Type 2 Diabetes MellitusNCT04722289
The Together on Diabetes Intervention - a Realist Evaluation
A study testing Together on Diabetes in people with Type 2 Diabetes Mellitus and Health Behavior, run by Center for Diabetes, Copenhagen Municipality.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes Mellitus, Health Behavior, Delivery of Health Care
- What is being tested?
- Together on Diabetes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Poorly regulated T2D
- multi-morbidity
- no employment
- low/no education
- no contact to the healthcare system
- living alone with no/spare social network.
Show all 12Show fewer
- 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).
Who cannot join
- Poor regulated mental disease.
- Peer supporters
About this study
Official title: The Together on Diabetes Intervention
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.
Read more
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.
Read the 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'
- Being tested
- Together on Diabetes
- Keywords
- Realist evaluation, Complex intervention, Implementation, Mechanism, Contextual factors, Peer support, Health inequalites, Diabetes self-management, Healthcare services
- Medical subject headings
- Diabetes Mellitus, Type 2, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Together on DiabetesBehavioural
Social and emotional support'; 'Assistance in daily management'; and 'Linkage to healthcare services'
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Together on Diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline, diet habits
Peers' diet habits (self-reported), Questionnaire data
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Assessed among peers after study participation, at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Dec 2017
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Diabetes, Copenhagen Municipality
- Sponsor type
- Other government
- Collaborators
- Novo Nordisk A/S, Innovation Fund Denmark, University of Copenhagen, The Danish Diabetes Association
- Responsible party
- Principal investigator, Stine Garn, Center for Diabetes, Copenhagen Municipality
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722289
- Sponsor's protocol ID
- CDiabetesCopenhagen
- Status last verified
- Jan 2021
- First submitted
- 8 Jan 2021
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34488884
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Together on Diabetes Intervention
- ClinicalTrials.gov ID
- NCT04722289
- Acronym / sponsor ID
- CDiabetesCopenhagen
- Keywords
- Realist evaluation, Complex intervention, Implementation, Mechanism, Contextual factors, Peer support, Health inequalites, Diabetes self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Center for Diabetes, Copenhagen MunicipalityOther government
- Collaborators
- Novo Nordisk A/S, Innovation Fund Denmark, University of Copenhagen, The Danish Diabetes Association
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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'
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Together on Diabetes | Experimental | Behavioral: Together on DiabetesThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Poorly regulated T2D
- multi-morbidity
- no employment
- low/no education
- no contact to the healthcare system
Key exclusion criteria (2 listed)
- Poor regulated mental disease.
- Peer supporters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Together on DiabetesSocial and emotional support'; 'Assistance in daily management'; and 'Linkage to healthcare services' | Behavioural | Together on Diabetes |
Primary outcome
Baseline, diet habits
Time frame: Assessed among peers before study participation, 0 month
Peers' diet habits (self-reported), Questionnaire data
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Derived from this study: PubMed 34488884Garn 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.
Related trials for Type 2 Diabetes Mellitus
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Together on Diabetes in people with Type 2 Diabetes Mellitus and Health Behavior, run by Center for Diabetes, Copenhagen Municipality.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline, diet habits (time frame: Assessed among peers before study participation, 0 month). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04722289, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.