NCT05651490

Problem Solving Treatment for Diabetes in Individuals With Poor Diabetes Control

RESONATE: A Randomised Controlled Trial of Problem Solving Treatment for Diabetes in Individuals With Poor Diabetes Control

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Singapore Eye Research Institute · Academic / Other
• Sex: All
• Age: 21 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
BEHAVIORAL	Problem Solving Treatment for Diabetes	In the introductory session, the structure of and rationale behind PST-D will be explained. The specialist will work with the participant to develop a problem list related to diabetes self-management and smoking cessation, if applicable. During the weekly sessions, the participant will be taught and guided through the seven steps of problem solving: 1. Clarifying and defining the problem 2. Setting a realistic goal 3. Brainstorming multiple solutions 4. Generating pros and cons for each solution 5. Evaluating and choosing a preferred solution 6. Developing a specific action plan to implement the solution 7. Evaluating outcomes from the previous session. Participants will also plan to engage in at least 1 enjoyable activity daily during the week. The number of sessions will differ based on the specialist's assessment of the participant's problem-solving skills. Maintenance sessions will be delivered monthly across 3 months in order to follow-up with participants.
BEHAVIORAL	Attention Control Group	During the sessions, the healthcare practitioners will provide general information and recommendations on general health topics such as oral health, hearing loss, sleep, dementia, adult vaccination, influenza, and dengue fever. Participants will also be given handouts adapted from government agencies and/or public bodies, such as HealthHub, National Health Service, National Addictions Management Service, and National Environmental Agency, on these topics. The healthcare practitioners will avoid discussing topics related to diabetes, diet, physical activity, and medication.

Timeline

• Start date: 2020-03-09
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2022-12-15
• Last updated: 2022-12-15

Locations

1 site across 1 country: Singapore