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Completed

NCT Number: NCT04948450

A Multidomain Intervention Program for Older People With Dementia

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

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Key information

Conditions

Dementia Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia, Mixed Mental Disorders Mixed Dementias Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dien Hong nursing home, Hanoi, Vietnam

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physical activity intervention

Behavioral

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.

Cognitive stimulation intervention

Behavioral

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.

Social intervention

Behavioral

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.

Management of metabolic and vascular risk factors

Other

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 %.

Primary outcomes

  1. Adherence

    Time frame: 6 months

    Percentageof sessions attended out of the total planned

  2. Retention

    Time frame: 6 months

    The retention rate was calculated as the number (percentage) of participants in each group who did not discontinue the study.

Secondary outcomes

  1. Global Cognition

    Time frame: 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.

  2. Executive Function Via Clock Drawing Test

    Time frame: Baseline, 6 months

    Excutive function will be assessed using Clock drawing test. Scores range from 0-10, with lower scores indicating greater cognitive impairment

  3. Attention Function Via Digit Span Forward

    Time frame: Baseline, 6 months

    Attention function will be assessed using digit span forward. Scores range from 0-12. Higher scores indicated better attention

  4. Atttention Function Will be Assessed Using Digit Span Backward.

    Time frame: Baseline, 6 months

    Higher scores indicated better attention. Scores range from 0-12. Higher scores indicated better attention

  5. Behavioral and Psychological Symptoms of Dementia (BPSD)

    Time frame: 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

  6. Total Dependence of Participants Assessed Using the Barthel Index

    Time frame: 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.

  7. Functional Ability Via the Handgrip Strength

    Time frame: Baseline, 6 months

    Functional ability will be assessed via the handgrip strength. Higher scores indicated better functional ability

  8. Functional Ability Via 30 Seconds Sit To Stand Test

    Time frame: Baseline, 6 months

    Count the total number of complete stands executed in 30 seconds

  9. Fall

    Time frame: Baseline, 6 months

    Falls will be assessed by the fall incident report at baseline and during the study period

  10. Quality of Sleep

    Time frame: 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

  11. Health-related Quality of Life

    Time frame: 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.

  12. Death

    Time frame: 6 months

    Death will be assessed through reports from care staff, nursing home records.

  13. Functional Ability Via the Instrumental Activities of Daily Living Scale

    Time frame: 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.

  14. Dependence of Participants Assessed Using the Instrumental Activities of Daily Living Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Geriatric Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 2, 2021
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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