A Digitally Supported Guided Self-determination Intervention Versus Attention Control for People With Type 2 Diabetes in Outpatient Clinics - a Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- diabetes distress
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>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
排除标准
- •Pregnancy
- •Prior participation in GSD course(s) for the past two years
- •Lack of signed of informed consent
结局指标
主要结局
diabetes distress
时间窗: 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)
次要结局
- 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)
- 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)
- 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)
研究者
Vibeke Zoffmann
Professor
Rigshospitalet, Denmark