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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
BACKGROUND: 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...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
BioMed Central
2021
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8475316/ https://www.ncbi.nlm.nih.gov/pubmed/34579783 http://dx.doi.org/10.1186/s13063-021-05636-4 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Konerding, Uwe |
| collection | PubMed |
| description | BACKGROUND: 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. |
| format | Online Article Text |
| id | pubmed-8475316 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2021 |
| publisher | BioMed Central |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-84753162021-09-28 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 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 Trials Study Protocol BACKGROUND: 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. BioMed Central 2021-09-27 /pmc/articles/PMC8475316/ /pubmed/34579783 http://dx.doi.org/10.1186/s13063-021-05636-4 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/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/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://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. |
| spellingShingle | Study Protocol 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 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Study Protocol |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8475316/ https://www.ncbi.nlm.nih.gov/pubmed/34579783 http://dx.doi.org/10.1186/s13063-021-05636-4 |
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pragmaticrandomisedcontrolledtrialreferringtoapersonalisedselfmanagementsupportprogrammepsupforpersonsenrolledinadiseasemanagementprogrammefortype2diabetesmellitusandorforcoronaryheartdisease AT vitiniusfrank pragmaticrandomisedcontrolledtrialreferringtoapersonalisedselfmanagementsupportprogrammepsupforpersonsenrolledinadiseasemanagementprogrammefortype2diabetesmellitusandorforcoronaryheartdisease AT weltermannbirgitta pragmaticrandomisedcontrolledtrialreferringtoapersonalisedselfmanagementsupportprogrammepsupforpersonsenrolledinadiseasemanagementprogrammefortype2diabetesmellitusandorforcoronaryheartdisease AT wilddorothea pragmaticrandomisedcontrolledtrialreferringtoapersonalisedselfmanagementsupportprogrammepsupforpersonsenrolledinadiseasemanagementprogrammefortype2diabetesmellitusandorforcoronaryheartdisease AT wilmstefan pragmaticrandomisedcontrolledtrialreferringtoapersonalisedselfmanagementsupportprogrammepsupforpersonsenrolledinadiseasemanagementprogrammefortype2diabetesmellitusandorforcoronaryheartdisease AT stockstephanie pragmaticrandomisedcontrolledtrialreferringtoapersonalisedselfmanagementsupportprogrammepsupforpersonsenrolledinadiseasemanagementprogrammefortype2diabetesmellitusandorforcoronaryheartdisease |