Clinical trial NCT05651490: Problem Solving Treatment for Diabetes in Individuals With Poor Diabetes Control
Official title: RESONATE: A Randomised Controlled Trial of Problem Solving Treatment for Diabetes in Individuals With Poor Diabetes Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
problem solving treatment
HbA1c
sugar control
Lead sponsor: Singapore Eye Research Institute
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 106
Sex: ALL
Minimum age (years): 21
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to one of the two arms: intervention group (PST-D) and attention control group. The random assignment will be based on a code generated by R statistical software, contained within sequential sealed envelopes. The random number sequence will be password protected and available to a statistician external to the study team who will conduct the randomisation process. The randomisation process is designed to yield an expected assignment ratio of 1:1
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Change in HbA1c over 18 months
timeFrame: Baseline, 6-month, 12-month, 18-month
Secondary outcomes:
measure: Change in total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides over 18 months
timeFrame: Baseline, 6-month, 12-month, 18-month
measure: Incidence and progression of diabetic retinopathy
timeFrame: Baseline, 6-month, 12-month, 18-month
measure: Incidence and progression of diabetic nephropathy
timeFrame: Baseline, 6-month, 12-month, 18-month
measure: Incidence and progression of diabetic peripheral neuropathy
timeFrame: Baseline, 6-month, 12-month, 18-month
measure: Incidence and progression of distance visual impairment
timeFrame: Baseline, 6-month, 12-month, 18-month
measure: Change in diabetes self-efficacy over 18 months
timeFrame: Baseline, 6-month, 12-month, 18-month
measure: Change in problem-focused coping self-efficacy over 18 months
timeFrame: Baseline, 6-month, 12-month, 18-month
measure: Change in diabetes self-care activities over 18 months
timeFrame: Baseline, 6-month, 12-month, 18-month
measure: Change in medication taking behaviour over 18 months
timeFrame: Baseline, 6-month, 12-month, 18-month
measure: Change in diabetes-related quality of life over 18 months
timeFrame: Baseline, 6-month, 12-month, 18-month
measure: Cost-effectiveness of PST-D
timeFrame: Baseline, 6-month, 12-month, 18-month
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore Eye Research Institute
Study officials:
affiliation: Singapore Eye Research Institute
name: Ecosse Lamoureux, PhD
role: PRINCIPAL_INVESTIGATOR
References: