The Together on Diabetes Intervention - a Realist Evaluation
Primary Purpose
Type 2 Diabetes Mellitus, Health Behavior, Delivery of Health Care
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Together on Diabetes
Sponsored by
About this trial
This is an interventional supportive care trial for Type 2 Diabetes Mellitus focused on measuring Realist evaluation, Complex intervention, Implementation, Mechanism, Contextual factors, Peer support, Health inequalites, Diabetes self-management, Healthcare services
Eligibility Criteria
Peers:
Inclusion Criteria:
- Poorly regulated T2D
- multi-morbidity
- no employment
- low/no education
- no contact to the healthcare system
- living alone with no/spare social network.
Exclusion Criteria:
- Poor regulated mental disease.
Peer supporters
Inclusion criteria:
- Well-regulated T2D
- Basic knowledge about T2D and the Danish healthcare system;
- Good communication skills
- Empathy
- An interest in supporting a socially vulnerable person with T2D
- Available two hours every second week for at least six-month (the intervention period).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Together on Diabetes
Arm Description
The intervention consists of five components: Recruitment of peers and peer supporters; training of peer supporters; matching peers and peer supporters; individual face-to-face meetings between peers and peer supporters; and ongoing supervision and network meetings for peer supporters.
Outcomes
Primary Outcome Measures
Baseline, diet habits
Peers' diet habits (self-reported), Questionnaire data
Change from Baseline, diet habits at 6 month
Improvements in the peers' diet habits (self-reported), Questionnaire data
Baseline, physical activity (training)
Peers' physical activity level measured by time spend in a typical week on physiclal acitivty were they are breathing (eg. running, exercise gymnastics or ball sports) (self-reported), Questionnaire data
Change from Baseline, physical activity (training) at 6 month
Improvements in the peers' physical activity level measured by time spend in a typical week on physiclal acitivty were they are breathing (eg. running, exercise gymnastics or ball sports) (self-reported), Questionnaire data
Baseline, physical activity (everyday activities)
Peers' physical activity level measured by time spend in a typical week on everyday activities (eg. walking, cycling or gardening? (self-reported), Questionnaire data
Change from Baseline, physical activity (everyday activities) at 6 month
Improvements in the peers' physical activity level measured by time spend in a typical week on everyday activities (eg. walking, cycling or gardening? (self-reported), Questionnaire data
Baseline, diabetes medication adherence
Peers' diabetes medication adherence measured by how often they forget to take their prescribed diabetes medication (self-reported), Questionnaire data
Baseline, diabetes medication adherence
Improvements in peers' diabetes medication adherence measured by how often they forget to take their prescribed diabetes medication (self-reported), Questionnaire data
Baseline, Use of healthcare services (diabetes controls at the GP)
Number of diabetes controls at GP (self-reported), Questionnaire data
Change from baseline, use of healthcare services (diabetes controls at the GP)
Improvements in the number of diabetes controls at the GP (self-reported), Questionnaire data
Baseline, use of healthcare services (diabetes controls at the foot therapist)
Number of diabetes controls at the food therapist) (self-reported), Questionnaire data
Change from baseline, use of healthcare services (diabetes controls at the foot therapist)
Improvements in the number of diabetes controls at the food therapist) (self-reported), Questionnaire data
Baseline, use of healthcare services (diabetes controls at the ophthalmologist )
Number of diabetes controls at the ophthalmologist ) (self-reported), Questionnaire data
Change from baseline, use of healthcare services (diabetes controls at the ophthalmologist )
Improvements in the number of diabetes controls at the ophthalmologist ) (self-reported), Questionnaire data
Secondary Outcome Measures
Full Information
NCT ID
NCT04722289
First Posted
January 8, 2021
Last Updated
January 20, 2021
Sponsor
Center for Diabetes, Copenhagen Municipality
Collaborators
Novo Nordisk A/S, Innovation Fund Denmark, University of Copenhagen, The Danish Diabetes Association
1. Study Identification
Unique Protocol Identification Number
NCT04722289
Brief Title
The Together on Diabetes Intervention - a Realist Evaluation
Official Title
The Together on Diabetes Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Center for Diabetes, Copenhagen Municipality
Collaborators
Novo Nordisk A/S, Innovation Fund Denmark, University of Copenhagen, The Danish Diabetes Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Danish healthcare system is universal and free of charge for Danish citizens, as all healthcare services are financed by general taxes. However, socioeconomic differences exist in access to healthcare services, treatment, and consequences of type 2-diabetes (T2D).
Using a realistic evaluation approach, this study aimed to evaluate the implementation of a Danish peer support intervention, targeted on improving self-management and use of healthcare services among socially vulnerable people with type 2-diabetes ("peers"). The study focused on the mechanisms generating the intended outcomes. Further, how contextual factors in peers' everyday life facilitated or hindered the mechanisms to operate.
The study design is a multi-method case study (n=9). Data include qualitative semi-structured interviews with four key groups of informants (peer, peer supporter, project manager, and a diabetes nurse). Each type of informant per case was interviewed (n=25) to obtain different perspectives of how the peers' interacted, and benefited from the intervention. All interviews were completed immediately after the after the 6-month intervention.
Further, a quantitative survey was conducted among peers at baseline (N=9) and follow-up (N=9) to obtain information about how peers' individual contextual factors, such as their sociodemographic characteristics, co-morbidity, diabetes complications, social relations, and other life events influenced how they perceived and interacted in the intervention. Further, to measure improvements in their diabetes-self management (DSM) and use of healthcare services (outcomes). Questions from the Danish National Health Survey were used to measure DSM: (eating habits, physical activity,and medication intake). Use of healthcare services was measured by the number of times (during a 12-month period) the peers' attended diabetes controls at the GP; food therapist, and ophthalmologist or had other form of contacts with relevant health care services.
All data were collected between February 2018 and April 2020.
Hypothesis: 6-month individual face-to-face peer support provided by non-professional persons with T2D can improve self-management and use of healthcare services among socially vulnerable people with T2D if contextual factors such as peers' sociodemographic characteristics, health condition, and social relations facilitate their engagement in the intervention. Potential mechanisms that generate the expected outcomes might be: peers' motivation, trust, perceived beliefs and needs; and experience of being supported by the peer supporters.
Detailed Description
The intervention consists of five components: Recruitment of peers and peer supporters; training of peer supporters; match making of peers and peer supporters; individual face-to-face meetings between peers and peer supporters; and ongoing supervision and network meetings for peer supporters. The peer support meetings are held approximately every second week for six months and contain three activities: 'Social and emotional support'; 'Assistance in daily management'; and 'Linkage to healthcare services'
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Health Behavior, Delivery of Health Care
Keywords
Realist evaluation, Complex intervention, Implementation, Mechanism, Contextual factors, Peer support, Health inequalites, Diabetes self-management, Healthcare services
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A multi-method case study approach was used to identify mechanisms generating improved diabetes self-management and use of healthcare services (outcome) Thus, using this method, it enabled to investigate similarities and differences in how the mechanisms operated depending on peers' context.
All peers and peer supporters included and matched in the intervention from February 2018 to July 2019 were invited by the project manager to participate in this study. In total, 9 out of 12 pairs who completed the intervention during this period accepted the invitation, and were thereby selected as cases. The peers were recruited through CfD (N=7), their GP (N=1), and the home care (N=2). The peer supporters were recruited among people who had completed a patient education in CFD (N=5), by members from the DDA (N=2), their GP (N=1), or by people who applied via 'Together on Diabetes' webpage (N=2).
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Together on Diabetes
Arm Type
Experimental
Arm Description
The intervention consists of five components: Recruitment of peers and peer supporters; training of peer supporters; matching peers and peer supporters; individual face-to-face meetings between peers and peer supporters; and ongoing supervision and network meetings for peer supporters.
Intervention Type
Behavioral
Intervention Name(s)
Together on Diabetes
Intervention Description
Social and emotional support'; 'Assistance in daily management'; and 'Linkage to healthcare services'
Primary Outcome Measure Information:
Title
Baseline, diet habits
Description
Peers' diet habits (self-reported), Questionnaire data
Time Frame
Assessed among peers before study participation, 0 month
Title
Change from Baseline, diet habits at 6 month
Description
Improvements in the peers' diet habits (self-reported), Questionnaire data
Time Frame
Assessed among peers after study participation, at 6 month
Title
Baseline, physical activity (training)
Description
Peers' physical activity level measured by time spend in a typical week on physiclal acitivty were they are breathing (eg. running, exercise gymnastics or ball sports) (self-reported), Questionnaire data
Time Frame
Assessed among peers before study participation, 0 month
Title
Change from Baseline, physical activity (training) at 6 month
Description
Improvements in the peers' physical activity level measured by time spend in a typical week on physiclal acitivty were they are breathing (eg. running, exercise gymnastics or ball sports) (self-reported), Questionnaire data
Time Frame
Assessed among peers after study participation, at 6 month
Title
Baseline, physical activity (everyday activities)
Description
Peers' physical activity level measured by time spend in a typical week on everyday activities (eg. walking, cycling or gardening? (self-reported), Questionnaire data
Time Frame
Assessed among peers before study participation, 0 month
Title
Change from Baseline, physical activity (everyday activities) at 6 month
Description
Improvements in the peers' physical activity level measured by time spend in a typical week on everyday activities (eg. walking, cycling or gardening? (self-reported), Questionnaire data
Time Frame
Assessed among peers after study participation, at 6 month
Title
Baseline, diabetes medication adherence
Description
Peers' diabetes medication adherence measured by how often they forget to take their prescribed diabetes medication (self-reported), Questionnaire data
Time Frame
Assessed among peers before study participation, at 0 month
Title
Baseline, diabetes medication adherence
Description
Improvements in peers' diabetes medication adherence measured by how often they forget to take their prescribed diabetes medication (self-reported), Questionnaire data
Time Frame
Assessed among peers before study participation, at 0 month
Title
Baseline, Use of healthcare services (diabetes controls at the GP)
Description
Number of diabetes controls at GP (self-reported), Questionnaire data
Time Frame
ssessed among peers before study participation, 0 month
Title
Change from baseline, use of healthcare services (diabetes controls at the GP)
Description
Improvements in the number of diabetes controls at the GP (self-reported), Questionnaire data
Time Frame
Assessed among peers after study participation, at 6 month
Title
Baseline, use of healthcare services (diabetes controls at the foot therapist)
Description
Number of diabetes controls at the food therapist) (self-reported), Questionnaire data
Time Frame
Assessed among peers before study participation, at 0 month
Title
Change from baseline, use of healthcare services (diabetes controls at the foot therapist)
Description
Improvements in the number of diabetes controls at the food therapist) (self-reported), Questionnaire data
Time Frame
Assessed among peers after study participation, at 6 month
Title
Baseline, use of healthcare services (diabetes controls at the ophthalmologist )
Description
Number of diabetes controls at the ophthalmologist ) (self-reported), Questionnaire data
Time Frame
Assessed among peers before study participation, at 0 month
Title
Change from baseline, use of healthcare services (diabetes controls at the ophthalmologist )
Description
Improvements in the number of diabetes controls at the ophthalmologist ) (self-reported), Questionnaire data
Time Frame
Assessed among peers after study participation, at 6 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Peers:
Inclusion Criteria:
Poorly regulated T2D
multi-morbidity
no employment
low/no education
no contact to the healthcare system
living alone with no/spare social network.
Exclusion Criteria:
- Poor regulated mental disease.
Peer supporters
Inclusion criteria:
Well-regulated T2D
Basic knowledge about T2D and the Danish healthcare system;
Good communication skills
Empathy
An interest in supporting a socially vulnerable person with T2D
Available two hours every second week for at least six-month (the intervention period).
12. IPD Sharing Statement
Citations:
PubMed Identifier
34488884
Citation
Garn SD, Glumer C, Villadsen SF, Malling GMH, Christensen U. Understanding the mechanisms generating outcomes in a Danish peer support intervention for socially vulnerable people with type 2-diabetes: a realist evaluation. Arch Public Health. 2021 Sep 6;79(1):160. doi: 10.1186/s13690-021-00676-3.
Results Reference
derived
Learn more about this trial
The Together on Diabetes Intervention - a Realist Evaluation
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