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Non-pharmacological Interventions for People With Mild Cognitive Impairment in the Community (CNPI-MCI)

11. juli 2026 oppdatert av: Yiran Yue, Anhui Medical University

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

70

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Community-Family Mutual Support Intervention
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.
Annen: Community-Family Mutual Support Intervention
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.
Aktiv komparator: Routine Community Care
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.
Annen: Routine Community Care
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change in Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)
Tidsramme: From enrollment to the end of treatment at 8 weeks
From enrollment to the end of treatment at 8 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Social Support Rating Scale (SSRS) Total Score
Tidsramme: From enrollment to the end of treatment at 8 weeks
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
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score
Tidsramme: From enrollment to the end of treatment at 8 weeks
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Anhui Medical University

Samarbeidspartnere

The First Affiliated Hospital of Anhui Medical University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

28. juli 2026

Primær fullføring (Antatt)

28. september 2026

Studiet fullført (Antatt)

28. oktober 2026

Datoer for studieregistrering

Først innsendt

7. juli 2026

Først innsendt som oppfylte QC-kriteriene

11. juli 2026

Først lagt ut (Faktiske)

14. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 81251000 (Annet stipend/finansieringsnummer: Biomedical Ethics Committee of Anhui Medical University)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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