About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Dyadic Cognitive Intervention Program for Older Couples
BehavioralGrounded 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
BehavioralStandard 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.
Treatment groups
Trial outcomes
Primary outcomes
Montreal Cognitive Assessment (MoCA) Total Score
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.
Secondary outcomes
Activities of Daily Living (ADL)
Assessed via structured interview with the older adult with cognitive impairment, using the standard Activities of Daily Living (ADL) scale. The scale covers 6 items of basic self-care (such as eating, dressing, bathing and toileting) and 8 items of instrumental daily activities (such as shopping, preparing meals, managing medications and handling finances). Each item is rated from 1 to 4 based on level of independence; total score ranges 14-56. Higher scores indicate greater difficulty and more impairment in performing daily life activities independently.
Depressive Symptoms Assessed by the Geriatric Depression Scale-15 (GDS-15)
Self-reported by both the older adult with cognitive impairment and the spousal caregiver, using the 15-item Geriatric Depression Scale (GDS-15). The scale measures common depressive symptoms over the past week, including low mood, loss of interest in activities, feelings of emptiness, hopelessness and social withdrawal. Items are answered with a simple yes/no format; total score ranges 0-15. Higher scores indicate more severe depressive symptoms.
Quality of Life Assessed by the Quality of Life-Alzheimer's Disease (QOL-AD) Scale
Assesses health-related quality of life of the older adult with cognitive impairment, using the Quality of Life in Alzheimer's Disease (QOL-AD) scale. For participants with mild to moderate impairment, the scale is administered as a structured self-report interview; for those with more severe impairment who cannot self-report, the spousal caregiver completes a proxy rating based on daily observation. It covers 13 life domains including physical health, energy, mood, memory, family relationships, social interaction and daily activities. Total score ranges 13-52; higher scores indicate better overall quality of life.
Dyadic Coping Ability Assessed by the Dyadic Coping Inventory (DCI)
Completed independently and privately by both members of the couple, using the validated Chinese version of the Dyadic Coping Inventory (DCI). The 37-item scale measures how couples communicate stress, provide emotional and practical support, solve problems together, and respond negatively when facing disease-related pressure. Items are rated on a 5-point frequency scale; negatively worded items are reverse-scored. Total score ranges 35-175. Higher scores indicate more positive, collaborative and supportive dyadic coping patterns within the couple.
Sponsors and contacts
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Gansu University of Chinese Medicine
Lead sponsor
Gansu Provincial Hospital
Collaborator
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