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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Apr 4, 2022
Open Peer Review Period: Apr 4, 2022 - May 30, 2022
Date Accepted: Jul 12, 2022
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Capturing Diabetes-Related Distress and Burden From the Perspective of Patients With Type 1 or Type 2 Diabetes: Protocol for an Explorative Mixed Methods Study

Zara S, Kruse J, Leveling AM, Schmitz J, Hempler I, Kampling H

Capturing Diabetes-Related Distress and Burden From the Perspective of Patients With Type 1 or Type 2 Diabetes: Protocol for an Explorative Mixed Methods Study

JMIR Res Protoc 2022;11(8):e38477

DOI: 10.2196/38477

PMID: 35916703

PMCID: 9379798

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

Capturing diabetes-related distress and burden from the individual perspective of patients with type 1 or type 2 diabetes: study protocol for an explorative study applying a mixed-methods design

  • Sandra Zara; 
  • Johannes Kruse; 
  • Anna Maria Leveling; 
  • Jana Schmitz; 
  • Isabelle Hempler; 
  • Hanna Kampling

ABSTRACT

Background:

Diabetes is one of the most common diseases worldwide and is associated with increased morbidity, mortality and reduced quality of life. Many patients experience high diabetes-related distress as well as depression and anxiety symptoms, which are associated with poor diabetes self-management. As the disease management is a central component in diabetes treatment, poor management enhances the occurrence of micro- and macrovascular complications. This emphasizes the relevance of reducing diabetes-related distress and providing adequate treatment options addressing the individual psychosocial burden of patients with diabetes. Since the patients’ perspective diverges significantly from the practitioners’ in terms of relevant treatment aspects, the patients’ individual perspective on e.g. barriers and facilitators of diabetes treatment are crucial for adequate and effective treatment as well as improvement of self-management, and therefore need to be further explored.

Objective:

This study aims to examine diabetes-related distress, the course of distress throughout the diabetes management as well as barriers and facilitating factors in dealing with diabetes from the individual perspective of patients with type 1 and type 2 diabetes.

Methods:

The study employs a mixed-methods design combining qualitative and quantitative data. Semi-structured interviews (N=40) will be conducted with patients with type 1 diabetes (n=20) and patients with type 2 diabetes (n=20). The primary outcomes comprise (I) diabetes-related distress, (II) the severity of distress, (III) the course of distress throughout the diabetes management, (IV) barriers as well as (V) facilitating factors. Questionnaires will provide data on secondary outcomes: diabetes-related emotional distress (PAID), symptoms of depression and anxiety (PHQ-D), personality functioning (OPD-SQS), mentalizing capacities (MZQ), epistemic trust (ETMCQ) as well as experiences of child maltreatment (CTQ), and the overall health status of the patient (routine medical data).

Results:

As of April 2022, the conceptualization phase of the study conduct was finalized. The ethics approval has been received in January 2022 from the local ethics committee of the Medical Department of the Justus-Liebig University Giessen (AZ 161/21).

Conclusions:

This study will provide insights into the individual perspective of patients with type 1 and type 2 diabetes regarding their experiences with diabetes management, and what they perceive to be particularly relevant, obstructive or beneficial. The insights gained could help tailor diabetes treatment more to the individual needs of patients with diabetes, and therefore optimize diabetes self-management. Clinical Trial: The study has been registered with the German Clinical Trial Register (DRKS-ID: DRKS00024999).


 Citation

Please cite as:

Zara S, Kruse J, Leveling AM, Schmitz J, Hempler I, Kampling H

Capturing Diabetes-Related Distress and Burden From the Perspective of Patients With Type 1 or Type 2 Diabetes: Protocol for an Explorative Mixed Methods Study

JMIR Res Protoc 2022;11(8):e38477

DOI: 10.2196/38477

PMID: 35916703

PMCID: 9379798

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