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Health care effects and medical benefits of a smartphone-based diabetes self-management application: study protocol for a randomized controlled trial

BACKGROUND: Diabetes self-management is a mainstay of diabetes care, but the implementation of self-management regimens into daily life is complex and often results in discouragement and distress. Modern approaches such as smartphone-based self-management applications are therefore needed to support...

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Autores principales: Ehrmann, D., Eichinger, V., Vesper, I., Kober, J., Kraus, M., Schäfer, V., Hermanns, N., Kulzer, B., Silbermann, S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8996650/
https://www.ncbi.nlm.nih.gov/pubmed/35410241
http://dx.doi.org/10.1186/s13063-022-06248-2
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author Ehrmann, D.
Eichinger, V.
Vesper, I.
Kober, J.
Kraus, M.
Schäfer, V.
Hermanns, N.
Kulzer, B.
Silbermann, S.
author_facet Ehrmann, D.
Eichinger, V.
Vesper, I.
Kober, J.
Kraus, M.
Schäfer, V.
Hermanns, N.
Kulzer, B.
Silbermann, S.
author_sort Ehrmann, D.
collection PubMed
description BACKGROUND: Diabetes self-management is a mainstay of diabetes care, but the implementation of self-management regimens into daily life is complex and often results in discouragement and distress. Modern approaches such as smartphone-based self-management applications are therefore needed to support people with diabetes. Since reimbursability would increase the availability of such digital applications to people with diabetes, we designed a study that meets all scientific and methodological requirements set by the German Digital Healthcare Act to allow reimbursement for a specific application (mySugr PRO). Here, we report the protocol of this study that aims at evaluating the efficacy of the digital self-management application with regard to patient-reported outcomes and medical benefits. METHODS/DESIGN: This multicenter, open-label, randomized, parallel-group, controlled trial will evaluate the health care effects and medical benefits of mySugr PRO. A total of 466 people with diabetes will be randomly allocated (2:1 randomization) to the interventional group (n = 311) that will use the digital self-management application during the 12-week study period or the control group (n = 155; no usage of the application). Baseline and follow-up examinations will assess diabetes distress as the primary endpoint as well as empowerment, HbA1c, blood glucose data, self-management, general well-being, and treatment satisfaction as secondary endpoints. Statistical analyses will use an intention-to-treat procedure (using multiple imputation for missing values) as well as a per-protocol approach for sensitivity analysis. DISCUSSION: To the best of our knowledge, this study will be one of the largest diabetes-specific evaluations of a digital health application supporting people with diabetes in their diabetes self-management that follow the requirements of the German Digital Healthcare Act. TRIAL REGISTRATION: German Clinical Trial Register DRKS00022923. Registered on 22 October 2020.
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spelling pubmed-89966502022-04-12 Health care effects and medical benefits of a smartphone-based diabetes self-management application: study protocol for a randomized controlled trial Ehrmann, D. Eichinger, V. Vesper, I. Kober, J. Kraus, M. Schäfer, V. Hermanns, N. Kulzer, B. Silbermann, S. Trials Study Protocol BACKGROUND: Diabetes self-management is a mainstay of diabetes care, but the implementation of self-management regimens into daily life is complex and often results in discouragement and distress. Modern approaches such as smartphone-based self-management applications are therefore needed to support people with diabetes. Since reimbursability would increase the availability of such digital applications to people with diabetes, we designed a study that meets all scientific and methodological requirements set by the German Digital Healthcare Act to allow reimbursement for a specific application (mySugr PRO). Here, we report the protocol of this study that aims at evaluating the efficacy of the digital self-management application with regard to patient-reported outcomes and medical benefits. METHODS/DESIGN: This multicenter, open-label, randomized, parallel-group, controlled trial will evaluate the health care effects and medical benefits of mySugr PRO. A total of 466 people with diabetes will be randomly allocated (2:1 randomization) to the interventional group (n = 311) that will use the digital self-management application during the 12-week study period or the control group (n = 155; no usage of the application). Baseline and follow-up examinations will assess diabetes distress as the primary endpoint as well as empowerment, HbA1c, blood glucose data, self-management, general well-being, and treatment satisfaction as secondary endpoints. Statistical analyses will use an intention-to-treat procedure (using multiple imputation for missing values) as well as a per-protocol approach for sensitivity analysis. DISCUSSION: To the best of our knowledge, this study will be one of the largest diabetes-specific evaluations of a digital health application supporting people with diabetes in their diabetes self-management that follow the requirements of the German Digital Healthcare Act. TRIAL REGISTRATION: German Clinical Trial Register DRKS00022923. Registered on 22 October 2020. BioMed Central 2022-04-11 /pmc/articles/PMC8996650/ /pubmed/35410241 http://dx.doi.org/10.1186/s13063-022-06248-2 Text en © The Author(s) 2022 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
Ehrmann, D.
Eichinger, V.
Vesper, I.
Kober, J.
Kraus, M.
Schäfer, V.
Hermanns, N.
Kulzer, B.
Silbermann, S.
Health care effects and medical benefits of a smartphone-based diabetes self-management application: study protocol for a randomized controlled trial
title Health care effects and medical benefits of a smartphone-based diabetes self-management application: study protocol for a randomized controlled trial
title_full Health care effects and medical benefits of a smartphone-based diabetes self-management application: study protocol for a randomized controlled trial
title_fullStr Health care effects and medical benefits of a smartphone-based diabetes self-management application: study protocol for a randomized controlled trial
title_full_unstemmed Health care effects and medical benefits of a smartphone-based diabetes self-management application: study protocol for a randomized controlled trial
title_short Health care effects and medical benefits of a smartphone-based diabetes self-management application: study protocol for a randomized controlled trial
title_sort health care effects and medical benefits of a smartphone-based diabetes self-management application: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8996650/
https://www.ncbi.nlm.nih.gov/pubmed/35410241
http://dx.doi.org/10.1186/s13063-022-06248-2
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