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
; 11(12): e047037, 2021 12 23.
Article
in English
| MEDLINE | ID: covidwho-1595822
ABSTRACT
INTRODUCTION:
In the management of type 2 diabetes, autonomy-supporting interventions may be a prerequisite to achieving more long-term improvement. Preliminary evidence has shown that the guided self-determination (GSD) method might have an effect on haemoglobin A1c and diabetes distress in people with type 1 diabetes. Previous trials were at risk of uncertainty. Thus, the objective is to investigate the benefits and harms of a GSD intervention versus an attention control group intervention in adults with type 2 diabetes. METHODS ANDANALYSIS:
This trial protocol is guided by the The Standard Protocol Items Recommendations for International Trials Statement. We describe the protocol for a pragmatic randomised, dual-centre, parallel-group, superiority clinical trial testing a GSD intervention versus an attention control for people with type 2 diabetes in outpatient clinics. The participants (n=224) will be recruited from two diverse regions of Denmark. The experimental stepped-care intervention will consist of three to five GSD sessions lasting up to 1 hour with a trained GSD facilitator. The sessions will be conducted face to face, by video conference or over the telephone. The attention controls will receive three to five sessions lasting up to an hour with a communication-trained healthcare professional provided face to-face, by video conference, or over the telephone. Participants will be included if they have type 2 diabetes,>18 years old, are not pregnant. Participants will be assessed before randomisation, at 5-month, and 12-month follow-up, the latter being the primary. The primary outcome is diabetes distress. Secondary outcomes are quality of life, depressive symptoms and non-serious adverse events. Exploratory outcomes are haemoglobin A1c, motivation and serious adverse events. Data will be collected using REDCap and analysed using Stata V.16. ETHICS AND DISSEMINATION The trial will be conducted in compliance with the protocol, the Helsinki Declaration in its latest form, International Harmonisation of Good Clinical Practice guidelines and the applicable regulatory requirement(s). The trial has been approved by the Danish Data Protection Agency (P-2020-864). The Ethics Committee of the Capital Region of Denmark reviewed the trial protocol, but exempted the trial protocol from full review (H-20003638). The results of the trial will be presented at the outpatient clinics treating people with type 2 diabetes, at national and international conferences as well as to associations for people with diabetes and their relatives. TRIAL REGISTRATION NUMBER ClinicalTrials.gov identifier NCT04601311.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Diabetes Mellitus, Type 2
Type of study:
Cohort study
/
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Topics:
Long Covid
Limits:
Adolescent
/
Adult
/
Female
/
Humans
/
Pregnancy
Language:
English
Journal:
BMJ Open
Year:
2021
Document Type:
Article
Affiliation country:
Bmjopen-2020-047037
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