Type 2 DiabetesOVERCOMENCT04601311
A Guided Self-determination Intervention Versus Attention Control for People With Type 2 Diabetes in Outpatient Clinics
A study testing Guided self-determination and Personal support in goal-pursuing in people with Type 2 Diabetes, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Background In management of type 2 diabetes, autonomy supporting interventions may be a prerequisite to achieve 'real life' patient engagement and more long-term improvement. Preliminary evidence has previously shown that the autonomy supporting intervention, guided self-determination method might have effect on HbA1c… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Guided self-determination and Personal support in goal-pursuing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Nov 2020to 1 Dec 2022
- 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 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age.
- Diagnosed with type 2 diabetes ≥ 3 months according to the International Classification System of Diseases (ICD-11.2-11.9) [43].
- Signed informed consent
Who cannot join
- Pregnancy
- Prior participation in GSD course(s) for the past two years
- Lack of signed of informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Anne Sophie Mathiesen
Copenhagen, 2200
Anne Sophie Mathiesen, Post doc, +45 27908669, anne.sophie.mathiesen@regionh.dk
About this study
Official title: A Digitally Supported Guided Self-determination Intervention Versus Attention Control for People With Type 2 Diabetes in Outpatient Clinics - a Randomised Clinical Trial
Background In management of type 2 diabetes, autonomy supporting interventions may be a prerequisite to achieve 'real life' patient engagement and more long-term improvement. Preliminary evidence has previously shown that the autonomy supporting intervention, guided self-determination method might have effect on HbA1c and diabetes distress in people with type 1 diabetes. However, previous trials were all rated as high risk of bias and did not assess potential harm of the the intervention. Thus, in the current trial, the objective is to investigate the benefits and harms of guided self-determination interventions versus an attention control group intervention in adults with type 2 diabetes.
Methods/design The trial planned is a randomised, pragmatic, investigator-initiated, dual-centre, parallel group, clinical superiority trial of guided self-determination intervention versus an attention control group for people diagnosed with type 2 diabetes in outpatient clinics. The participants (n=224) will be recruited from the department of Endocrinology at a University hospital of Copenhagen, the Capital Region of Denmark and from Steno Diabetes Center Odense, University hospital in the Southern Region of Denmark. The experimental stepped-care intervention will consist of 3-5 analogue or digitally provided guided self-determination sessions lasting up to one hour with a guided self-determination facilitator. The attention control group will receive similar number of sessions lasting up to one hour with a communication trained healthcare professional provided face-to-face, digitally, or over telephone.This trial protocol is guided by the SPIRIT and CONSORT guidelines. Participants will be included if they have type 2 diabetes, > 18 years old, and, are not pregnant. Participants will be assessed before randomisation, at 5- and 12-months follow-up. The primary follow-up timepoint will be 12-months follow-up. The primary outcome will be diabetes distress. Secondary outcomes will be quality of life, depressive symptoms, and adverse events not considered serious. Exploratory outcome will be glycated haemoglobin, motivation, and serious adverse events. Data will be collected using REDCap. The analyses will be performed using the statistical programme Stata version 16.
- Conditions
- Type 2 Diabetes
- Being tested
- Guided self-determination, Personal support in goal-pursuing
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided self-determinationBehavioural
Before randomisation, the participants are supported in formulating one personal value-clarifying goal: 'One thing I want to achieve in my life with diabetes within a year is'….
The goal is registered.
Patients go through a guided self-determination intervention preparing themselves by completing reflection sheets, analogue or digital by patient's choice, and individually facilitated by a guided self-determination-certified nurse, face-to-face, over video or over telephone. Sessions scheduled every second week. Number of sessions 3-5 is decided at session 2.
A relative may take part in one session completing an analogue reflection sheet as preparation.
Participants continue usual care.
Personal support in goal-pursuingBehavioural
Before randomisation, the participants are supported in formulating one personal value-clarifying goal: 'One thing I want to achieve in my life with diabetes within a year is'….
The goal is registered.
Patients receive personal goal pursuing support up to five sessions, lasting up to one hour with a communication trained healthcare professional following up on the goal, face-to-face, digitally, or over telephone. The sessions are scheduled every second week. A relative may take part in one session.
Participants continue usual care.
| Study group | Role | What they receive |
|---|---|---|
| Guided self-determination | Experimental | 3 to 5 one-hour digital or analogue guided self-determination sessions Receives: Behavioral: Guided self-determination |
| Personal support in goal-pursuing | Active comparator | Up to five personal goal pursuing support sessions Receives: Behavioral: Personal support in goal-pursuing |
What is being measured
The primary outcome is the main question the study is designed to answer.
diabetes distress
Assessed by the validated 20-item scale of diabetes-related distress burden, Problem Areas in Diabetes (PAID)
Measured: The Problem area in diabetes (PAID) will be measured at 12-months follow-up. A higher score on the scale (0-100) indicate higher diabetes distress
Secondary outcomes (4)
Depressive symptoms
Assessed by the Hospital Anxiety and Depression Scale (HADS)
Measured: Hospital anxiety and depression scale (HADS) will be measured at 12-months follow-up. A higher score on the scale (0-42) indicate higher anxiety and depression
Generic Quality of life: SF-36
Generic quality of life assessed by SF-36 The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability.
Measured: SF-36 will be measured at baseline 12-months follow-up.
Adverse events not considered serious
Assessed by the Negative Effects questionnaire (NEQ-20) at 12-months follow-up. A higher score (0-80) indicate more adverse events related to the intervention.
Measured: 12-months follow-up
diabetes distress
Assessed by the validated 20-item scale of diabetes-related distress burden, Problem Areas in Diabetes (PAID)
Measured: Problem areas in diabetes (PAID) will be measured at 5 months follow-up. A higher score on the scale (0-100) indicate higher diabetes distress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start11 Nov 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen University Hospital, Denmark
- Responsible party
- Principal investigator, Vibeke Zoffmann, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601311
- Sponsor's protocol ID
- P-2020-864
- Acronym
- OVERCOME
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2020
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the International Committee of Medical Journal Editors (ICMJE), a detailed data sharing plan is a requirement. We adhere to the requirements with the following statements: Depersonalised individual patient data will be made available to increase transparancy and use of data. Immediately following publication the Trial Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code will be made available through a link for anyone who wishes to a access data. There will be no end date for this access.
Publications
Mathiesen AS, Zoffmann V, Lindschou J, Jakobsen JC, Gluud C, Olsen MH, Rasmussen B, Marqvorsen EHS, Rothmann MJ. Guided self-determination intervention versus an attention control group of people with type 2 diabetes in an outpatient clinic setting-the OVERCOME randomised clinical trial. BMJ Open. 2026 Jun 25;16(6):e111164. doi: 10.1136/bmjopen-2025-111164.
PubMed 42350025Mathiesen AS, Zoffmann V, Lindschou J, Jakobsen JC, Gluud C, Olsen MH, Rasmussen B, Marqvorsen EHS, Rothmann MJ. Detailed statistical analysis plan for a guided self-determination intervention versus an attention control for outpatients with type 2 diabetes in the randomised OVERCOME trial. Trials. 2024 Nov 11;25(1):751. doi: 10.1186/s13063-024-08589-6.
PubMed 39523352Mathiesen AS, Zoffmann V, Skytte TB, Jakobsen JC, Gluud C, Lindschou J, Rasmussen B, Marqvorsen E, Thomsen T, Rothmann M. Guided self-determination intervention versus attention control for people with type 2 diabetes in outpatient clinics: a protocol for a randomised clinical trial. BMJ Open. 2021 Dec 23;11(12):e047037. doi: 10.1136/bmjopen-2020-047037.
PubMed 34949603
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digitally Supported Guided Self-determination Intervention Versus Attention Control for People With Type 2 Diabetes in Outpatient Clinics - a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04601311
- Acronym / sponsor ID
- OVERCOME / P-2020-864
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Odense University Hospital, Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen University Hospital, Denmark
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 23 Oct 2020 (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.
Background In management of type 2 diabetes, autonomy supporting interventions may be a prerequisite to achieve 'real life' patient engagement and more long-term improvement. Preliminary evidence has previously shown that the autonomy supporting intervention, guided self-determination method might have effect on HbA1c and diabetes distress in people with type 1 diabetes. However, previous trials were all rated as high risk of bias and did not assess potential harm of the the intervention. Thus, in the current trial, the objective is to investigate the benefits and harms of guided self-determination interventions versus an attention control group intervention in adults with type 2 diabetes.
Methods/design The trial planned is a randomised, pragmatic, investigator-initiated, dual-centre, parallel group, clinical superiority trial of guided self-determination intervention versus an attention control group for people diagnosed with type 2 diabetes in outpatient clinics. The participants (n=224) will be recruited from the department of Endocrinology at a University hospital of Copenhagen, the Capital Region of Denmark and from Steno Diabetes Center Odense, University hospital in the Southern Region of Denmark. The experimental stepped-care intervention will consist of 3-5 analogue or digitally provided guided self-determination sessions lasting up to one hour with a guided self-determination facilitator. The attention control group will receive similar number of sessions lasting up to one hour with a communication trained healthcare professional provided face-to-face, digitally, or over telephone.This trial protocol is guided by the SPIRIT and CONSORT guidelines. Participants will be included if they have type 2 diabetes, > 18 years old, and, are not pregnant. Participants will be assessed before randomisation, at 5- and 12-months follow-up. The primary follow-up timepoint will be 12-months follow-up. The primary outcome will be diabetes distress. Secondary outcomes will be quality of life, depressive symptoms, and adverse events not considered serious. Exploratory outcome will be glycated haemoglobin, motivation, and serious adverse events. Data will be collected using REDCap. The analyses will be performed using the statistical programme Stata version 16.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided self-determination | Experimental | Behavioral: Guided self-determination3 to 5 one-hour digital or analogue guided self-determination sessions |
| Personal support in goal-pursuing | Active comparator | Behavioral: Personal support in goal-pursuingUp to five personal goal pursuing support sessions |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years of age.
- Diagnosed with type 2 diabetes ≥ 3 months according to the International Classification System of Diseases (ICD-11.2-11.9) [43].
- Signed informed consent
Key exclusion criteria (3 listed)
- Pregnancy
- Prior participation in GSD course(s) for the past two years
- Lack of signed of informed consent
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 |
|---|---|---|
| Guided self-determinationBefore randomisation, the participants are supported in formulating one personal value-clarifying goal: 'One thing I want to achieve in my life with diabetes within a year is'…. The goal is registered. Patients go through a guided self-determination intervention preparing themselves by completing reflection sheets, analogue or digital by patient's choice, and individually facilitated by a guided self-determination-certified nurse, face-to-face, over video or over telephone. Sessions scheduled every second week. Number of sessions 3-5 is decided at session 2. A relative may take part in one session completing an analogue reflection sheet as preparation. Participants continue usual care. | Behavioural | Guided self-determination |
| Personal support in goal-pursuingBefore randomisation, the participants are supported in formulating one personal value-clarifying goal: 'One thing I want to achieve in my life with diabetes within a year is'…. The goal is registered. Patients receive personal goal pursuing support up to five sessions, lasting up to one hour with a communication trained healthcare professional following up on the goal, face-to-face, digitally, or over telephone. The sessions are scheduled every second week. A relative may take part in one session. Participants continue usual care. | Behavioural | Personal support in goal-pursuing |
Primary outcome
diabetes distress
Time frame: The Problem area in diabetes (PAID) will be measured at 12-months follow-up. A higher score on the scale (0-100) indicate higher diabetes distress
Assessed by the validated 20-item scale of diabetes-related distress burden, Problem Areas in Diabetes (PAID)
4 secondary outcomes
Depressive symptoms
Time frame: Hospital anxiety and depression scale (HADS) will be measured at 12-months follow-up. A higher score on the scale (0-42) indicate higher anxiety and depression
Generic Quality of life: SF-36
Time frame: SF-36 will be measured at baseline 12-months follow-up.
Adverse events not considered serious
Time frame: 12-months follow-up
diabetes distress
Time frame: Problem areas in diabetes (PAID) will be measured at 5 months follow-up. A higher score on the scale (0-100) indicate higher diabetes distress
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Derived from this study: PubMed 42350025Mathiesen AS, Zoffmann V, Lindschou J, Jakobsen JC, Gluud C, Olsen MH, Rasmussen B, Marqvorsen EHS, Rothmann MJ. Guided self-determination intervention versus an attention control group of people with type 2 diabetes in an outpatient clinic setting-the OVERCOME randomised clinical trial. BMJ Open. 2026 Jun 25;16(6):e111164. doi: 10.1136/bmjopen-2025-111164.
- Derived from this study: PubMed 39523352Mathiesen AS, Zoffmann V, Lindschou J, Jakobsen JC, Gluud C, Olsen MH, Rasmussen B, Marqvorsen EHS, Rothmann MJ. Detailed statistical analysis plan for a guided self-determination intervention versus an attention control for outpatients with type 2 diabetes in the randomised OVERCOME trial. Trials. 2024 Nov 11;25(1):751. doi: 10.1186/s13063-024-08589-6.
- Derived from this study: PubMed 34949603Mathiesen AS, Zoffmann V, Skytte TB, Jakobsen JC, Gluud C, Lindschou J, Rasmussen B, Marqvorsen E, Thomsen T, Rothmann M. Guided self-determination intervention versus attention control for people with type 2 diabetes in outpatient clinics: a protocol for a randomised clinical trial. BMJ Open. 2021 Dec 23;11(12):e047037. doi: 10.1136/bmjopen-2020-047037.
- Individual participant dataSharing planned: Yes. According to the International Committee of Medical Journal Editors (ICMJE), a detailed data sharing plan is a requirement. We adhere to the requirements with the following statements: Depersonalised individual patient data will be made available to increase transparancy and use of data. Immediately following publication the Trial Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code will be made available through a link for anyone who wishes to a access data. There will be no end date for this access.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided self-determination and Personal support in goal-pursuing in people with Type 2 Diabetes, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diabetes distress (time frame: The Problem area in diabetes (PAID) will be measured at 12-months follow-up. A higher score on the scale (0-100) indicate higher diabetes distress). 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 NCT04601311, which also lists 3 linked publications.
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 26 Oct 2021.