Problem Solving Treatment for Diabetes in Individuals With Poor Diabetes Control
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Behavioral: Problem Solving Treatment for DiabetesBehavioral: Attention Control Group
- Registration Number
- NCT05651490
- Lead Sponsor
- Singapore Eye Research Institute
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 106
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group (PST-D) Problem Solving Treatment for Diabetes 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. Attention control group Attention Control Group 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.
- Primary Outcome Measures
Name Time Method Change in HbA1c over 18 months Baseline, 6-month, 12-month, 18-month Blood test
- Secondary Outcome Measures
Name Time Method Incidence and progression of diabetic retinopathy Baseline, 6-month, 12-month, 18-month Grading of digital retinal photographs and spectral-domain optical coherence tomography scans
Incidence and progression of diabetic peripheral neuropathy Baseline, 6-month, 12-month, 18-month Semmes-Weinstein monofilament examination (SWME) results
Change in total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides over 18 months Baseline, 6-month, 12-month, 18-month Blood tests
Incidence and progression of diabetic nephropathy Baseline, 6-month, 12-month, 18-month Blood tests results of epidermal growth factor receptor from serum creatinine and estimated using the CKD-EPI equation
Incidence and progression of distance visual impairment Baseline, 6-month, 12-month, 18-month Pinhole visual acuity values
Change in diabetes self-care activities over 18 months Baseline, 6-month, 12-month, 18-month Diabetes Self-management Questionnaire
Minimum value: 0 Maximum value: 12
Higher values indicate more effective self-care.Change in diabetes self-efficacy over 18 months Baseline, 6-month, 12-month, 18-month Perceived Diabetes Self-management scale.
Minimum value: 8 Maximum value: 40
Higher scores indicate more confidence in self-managing one's diabetes.Change in problem-focused coping self-efficacy over 18 months Baseline, 6-month, 12-month, 18-month Problem-Focusing subscale from Coping Self-Efficacy Scale
Minimum value: 0 Maximum value: 120
Higher scores indicate higher level of problem-focused coping self-efficacy.Cost-effectiveness of PST-D Baseline, 6-month, 12-month, 18-month EQ-5D-5L
There are five dimensions in the EQ-5D-5L descriptive system - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses to the five dimensions are used to calculate an index score ranging from -0.59 for the worst health state to 1.00 for perfect health. A score of 0 represents death and a negative score indicates a state worse than death.Change in medication taking behaviour over 18 months Baseline, 6-month, 12-month, 18-month Domains of Subjective Extent of Nonadherence
It comprises two domains - the extent of and reasons for medication non-adherence over the past 7 days.
For the Extent of Non-Adherence domain, the overall score is calculated by the average score of the three items, with higher scores indicating greater levels of non-adherence (Minimum value: 0; Maximum value: 4).
There are 18 items in the Reasons for Non-Adherence domain which stand on their own as descriptors. The reasons scale is a causal indicator model and higher scores indicate greater endorsement of each reason for non-adherence (Minimum value: 0; Maximum value: 4).Change in diabetes-related quality of life over 18 months Baseline, 6-month, 12-month, 18-month Asian Diabetes Quality of Life
Minimum value: 18 (English version); 15 (Chinese version) Maximum value: 105 (English version); 90 (Chinese version)
Higher scores indicate better quality of life.
Trial Locations
- Locations (1)
Singapore Eye Research Institute
🇸🇬Singapore, Singapore