N/A N=60 Randomized Triple-blind Supportive Care

A Multidomain Intervention Program for Older People With Dementia

Dementia · Alzheimer Disease · Dementia, Mixed

Bottom Line

View on ClinicalTrials.gov: NCT04948450 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Adherence — 85.4 percentage of Adherence

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Physical activity intervention (Behavioral); Cognitive stimulation intervention (Behavioral); Social intervention (Behavioral); Management of metabolic and vascular risk factors (Other)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: National Geriatric Hospital
Primary completion: Jan 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Adherence	85.4	—
PRIMARY Retention	1; 3	—
SECONDARY Global Cognition	28; 24.5; 27.3; 29.1	—
SECONDARY Executive Function Via Clock Drawing Test	0.5; 2.3; 2.3; 2.7	—
SECONDARY Attention Function Via Digit Span Forward	8.9; 9.5; 9; 9.1	—
SECONDARY Atttention Function Will be Assessed Using Digit Span Backward.	2.5; 2.6; 2.7; 3	—
SECONDARY Behavioral and Psychological Symptoms of Dementia (BPSD)	1; 1; 0.8; 0.9	—
SECONDARY Total Dependence of Participants Assessed Using the Barthel Index	4; 2; 4; 7	—
SECONDARY Functional Ability Via the Handgrip Strength	8; 12.4; 12.8; 11.1	—
SECONDARY Functional Ability Via 30 Seconds Sit To Stand Test	4.5; 3.4; 5.4; 1.9	—
SECONDARY Fall	11; 8; 6; 7	—
SECONDARY Quality of Sleep	26; 17; 19; 17	—
SECONDARY Health-related Quality of Life	27.3; 33.6; 28.9; 34.4	—
SECONDARY Death	0; 0	—
SECONDARY Functional Ability Via the Instrumental Activities of Daily Living Scale	26; 29; 23; 27	—
SECONDARY Dependence of Participants Assessed Using the Instrumental Activities of Daily Living Scale	26; 29; 23; 27	—

Summary

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

Eligibility Criteria

Inclusion criteria

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.

Exclusion criteria are:

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)
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)

g. Participant or family unwilling to participate in the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04948450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.