RESONATE: A Randomised Controlled Trial of Problem Solving Treatment for Diabetes in Individuals With Poor Diabetes Control
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Change in HbA1c over 18 months
研究概览
简要总结
The goal of this randomised controlled trial is to test a cognitive-behavioural intervention, Problem Solving Treatment for Diabetes (PST-D) in patients with type 2 diabetes. The main questions it aims to answer are:
- To evaluate the clinical effectiveness of PST-D compared with the attention control group.
- To determine the impact of PST-D on patient-centred, behavioural, and psychosocial outcomes.
- To identify independent factors associated with an improvement in HbA1c and reductions in incidence and progression diabetic retinopathy, diabetic neuropathy, diabetic peripheral neuropathy, and visual impairment at 18-month follow-up in both groups; and determine if these factors mediate the associations between the PST-D intervention with the above outcomes.
- To quantify the incremental cost-effectiveness of PST-D compared with the attention control group at 18-month follow-up.
- To understand participants' views, experiences, and opinions about PST-D; and the barriers and facilitators to program completion.
Participants will complete blood tests, ocular examinations, and a series of questionnaires at baseline, 6-month, 12-month, and 18-month follow-up. Participants will also complete the intervention/ control group sessions conducted over the phone, video call, or face-to-face depending on the participant's preference.
Researchers will compare the intervention group against the attention control group to determine the effectiveness of PST-D on improving clinical, patient-centred, behavioural, and psychosocial outcomes.
详细描述
Assuming the recent rise in obesity prevalence persists, the lifetime risk of diabetes in Singapore will almost double by 2050. Poorly controlled diabetes leads to various diabetes-related complications which may consequently require costly lifelong treatment and have a profound impact on patients' quality of life.
Based on a previous trial on problem solving therapy in people with diabetic retinopathy and significant levels of distress, the investigators have designed a cognitive-behavioural intervention which aims to teach individuals skills to cope with and solve problems related to diabetes self-management. This novel intervention will be carried out at one tertiary hospital in Singapore, with the option for interested community-dwelling individuals with diabetes to participate, to facilitate its implementation and transition to the real world setting to assist patients with diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes and at least 1 recent reading of suboptimal glycaemic control (HbA1c ≥7.0%)
- •Able to speak English and/or Mandarin
- •Singapore citizens or those with Singapore permanent residency status
- •Aged 21 years and above
- •No cognitive impairment, as assessed using the 6-item Cognitive Impairment Test (6CIT)
- •Adequate hearing with/without hearing aids to respond to normal conversation
- •Consent to participate in the sessions if randomised to the PST-D treatment arm
排除标准
- •Have hearing or cognitive impairment compromising consent or study procedures
- •All recent HbA1c readings are <7.0%
- •Uncontactable or unwilling/unable to participate in all the PST-D sessions if randomised to the PST-D group
结局指标
主要结局
Change in HbA1c over 18 months
时间窗: Baseline, 6-month, 12-month, 18-month
Blood test
次要结局
- Incidence and progression of diabetic retinopathy(Baseline, 6-month, 12-month, 18-month)
- Incidence and progression of diabetic peripheral neuropathy(Baseline, 6-month, 12-month, 18-month)
- Change in total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides over 18 months(Baseline, 6-month, 12-month, 18-month)
- Incidence and progression of diabetic nephropathy(Baseline, 6-month, 12-month, 18-month)
- Incidence and progression of distance visual impairment(Baseline, 6-month, 12-month, 18-month)
- Change in diabetes self-care activities over 18 months(Baseline, 6-month, 12-month, 18-month)
- Change in diabetes self-efficacy over 18 months(Baseline, 6-month, 12-month, 18-month)
- Change in problem-focused coping self-efficacy over 18 months(Baseline, 6-month, 12-month, 18-month)
- Cost-effectiveness of PST-D(Baseline, 6-month, 12-month, 18-month)
- Change in medication taking behaviour over 18 months(Baseline, 6-month, 12-month, 18-month)
- Change in diabetes-related quality of life over 18 months(Baseline, 6-month, 12-month, 18-month)
研究者
Ecosse Lamoureux
Director
Singapore Eye Research Institute