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A Guided Self-determination Intervention Versus Attention Control for People With Type 2 Diabetes in Outpatient Clinics (OVERCOME)

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ClinicalTrials.gov Identifier: NCT04601311
Recruitment Status : Not yet recruiting
First Posted : October 23, 2020
Last Update Posted : October 23, 2020
Sponsor:
Collaborators:
Odense University Hospital
Copenhagen Trial Unit, Center for Clinical Intervention Research
Copenhagen University Hospital, Denmark
Information provided by (Responsible Party):
Vibeke Zoffmann, Rigshospitalet, Denmark

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Guided self-determination Behavioral: Personal support in goal-pursuing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Supportive Care
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
Estimated Study Start Date : October 22, 2020
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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 ]
    Assessed by the Hospital Anxiety and Depression Scale (HADS)

  2. Generic Quality of life: SF-36 [ Time Frame: SF-36 will be measured at baseline 12-months follow-up. ]
    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.

  3. Adverse events not considered serious [ Time Frame: 12-months follow-up ]
    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.

  4. 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 ]
    Assessed by the validated 20-item scale of diabetes-related distress burden, Problem Areas in Diabetes (PAID)


Other Outcome Measures:
  1. Type of motivation (autonomous/external), controlled (external) or resigned (amotivated) regarding diabetes self-care practices [ Time Frame: 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) ]
    Assessed by the Treatment self-regulation Questionnaire

  2. HbA1c [ Time Frame: Assessed at baseline and 12-months follow-up. ]
    Assessed from the participants' record. A higher value indicate poorer glycaemic control

  3. Proportion of participants with one or more serious adverse events in the intervention period [ Time Frame: 12-months follow-up ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601311


Locations
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Denmark
Anne Sophie Mathiesen
Copenhagen, Denmark, 2200
Contact: Anne Sophie Mathiesen, Post doc    +45 27908669    anne.sophie.mathiesen@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Odense University Hospital
Copenhagen Trial Unit, Center for Clinical Intervention Research
Copenhagen University Hospital, Denmark
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Responsible Party: Vibeke Zoffmann, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04601311    
Other Study ID Numbers: P-2020-864
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases