NCT04948450

A Multidomain Intervention Program for Older People With Dementia

A Multidomain Intervention Program for Older People With Dementia: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Geriatric Hospital · Other Government
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Dementia
• Alzheimer Disease
• Dementia, Mixed

Interventions

Type	Name	Description
BEHAVIORAL	Physical activity intervention	Progressive resistance training (PRT) for the physical intervention will be provided at the nursing home for 45 minutes twice a week. The sessions will be organized in groups (6-10 patients/ group) and supervised by 2 physiotherapists. Within each small group (maximum 10), participants will follow the program tailored to their individual functioning level, with constant oversight by trainers. People with dementia and care staff will be instructed to follow the prescribed PRT exercises for the rest of the week. Subjects will be encouraged to exercise daily.
BEHAVIORAL	Cognitive stimulation intervention	The study subjects will receive cognitive intervention based on Cognitive Stimulation Therapy with rehabilitation experts. The intervention involves 14 sessions of themed activities, which typically run twice weekly. The sessions will be organized in groups (6-10 patients/ group). People with dementia and their care staff will be instructed on how to practice the various activities at their nursing home for the rest of the week.
BEHAVIORAL	Social intervention	Social intervention will be combined with physical and cognitive interventions through doing these in a group, playing games during exercises (dancing, throwing ball to each other) or doing cognitive stimulation therapy in a group.
OTHER	Management of metabolic and vascular risk factors	Study physicians will assess the risk of developing new chronic diseases, change in blood pressure, weight and BMI, and hip and waist circumference, blood test (glucose, lipid parameters, fasting glucose, and HbA1C if the person with dementia has diabetes) at 3 and 6 months. Participants in the intervention group will be provided with information on the importance of reducing risk factors, guidance on lifestyle changes and prescribing treatment if necessary by cardiologists and endocrinologists. The target for blood pressure is less than 120/90 mmHg and the target for HbA1c is less than 8 %.

Timeline

• Start date: 2022-11-24
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2021-07-02
• Last updated: 2025-04-06
• Results posted: 2025-04-06

Locations

4 sites across 1 country: Vietnam