Problem Solving Treatment for Diabetes in Individuals With Poor Diabetes Control

Diabetes Mellitus, Type 2 Clinical Trial

— RESONATE  

Official title:

RESONATE: A Randomised Controlled Trial of Problem Solving Treatment for Diabetes in Individuals With Poor Diabetes Control

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05651490
• Other study ID #: R1596/95/2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 9, 2020
• Est. completion date: March 2024

Study information

• Verified date: December 2022
• Source: Singapore Eye Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Problem Solving Treatment for Diabetes
In the introductory session, the structure of and rationale behind PST-D will be explained. The specialist will work with the participant to develop a problem list related to diabetes self-management and smoking cessation, if applicable. During the weekly sessions, the participant will be taught and guided through the seven steps of problem solving: Clarifying and defining the problem Setting a realistic goal Brainstorming multiple solutions Generating pros and cons for each solution Evaluating and choosing a preferred solution Developing a specific action plan to implement the solution Evaluating outcomes from the previous session. Participants will also plan to engage in at least 1 enjoyable activity daily during the week. The number of sessions will differ based on the specialist's assessment of the participant's problem-solving skills. Maintenance sessions will be delivered monthly across 3 months in order to follow-up with participants.
• Attention Control Group
During the sessions, the healthcare practitioners will provide general information and recommendations on general health topics such as oral health, hearing loss, sleep, dementia, adult vaccination, influenza, and dengue fever. Participants will also be given handouts adapted from government agencies and/or public bodies, such as HealthHub, National Health Service, National Addictions Management Service, and National Environmental Agency, on these topics. The healthcare practitioners will avoid discussing topics related to diabetes, diet, physical activity, and medication.

Locations

Country	Name	City	State
Singapore	Singapore Eye Research Institute	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore Eye Research Institute

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c over 18 months	Blood test	Baseline, 6-month, 12-month, 18-month
Secondary	Change in total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides over 18 months	Blood tests	Baseline, 6-month, 12-month, 18-month
Secondary	Incidence and progression of diabetic retinopathy	Grading of digital retinal photographs and spectral-domain optical coherence tomography scans	Baseline, 6-month, 12-month, 18-month
Secondary	Incidence and progression of diabetic nephropathy	Blood tests results of epidermal growth factor receptor from serum creatinine and estimated using the CKD-EPI equation	Baseline, 6-month, 12-month, 18-month
Secondary	Incidence and progression of diabetic peripheral neuropathy	Semmes-Weinstein monofilament examination (SWME) results	Baseline, 6-month, 12-month, 18-month
Secondary	Incidence and progression of distance visual impairment	Pinhole visual acuity values	Baseline, 6-month, 12-month, 18-month
Secondary	Change in diabetes self-efficacy over 18 months	Perceived Diabetes Self-management scale.; Minimum value: 8 Maximum value: 40; Higher scores indicate more confidence in self-managing one's diabetes.	Baseline, 6-month, 12-month, 18-month
Secondary	Change in problem-focused coping self-efficacy over 18 months	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.	Baseline, 6-month, 12-month, 18-month
Secondary	Change in diabetes self-care activities over 18 months	Diabetes Self-management Questionnaire; Minimum value: 0 Maximum value: 12; Higher values indicate more effective self-care.	Baseline, 6-month, 12-month, 18-month
Secondary	Change in medication taking behaviour over 18 months	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).	Baseline, 6-month, 12-month, 18-month
Secondary	Change in diabetes-related quality of life over 18 months	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.	Baseline, 6-month, 12-month, 18-month
Secondary	Cost-effectiveness of PST-D	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.	Baseline, 6-month, 12-month, 18-month