TY - JOUR
T1 - Improving glycemic control in patients with type 2 diabetes mellitus through a peer support instant messaging service intervention (DiabPeerS)
T2 - study protocol for a randomized controlled trial
AU - Höld, Elisabeth
AU - Grüblbauer, Johanna
AU - Wiesholzer, Martin
AU - Wewerka-Kreimel, Daniela
AU - Stieger, Stefan
AU - Kuschei, Werner
AU - Kisser, Philip
AU - Gützer, Elisabeth
AU - Hemetek, Ursula
AU - Ebner-Zarl, Astrid
AU - Pripfl, Jürgen
N1 - Funding Information:
This study is publicly funded by the Gesellschaft für Forschungsförderung Niederösterreich m.b.H, Austria (Life Science Call 2018, LS18-021). The funding organization has no influence on the design, collection, analysis, and interpretation of data, or the writing of the manuscript.
Funding Information:
The authors gratefully acknowledge the financial support of the Gesellschaft für Forschungsförderung Niederösterreich m.b.H (GFF) and the provincial government of Lower Austria through the (Life) Science Calls (Project ID LS18-021). We would like to thank the NÖ Landesgesundheitsagentur, the Austrian diabetes self-help groups, and involved students for their support of this study. Furthermore, we acknowledge the permission to use the following questionnaires:
Funding Information:
The authors gratefully acknowledge the financial support of the Gesellschaft f?r Forschungsf?rderung Nieder?sterreich m.b.H (GFF) and the provincial government of Lower Austria through the (Life) Science Calls (Project ID LS18-021). We would like to thank the N? Landesgesundheitsagentur, the Austrian diabetes self-help groups, and involved students for their support of this study. Furthermore, we acknowledge the permission to use the following questionnaires: Department of General Practice and Health Services Research, University Hospital Heidelberg, Heidelberg, Germany for the SDSCA-G: Kamradt M, Bozorgmehr K, Krisam J, Freund T, Kiel M, Qreini M, et al. Assessing self-management in patients with diabetes mellitus type 2 in Germany: validation of a German version of the Summary of Diabetes Self-Care Activities measure (SDSCA-G). Health Qual Life Outcomes. 2014 Dec 18;12:185. Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University, Germany for the A14-Scale: Jank S, Bertsche T, Schellberg D, Herzog W, Haefeli WE. The A14-scale: development and evaluation of a questionnaire for assessment of adherence and individual barriers. Pharm World Sci 2009;31:426-31. Michigan Diabetes Research Center, Michigan, USA for the Diabetes Knowledge Scale. The project was supported by Grant Number P30DK020572 (MDRC) from the National Institute of Diabetes and Digestive and Kidney Diseases Collins GS, Mughal S, Barnett AH, Fitzgerald J, Lloyd CE. Modification and validation of the Revised Diabetes Knowledge Scale. Diabet Med. 2010. Finally, we thank for the opportunity to use the following questionnaires Schwarzer R, Jerusalem M. Generalized Self-Efficacy scale. In: Measures in health psychology: A user?s portfolio Causal and control beliefs. Winsor: NFER-NELSON; 1995. p. 35?7. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606?13. Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, et al. Assessing Psychosocial Distress in Diabetes: Development of the Diabetes Distress Scale. Diabetes Care. 2005 Mar 1;28(3):626?31 IPAQ International Questionnaire. Downloadable questionnaires [Internet]. [cited 2018 Aug 31]. Available from: https://sites.google.com/site/theipaq/questionnaire_links Danner D, Rammstedt B, Bluemke M, Treiber L, Berres S, Soto C, et al. Die deutsche Version des Big Five Inventory 2 (BFI-2). Zusammenstellung Sozialwissenschaftlicher Items Skalen ZIS [Internet]. 2016 [cited 2021 May 11]; Available from: http://zis.gesis.org/DoiId/zis247 EH is the study coordinator. EH, JG, MW, DWK, and JP conceived the study and led the proposal and protocol development. EH and JG wrote the first draft of the manuscript. JP edited and made substantial contributions to the manuscript. EH is responsible for study management, measurements, and data management. UH, AEZ, EH, JG, DWK, WK, and SS developed the IMS strategy and the trainings. JG and AEZ will be responsible for interpreting communication data. UH is the dietitian in contact with moderators. MW and WK are the clinicians responsible for analyzing biochemical parameters. PK and EG will carry out the FoKo database query and contact potential participants as well as internists and physicians in Lower Austria. SS will be responsible for statistical analysis. All authors read and approved the final manuscript. This study is publicly funded by the Gesellschaft f?r Forschungsf?rderung Nieder?sterreich m.b.H, Austria (Life Science Call 2018, LS18-021). The funding organization has no influence on the design, collection, analysis, and interpretation of data, or the writing of the manuscript. The Data Management Coordinating Center (EH, UH, AEZ, JG) will oversee the intra-study data sharing process, with input from the Data Management Subcommittee. Data sharing will be done in exclusively encrypted form. Also, only the encrypted data will be used for any publications. Medical samples will be destroyed after the analyses according to the quality criteria of ISO 9001 and will not be stored for further examinations. The collected data and backup copies are protected by passwords and are also only accessible to those persons who are entrusted with their processing and evaluation. For evaluation and publication, the data will be used in anonymized form only. Personal data will be kept separately from collected measurement data. An ID code is created for each participant (encryption by means of sequential numbering, from which only the assignment to the corresponding group is possible, but no conclusion regarding the identity of the participant).
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - BACKGROUND: Diabetes mellitus is one of the four priority non-communicable diseases worldwide. It can lead to serious long-term complications and produces significant costs. Due to the chronicle character of the disease, it requires continuous medical treatment and good therapy adherence of those suffering. Therefore, diabetes self-management education (DSME) (and support DSMES) plays a significant role to increase patient's self-management capacity and improve diabetes therapy. Research indicates that these outcomes might be difficult to maintain. Consequently, effective strategies to preserve the positive effects of DSMES are needed. Preliminary results show that peer support, which means support from a person who has experiential knowledge of a specific behavior or stressor and similar characteristics as the target population, is associated with better outcomes in terms of HbA1c, cardiovascular disease risk factors or self-efficacy at a lower cost compared to standard therapy. Peer-supported instant messaging services (IMS) approaches have significant potential for diabetes management because support can be provided easily and prompt, is inexpensive, and needs less effort to attend compared to standard therapy. The major objective of the study is to analyze the impact of a peer-supported IMS intervention in addition to a standard diabetes therapy on the glycemic control of type 2 diabetic patients.METHODS: A total of 205 participants with type 2 diabetes mellitus will be included and randomly assigned to an intervention or control group. Both groups will receive standard therapy, but the intervention group will participate in the peer-supported IMS intervention, additionally. The duration of the intervention will last for 7 months, followed by a follow-up of 7 months. Biochemical, behavioral, and psychosocial parameters will be measured before, in the middle, and after the intervention as well as after the follow-up.DISCUSSION: Type 2 diabetes mellitus and other non-communicable diseases put healthcare systems worldwide to the test. Peer-supported IMS interventions in addition to standard therapy might be part of new and cost-effective approaches to support patients independent from time and place.TRIAL REGISTRATION: ClinicalTrials.gov NCT04797429 . Registered on 15 March 2021.
AB - BACKGROUND: Diabetes mellitus is one of the four priority non-communicable diseases worldwide. It can lead to serious long-term complications and produces significant costs. Due to the chronicle character of the disease, it requires continuous medical treatment and good therapy adherence of those suffering. Therefore, diabetes self-management education (DSME) (and support DSMES) plays a significant role to increase patient's self-management capacity and improve diabetes therapy. Research indicates that these outcomes might be difficult to maintain. Consequently, effective strategies to preserve the positive effects of DSMES are needed. Preliminary results show that peer support, which means support from a person who has experiential knowledge of a specific behavior or stressor and similar characteristics as the target population, is associated with better outcomes in terms of HbA1c, cardiovascular disease risk factors or self-efficacy at a lower cost compared to standard therapy. Peer-supported instant messaging services (IMS) approaches have significant potential for diabetes management because support can be provided easily and prompt, is inexpensive, and needs less effort to attend compared to standard therapy. The major objective of the study is to analyze the impact of a peer-supported IMS intervention in addition to a standard diabetes therapy on the glycemic control of type 2 diabetic patients.METHODS: A total of 205 participants with type 2 diabetes mellitus will be included and randomly assigned to an intervention or control group. Both groups will receive standard therapy, but the intervention group will participate in the peer-supported IMS intervention, additionally. The duration of the intervention will last for 7 months, followed by a follow-up of 7 months. Biochemical, behavioral, and psychosocial parameters will be measured before, in the middle, and after the intervention as well as after the follow-up.DISCUSSION: Type 2 diabetes mellitus and other non-communicable diseases put healthcare systems worldwide to the test. Peer-supported IMS interventions in addition to standard therapy might be part of new and cost-effective approaches to support patients independent from time and place.TRIAL REGISTRATION: ClinicalTrials.gov NCT04797429 . Registered on 15 March 2021.
KW - Diabetes Mellitus, Type 2/diagnosis
KW - Glycemic Control
KW - Humans
KW - Noncommunicable Diseases
KW - Randomized Controlled Trials as Topic
KW - Self Care
KW - Self-Management
UR - http://www.scopus.com/inward/record.url?scp=85128325674&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06202-2
DO - 10.1186/s13063-022-06202-2
M3 - Journal article
C2 - 35422003
SN - 1745-6215
VL - 23
SP - 308
JO - Trials
JF - Trials
IS - 1
M1 - 308
ER -