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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

      research-article
      1 , 2 , , 3 , 4 , 5 , 1 , 2 , 6 , 7 , 8 , 9 , 10 , 7 , 8 , 11 , 9 , 3 , 3 , 12 , 13 , 8 , 5 , 9 , 3 , 14 , 15 , 7 , 6 , 14 , 4 , 4 , 7 , 4 , 6 , 3 , 10 , 14 , 15 , 4 , 14 , 14 , 11 , 3
      Trials
      BioMed Central
      Health services research, Type 2 diabetes mellitus, Coronary heart disease, Peer support group, Self-management, Study protocol, Pragmatic RCT, Pragmatic randomised controlled trial

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          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.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s13063-021-05636-4.

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          Most cited references36

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          Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)

          Purpose This article introduces the new 5-level EQ-5D (EQ-5D-5L) health status measure. Methods EQ-5D currently measures health using three levels of severity in five dimensions. A EuroQol Group task force was established to find ways of improving the instrument’s sensitivity and reducing ceiling effects by increasing the number of severity levels. The study was performed in the United Kingdom and Spain. Severity labels for 5 levels in each dimension were identified using response scaling. Focus groups were used to investigate the face and content validity of the new versions, including hypothetical health states generated from those versions. Results Selecting labels at approximately the 25th, 50th, and 75th centiles produced two alternative 5-level versions. Focus group work showed a slight preference for the wording ‘slight-moderate-severe’ problems, with anchors of ‘no problems’ and ‘unable to do’ in the EQ-5D functional dimensions. Similar wording was used in the Pain/Discomfort and Anxiety/Depression dimensions. Hypothetical health states were well understood though participants stressed the need for the internal coherence of health states. Conclusions A 5-level version of the EQ-5D has been developed by the EuroQol Group. Further testing is required to determine whether the new version improves sensitivity and reduces ceiling effects.
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            The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions.

            CONSORT guidelines call for precise reporting of behavior change interventions: we need rigorous methods of characterizing active content of interventions with precision and specificity. The objective of this study is to develop an extensive, consensually agreed hierarchically structured taxonomy of techniques [behavior change techniques (BCTs)] used in behavior change interventions. In a Delphi-type exercise, 14 experts rated labels and definitions of 124 BCTs from six published classification systems. Another 18 experts grouped BCTs according to similarity of active ingredients in an open-sort task. Inter-rater agreement amongst six researchers coding 85 intervention descriptions by BCTs was assessed. This resulted in 93 BCTs clustered into 16 groups. Of the 26 BCTs occurring at least five times, 23 had adjusted kappas of 0.60 or above. "BCT taxonomy v1," an extensive taxonomy of 93 consensually agreed, distinct BCTs, offers a step change as a method for specifying interventions, but we anticipate further development and evaluation based on international, interdisciplinary consensus.
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              Is Open Access

              Health literacy and public health: A systematic review and integration of definitions and models

              Background Health literacy concerns the knowledge and competences of persons to meet the complex demands of health in modern society. Although its importance is increasingly recognised, there is no consensus about the definition of health literacy or about its conceptual dimensions, which limits the possibilities for measurement and comparison. The aim of the study is to review definitions and models on health literacy to develop an integrated definition and conceptual model capturing the most comprehensive evidence-based dimensions of health literacy. Methods A systematic literature review was performed to identify definitions and conceptual frameworks of health literacy. A content analysis of the definitions and conceptual frameworks was carried out to identify the central dimensions of health literacy and develop an integrated model. Results The review resulted in 17 definitions of health literacy and 12 conceptual models. Based on the content analysis, an integrative conceptual model was developed containing 12 dimensions referring to the knowledge, motivation and competencies of accessing, understanding, appraising and applying health-related information within the healthcare, disease prevention and health promotion setting, respectively. Conclusions Based upon this review, a model is proposed integrating medical and public health views of health literacy. The model can serve as a basis for developing health literacy enhancing interventions and provide a conceptual basis for the development and validation of measurement tools, capturing the different dimensions of health literacy within the healthcare, disease prevention and health promotion settings.
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                Author and article information

                Contributors
                uwe.konerding@uni-bamberg.de
                marcus.redaelli@uk-koeln.de
                karolin.ackermann@uk-koeln.de
                sibelvildan.altin@rh.aok.de
                sebastian.appelbaum@uni-bamberg.de
                Biallas@dshs-koeln.de
                august-wilhelm.boedecker@uk-koeln.de
                Suzan.Botzenhardt@uk-essen.de
                c.chermette@dshs-koeln.de
                martin.cichocki@meduniwien.ac.at
                iris.dapper@uk-koeln.de
                Katja.Dehnen@uk-essen.de
                Christian.Funke@med.uni-duesseldorf.de
                a.gawlik@dshs-koeln.de
                lisa.giesen@uk-koeln.de
                Hannes.Goetz@gmx.de
                christian.graf@barmer.de
                BHagen@zi.de
                Martina.Hessbruegge@uk-essen.de
                philliphendrik.hoehne@rh.aok.de
                Kleinert@dshs-koeln.de
                helene.koennecke@uk-koeln.de
                lucas.kueppers@ukbonn.de
                nkuth@ukaachen.de
                lion.lehmann@uk-koeln.de
                C.Lendt@dshs-koeln.de
                Khalid.Majjouti@ukbonn.de
                yeliz.nacak@uk-koeln.de
                aliza.neuhausen@uk-koeln.de
                larisa.pilic@uk-koeln.de
                lara.schneider@uk-koeln.de
                m.scholl@dshs-koeln.de
                dusan.simic@uk-koeln.de
                andreas.soennichsen@meduniwien.ac.at
                Anika.Thielmann@ukbonn.de
                ivanderarend@ukaachen.de
                frank.vitinius@uk-koeln.de
                Birgitta.Weltermann@ukbonn.de
                Dorothea.Wild@ukbonn.de
                Stefan.Wilm@med.uni-duesseldorf.de
                Stephanie.Stock@uk-koeln.de
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                27 September 2021
                27 September 2021
                2021
                : 22
                : 659
                Affiliations
                [1 ]GRID grid.7359.8, ISNI 0000 0001 2325 4853, Trimberg Research Academy, , University of Bamberg, ; D-96045 Bamberg, Germany
                [2 ]GRID grid.412581.b, ISNI 0000 0000 9024 6397, Department of Psychology and Psychotherapy, , Witten/Herdecke University, ; Alfred-Herrhausen-Straße 50, D-58448 Witten, Germany
                [3 ]GRID grid.411097.a, ISNI 0000 0000 8852 305X, Institute of Health Economics and Clinical Epidemiology, , University Hospital Cologne (Institut für Gesundheitsökonomie und Klinische Epidemiologie, Universitätsklinikum Köln), ; D-50924 Köln, Germany
                [4 ]GRID grid.411097.a, ISNI 0000 0000 8852 305X, 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 ]GRID grid.27593.3a, ISNI 0000 0001 2244 5164, 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 ]GRID grid.411097.a, ISNI 0000 0000 8852 305X, Teaching Unit of General Practice, , University Hospital Cologne (Schwerpunkt Allgemeinmedizin, Universitätsklinikum Köln), ; D-50924 Köln, Germany
                [8 ]GRID grid.5718.b, ISNI 0000 0001 2187 5445, Institute of General Practice, , University Duisburg-Essen (Institut für Allgemeinmedizin, Universität Duisburg-Essen), ; Hufelandstr. 55, D-45122 Essen, Germany
                [9 ]GRID grid.27593.3a, ISNI 0000 0001 2244 5164, Institute of Psychology, , German Sport University Cologne (Institut für Psychologie, Deutsche Sporthochschule Köln), ; Am Sportpark Müngersdorf 6, D-50933 Köln, Germany
                [10 ]GRID grid.22937.3d, ISNI 0000 0000 9259 8492, 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 ]GRID grid.411327.2, ISNI 0000 0001 2176 9917, 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
                [12 ]Barmer Health Insurance (Barmer Krankenversicherung), BARMER, Heerdter Lohweg 35, D-40549 Düsseldorf, Germany
                [13 ]GRID grid.439300.d, Central Research Institute of Ambulatory Health Care in Germany (Zentralinstitut für die Kassenärztliche Versorgung in Deutschland), ; Salzufer 8, D-10587 Berlin, Germany
                [14 ]GRID grid.10388.32, ISNI 0000 0001 2240 3300, Institute of Family Medicine and General Practice, , University of Bonn (Institut für Hausarztmedizin, Universität Bonn), ; Venusberg-Campus 1, D-53127 Bonn, Germany
                [15 ]GRID grid.412301.5, ISNI 0000 0000 8653 1507, Teaching Area of General Practice, , University Hospital RWTH Aachen (Lehrgebiet für Allgemeinmedizin Uniklinik RWTH Aachen), ; Pauwelsstraße 30, D-52074 Aachen, Germany
                Author information
                http://orcid.org/0000-0002-6993-5977
                Article
                5636
                10.1186/s13063-021-05636-4
                8475316
                34579783
                4b335f7a-5eb8-4492-8a96-881d14e7751a
                © The Author(s) 2021

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 2 April 2021
                : 15 September 2021
                Funding
                Funded by: G-BA
                Award ID: 01NVF18033
                Funded by: Otto-Friedrich-Universität Bamberg (3120)
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2021

                Medicine
                health services research,type 2 diabetes mellitus,coronary heart disease,peer support group,self-management,study protocol,pragmatic rct,pragmatic randomised controlled trial

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