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The Together on Diabetes Intervention - a Realist Evaluation

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Together on Diabetes
Sponsored by
Center for Diabetes, Copenhagen Municipality
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Mellitus focused on measuring Realist evaluation, Complex intervention, Implementation, Mechanism, Contextual factors, Peer support, Health inequalites, Diabetes self-management, Healthcare services

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Together on Diabetes

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Baseline, diet habits
    Peers' diet habits (self-reported), Questionnaire data
    Change from Baseline, diet habits at 6 month
    Improvements in the peers' diet habits (self-reported), Questionnaire data
    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
    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
    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
    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
    Baseline, diabetes medication adherence
    Peers' diabetes medication adherence measured by how often they forget to take their prescribed diabetes medication (self-reported), Questionnaire data
    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
    Baseline, Use of healthcare services (diabetes controls at the GP)
    Number of diabetes controls at GP (self-reported), Questionnaire data
    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
    Baseline, use of healthcare services (diabetes controls at the foot therapist)
    Number of diabetes controls at the food therapist) (self-reported), Questionnaire data
    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
    Baseline, use of healthcare services (diabetes controls at the ophthalmologist )
    Number of diabetes controls at the ophthalmologist ) (self-reported), Questionnaire data
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    January 8, 2021
    Last Updated
    January 20, 2021
    Sponsor
    Center for Diabetes, Copenhagen Municipality
    Collaborators
    Novo Nordisk A/S, Innovation Fund Denmark, University of Copenhagen, The Danish Diabetes Association
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04722289
    Brief Title
    The Together on Diabetes Intervention - a Realist Evaluation
    Official Title
    The Together on Diabetes Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2017 (Actual)
    Primary Completion Date
    May 1, 2020 (Actual)
    Study Completion Date
    May 1, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Center for Diabetes, Copenhagen Municipality
    Collaborators
    Novo Nordisk A/S, Innovation Fund Denmark, University of Copenhagen, The Danish Diabetes Association

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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'

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Together on Diabetes
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Together on Diabetes
    Intervention Description
    Social and emotional support'; 'Assistance in daily management'; and 'Linkage to healthcare services'
    Primary Outcome Measure Information:
    Title
    Baseline, diet habits
    Description
    Peers' diet habits (self-reported), Questionnaire data
    Time Frame
    Assessed among peers before study participation, 0 month
    Title
    Change from Baseline, diet habits at 6 month
    Description
    Improvements in the peers' diet habits (self-reported), Questionnaire data
    Time Frame
    Assessed among peers after study participation, at 6 month
    Title
    Baseline, physical activity (training)
    Description
    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
    Time Frame
    Assessed among peers before study participation, 0 month
    Title
    Change from Baseline, physical activity (training) at 6 month
    Description
    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
    Time Frame
    Assessed among peers after study participation, at 6 month
    Title
    Baseline, physical activity (everyday activities)
    Description
    Peers' physical activity level measured by time spend in a typical week on everyday activities (eg. walking, cycling or gardening? (self-reported), Questionnaire data
    Time Frame
    Assessed among peers before study participation, 0 month
    Title
    Change from Baseline, physical activity (everyday activities) at 6 month
    Description
    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
    Time Frame
    Assessed among peers after study participation, at 6 month
    Title
    Baseline, diabetes medication adherence
    Description
    Peers' diabetes medication adherence measured by how often they forget to take their prescribed diabetes medication (self-reported), Questionnaire data
    Time Frame
    Assessed among peers before study participation, at 0 month
    Title
    Baseline, diabetes medication adherence
    Description
    Improvements in peers' diabetes medication adherence measured by how often they forget to take their prescribed diabetes medication (self-reported), Questionnaire data
    Time Frame
    Assessed among peers before study participation, at 0 month
    Title
    Baseline, Use of healthcare services (diabetes controls at the GP)
    Description
    Number of diabetes controls at GP (self-reported), Questionnaire data
    Time Frame
    ssessed among peers before study participation, 0 month
    Title
    Change from baseline, use of healthcare services (diabetes controls at the GP)
    Description
    Improvements in the number of diabetes controls at the GP (self-reported), Questionnaire data
    Time Frame
    Assessed among peers after study participation, at 6 month
    Title
    Baseline, use of healthcare services (diabetes controls at the foot therapist)
    Description
    Number of diabetes controls at the food therapist) (self-reported), Questionnaire data
    Time Frame
    Assessed among peers before study participation, at 0 month
    Title
    Change from baseline, use of healthcare services (diabetes controls at the foot therapist)
    Description
    Improvements in the number of diabetes controls at the food therapist) (self-reported), Questionnaire data
    Time Frame
    Assessed among peers after study participation, at 6 month
    Title
    Baseline, use of healthcare services (diabetes controls at the ophthalmologist )
    Description
    Number of diabetes controls at the ophthalmologist ) (self-reported), Questionnaire data
    Time Frame
    Assessed among peers before study participation, at 0 month
    Title
    Change from baseline, use of healthcare services (diabetes controls at the ophthalmologist )
    Description
    Improvements in the number of diabetes controls at the ophthalmologist ) (self-reported), Questionnaire data
    Time Frame
    Assessed among peers after study participation, at 6 month

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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).

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34488884
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    The Together on Diabetes Intervention - a Realist Evaluation

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