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| ID | Type | Description | Link |
|---|---|---|---|
| 81251000 | Other Grant/Funding Number | Biomedical Ethics Committee of Anhui Medical University |
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| Name | Class |
|---|---|
| The First Affiliated Hospital of Anhui Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community-Family Mutual Support Intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA) | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yiran Yue | Contact | 8617333266696 | yueyiran1@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 9, 2025 | Jul 7, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 9, 2025 | Jul 7, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Routine Community Care | Other | 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. |
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| 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. | From enrollment to the end of treatment at 8 weeks |