The Together on Diabetes Intervention - a Realist Evaluation

NCT04722289 | Completed

• 1 other identifier: CDiabetesCopenhagen
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (14)

• Baseline, diet habits

  Peers' diet habits (self-reported), Questionnaire data

  Assessed among peers before study participation, 0 month

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Together on Diabetes

EXPERIMENTAL

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

Interventions

Together on Diabetes BEHAVIORAL

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

Together on Diabetes

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Poorly regulated T2D
• multi-morbidity
• no employment
• low/no education
• no contact to the healthcare system
• living alone with no/spare social network.

You may not qualify if:

• \- Poor regulated mental disease.
• Peer supporters
• 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).

Sponsors & Collaborators

• Center for Diabetes, Copenhagen Municipality: lead
• Novo Nordisk A/S: collaborator
• Innovation Fund Denmark: collaborator
• University of Copenhagen: collaborator
• The Danish Diabetes Association: collaborator

Related Publications (1)

• 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.

  PMID: 34488884 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Health Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Evaluator, PhD

Model Details: 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).

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 25, 2021
• Study Start: December 1, 2017
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: January 25, 2021

Record last verified: 2021-01