Choroid DiseaseNCT07496359
Dyadic Management Intervention in Older People With Co-occurring Cognitive Impairment and Diabetes as a Supplementary Approach to Chronic Diseases Self-Management Program
A study testing CDSMP + caregiver support in people with Choroid Disease and Caregiver, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Choroid Disease, Caregiver, Self-management
- What is being tested?
- CDSMP + caregiver support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Jed Montayre, 85227666393, jed-ray.montayre@polyu.edu.hk
About this study
Official title: Dyadic Management Intervention in Older People With Co-occurring Cognitive Impairment and Diabetes as a Supplementary Approach to Chronic Diseases Self-Management Program: A Hybrid Effectiveness-implementation Study
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.
- Conditions
- Choroid Disease, Caregiver, Self-management, Diabetes, Mild Cognitive Impairment, Older Adults
- Being tested
- CDSMP + caregiver support, Usual Care
- Medical subject headings
- Choroid Diseases, Diabetes Mellitus, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDSMP + caregiver supportBehavioural
The CDSMP is an evidence-based program consisting of 2.5-hour sessions held weekly over a six-week period, delivered by two trained leaders per session in person.
Usual CareBehavioural
Usual care (diabetes education, glucose monitoring and medical consultation)
| Study group | Role | What they receive |
|---|---|---|
| CDSMP | Experimental | Participants in the intervention group will receive a 6-week CDSMP course plus support from one informal caregiver throughout the program. Receives: Behavioral: CDSMP + caregiver support |
| Usual care | Active comparator | User care will receive diabetes education, glucose monitoring, and medical consultations, but no informal caregiver support. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Care of Diabetes Index
Self-Care of Diabetes Index (SCODI) is a scale, scoring from 0 to 100, where higher scores indicate better self-care for diabetes.
Measured: From enrollment to 6 months after the intervention begins
Secondary outcomes (13)
Glycated hemoglobin (HbA1c)
Glycated hemoglobin (HbA1c) measures average blood sugar levels over the past 2-3 months, acting as a crucial diagnostic and management tool for diabetes. A level below 7% is recommended for patients with diabetes.
Measured: From enrollment to 6 months after the intervention begins
Subjective Cognitive Decline Questionnaire 21
Subjective Cognitive Decline Questionnaire 21 (SCD-Q21) is a reliable, validated 21-item tool designed to detect self-reported cognitive changes, helping distinguish Mild Cognitive Impairment (MCI) from healthy people. The score is from 0 to 21, with a higher score corresponding to a greater likelihood of MCI.
Measured: From enrollment to 6 months after the intervention begins
Montreal Cognitive Assessment
Montreal Cognitive Assessment (MoCA) is a widely used screening scale designed to detect mild cognitive impairment, with scores from 0 to a maximum of 30 points. A higher score on MoCA indicates better cognitive function and less impairment.
Measured: From enrollment to 6 months after the intervention begins
Caregiver Contribution to Self-Care of Diabetes Inventory
Caregiver Contribution to Self-Care of Diabetes Inventory (CC-SCODI) is a validated scale measuring caregiver efforts in diabetes maintenance, monitoring, and management. The score is from 0 to 100 points, with a higher score indicating higher caregiver involvement.
Measured: From enrollment to 6 months after the intervention begins
Caregiver Burden Inventory
Caregiver Burden Inventory (CBI) is a scale measuring multidimensional caregiver burden. Score is from 0 to 96 points, with a higher score indicating higher perceived caregiver burden.
Measured: From enrollment to 6 months after the intervention begins
Implementation Outcome: Acceptability of Intervention Measure
Acceptability of Intervention Measure (AIM) is a questionnaire assesses how acceptable the intervention is perceived to be by the participants. The total score ranges from 4 to 20, with higher scores indicating greater acceptability of the intervention. Additionally, qualitative interviews with patients and relevant stakeholders are conducted to further evaluate this outcome.
Measured: From 3 months after the intervention begins to 6 months after the intervention begins
Implementation Outcome: Intervention Appropriateness Measure
Intervention Appropriateness Measure (IAM) is a questionnaire evaluates how suitable or relevant the intervention is for the intended purpose or context. The total score ranges from 4 to 20, with higher scores indicating the intervention is perceived as more appropriate. Additionally, qualitative interviews with patients and relevant stakeholders are conducted to further evaluate this outcome.
Measured: From 3 months after the intervention begins to 6 months after the intervention begins
Implementation Outcome: Feasibility of Intervention Measure
Implementation Outcome: Feasibility of Intervention Measure (FIM) is a questionnaire examines how practical and implementable the intervention is in real-world settings. The total score ranges from 4 to 20, with higher scores indicating greater feasibility of implementing the intervention. Additionally, qualitative interviews with patients and relevant stakeholders are conducted to further evaluate this outcome.
Measured: From 3 months after the intervention begins to 6 months after the intervention begins
Implementation Outcome: Adoption
This Adoption questionnaire is derived from the Measuring the Use of the RE-AIM Model Dimension Items Checklist and is designed to assess the adoption of an intervention at both the setting and staff levels. It evaluates factors such as participation rates, reasons for exclusion, and characteristics of participating versus non-participating settings and staff. The measure does not use a specific scoring system; instead, it relies on qualitative and descriptive insights to explore adoption. Additionally, qualitative interviews with patients and relevant stakeholders are conducted to further evaluate this outcome.
Measured: From 3 months after the intervention begins to 6 months after the intervention begins
Implementation Outcome: Fidelity
This Fidelity questionnaire is derived from the Fidelity Checklist for Chronic Disease Self-Management Education Programs and is designed to evaluate the consistency and quality of program implementation. It uses a performance checklist to ensure that the intervention is delivered as intended. The measure does not use a specific scoring system; instead, it relies on qualitative and descriptive insights to explore adoption. If more items on the Fidelity Checklist are met, it indicates better fidelity to the program's design. Additionally, qualitative interviews with patients and relevant stakeholders are conducted to further evaluate this outcome.
Measured: From 3 months after the intervention begins to 6 months after the intervention begins
Implementation Outcome: Cost
This cost outcome focuses on evaluating the economic aspects of the intervention by measuring health-related quality of life using the EQ-5D-5L questionnaire (EuroQol 5-Dimension 5-Level questionnaire), collecting expenditures associated with delivering the intervention (e.g., material costs, staff training, and technical support), and assessing patients' health utilization costs, such as medical expenses, follow-up time, and related financial costs (e.g., transportation). It also considers indirect costs, such as income loss for patients or caregivers, long-term healthcare savings from improved outcomes, and time costs for participants and staff. The collected data will support a cost-effectiveness analysis, providing a comprehensive evaluation of the intervention's value relative to its costs. Additionally, qualitative interviews with patients and relevant stakeholders are conducted to further evaluate this outcome.
Measured: From 3 months after the intervention begins to 6 months after the intervention begins
Implementation Outcome: Penetration
This Penetration questionnaire is derived from the RE-AIM Model Dimension Items Checklist and is designed to evaluate how representative the enrolled patients are of the target population by counting and comparing the number of patients with co-occurring diabetes and MCI who are eligible, invited, excluded, and enrolled to receive CDSMP within participating organizations. Comparisons will be made to non-participants based on key demographic data, including age, diabetes type, MOCA scores and duration, and the number of follow-up attendances. Additionally, qualitative interviews with patients and relevant stakeholders are conducted to further evaluate this outcome.
Measured: From 3 months after the intervention begins to 6 months after the intervention begins
Implementation Outcome: Sustainability
This Sustainability questionnaire is derived from the RE-AIM Model Dimension Items Checklist and is designed to assess the sustainability of an intervention over time. It includes three key components: Maintenance, which evaluates the long-term impact and continuation of the intervention; Individual Level, which focuses on the persistence of individual behavior changes and health outcomes (e.g., maintaining improvements in quality of life or clinical outcomes at 6 months or more post-intervention); and Setting Level, which examines whether the intervention is institutionalized within the organization, including alignment with the organization's mission, resource allocation, and adaptation for long-term implementation. The measure relies on qualitative and descriptive insights rather than a specific scoring system. Additionally, qualitative interviews with patients and relevant stakeholders are conducted to further evaluate this outcome.
Measured: From 3 months after the intervention begins to 6 months after the intervention begins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroid DiseaseStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 309 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496359
- Sponsor's protocol ID
- 22231531
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyadic Management Intervention in Older People With Co-occurring Cognitive Impairment and Diabetes as a Supplementary Approach to Chronic Diseases Self-Management Program: A Hybrid Effectiveness-implementation Study
- ClinicalTrials.gov ID
- NCT07496359
- Acronym / sponsor ID
- 22231531
- Conditions
- Choroid Disease, Caregiver, Self-management, Diabetes, Mild Cognitive Impairment, Older Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 309 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Mar 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDSMP | Experimental | Behavioral: CDSMP + caregiver supportParticipants in the intervention group will receive a 6-week CDSMP course plus support from one informal caregiver throughout the program. |
| Usual care | Active comparator | Behavioral: Usual CareUser care will receive diabetes education, glucose monitoring, and medical consultations, but no informal caregiver support. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| CDSMP + caregiver supportThe CDSMP is an evidence-based program consisting of 2.5-hour sessions held weekly over a six-week period, delivered by two trained leaders per session in person. | Behavioural | CDSMP |
| Usual CareUsual care (diabetes education, glucose monitoring and medical consultation) | Behavioural | Usual care |
Primary outcome
Self-Care of Diabetes Index
Time frame: From enrollment to 6 months after the intervention begins
Self-Care of Diabetes Index (SCODI) is a scale, scoring from 0 to 100, where higher scores indicate better self-care for diabetes.
13 secondary outcomes
Glycated hemoglobin (HbA1c)
Time frame: From enrollment to 6 months after the intervention begins
Subjective Cognitive Decline Questionnaire 21
Time frame: From enrollment to 6 months after the intervention begins
Montreal Cognitive Assessment
Time frame: From enrollment to 6 months after the intervention begins
Caregiver Contribution to Self-Care of Diabetes Inventory
Time frame: From enrollment to 6 months after the intervention begins
Caregiver Burden Inventory
Time frame: From enrollment to 6 months after the intervention begins
Implementation Outcome: Acceptability of Intervention Measure
Time frame: From 3 months after the intervention begins to 6 months after the intervention begins
Implementation Outcome: Intervention Appropriateness Measure
Time frame: From 3 months after the intervention begins to 6 months after the intervention begins
Implementation Outcome: Feasibility of Intervention Measure
Time frame: From 3 months after the intervention begins to 6 months after the intervention begins
Implementation Outcome: Adoption
Time frame: From 3 months after the intervention begins to 6 months after the intervention begins
Implementation Outcome: Fidelity
Time frame: From 3 months after the intervention begins to 6 months after the intervention begins
Implementation Outcome: Cost
Time frame: From 3 months after the intervention begins to 6 months after the intervention begins
Implementation Outcome: Penetration
Time frame: From 3 months after the intervention begins to 6 months after the intervention begins
Implementation Outcome: Sustainability
Time frame: From 3 months after the intervention begins to 6 months after the intervention begins
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDSMP + caregiver support in people with Choroid Disease and Caregiver, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 5 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jed Montayre (85227666393, jed-ray.montayre@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Care of Diabetes Index (time frame: From enrollment to 6 months after the intervention begins). 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 17 Sep 2026.