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The Together on Diabetes Intervention - a Realist Evaluation

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ClinicalTrials.gov Identifier: NCT04722289
Recruitment Status : Completed
First Posted : January 25, 2021
Last Update Posted : January 25, 2021
Sponsor:
Collaborators:
Novo Nordisk A/S
Innovation Fund Denmark
University of Copenhagen
The Danish Diabetes Association
Information provided by (Responsible Party):
Stine Garn, Center for Diabetes, Copenhagen Municipality

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 Not Applicable

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'

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Study Type : Interventional  (Clinical Trial)
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).

Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Together on Diabetes Intervention
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


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'




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
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Responsible Party: Stine Garn, Evaluator, PhD, Center for Diabetes, Copenhagen Municipality
ClinicalTrials.gov Identifier: NCT04722289    
Other Study ID Numbers: CDiabetesCopenhagen
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stine Garn, Center for Diabetes, Copenhagen Municipality:
Realist evaluation
Complex intervention
Implementation
Mechanism
Contextual factors
Peer support
Health inequalites
Diabetes self-management
Healthcare services
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases