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Completed

NCT Number: NCT04722289

The Together on Diabetes Intervention - a Realist Evaluation

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Behavior Delivery of Health Care Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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'

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Together on Diabetes

Behavioral

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

Primary outcomes

  1. Baseline, diet habits

    Time frame: Assessed among peers before study participation, 0 month

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

  2. Change from Baseline, diet habits at 6 month

    Time frame: Assessed among peers after study participation, at 6 month

    Improvements in the peers' diet habits (self-reported), Questionnaire data

  3. Baseline, physical activity (training)

    Time frame: 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

  4. Change from Baseline, physical activity (training) at 6 month

    Time frame: 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

  5. Baseline, physical activity (everyday activities)

    Time frame: 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

  6. Change from Baseline, physical activity (everyday activities) at 6 month

    Time frame: 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

  7. Baseline, diabetes medication adherence

    Time frame: 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

  8. Baseline, diabetes medication adherence

    Time frame: 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

  9. Baseline, Use of healthcare services (diabetes controls at the GP)

    Time frame: ssessed among peers before study participation, 0 month

    Number of diabetes controls at GP (self-reported), Questionnaire data

  10. Change from baseline, use of healthcare services (diabetes controls at the GP)

    Time frame: Assessed among peers after study participation, at 6 month

    Improvements in the number of diabetes controls at the GP (self-reported), Questionnaire data

  11. Baseline, use of healthcare services (diabetes controls at the foot therapist)

    Time frame: Assessed among peers before study participation, at 0 month

    Number of diabetes controls at the food therapist) (self-reported), Questionnaire data

  12. Change from baseline, use of healthcare services (diabetes controls at the foot therapist)

    Time frame: Assessed among peers after study participation, at 6 month

    Improvements in the number of diabetes controls at the food therapist) (self-reported), Questionnaire data

  13. Baseline, use of healthcare services (diabetes controls at the ophthalmologist )

    Time frame: Assessed among peers before study participation, at 0 month

    Number of diabetes controls at the ophthalmologist ) (self-reported), Questionnaire data

  14. Change from baseline, use of healthcare services (diabetes controls at the ophthalmologist )

    Time frame: Assessed among peers after study participation, at 6 month

    Improvements in the number of diabetes controls at the ophthalmologist ) (self-reported), Questionnaire data

Sponsors and collaborators

Lead sponsor

Center for Diabetes, Copenhagen Municipality

Other Gov

Collaborators

  • Innovation Fund Denmark
  • Novo Nordisk A/S
  • The Danish Diabetes Association
  • University of Copenhagen

Registry information

Official study title

The Together on Diabetes Intervention

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 25, 2021
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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