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Active Not Recruiting NCT05651490

Problem Solving Treatment for Diabetes in Individuals With Poor Diabetes Control

Conditions: Diabetes Mellitus, Type 2

Sex: All
Ages: 21 Years – 110 Years
Phase: NA
Enrollment: 106
Sponsor: Singapore Eye Research Institute

Location: Singapore

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.

Eligibility Criteria

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 MandarinSingapore citizens or those with Singapore permanent residency statusAged 21 years and aboveNo cognitive impairment, as assessed using the 6-item Cognitive Impairment Test (6CIT)Adequate hearing with/without hearing aids to respond to normal conversationConsent to participate in the sessions if randomised to the PST-D treatment armExclusion Criteria:Have hearing or cognitive impairment compromising consent or study proceduresAll 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05651490). StuddyBuddy aggregates publicly available trial information.