The Together on Diabetes Intervention - a Realist Evaluation

NCT ID: NCT04722289

Last Updated: 2021-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2020-05-01

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'

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Together on Diabetes

Intervention Type: BEHAVIORAL

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

Interventions

Together on Diabetes

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• 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).

Exclusion Criteria

• Poor regulated mental disease.

Peer supporters

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Innovation Fund Denmark

INDIV

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

The Danish Diabetes Association

OTHER

Sponsor Role: collaborator

Center for Diabetes, Copenhagen Municipality

OTHER_GOV

Sponsor Role: lead

Responsible Party

Stine Garn

Evaluator, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 34488884 (View on PubMed)

Other Identifiers

CDiabetesCopenhagen

Identifier Type: -

Identifier Source: org_study_id