Diabetes Mellitus, Type 2RESONATENCT05651490
Problem Solving Treatment for Diabetes in Individuals With Poor Diabetes Control
A study testing Problem Solving Treatment for Diabetes in people with Diabetes Mellitus, Type 2, run by Singapore Eye Research Institute at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 110 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Problem Solving Treatment for Diabetes
- Type of treatment
- Vaccines, Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSingapore
- Study dates
- 9 Mar 2020to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: RESONATE: A Randomised Controlled Trial of Problem Solving Treatment for Diabetes in Individuals With Poor Diabetes Control
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.
Read more
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Problem Solving Treatment for Diabetes, Attention Control Group
- Keywords
- diabetes, problem solving treatment, HbA1c, sugar control
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving Treatment for DiabetesBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Attention Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c over 18 months
Blood test
Measured: Baseline, 6-month, 12-month, 18-month
Secondary outcomes (11)
Change in total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides over 18 months
Blood tests
Measured: Baseline, 6-month, 12-month, 18-month
Incidence and progression of diabetic retinopathy
Grading of digital retinal photographs and spectral-domain optical coherence tomography scans
Measured: Baseline, 6-month, 12-month, 18-month
Incidence and progression of diabetic nephropathy
Blood tests results of epidermal growth factor receptor from serum creatinine and estimated using the CKD-EPI equation
Measured: Baseline, 6-month, 12-month, 18-month
Incidence and progression of diabetic peripheral neuropathy
Semmes-Weinstein monofilament examination (SWME) results
Measured: Baseline, 6-month, 12-month, 18-month
Incidence and progression of distance visual impairment
Pinhole visual acuity values
Measured: Baseline, 6-month, 12-month, 18-month
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.
Measured: Baseline, 6-month, 12-month, 18-month
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.
Measured: Baseline, 6-month, 12-month, 18-month
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.
Measured: Baseline, 6-month, 12-month, 18-month
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).
Measured: Baseline, 6-month, 12-month, 18-month
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.
Measured: Baseline, 6-month, 12-month, 18-month
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.
Measured: Baseline, 6-month, 12-month, 18-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start9 Mar 2020
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Eye Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ecosse Lamoureux, Singapore Eye Research Institute
- Investigators
- Ecosse Lamoureux, PhD, Principal investigator, Singapore Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651490
- Sponsor's protocol ID
- R1596/95/2018
- Acronym
- RESONATE
- Status last verified
- Dec 2022
- First submitted
- 1 Dec 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESONATE: A Randomised Controlled Trial of Problem Solving Treatment for Diabetes in Individuals With Poor Diabetes Control
- ClinicalTrials.gov ID
- NCT05651490
- Acronym / sponsor ID
- RESONATE / R1596/95/2018
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes, problem solving treatment, HbA1c, sugar control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Singapore Eye Research InstituteUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (PST-D) | Experimental | Behavioral: Problem Solving Treatment for DiabetesParticipants 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 | Active comparator | Behavioral: Attention Control GroupThe 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. |
Who may qualify
- Ages
- 21 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem Solving Treatment for DiabetesIn 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. | Behavioural | Intervention Group (PST-D) |
| Attention Control GroupDuring 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. | Behavioural | Attention control group |
Primary outcome
Change in HbA1c over 18 months
Time frame: Baseline, 6-month, 12-month, 18-month
Blood test
11 secondary outcomes
Change in total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides over 18 months
Time frame: Baseline, 6-month, 12-month, 18-month
Incidence and progression of diabetic retinopathy
Time frame: Baseline, 6-month, 12-month, 18-month
Incidence and progression of diabetic nephropathy
Time frame: Baseline, 6-month, 12-month, 18-month
Incidence and progression of diabetic peripheral neuropathy
Time frame: Baseline, 6-month, 12-month, 18-month
Incidence and progression of distance visual impairment
Time frame: Baseline, 6-month, 12-month, 18-month
Change in diabetes self-efficacy over 18 months
Time frame: Baseline, 6-month, 12-month, 18-month
Change in problem-focused coping self-efficacy over 18 months
Time frame: Baseline, 6-month, 12-month, 18-month
Change in diabetes self-care activities over 18 months
Time frame: Baseline, 6-month, 12-month, 18-month
Change in medication taking behaviour over 18 months
Time frame: Baseline, 6-month, 12-month, 18-month
Change in diabetes-related quality of life over 18 months
Time frame: Baseline, 6-month, 12-month, 18-month
Cost-effectiveness of PST-D
Time frame: Baseline, 6-month, 12-month, 18-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ecosse Lamoureux, PhD principal investigator
Singapore Eye Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Solving Treatment for Diabetes in people with Diabetes Mellitus, Type 2, run by Singapore Eye Research Institute at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c over 18 months (time frame: Baseline, 6-month, 12-month, 18-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.