NCT04948450Completed
A Multidomain Intervention Program for Older People With Dementia
A Multidomain Intervention Program for Older People With Dementia: A Pilot Study
Source: ClinicalTrials.gov · Last updated 6 Apr 2025
Brief summary (registry, in English)
This is a pilot study to assess the feasibility of a multidomain intervention for older people with dementia in nursing homes. Participants will be randomized into two equal groups, to receive either an intensive multidomain intervention (intervention group) or regular health advice (control group). The intervention will include physical, cognitive, and social interventions and management of metabolic and vascular risk factors. We hypothesize that the multidomain intervention will be feasible in Vietnam, and participants who receive the intervention will show improvement in cognitive function, quality of life, behaviors, functional ability, sleep, and in reduction of falls, and death rate compared to those in the control group during the 6 months intervention period
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 4 Jun 2021
- Start date
- 24 Nov 2022
- Primary completion date
- 31 Jan 2024
- Lead sponsor
- National Geriatric Hospital
- Diseases
- Alzheimer disease
- NCT number
- NCT04948450
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 24 Nov 2022 to the primary completion date, 31 Jan 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Acute and malignant diseases (e.g., advanced cancers, end-stage chronic diseases, acute myocardial infarction, stroke)
- Symptomatic cardiovascular disease, coronary revascularization within 1 year
- Clinical evidence of schizophrenia, severe depression, psychiatric or bipolar disorder (according to DSM-V TR criteria)
Other
- Alcoholism or substance dependence (according to DSM-5 criteria), currently, or within the past 2 years
- Severe loss of vision, hearing, or communicative ability (according to the interRAI Community Health Assessment)
- Participant or family unwilling to participate in the study
Who the study is looking for
- We aim to enroll participants aged over 60 years old, living in nursing home, who have a diagnosis of dementia (according to DSM 5 criteria), stage mild to moderate (according to Clinical Dementia Rating scale - CDR). Participants receiving pharmacological treatment for dementia must be on a stable dose for at least 3 months prior to the study. Eligible participants must be able to mobilize independently with or without a mobility aid and without physical assistance.
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nhan Ai nursing home Coordinator of this site? Confirm its status | Hanoi | Vietnam | Unknown status |
| Orihome Coordinator of this site? Confirm its status | Hanoi | Vietnam | Unknown status |
| National Geriatric Hospital Coordinator of this site? Confirm its status | Hanoi | Vietnam | Unknown status |
| Dien Hong nursing home Coordinator of this site? Confirm its status | Hanoi | Vietnam | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.