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Not yet recruiting NCT07496359

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

No phase Interventional Choroid Disease Caregiver Self-management Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CDSMP + caregiver support, Usual Care.
Who it may be relevant to
Registry conditions: Choroid Disease, Caregiver, Self-management, Diabetes. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.
  • Behavioral Usual Care
    Usual care (diabetes education, glucose monitoring and medical consultation)

Primary outcome measures

  • Self-Care of Diabetes Index [Time frame: From enrollment to 6 months after the intervention begins]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07496359 · 22231531

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗