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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05651490
Study type Interventional
Source Singapore Eye Research Institute
Contact
Status Active, not recruiting
Phase N/A
Start date March 9, 2020
Completion date March 2024

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