Clinical trial NCT04948450: A Multidomain Intervention Program for Older People With Dementia
Official title: A Multidomain Intervention Program for Older People With Dementia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer Disease
Dementia, Mixed
Keywords: Dementia
Multidomain intervention
Older people
Lead sponsor: National Geriatric Hospital
Sponsor class: OTHER_GOV
First posted: 2021-07-02
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed description: This is a two-armed, multicenter, randomized controlled pilot study, based in 3 nursing homes in Hanoi, Vietnam.

The study PI and/or researchers in the research team will contact adults aged 60 years and older in the nursing homes to introduce the study. If they are interested in participating, the study PI and/or researchers in the research team will screen them for their eligibility. If they meet the inclusion criteria and are interested in participating, written informed consent will be obtained.

Participants who agreed to participate in the study will be randomized into two equal groups, to receive either an intensive multidomain intervention (intervention group) or regular health advice (control group).

Participants in both the intervention and the control groups will be treated for dementia according to the recommendations of the Vietnam Alzheimer's Disease and Neurocognitive Disorders Association.

All participants will meet the study physician to have an examination at baseline, 3 months, and 6 months. At each examination, participants will undergo a physical examination, anthropometry (weight, hip and waist circumference), blood pressure determination, pulse rate and rhythm, risks of cardiovascular and metabolic diseases (smoking, drinking, hypertension, coronary artery disease, dyslipidemia, atherosclerosis, diabetes) and assess blood test results (lipid profile, HbA1C, and fasting glucose if patients have diabetes). Results will be provided to participants and their doctors.

In addition to what is given to both groups, participants in the intervention group will receive four intervention components: (1) physical activity intervention; (2) cognitive intervention; (3) social intervention; and (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions.

All outcome measures will be administered at baseline, 6 months

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:

1. Acute and malignant diseases (e.g., advanced cancers, end-stage chronic diseases, acute myocardial infarction, stroke)
2. Symptomatic cardiovascular disease, coronary revascularization within 1 year
3. Clinical evidence of schizophrenia, severe depression, psychiatric or bipolar disorder (according to DSM-V TR criteria)
4. Alcoholism or substance dependence (according to DSM-5 criteria), currently, or within the past 2 years
5. 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

Primary outcomes:
measure: Adherence
timeFrame: 6 months
measure: Retention
timeFrame: 6 months
Secondary outcomes:
measure: Global Cognition
timeFrame: Baseline, 6 months
measure: Executive Function Via Clock Drawing Test
timeFrame: Baseline, 6 months
measure: Attention Function Via Digit Span Forward
timeFrame: Baseline, 6 months
measure: Atttention Function Will be Assessed Using Digit Span Backward.
timeFrame: Baseline, 6 months
measure: Behavioral and Psychological Symptoms of Dementia (BPSD)
timeFrame: Baseline, 6 months
measure: Total Dependence of Participants Assessed Using the Barthel Index
timeFrame: Baseline, 6 months
measure: Functional Ability Via the Handgrip Strength
timeFrame: Baseline, 6 months
measure: Functional Ability Via 30 Seconds Sit To Stand Test
timeFrame: Baseline, 6 months
measure: Fall
timeFrame: Baseline, 6 months
measure: Quality of Sleep
timeFrame: Baseline, 6 months
measure: Health-related Quality of Life
timeFrame: Baseline, 6 months
measure: Death
timeFrame: 6 months
measure: Functional Ability Via the Instrumental Activities of Daily Living Scale
timeFrame: Baseline, 6 months
measure: Dependence of Participants Assessed Using the Instrumental Activities of Daily Living Scale
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Dien Hong nursing home
city: Hanoi
country: Vietnam
facility: National Geriatric Hospital
city: Hanoi
country: Vietnam
facility: Nhan Ai nursing home
city: Hanoi
country: Vietnam
facility: Orihome
Study officials:
affiliation: National Geriatric Hospital
name: Anh T Nguyen, PhD
role: STUDY_DIRECTOR
affiliation: National Geriatric Hospital
name: Thanh X Nguyen, MS
role: PRINCIPAL_INVESTIGATOR
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