UnknownNot Applicable

Problem Solving Treatment for Diabetes in Individuals With Poor Diabetes Control

Singapore106 participantsStarted 2020-03-09

Plain-language 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.

Who can participate

Age range

21 Years – 110 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in HbA1c over 18 months

Timeframe: Baseline, 6-month, 12-month, 18-month

Trial details

NCT IDNCT05651490

SponsorSingapore Eye Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials