A Multidomain Intervention Program for Older People With Dementia

National Geriatric Hospital

Status: Completed

Conditions: Alzheimer Disease; Dementia; Dementia, Mixed

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04948450

CB1.02

Details and patient eligibility

About

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

Full 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

Enrollment: 60 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive stimulation intervention

Behavioral: Physical activity intervention

Other: Management of metabolic and vascular risk factors

Behavioral: Social intervention

Control group

No Intervention group

Description:

The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise.