An interventional study of Dyadic Cognitive Intervention Program for Older Couples and Standard Community Health Education on Cognitive Impairment in Cognitive Impairment, sponsored by Gansu University of Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Gansu University of Chinese Medicine · Not applicable, Interventional, and Treatment
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:
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:
Cognitive impairment represents a major and growing public health challenge against the backdrop of global population aging. It impairs older adults' independent living ability and quality of life, and also places substantial physical, emotional, and economic strain on family caregivers, with spouses being the primary source of informal care in community settings. Epidemiological evidence has documented a spousal concordance effect for cognitive impairment: spouses of people with cognitive decline face a significantly elevated risk of developing cognitive impairment themselves, driven by shared lifestyles, common risk factors, and long-term caregiving stress. Most current interventions target either the patient or the caregiver as an individual, rather than treating the couple as an interdependent dyadic unit.
To address this research gap, this study applies the Theory of Dyadic Illness Management (TDIM) to develop and test a couple-centered cognitive intervention for community-dwelling older adults with mild cognitive impairment and their spouses. The core premise of the theory is that illness management is a shared process within a couple: shared appraisal of the condition, collaborative disease management behaviors, and mutual support together shape health outcomes for both partners. This study moves beyond the traditional patient-only or caregiver-only intervention model, and instead designs the program around the dyad to target shared risk factors and support joint coping.
This is a single-center, parallel-group randomized controlled trial conducted in an urban community health service setting in China. A total of 68 eligible older couples (in which one partner meets diagnostic criteria for mild cognitive impairment and the other serves as the spousal caregiver) will be enrolled. Eligible couples will be randomly allocated to either the intervention group or the control group in a 1:1 ratio. To reduce measurement and analytic bias, outcome assessors and data analysts will be blinded to group assignment throughout the study.
Participants assigned to the control group will receive standard community health education covering cognitive impairment risk factors, early warning signs, basic care knowledge, and healthy lifestyle guidance. Participants assigned to the intervention group will receive the same standard health education, plus a structured dyadic cognitive intervention program. The intervention is designed for joint participation by both members of the couple, and focuses on building a shared understanding of cognitive health, practicing collaborative cognitive maintenance strategies, developing dyadic coping and communication skills, and establishing shared healthy daily routines.
All enrolled couples will complete follow-up assessments at three time points: baseline (prior to randomization), 3 months post-intervention, and 6 months post-intervention. Assessments will cover multiple core domains of dyadic health: cognitive function of the older adult with impairment, daily living functional status, emotional well-being for both partners, overall quality of life, dyadic coping capacity of the couple, and caregiving burden experienced by the spouse.
This trial aims to generate evidence regarding the effectiveness, feasibility, and acceptability of a couple-based cognitive intervention in a Chinese community context. The findings are expected to provide a practical, evidence-based intervention model for primary care and community health services, and to support the transition from individual-focused cognitive care to dyadic, couple-centered care for older adults with cognitive impairment and their families.
3,930 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.
This study's planned enrollment of 136 is above the median of 64 across 2,855 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Gansu University of Chinese Medicine is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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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
Exclusion Criteria:
This arm receives standard community health education plus an 8-week theory-based dyadic cognitive intervention, in which both the older adult with mild cognitive impairment and their spousal caregiver participate as a dyadic unit. Grounded in the Theory of Dyadic Illness Management, the intervention includes 4 core modules: (1) shared disease education and unified cognitive health appraisal; (2) joint cognitive maintenance exercises and compensatory strategy training; (3) dyadic communication and collaborative coping skills practice; (4) shared healthy lifestyle planning and daily activity co-management. The program is delivered via weekly 60-minute in-person group sessions, supplemented by structured home practice tasks and biweekly telephone follow-up guidance throughout the intervention period.
Behavioral: Dyadic Cognitive Intervention Program for Older Couples
This arm receives standard community health education on cognitive impairment for older adults and family caregivers. Educational content covers disease etiology, modifiable risk factors, early warning signs, healthy lifestyle recommendations, basic daily care knowledge, medication safety, and available community health resources. Content is delivered through monthly 45-60 minute group health lectures and printed educational brochures. Follow-up contact frequency and all assessment time points are identical to the intervention arm; no additional structured dyadic cognitive intervention program is provided.
Behavioral: Dyadic Cognitive Intervention Program for Older Couples · Behavioral: Standard Community Health Education on Cognitive Impairment
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.
Also known as: TDIM-based Couple Cognitive Intervention, Couple-centered Cognitive Intervention for MCI, Dyadic Cognitive Intervention
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.
Also known as: Routine Cognitive Health Education, Community Dementia Prevention Education
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.
Time frame: Baseline (before intervention initiation), 3 months after intervention completion, and 6 months after intervention completion
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.
Time frame: Baseline (before intervention initiation), 3 months after intervention completion, and 6 months after intervention completion
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.
Time frame: Baseline (before intervention initiation), 3 months after intervention completion, and 6 months after intervention completion
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.
Time frame: Baseline (before intervention initiation), 3 months after intervention completion, and 6 months after intervention completion
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.
Time frame: Baseline (before intervention initiation), 3 months after intervention completion, and 6 months after intervention completion
Zarit Caregiver Burden Interview (ZBI) Score
Completed independently by the spousal caregiver using the validated Chinese version of the Zarit Caregiver Burden Interview (ZBI). This is a widely used self-report tool that measures the subjective physical, emotional, social, and financial burden experienced by people caring for a partner with cognitive impairment. The scale contains 22 items, each rated on a 5-point scale from 0 (never) to 4 (nearly always). Total scores range from 0 to 88, where higher scores indicate greater levels of caregiving-related strain. Burden severity is interpreted as: 0-21 = little to no burden, 22-40 = mild to moderate burden, 41-60 = moderate to severe burden, 61-88 = severe burden.
Time frame: Baseline (before intervention initiation), 3 months after intervention completion, and 6 months after intervention completion
Plan to share: No — The individual participant data (IPD) collected in this study includes sensitive personal health information from older adults with cognitive impairment and their spouses. Due to ethical restrictions, participant privacy protection requirements, and the absence of specific informed consent for public data sharing, the IPD will not be shared with other researchers. The data will be securely stored and only accessible to the approved research team.
No publications or documents are linked to this record.
Start is estimated for Jun 2027; primary completion for Jan 2028, 7 months later.
Of 1,439 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's planned 7 months is below that.
Counting every sponsor, half of 1,512 studies reached it within 26 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Gansu University of Chinese Medicine