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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorThe Hong Kong Polytechnic University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Usual Care

    Behavioral

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

Treatment groups

309 Participants
are divided into 2 treatment groups
Group A: CDSMPExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention

Trial outcomes

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.

Time frame
From enrollment to 6 months after the intervention begins

Secondary outcomes

1

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.

Time frame
From enrollment to 6 months after the intervention begins
2

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.

Time frame
From enrollment to 6 months after the intervention begins
3

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.

Time frame
From enrollment to 6 months after the intervention begins
4

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.

Time frame
From enrollment to 6 months after the intervention begins

Other outcomes

Sponsors and contacts

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