Cognitive ImpairmentNCT07872189
Dyadic Cognitive Intervention for Older Adults With Cognitive Impairment and Their Spouses
A study testing Dyadic Cognitive Intervention Program for Older Couples and Standard Community Health Education on Cognitive Impairment in people with Cognitive Impairment, run by Gansu University of Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Dyadic Cognitive Intervention Program for Older Couples and Standard Community Health Education on Cognitive Impairment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- Jun 2027to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tuanjienxincun Community Health Service Center
Lanzhou, Gansu, 730000
Xue Yang, Master's Candidate, +86-17693209805, 3405288639@qq.com
Juxia Zhang, Professor, +86-13893437575, 3031548132@qq.com
About this study
Official title: Development and Application of a Dyadic Cognitive Intervention Program for Older Adults With Cognitive Impairment and Their Spouses
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Cognitive Impairment
- Being tested
- Dyadic Cognitive Intervention Program for Older Couples, Standard Community Health Education on Cognitive Impairment
- Keywords
- Dyadic Intervention, Community, Spousal Caregivers, Older Adults, Dyadic Illness Management, Cognitive Intervention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic Cognitive Intervention Program for Older CouplesBehavioural
Also called TDIM-based Couple Cognitive Intervention, Couple-centered Cognitive Intervention for MCI, Dyadic Cognitive Intervention
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 ImpairmentBehavioural
Also called Routine Cognitive Health Education, Community Dementia Prevention Education
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 group | Role | What they receive |
|---|---|---|
| Dyadic Intervention Group | Experimental | 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. Receives: Behavioral: Dyadic Cognitive Intervention Program for Older Couples |
| Standard Community Health Education | Active comparator | 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. Receives: Behavioral: Dyadic Cognitive Intervention Program for Older Couples; Behavioral: Standard Community Health Education on Cognitive Impairment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before intervention initiation), 3 months after intervention completion, and 6 months after intervention completion
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (before intervention initiation), 3 months after intervention completion, and 6 months after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startJun 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm parallel-group randomized controlled trial. Eligible community-dwelling older couples (one partner with mild cognitive impairment and one spousal caregiver) will be randomly allocated to the intervention arm or the control arm at a 1:1 ratio. Both arms will receive follow-up assessments at the same time points: baseline, 3 months post-intervention, and 6 months post-intervention. Outcome assessors will be masked to group assignment to reduce measurement bias.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gansu University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Gansu Provincial Hospital
- Responsible party
- Principal investigator, Yang Xue, Gansu University of Chinese Medicine
- Investigators
- Juxia Zhang, Professor, Study director, Gansu Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872189
- Sponsor's protocol ID
- 24JRRA594
- Other IDs
- 24JRRA594
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of a Dyadic Cognitive Intervention Program for Older Adults With Cognitive Impairment and Their Spouses
- ClinicalTrials.gov ID
- NCT07872189
- Acronym / sponsor ID
- 24JRRA594
- Conditions
- Cognitive Impairment
- Keywords
- Dyadic Intervention, Community, Spousal Caregivers, Older Adults, Dyadic Illness Management, Cognitive Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Gansu University of Chinese MedicineUniversity, hospital or other
- Collaborators
- Gansu Provincial Hospital
- Study start
- Jun 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm parallel-group randomized controlled trial. Eligible community-dwelling older couples (one partner with mild cognitive impairment and one spousal caregiver) will be randomly allocated to the intervention arm or the control arm at a 1:1 ratio. Both arms will receive follow-up assessments at the same time points: baseline, 3 months post-intervention, and 6 months post-intervention. Outcome assessors will be masked to group assignment to reduce measurement bias.
| Arm | Type | Receives |
|---|---|---|
| Dyadic Intervention Group | Experimental | Behavioral: Dyadic Cognitive Intervention Program for Older CouplesThis 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. |
| Standard Community Health Education | Active comparator | Behavioral: Dyadic Cognitive Intervention Program for Older Couples, Behavioral: Standard Community Health Education on Cognitive ImpairmentThis 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Permanent residents of the Tuanjie Xincun community (with a residence duration of more than 6 months)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyadic Cognitive Intervention Program for Older CouplesAlso: TDIM-based Couple Cognitive Intervention, Couple-centered Cognitive Intervention for MCI, Dyadic Cognitive InterventionGrounded 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. | Behavioural | Dyadic Intervention Group, Standard Community Health Education |
| Standard Community Health Education on Cognitive ImpairmentAlso: Routine Cognitive Health Education, Community Dementia Prevention EducationStandard 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. | Behavioural | Standard Community Health Education |
Primary outcome
Montreal Cognitive Assessment (MoCA) Total Score
Time frame: 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.
5 secondary outcomes
Activities of Daily Living (ADL)
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)
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
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)
Time frame: Baseline (before intervention initiation), 3 months after intervention completion, and 6 months after intervention completion
Zarit Caregiver Burden Interview (ZBI) Score
Time frame: Baseline (before intervention initiation), 3 months after intervention completion, and 6 months after intervention completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juxia Zhang, Professor study director
Gansu Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic Cognitive Intervention Program for Older Couples and Standard Community Health Education on Cognitive Impairment in people with Cognitive Impairment, run by Gansu University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xue Yang, Master's Candidate (+86-17693209805, 3405288639@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) Total Score (time frame: Baseline (before intervention initiation), 3 months after intervention completion, and 6 months after intervention completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.