Mild Cognitive Impairment (MCI)CNPI-MCINCT07703267
Non-pharmacological Interventions for People With Mild Cognitive Impairment in the Community
A study testing Community-Family Mutual Support Intervention and Routine Community Care in people with Mild Cognitive Impairment (MCI), run by Anhui Medical University.
Trial summary
Mild cognitive impairment (MCI) may increase the risk of dementia. This study will evaluate an 8-week community-family mutual support intervention for adults aged 60 years or older with MCI. Participants will be randomly assigned to an intervention group or a control group. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Community-Family Mutual Support Intervention and Routine Community Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 28 Jul 2026to 28 Oct 2026
- 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
- Aged 60 years or older.
- Meets the diagnostic criteria for mild cognitive impairment, including subjective cognitive decline, objective impairment in at least one cognitive domain, relatively preserved activities of daily living, and no diagnosis of dementia.
- Has lived in the study community for at least 6 months.
- Has completed primary school or above and is able to read and write.
- Is able to communicate and complete the study assessments and intervention activities.
- Voluntarily participates and provides written informed consent.
Who cannot join
- Unable to communicate effectively.
- Has severe visual or hearing impairment that prevents participation.
- Has dementia, schizophrenia, or another severe psychiatric disorder.
- Has a serious or unstable physical illness that prevents participation in the intervention.
- Is currently participating in another cognitive training or similar intervention study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development of a 'Community-Family Mutual Support' Intervention Model for Patients With Mild Cognitive Impairment Based on Social Support Theory
Mild cognitive impairment (MCI) may increase the risk of dementia. This study will evaluate an 8-week community-family mutual support intervention for adults aged 60 years or older with MCI. Participants will be randomly assigned to an intervention group or a control group. The control group will receive routine community care, while the intervention group will additionally receive cognitive training, health education, family support, mutual support activities, and individualized feedback. Cognitive function, daily functioning, emotional status, and social support will be assessed before and after the intervention.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Community-Family Mutual Support Intervention, Routine Community Care
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-Family Mutual Support InterventionOther
Participants will receive an 8-week community-family mutual support intervention in addition to routine community care. Guided by social support theory, the program integrates informational, emotional, instrumental, and appraisal support. It includes MCI-related health education, cognitive training, physical activity guidance, emotional self-monitoring, home-based practice with family assistance, mutual support between paired families, group activities, and individualized feedback. The intervention will be delivered through community-based sessions and supported home activities by trained researchers and community nurses.
Routine Community CareOther
Participants will receive routine community care, including standard health education and usual community-based health services, during the 8-week study period. They will not receive the community-family mutual support intervention.
| Study group | Role | What they receive |
|---|---|---|
| Community-Family Mutual Support Intervention | Experimental | Participants will receive routine community care plus an 8-week community-family mutual support intervention based on social support theory. The intervention includes health education, cognitive training, emotional self-monitoring, family involvement, mutual support between participating families, group activities, and individualized feedback. Receives: Other: Community-Family Mutual Support Intervention |
| Routine Community Care | Active comparator | Participants will receive routine community care, including standard health education and usual community-based health services, during the 8-week study period. They will not receive the community-family mutual support intervention. Receives: Other: Routine Community Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (2)
Change From Baseline in Social Support Rating Scale (SSRS) Total Score
Social support will be assessed using the 10-item Social Support Rating Scale (SSRS). The total score ranges from 12 to 66 points, with higher scores indicating greater social support. The outcome measure is the change in the total score from baseline to Week 8.
Measured: From enrollment to the end of treatment at 8 weeks
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 27. Higher scores indicate more severe depressive symptoms. The outcome measure is the change in the PHQ-9 total score from baseline to Week 8.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start28 Jul 2026 (estimated)
- Primary completion28 Sep 2026 (estimated)
- Study completion28 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University
- Responsible party
- Principal investigator, Yiran Yue, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703267
- Sponsor's protocol ID
- 81251000
- Other IDs
- 81251000
- Acronym
- CNPI-MCI
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a 'Community-Family Mutual Support' Intervention Model for Patients With Mild Cognitive Impairment Based on Social Support Theory
- ClinicalTrials.gov ID
- NCT07703267
- Acronym / sponsor ID
- CNPI-MCI / 81251000
- Conditions
- Mild Cognitive Impairment (MCI)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University
- Study start
- 28 Jul 2026 (estimated)
- Primary completion
- 28 Sep 2026 (estimated)
- Study completion
- 28 Oct 2026 (estimated)
- First posted
- 14 Jul 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.
Mild cognitive impairment (MCI) may increase the risk of dementia. This study will evaluate an 8-week community-family mutual support intervention for adults aged 60 years or older with MCI. Participants will be randomly assigned to an intervention group or a control group. The control group will receive routine community care, while the intervention group will additionally receive cognitive training, health education, family support, mutual support activities, and individualized feedback. Cognitive function, daily functioning, emotional status, and social support will be assessed before and after the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community-Family Mutual Support Intervention | Experimental | Other: Community-Family Mutual Support InterventionParticipants will receive routine community care plus an 8-week community-family mutual support intervention based on social support theory. The intervention includes health education, cognitive training, emotional self-monitoring, family involvement, mutual support between participating families, group activities, and individualized feedback. |
| Routine Community Care | Active comparator | Other: Routine Community CareParticipants will receive routine community care, including standard health education and usual community-based health services, during the 8-week study period. They will not receive the community-family mutual support intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 60 years or older.
- Meets the diagnostic criteria for mild cognitive impairment, including subjective cognitive decline, objective impairment in at least one cognitive domain, relatively preserved activities of daily living, and no diagnosis of dementia.
- Has lived in the study community for at least 6 months.
- Has completed primary school or above and is able to read and write.
- Is able to communicate and complete the study assessments and intervention activities.
Key exclusion criteria (5 listed)
- Unable to communicate effectively.
- Has severe visual or hearing impairment that prevents participation.
- Has dementia, schizophrenia, or another severe psychiatric disorder.
- Has a serious or unstable physical illness that prevents participation in the intervention.
- Is currently participating in another cognitive training or similar intervention 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 |
|---|---|---|
| Community-Family Mutual Support InterventionParticipants will receive an 8-week community-family mutual support intervention in addition to routine community care. Guided by social support theory, the program integrates informational, emotional, instrumental, and appraisal support. It includes MCI-related health education, cognitive training, physical activity guidance, emotional self-monitoring, home-based practice with family assistance, mutual support between paired families, group activities, and individualized feedback. The intervention will be delivered through community-based sessions and supported home activities by trained researchers and community nurses. | Other | Community-Family Mutual Support Intervention |
| Routine Community CareParticipants will receive routine community care, including standard health education and usual community-based health services, during the 8-week study period. They will not receive the community-family mutual support intervention. | Other | Routine Community Care |
Primary outcome
Change in Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)
Time frame: From enrollment to the end of treatment at 8 weeks
2 secondary outcomes
Change From Baseline in Social Support Rating Scale (SSRS) Total Score
Time frame: From enrollment to the end of treatment at 8 weeks
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score
Time frame: From enrollment to the end of treatment at 8 weeks
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 14 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Community-Family Mutual Support Intervention and Routine Community Care in people with Mild Cognitive Impairment (MCI), run by Anhui Medical University.
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 6 inclusion and 5 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 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Yiran Yue (8617333266696, yueyiran1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA) (time frame: From enrollment to the end of treatment at 8 weeks). 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 14 Jul 2026.