The Together on Diabetes Intervention - a Realist Evaluation

Type 2 Diabetes Mellitus Clinical Trial

Official title:

The Together on Diabetes Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04722289
• Other study ID #: CDiabetesCopenhagen
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: January 2021
• Source: Center for Diabetes, Copenhagen Municipality
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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'

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Delivery of Health Care
• Diabetes Mellitus
• Health Behavior
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Together on Diabetes
Social and emotional support'; 'Assistance in daily management'; and 'Linkage to healthcare services'

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Center for Diabetes, Copenhagen Municipality	Innovation Fund Denmark, Novo Nordisk A/S, The Danish Diabetes Association, University of Copenhagen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline, diet habits	Peers' diet habits (self-reported), Questionnaire data	Assessed among peers before study participation, 0 month
Primary	Change from Baseline, diet habits at 6 month	Improvements in the peers' diet habits (self-reported), Questionnaire data	Assessed among peers after study participation, at 6 month
Primary	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	Assessed among peers before study participation, 0 month
Primary	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	Assessed among peers after study participation, at 6 month
Primary	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	Assessed among peers before study participation, 0 month
Primary	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	Assessed among peers after study participation, at 6 month
Primary	Baseline, diabetes medication adherence	Peers' diabetes medication adherence measured by how often they forget to take their prescribed diabetes medication (self-reported), Questionnaire data	Assessed among peers before study participation, at 0 month
Primary	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	Assessed among peers before study participation, at 0 month
Primary	Baseline, Use of healthcare services (diabetes controls at the GP)	Number of diabetes controls at GP (self-reported), Questionnaire data	ssessed among peers before study participation, 0 month
Primary	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	Assessed among peers after study participation, at 6 month
Primary	Baseline, use of healthcare services (diabetes controls at the foot therapist)	Number of diabetes controls at the food therapist) (self-reported), Questionnaire data	Assessed among peers before study participation, at 0 month
Primary	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	Assessed among peers after study participation, at 6 month
Primary	Baseline, use of healthcare services (diabetes controls at the ophthalmologist )	Number of diabetes controls at the ophthalmologist ) (self-reported), Questionnaire data	Assessed among peers before study participation, at 0 month
Primary	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	Assessed among peers after study participation, at 6 month