Dyadic Management Intervention in Older People With Co-occurring Cognitive Impairment and Diabete… (NCT07496359) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Dyadic Management Intervention in Older People With Co-occurring Cognitive Impairment and Diabetes as a Supplementary Approach to Chronic Diseases Self-Management Program
309 participantsStarted 2026-03
Plain-language summary
The goal of this study is to evaluate the effectiveness and implementation of a dyadic management of the Chronic Disease Self-Management Program (CDSMP) for older adults with co-occurring cognitive impairment and diabetes with the involvement of caregivers.
The main questions it aims to answer are:
* Does the intervention improve diabetes self-management and cognitive function in older adults?
* How is the implementation of the intervention in real-world settings?
Participants will:
* Attend weekly CDSMP session over a 6-week period (2.5-hour per session).
* Provide feedback on their experience with the intervention through interviews and surveys.
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Individuals with DM aged \>= 55 years old;
* Recent glycosylated haemoglobin (HbA1c) level of 6.5% or above without change in diabetes medication within the last 3 months based on centre's records;
* Subjective cognitive decline (using SCDQ21) (separately reported by the patient and/or caregiver) and confirmed by MOCA (Chinese version) screened by the research nurses;
* Subjects with nominated primary caregivers will be recruited in the intervention group;
* For caregivers: they will be considered in the project if they have been the primary caregiver for the person for at least 1 year and are providing or involved in the patient's care on a daily basis.
Exclusion Criteria:
* Medical diagnoses of dementia;
* Those who have terminal illness;
* For caregivers: those who are temporary caregivers and have only provided/involved in care for less than a year.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Self-Care of Diabetes Index
Timeframe: From enrollment to 6 months after the intervention begins