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Starting soon Not applicable

Dyadic Cognitive Intervention for Older Adults With Cognitive Impairment and Their Spouses

NCT07872189 · tracked via the Priya Life Science China tracker
Sponsor
Gansu University of Chinese Medicine
Phase
Not applicable
Started
2027-06
Last updated
2026-10-13

Condition(s) studied

Cognitive Impairment

Investigational drug(s) / intervention(s)

Dyadic Cognitive Intervention Program for Older CouplesStandard Community Health Education on Cognitive Impairment

Dyadic Cognitive Intervention Program for Older Couples: Grounded in the Theory of Dyadic Illness Management, this 8-week structured intervention treats older couples (one partner with mild cognitive impairment, one spousal caregiver) as an interdependent dyadic unit. It includes 4 progressive core modules: (1) shared disease education to align both partners' understanding of cognitive impairment and care goals; (2) joint cognitive maintenance exercises and compensatory memory strategy training for daily life support; (3) dyadic communication and collaborative coping skills for disease-related stress; (4) shared healthy lifestyle planning and long-term disease co-management. Delivered via weekly 60-minute in-person group sessions by trained geriatric nurses and social workers, supplemented by structured daily home practice and biweekly telephone follow-up, following a standardized manual to ensure intervention fidelity.

Standard Community Health Education on Cognitive Impairment: Standard community health education on cognitive impairment for older adults and family caregivers, covering disease etiology, modifiable risk factors, early warning signs, healthy lifestyle recommendations, basic daily care principles, medication safety, and available local community health resources. Delivered through monthly 45-60 minute group health lectures and printed educational brochures by community health care staff. Provided to all enrolled couples in both study arms; serves as the sole intervention for the control arm, with matched contact frequency and identical assessment time points to control for attention effects.

Study summary

The goal of this randomized controlled clinical trial is to learn if a couple-centered cognitive intervention program can improve cognitive health, reduce caregiving burden, and support overall well-being for community-dwelling older adults (aged 60 and above) with mild cognitive impairment and their spouses. The main questions it aims to answer are:

* Does the couple-based cognitive intervention improve the cognitive function of older adults with mild cognitive impairment?
* Can the intervention reduce the caregiving burden experienced by spouses who care for a partner with cognitive impairment?
* Can the intervention help reduce depressive symptoms, improve quality of life, and strengthen the ability of couples to cope with the disease together?

Researchers will compare two groups of participants: the intervention group receives the couple-based cognitive program in addition to regular community health education, while the control group receives only regular community health education. The study will test whether the intervention leads to better health and well-being outcomes for both the older adults with cognitive impairment and their spouse caregivers.

Participants will:

* Be randomly assigned to either the intervention group or the control group
* If in the intervention group: join an 8-week structured couple intervention with their spouse. The program covers cognitive health knowledge, joint memory and thinking exercises, communication and coping skill practice, and guidance for shared healthy daily habits
* If in the control group: receive standard community health education about cognitive impairment prevention and care
* Complete health and well-being assessments at the start of the study, 3 months after the intervention, and 6 months after the intervention. Assessments include tests of cognitive function, daily living ability, mood, quality of life, how well couples cope with the disease together, and how much burden spouses feel from providing day-to-day care.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Permanent residents of the Tuanjie Xincun community (with a residence duration of more than 6 months) * Aged 60 years old and above ③ Married and cohabiting with their spouse * One member of the elderly couple has a confirmed diagnosis of mild cognitive impairment (MCI) * Have basic verbal communication competence * Provide written informed consent and voluntarily participate in the study Exclusion Criteria: * Either member of the couple has a severe systemic disease that renders them unable to cooperate with study procedures, or has severe visual or auditory impairment ② Either member of the couple has schizophrenia or other severe psychiatric disorders ③Currently enrolled in another interventional research study

Primary outcome measure(s)

  • Montreal Cognitive Assessment (MoCA) Total Score — Baseline (before intervention initiation), 3 months after intervention completion, and 6 months after intervention completion
    Administered face-to-face by trained outcome assessors blinded to group assignment, using the validated Chinese version of the Montreal Cognitive Assessment (MoCA). The test evaluates 8 core cognitive domains: visuospatial function, naming, attention, language, verbal fluency, abstraction, delayed recall, and orientation. Total score ranges from 0 to 30; a score of 26 or above indicates normal cognition, and lower scores indicate greater cognitive impairment. One point is added for participants with 12 years or less of education to adjust for educational attainment. This measure is completed only by the older adult diagnosed with mild cognitive impairment.

Trial sites (1)

FacilityCityRegionStatus
Tuanjienxincun Community Health Service Center Lanzhou Gansu

More Gansu University of Chinese Medicine trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07872189 on ClinicalTrials.gov ↗ ← All trials in China