A Guided Self-determination Intervention Versus Attention Control for People With Type 2 Diabetes in Outpatient Clinics
OVERCOME
A Digitally Supported Guided Self-determination Intervention Versus Attention Control for People With Type 2 Diabetes in Outpatient Clinics - a Randomised Clinical Trial
1 other identifier
interventional
224
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2020
CompletedFirst Posted
Study publicly available on registry
October 23, 2020
CompletedStudy Start
First participant enrolled
November 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedOctober 26, 2021
October 1, 2021
2.1 years
October 7, 2020
October 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
diabetes distress
Assessed by the validated 20-item scale of diabetes-related distress burden, Problem Areas in Diabetes (PAID)
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
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
SF-36 will be measured at baseline 12-months follow-up.
Adverse events not considered serious
12-months follow-up
diabetes distress
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
Other Outcomes (3)
Type of motivation (autonomous/external), controlled (external) or resigned (amotivated) regarding diabetes self-care practices
Assessed at 12-months follow-up.Autonomous motivation indicated by higher treatment self-regulation Questionnaire (TSRQ)-scores on autonomy (8-56) or autonomy-index (autonomy (8-56) minus control(9-63) or lower TSRQ-scores on amotivation (4-28)
HbA1c
Assessed at baseline and 12-months follow-up.
Proportion of participants with one or more serious adverse events in the intervention period
12-months follow-up
Study Arms (2)
Guided self-determination
EXPERIMENTAL3 to 5 one-hour digital or analogue guided self-determination sessions
Personal support in goal-pursuing
ACTIVE COMPARATORUp to five personal goal pursuing support sessions
Interventions
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.
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
You may qualify if:
- \>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
You may not qualify if:
- Pregnancy
- Prior participation in GSD course(s) for the past two years
- Lack of signed of informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Odense University Hospitalcollaborator
- Copenhagen Trial Unit, Center for Clinical Intervention Researchcollaborator
- Copenhagen University Hospital, Denmarkcollaborator
Study Sites (1)
Anne Sophie Mathiesen
Copenhagen, 2200, Denmark
Related Publications (2)
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.
PMID: 39523352DERIVEDMathiesen 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.
PMID: 34949603DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participants and treatment providers will not be blinded to the allocated trial intervention. The treatment providers are not involved in the analyses. All other medical personnel will be blinded by blinding of notes in the participant's electronic records. Outcome assessors and external statisticians at the Copenhagen Trial Unit will be blinded to the randomisation status of the participants. The statistical analyses will be conducted with the intervention groups coded as X and Y. The steering committee will write two abstracts while the blinding is intact, one assuming the experimental intervention group is X and the control intervention group is Y, and one assuming the opposite. After this, the code will be broken.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 7, 2020
First Posted
October 23, 2020
Study Start
November 11, 2020
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
October 26, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 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
- Access Criteria
- There will be no end date for this access.
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.