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

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 Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Guided self-determination; Behavioral: Personal support in goal-pursuing

• Study Type: Interventional
• Enrollment (Anticipated): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2200
    • Recruiting
    • Anne Sophie Mathiesen
    • Contact: Anne Sophie Mathiesen, Post doc; Phone Number: +45 27908669; Email: anne.sophie.mathiesen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• >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

Exclusion Criteria:

• Pregnancy
• Prior participation in GSD course(s) for the past two years
• Lack of signed of informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Guided self-determination; 3 to 5 one-hour digital or analogue guided self-determination sessions	Behavioral: 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.
ACTIVE_COMPARATOR: Personal support in goal-pursuing; Up to five personal goal pursuing support sessions	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms	Assessed by the Hospital Anxiety and Depression Scale (HADS)	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.	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.	12-months follow-up
diabetes distress	Assessed by the validated 20-item scale of diabetes-related distress burden, Problem Areas in Diabetes (PAID)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of motivation (autonomous/external), controlled (external) or resigned (amotivated) regarding diabetes self-care practices	Assessed by the Treatment self-regulation Questionnaire	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 from the participants' record. A higher value indicate poorer glycaemic control	Assessed at baseline and 12-months follow-up.
Proportion of participants with one or more serious adverse events in the intervention period	Defined according to the ICH-GCP definition, as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolonging of existing hospitalization and resulted in persistent or significant disability or jeopardized the patient	12-months follow-up

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Odense University Hospital; Copenhagen University Hospital, Denmark; Copenhagen Trial Unit, Center for Clinical Intervention Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 11, 2020
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (ACTUAL): October 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: P-2020-864

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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
• IPD Sharing Access Criteria: There will be no end date for this access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No