NCT07703267

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Jul 2026Oct 2026

First Submitted

Initial submission to the registry

July 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

July 28, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2026

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 7, 2026

Last Update Submit

July 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

  • Change From Baseline in Social Support Rating Scale (SSRS) Total Score

    From enrollment to the end of treatment at 8 weeks

  • Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score

    From enrollment to the end of treatment at 8 weeks

Study Arms (2)

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.

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.

Other: Routine Community Care

Interventions

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.

Community-Family Mutual Support Intervention

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.

Routine Community Care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 14, 2026

Study Start

July 28, 2026

Primary Completion (Estimated)

September 28, 2026

Study Completion (Estimated)

October 28, 2026

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share