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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes; Mild Cognitive Impairment; Older Adults; Self-management; Caregiver; Choroid Disease
• Intervention / Treatment: Behavioral: CDSMP + caregiver support; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 309
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CDSMP; 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; 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.
Active Comparator: Usual care; User care will receive diabetes education, glucose monitoring, and medical consultations, but no informal caregiver support.	Behavioral: Usual Care; Usual care (diabetes education, glucose monitoring and medical consultation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	From 3 months after the intervention begins to 6 months after the intervention begins

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Mental Disorders; Metabolic Diseases; Neurocognitive Disorders; Glucose Metabolism Disorders; Eye Diseases; Cognition Disorders; Uveal Diseases; Nutritional and Metabolic Diseases; Cognitive Dysfunction; Diabetes Mellitus; Choroid Diseases
• Other Study ID Numbers: 22231531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No