Problem Solving Treatment for Diabetes in Individuals With Poor Diabetes Control

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

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.

Sponsors & Collaborators

• Singapore Eye Research Institute

  lead OTHER

Principal Investigators

• Ecosse Lamoureux, PhD · Singapore Eye Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

110 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-09

Primary Completion

2024-03-31

Completion

2024-03-31

Countries

• Singapore

Study Locations