Problem Solving Treatment for Diabetes in Individuals With Poor Diabetes Control

NCT05651490 | Unknown

• 1 other identifier: R1596/95/2018
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes; problem solving treatment; HbA1c; sugar control

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c over 18 months

  Blood test

  Baseline, 6-month, 12-month, 18-month

Secondary Outcomes (11)

• Change in total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides over 18 months

  Baseline, 6-month, 12-month, 18-month

• Incidence and progression of diabetic retinopathy

  Baseline, 6-month, 12-month, 18-month

• Incidence and progression of diabetic nephropathy

  Baseline, 6-month, 12-month, 18-month

• Incidence and progression of diabetic peripheral neuropathy

  Baseline, 6-month, 12-month, 18-month

• Incidence and progression of distance visual impairment

  Baseline, 6-month, 12-month, 18-month

Study Arms (2)

Intervention Group (PST-D)

EXPERIMENTAL

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.

Behavioral: Problem Solving Treatment for Diabetes

Attention control group

ACTIVE COMPARATOR

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.

Behavioral: Attention Control Group

Interventions

Problem Solving Treatment for Diabetes BEHAVIORAL

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: 1. Clarifying and defining the problem 2. Setting a realistic goal 3. Brainstorming multiple solutions 4. Generating pros and cons for each solution 5. Evaluating and choosing a preferred solution 6. Developing a specific action plan to implement the solution 7. 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.

Intervention Group (PST-D)

Attention Control Group BEHAVIORAL

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.

Attention control group

Eligibility Criteria

• Age: 21 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore Eye Research Institute: lead

Study Sites (1)

Singapore Eye Research Institute

Singapore, 169856, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ecosse Lamoureux, PhD

  Singapore Eye Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: 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

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 15, 2022
• Study Start: March 9, 2020
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

SG (1)