Dyadic Management Intervention in Older People With Co-occurring Cognitive Impairment and Diabetes as a Supplementary Approach to Chronic Diseases Self-Management Program

NCT07496359 | Not Yet Recruiting

• 1 other identifier: 22231531
• Study Type: interventional
• Target: 309
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Choroid Disease; Caregiver; Self-management; Diabetes; Mild Cognitive Impairment; Older Adults

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to 6 months after the intervention begins

Secondary Outcomes (13)

• Glycated hemoglobin (HbA1c)

  From enrollment to 6 months after the intervention begins

• Subjective Cognitive Decline Questionnaire 21

  From enrollment to 6 months after the intervention begins

• Montreal Cognitive Assessment

  From enrollment to 6 months after the intervention begins

• Caregiver Contribution to Self-Care of Diabetes Inventory

  From enrollment to 6 months after the intervention begins

• Caregiver Burden Inventory

  From enrollment to 6 months after the intervention begins

Study Arms (2)

CDSMP

EXPERIMENTAL

Participants in the intervention group will receive a 6-week CDSMP course plus support from one informal caregiver throughout the program.

Behavioral: CDSMP + caregiver support

Usual care

ACTIVE COMPARATOR

User care will receive diabetes education, glucose monitoring, and medical consultations, but no informal caregiver support.

Behavioral: Usual Care

Interventions

CDSMP + caregiver support BEHAVIORAL

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.

CDSMP

Usual Care BEHAVIORAL

Usual care (diabetes education, glucose monitoring and medical consultation)

Usual care

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Choroid Diseases; Diabetes Mellitus; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

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: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share