Problem Solving Treatment for Diabetes in Individuals With Poor Diabetes Control (RESONATE)

Singapore Eye Research Institute

Status: Active, not recruiting

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Attention Control Group; Behavioral: Problem Solving Treatment for Diabetes

Study type: Interventional

Funder types: Other

Identifiers

NCT05651490

R1596/95/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 21 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

Intervention Group (PST-D)

Experimental group

Description:

Participants in the intervention group will receive usual care comprising of routine follow-up checks from their hospitals on top of the intervention (PST-D). The intervention consists of one introductory session, up to eight weekly treatment sessions, and three monthly maintenance sessions; these are individual sessions of approximately 30 to 45 minutes each and will be conducted over the phone, video call, or face-to-face depending on the participant's preference.

Treatment:

Behavioral: Problem Solving Treatment for Diabetes

Attention control group

Active Comparator group

Description:

The participants in the control group will receive usual care comprising of routine follow-up checks from their hospitals. They will also receive one introductory session and up to eight weekly treatment sessions; these are individual sessions of approximately 30 to 45 minutes each and will be conducted over the phone, video call, or face-to-face depending on the participant's preference.

Treatment:

Behavioral: Attention Control Group