Chloé Chermette, Martin Cichocki and 31 more

Abstract readPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

41 authors.

Uwe KonerdingTrimberg Research Academy, University of Bamberg, D-96045, Bamberg, Germany. uwe.konerding@uni-bamberg.de.ORCID http://orcid.org/0000-0002-6993-5977
Marcus RedaèlliInstitute of Health Economics and Clinical Epidemiology, University Hospital Cologne (Institut für Gesundheitsökonomie und Klinische Epidemiologie, Universitätsklinikum Köln), D-50924, Köln, Germany.
Karolin AckermannDepartment of Psychosomatics and Psychotherapy, University Hospital Cologne (Klinik und Poliklinik für Psychosomatik und Psychotherapie, Universitätsklinikum Köln), Weyertal 76, 50931, Köln, Germany.
Sibel AltinGeneral Local Health Insurance, Rheinland/Hamburg (Allgemeine Ortskrankenkasse, Rheinland/Hamburg), Kasernenstraße 61, D-40213, Düsseldorf, Germany.
Sebastian AppelbaumTrimberg Research Academy, University of Bamberg, D-96045, Bamberg, Germany.
Bianca BiallasInstitute 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.
August-Wilhelm BödeckerTeaching Unit of General Practice, University Hospital Cologne (Schwerpunkt Allgemeinmedizin, Universitätsklinikum Köln), D-50924, Köln, Germany.
Suzan BotzenhardtInstitute of General Practice, University Duisburg-Essen (Institut für Allgemeinmedizin, Universität Duisburg-Essen), Hufelandstr. 55, D-45122, Essen, Germany.
Chloé ChermetteInstitute of Psychology, German Sport University Cologne (Institut für Psychologie, Deutsche Sporthochschule Köln), Am Sportpark Müngersdorf 6, D-50933, Köln, Germany.
Martin CichockiDepartment 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.
Iris DapperTeaching Unit of General Practice, University Hospital Cologne (Schwerpunkt Allgemeinmedizin, Universitätsklinikum Köln), D-50924, Köln, Germany.
Katja DehnenInstitute of General Practice, University Duisburg-Essen (Institut für Allgemeinmedizin, Universität Duisburg-Essen), Hufelandstr. 55, D-45122, Essen, Germany.
Christian FunkeInstitute of General Practice, Heinrich Heine University Düsseldorf (Institut für Allgemeinmedizin, Heinrich-Heine-Universität Düsseldorf), Post Office Box 10 10 07, D-40001, Düsseldorf, Germany.
Angeli GawlikInstitute of Psychology, German Sport University Cologne (Institut für Psychologie, Deutsche Sporthochschule Köln), Am Sportpark Müngersdorf 6, D-50933, Köln, Germany.
Lisa GiesenInstitute of Health Economics and Clinical Epidemiology, University Hospital Cologne (Institut für Gesundheitsökonomie und Klinische Epidemiologie, Universitätsklinikum Köln), D-50924, Köln, Germany.
Johannes GoetzInstitute of Health Economics and Clinical Epidemiology, University Hospital Cologne (Institut für Gesundheitsökonomie und Klinische Epidemiologie, Universitätsklinikum Köln), D-50924, Köln, Germany.
Christian GrafBarmer Health Insurance (Barmer Krankenversicherung), BARMER, Heerdter Lohweg 35, D-40549, Düsseldorf, Germany.
Bernd HagenCentral Research Institute of Ambulatory Health Care in Germany (Zentralinstitut für die Kassenärztliche Versorgung in Deutschland), Salzufer 8, D-10587, Berlin, Germany.
Martina HeßbrüggeInstitute of General Practice, University Duisburg-Essen (Institut für Allgemeinmedizin, Universität Duisburg-Essen), Hufelandstr. 55, D-45122, Essen, Germany.
Phillip Hendrick HöhneGeneral Local Health Insurance, Rheinland/Hamburg (Allgemeine Ortskrankenkasse, Rheinland/Hamburg), Kasernenstraße 61, D-40213, Düsseldorf, Germany.
Jens KleinertInstitute of Psychology, German Sport University Cologne (Institut für Psychologie, Deutsche Sporthochschule Köln), Am Sportpark Müngersdorf 6, D-50933, Köln, Germany.
Helene KönneckeInstitute of Health Economics and Clinical Epidemiology, University Hospital Cologne (Institut für Gesundheitsökonomie und Klinische Epidemiologie, Universitätsklinikum Köln), D-50924, Köln, Germany.
Lucas KüppersInstitute of Family Medicine and General Practice, University of Bonn (Institut für Hausarztmedizin, Universität Bonn), Venusberg-Campus 1, D-53127, Bonn, Germany.
Nicole KuthTeaching Area of General Practice, University Hospital RWTH Aachen (Lehrgebiet für Allgemeinmedizin Uniklinik RWTH Aachen), Pauwelsstraße 30, D-52074, Aachen, Germany.
Lion LehmannTeaching Unit of General Practice, University Hospital Cologne (Schwerpunkt Allgemeinmedizin, Universitätsklinikum Köln), D-50924, Köln, Germany.
Claas LendtInstitute 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.
Khalid MajjoutiInstitute of Family Medicine and General Practice, University of Bonn (Institut für Hausarztmedizin, Universität Bonn), Venusberg-Campus 1, D-53127, Bonn, Germany.
Yeliz NacakDepartment of Psychosomatics and Psychotherapy, University Hospital Cologne (Klinik und Poliklinik für Psychosomatik und Psychotherapie, Universitätsklinikum Köln), Weyertal 76, 50931, Köln, Germany.
Aliza NeuhausenDepartment of Psychosomatics and Psychotherapy, University Hospital Cologne (Klinik und Poliklinik für Psychosomatik und Psychotherapie, Universitätsklinikum Köln), Weyertal 76, 50931, Köln, Germany.
Larisa PilicTeaching Unit of General Practice, University Hospital Cologne (Schwerpunkt Allgemeinmedizin, Universitätsklinikum Köln), D-50924, Köln, Germany.
Lara SchneiderDepartment of Psychosomatics and Psychotherapy, University Hospital Cologne (Klinik und Poliklinik für Psychosomatik und Psychotherapie, Universitätsklinikum Köln), Weyertal 76, 50931, Köln, Germany.
Maximilian SchollInstitute 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.
Dusan SimicInstitute of Health Economics and Clinical Epidemiology, University Hospital Cologne (Institut für Gesundheitsökonomie und Klinische Epidemiologie, Universitätsklinikum Köln), D-50924, Köln, Germany.
Andreas SönnichsenDepartment 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.
Anika ThielmannInstitute of Family Medicine and General Practice, University of Bonn (Institut für Hausarztmedizin, Universität Bonn), Venusberg-Campus 1, D-53127, Bonn, Germany.
Ines Van der ArendTeaching Area of General Practice, University Hospital RWTH Aachen (Lehrgebiet für Allgemeinmedizin Uniklinik RWTH Aachen), Pauwelsstraße 30, D-52074, Aachen, Germany.
Frank VitiniusDepartment of Psychosomatics and Psychotherapy, University Hospital Cologne (Klinik und Poliklinik für Psychosomatik und Psychotherapie, Universitätsklinikum Köln), Weyertal 76, 50931, Köln, Germany.
Birgitta WeltermannInstitute of Family Medicine and General Practice, University of Bonn (Institut für Hausarztmedizin, Universität Bonn), Venusberg-Campus 1, D-53127, Bonn, Germany.
Dorothea WildInstitute of Family Medicine and General Practice, University of Bonn (Institut für Hausarztmedizin, Universität Bonn), Venusberg-Campus 1, D-53127, Bonn, Germany.
Stefan WilmInstitute of General Practice, Heinrich Heine University Düsseldorf (Institut für Allgemeinmedizin, Heinrich-Heine-Universität Düsseldorf), Post Office Box 10 10 07, D-40001, Düsseldorf, Germany.
Stephanie StockInstitute of Health Economics and Clinical Epidemiology, University Hospital Cologne (Institut für Gesundheitsökonomie und Klinische Epidemiologie, Universitätsklinikum Köln), D-50924, Köln, Germany.

Funding

G-BA 01NVF18033
6 · The paper itself

Abstract

backgroundType 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

methodsStudy 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 registrationThe 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.

Indexed as

Coronary DiseaseDiabetes Mellitus, Type 2Self-ManagementAdultDisease ManagementGermanyHumansCoronary heart diseaseHealth services researchPeer support groupPragmatic randomised controlled trialPragmatic RCTSelf-managementStudy protocolType 2 diabetes mellitus

Identifiers

PMID34579783
PMCPMC8475316

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.