The Together on Diabetes Intervention - a Realist Evaluation

Sponsor

Center for Diabetes, Copenhagen Municipality (Other)

Overall Status

Completed

CT.gov ID

NCT04722289

Collaborator

Novo Nordisk A/S (Industry), Innovation Fund Denmark (Other), University of Copenhagen (Other), The Danish Diabetes Association (Other)

Enrollment

Arm

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Health Behavior Delivery of Health Care	Behavioral: Together on Diabetes	N/A

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'

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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).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)

Primary Purpose:

Supportive Care

Official Title:

The Together on Diabetes Intervention

Actual Study Start Date :

Dec 1, 2017

Actual Primary Completion Date :

May 1, 2020

Actual Study Completion Date :

May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Together on Diabetes 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.	Behavioral: Together on Diabetes Social and emotional support'; 'Assistance in daily management'; and 'Linkage to healthcare services'

Arm

Intervention/Treatment

Experimental: Together on Diabetes

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.

Behavioral: Together on Diabetes

Social and emotional support'; 'Assistance in daily management'; and 'Linkage to healthcare services'

Outcome Measures

Primary Outcome Measures

Baseline, diet habits [Assessed among peers before study participation, 0 month]
Peers' diet habits (self-reported), Questionnaire data
Change from Baseline, diet habits at 6 month [Assessed among peers after study participation, at 6 month]
Improvements in the peers' diet habits (self-reported), Questionnaire data
Baseline, physical activity (training) [Assessed among peers before study participation, 0 month]
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 [Assessed among peers after study participation, 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) [Assessed among peers before study participation, 0 month]
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 [Assessed among peers after study participation, 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 [Assessed among peers before study participation, at 0 month]
Peers' diabetes medication adherence measured by how often they forget to take their prescribed diabetes medication (self-reported), Questionnaire data
Baseline, diabetes medication adherence [Assessed among peers before study participation, at 0 month]
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) [ssessed among peers before study participation, 0 month]
Number of diabetes controls at GP (self-reported), Questionnaire data
Change from baseline, use of healthcare services (diabetes controls at the GP) [Assessed among peers after study participation, at 6 month]
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) [Assessed among peers before study participation, at 0 month]
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) [Assessed among peers after study participation, at 6 month]
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 ) [Assessed among peers before study participation, at 0 month]
Number of diabetes controls at the ophthalmologist ) (self-reported), Questionnaire data
Change from baseline, use of healthcare services (diabetes controls at the ophthalmologist ) [Assessed among peers after study participation, at 6 month]
Improvements in the number of diabetes controls at the ophthalmologist ) (self-reported), Questionnaire data

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).