A Multidomain Intervention Program for Older People With Dementia

Not Applicable

Completed

Conditions: Dementia, Mixed
Alzheimer Disease
Dementia

Interventions: Behavioral: Physical activity intervention
Behavioral: Cognitive stimulation intervention
Behavioral: Social intervention
Other: Management of metabolic and vascular risk factors

Registration Number: NCT04948450

Lead Sponsor: National Geriatric Hospital

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Cognitive stimulation intervention	Physical activity intervention: Progressive resistance training (PRT) for the physical intervention will be provided at the nursing home. Cognitive stimulation intervention: The study subjects will receive cognitive intervention based on Cognitive Stimulation Therapy with rehabilitation experts. Social intervention: The social intervention will be combined with physical and cognitive interventions by doing in a group. Metabolic and vascular risk factors: Metabolic and vascular risk factors of the intervention group will be evaluated by cardiologists and endocrinologists in the study.
Intervention group	Social intervention	Physical activity intervention: Progressive resistance training (PRT) for the physical intervention will be provided at the nursing home. Cognitive stimulation intervention: The study subjects will receive cognitive intervention based on Cognitive Stimulation Therapy with rehabilitation experts. Social intervention: The social intervention will be combined with physical and cognitive interventions by doing in a group. Metabolic and vascular risk factors: Metabolic and vascular risk factors of the intervention group will be evaluated by cardiologists and endocrinologists in the study.
Intervention group	Physical activity intervention	Physical activity intervention: Progressive resistance training (PRT) for the physical intervention will be provided at the nursing home. Cognitive stimulation intervention: The study subjects will receive cognitive intervention based on Cognitive Stimulation Therapy with rehabilitation experts. Social intervention: The social intervention will be combined with physical and cognitive interventions by doing in a group. Metabolic and vascular risk factors: Metabolic and vascular risk factors of the intervention group will be evaluated by cardiologists and endocrinologists in the study.
Intervention group	Management of metabolic and vascular risk factors	Physical activity intervention: Progressive resistance training (PRT) for the physical intervention will be provided at the nursing home. Cognitive stimulation intervention: The study subjects will receive cognitive intervention based on Cognitive Stimulation Therapy with rehabilitation experts. Social intervention: The social intervention will be combined with physical and cognitive interventions by doing in a group. Metabolic and vascular risk factors: Metabolic and vascular risk factors of the intervention group will be evaluated by cardiologists and endocrinologists in the study.

Primary Outcome Measures

Name	Time	Method
Adherence	6 months	Percentageof sessions attended out of the total planned
Retention	6 months	The retention rate was calculated as the number (percentage) of participants in each group who did not discontinue the study.

Secondary Outcome Measures

Name	Time	Method
Behavioral and Psychological Symptoms of Dementia (BPSD)	Baseline, 6 months	Behavioral and psychological symptoms of dementia (BPSD) will be measured using the Neuropsychiatric Inventory (NPI) questionnaire. The total NPI score ranging from 0 to 144 points. Higher scores indicate greater severity of BPSD
Total Dependence of Participants Assessed Using the Barthel Index	Baseline, 6 months	Total dependence will be assessed using the Barthel Index, with a total score of 100, where scores between 0 and 20 indicate total dependence.
Functional Ability Via the Handgrip Strength	Baseline, 6 months	Functional ability will be assessed via the handgrip strength. Higher scores indicated better functional ability
Functional Ability Via 30 Seconds Sit To Stand Test	Baseline, 6 months	Count the total number of complete stands executed in 30 seconds
Fall	Baseline, 6 months	Falls will be assessed by the fall incident report at baseline and during the study period
Quality of Sleep	Baseline, 6 months	Quality of sleep will be assessed using Pittsburgh Sleep Quality Index. A global PSQI score greater than 5 distinguishing good and poor sleepers
Functional Ability Via the Instrumental Activities of Daily Living Scale	Baseline, 6 months	Functional ability will be assessed using the Instrumental Activities of Daily Living Scale. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.
Global Cognition	Baseline, 6 months	Global cognition will be measured by Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog); score ranging from 0-70, a higher score indicates worse impairment.
Executive Function Via Clock Drawing Test	Baseline, 6 months	Excutive function will be assessed using Clock drawing test. Scores range from 0-10, with lower scores indicating greater cognitive impairment
Attention Function Via Digit Span Forward	Baseline, 6 months	Attention function will be assessed using digit span forward. Scores range from 0-12. Higher scores indicated better attention
Atttention Function Will be Assessed Using Digit Span Backward.	Baseline, 6 months	Higher scores indicated better attention. Scores range from 0-12. Higher scores indicated better attention
Health-related Quality of Life	Baseline, 6 months	Health-related quality of life will be assessed using the Quality of Life in Alzheimer's Disease scale. The Quality of Life in Alzheimer's Disease scale measures the overall quality of life in individuals with Alzheimer's disease. It consists of 13 items, each rated on a 4-point Likert scale. The total score is obtained by summing the scores of all 13 items, resulting in a possible range from 13 to 52 points. Higher scores indicate a better quality of life.
Death	6 months	Death will be assessed through reports from care staff, nursing home records.
Dependence of Participants Assessed Using the Instrumental Activities of Daily Living Scale	Baseline, 6 months	Dependence will be assessed using the Instrumental Activities of Daily Living scale, which evaluates the ability to perform eight daily tasks, including using the telephone, shopping, meal preparation, housekeeping, laundry, transportation, medication management, and financial management. The total score ranges from 0 to 8, with 8 indicating full independence and scores below 8 suggesting dependence in functional activities.

Trial Locations

Locations (4): Nhan Ai nursing home
🇻🇳
Hanoi, Vietnam
National Geriatric Hospital
🇻🇳
Hanoi, Vietnam
Dien Hong nursing home
🇻🇳
Hanoi, Vietnam
Orihome
🇻🇳
Hanoi, Vietnam