Clinical trial NCT04601311: A Guided Self-determination Intervention Versus Attention Control for People With Type 2 Diabetes in Outpatient Clinics
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: Copenhagen University Hospital, Denmark
First posted: 2020-10-23
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: diabetes distress
timeFrame: 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:
measure: Depressive symptoms
timeFrame: 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
measure: Generic Quality of life: SF-36
timeFrame: SF-36 will be measured at baseline 12-months follow-up.
measure: Adverse events not considered serious
timeFrame: 12-months follow-up
measure: diabetes distress
timeFrame: 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:
measure: Type of motivation (autonomous/external), controlled (external) or resigned (amotivated) regarding diabetes self-care practices
timeFrame: 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)
measure: HbA1c
timeFrame: Assessed at baseline and 12-months follow-up.
measure: Proportion of participants with one or more serious adverse events in the intervention period
timeFrame: 12-months follow-up
Locations:
city: Copenhagen
country: Denmark
facility: Anne Sophie Mathiesen
Study officials:
References:
citation: 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.