- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07831616
Development and Empirical Evaluation of a Brief Lifestyle Intervention for Older Adults at Risk of Dementia Within an Integrated Medical-Preventive Grid-Based Service Model
Lifestyle factors are among the most important modifiable risk factors for dementia, and primary prevention through lifestyle interventions is considered the most cost-effective approach to reducing the incidence of dementia. However, traditional face-to-face interventions have limitations that hinder large-scale implementation. With the development of primary healthcare systems, the delivery of simple, feasible, and brief lifestyle interventions within primary care settings offers a promising avenue for the continuous management and early prevention of dementia risk in older adults.
In this study, brief lifestyle interventions were administered to older adults at risk of dementia by registered physicians at community health service centers.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age ≥ 60 years
- CAIDE dementia risk score ≥ 6
- Possessing basic comprehension and verbal expression abilities
- Voluntarily participating in the study and signing the informed consent form
- Not participating in other clinical trials during the intervention period.
Exclusion Criteria:
- Individuals already diagnosed with dementia
- individuals with severe heart, liver, or kidney disease
- individuals with severe chronic diseases and comorbidities (e.g., congestive heart failure, or hypertension or diabetes with severe complications)
- individuals with severe visual or hearing impairment.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Only assessment
|
|
|
Aktiv komparator: brief lifestyle intervention
|
Primary care physicians provide brief lifestyle interventions to older adults at risk of dementia |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Lifestyle Scale for Reducing Dementia Risk
Tidsramme: From the start through the end of the 12-week intervention
|
From the start through the end of the 12-week intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Scale of Motivation to Change Lifestyle and Health Behaviors to Reduce Dementia Risk
Tidsramme: From the beginning to the end of the 12-week intervention
|
From the beginning to the end of the 12-week intervention
|
|
|
Adherence-related outcomes
Tidsramme: From the start through the end of the 12-week intervention
|
Adherence-related outcomes included rates of intervention receipt, retention, protocol adherence, and session attendance |
From the start through the end of the 12-week intervention
|
|
Readiness to change behaviour
Tidsramme: From the start through the end of the 12-week intervention
|
4 for "Already working on improvement," 3 for "Intending to improve," 2 for "No intention to improve," and 1 for "No improvement needed." |
From the start through the end of the 12-week intervention
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FJMU2026183
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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