A Guided Self-determination Intervention Versus Attention Control for People With Type 2 Diabetes in Outpatient Clinics
NCT ID: NCT04601311
Last Updated: 2021-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
224 participants
INTERVENTIONAL
2020-11-11
2022-12-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Guided self-determination
3 to 5 one-hour digital or analogue guided self-determination sessions
Guided self-determination
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-pursuing
Up to five personal goal pursuing support sessions
Personal support in goal-pursuing
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.
Interventions
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Guided self-determination
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-pursuing
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with type 2 diabetes ≥ 3 months according to the International Classification System of Diseases (ICD-11.2-11.9) \[43\].
* Signed informed consent
Exclusion Criteria
* Prior participation in GSD course(s) for the past two years
* Lack of signed of informed consent
18 Years
110 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
Copenhagen University Hospital, Denmark
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Vibeke Zoffmann
Professor
Locations
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Anne Sophie Mathiesen
Copenhagen, , Denmark
Countries
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Facility Contacts
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References
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Mathiesen 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.
Mathiesen 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.
Other Identifiers
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P-2020-864
Identifier Type: -
Identifier Source: org_study_id