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

Authors Xuan Nguyen T , Thi Thanh Vu H , Nguyen T, Esterman A , Viet Tran L, Thillainadesan J, Naganathan V, Brodaty H, Trung Nguyen A 

Received 1 January 2023

Accepted for publication 29 March 2023

Published 17 April 2023 Volume 2023:15 Pages 1—10

DOI https://doi.org/10.2147/OAJCT.S403282

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Professor Arthur E. Frankel



Thanh Xuan Nguyen,1,2 Huyen Thi Thanh Vu,1,2 Tuan Nguyen,3– 6 Adrian Esterman,5 Luc Viet Tran,1,2 Janani Thillainadesan,7,8 Vasikaran Naganathan,7,8 Henry Brodaty,9 Anh Trung Nguyen1,2

1Scientific Research Department, National Geriatric Hospital, Hanoi, 10000, Vietnam; 2Department of Geriatrics, Hanoi Medical University, Hanoi, 10000, Vietnam; 3Division of Social Gerontology, National Ageing Research Institute, Parkville, VIC, 3050, Australia; 4School of Health Sciences, Swinburne University of Technology, Hawthorn, VIC, 3122, Australia; 5UniSA Clinical & Health Sciences, University of South Australia, Adelaide, SA, 5001, Australia; 6Health Strategy and Policy Institute, Ministry of Health of Vietnam, Hanoi, 10000, Vietnam; 7Department of Geriatric Medicine and Centre for Education and Research on Ageing (CERA), Concord Hospital, Sydney, NSW, Australia; 8Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia; 9Centre for Healthy Brain Ageing (CHeBA), Discipline of Psychiatry and Mental Health, UNSW, Sydney, NSW, Australia

Correspondence: Thanh Xuan Nguyen, Scientific Research Department, National Geriatric Hospital, 1A, Phuong Mai, Dong Da, Hanoi, 10000, Vietnam, Tel +84 983277646, Email [email protected]

Background: Multidomain interventions have been shown to be effective in improving cognition, quality of life, reducing neuropsychiatric symptoms and delaying progression of functional impairment or disability in dementia patients. To investigate the multidomain intervention in other populations and diverse cultural and geographical settings, this pilot study will assess the feasibility of a multidomain intervention for older people with dementia in nursing homes in Vietnam.
Methods: Participants will be randomized into two equal groups, to receive either a multidomain intervention (intervention group) or regular health advice (control group). The intervention will include physical, cognitive, and social interventions as well as management of metabolic and vascular risk factors. We will hypothesize that the multidomain intervention will be feasible in Vietnam, and participants who receive the intervention will show improvement in quality of life, behaviors, functional ability, cognitive function, sleep, and in reduction of falls, use of healthcare services, and death rate compared to those in the control group during the 6 months intervention period and after the 6 months extended follow-up.
Discussion: This is the first study to evaluate the feasibility of a multidomain intervention program for older people with dementia in nursing homes in Vietnam. The results from the trial will inform clinicians and the public of the possibility of comprehensive treatment beyond simply drug treatments for dementia. This paves the way for further studies to evaluate the long-term effects of multidomain interventions in dementia patients. Furthermore, the research results will provide information on the effectiveness of multidomain interventions which will inform policy development on dementia.
Trial Registration: The trial is registered with ClinicalTrials.gov identifier: NCT04948450 on 02/07/2021.

Keywords: dementia, multidomain, intervention, feasibility

Background

Dementia is a syndrome characterized by cognitive decline interfering with daily function.1,2 Alzheimer’s disease and vascular dementia are the commonest causes of dementia separately or in combination accounting for over 80% of all dementia cases.3 Dementia is one of the major causes of disability and dependency among older people worldwide.4 The number of deaths due to dementia increased by 148% (140–157%) between 1990 and 2016.5 Dementia has significant social and economic implications in terms of direct medical and social care costs, and the costs of informal care. In 2020, the total global societal cost of dementia was more than 1 trillion USD.6

Medications for dementia are considered to be only modestly effective.7 The most commonly prescribed drugs are acetylcholinesterase inhibitors (AChEIs), and N-methyl-d-aspartate receptor (NMDAr) antagonists, such as memantine, may improve cognitive and behavioral outcomes, but their clinical impact remains modest and controversial.8 Many of these pharmacological treatments have been associated with adverse effects and greater risk of contraindications.9 Currently, no disease-modifying treatments has been demonstrated to be fully effective in controlling the symptoms of dementia.10 The effect of single-domain trials for people with dementia is still unclear.11 Some positive benefits have been reported for physical activity-based interventions, cognitive training.12 However, these benefits are of only borderline clinical relevance, and the overall quality of evidence in relation to most other outcomes was low.13–18 Many experts consider that since dementia is a complex, multifactorial disorder multidomain intervention targeting several risk factors and disease mechanisms may be more effective than single interventions to increase cognitive function, increase social activity and reduce depression, delay functional decline, while enhancing the quality of life of caregivers.19,20 The multidomain approach in many prevention trials has already proven its efficacy in chronic conditions that are associated with the development of dementia such as type 2 diabetes mellitus and cardiovascular disease.21,22 Multidomain interventions have been shown to be effective in improving cognition, reducing neuropsychiatric symptoms and delaying progression of functional impairment or disability in dementia patients in community-dwelling and nursing homes.17,20

In Vietnam, the older adult population is increasing rapidly in both absolute and relative numbers with the average lifespan increasing by four to 75 years in the last two decades. The prevalence of cognitive symptoms of dementia in adults aged 60 years and above is relatively high in Vietnam (14.4–46.4%)23,24 with an estimated 2.4 million people living with dementia in Vietnam by 2050.25 Advancing the mental health of older people in Vietnam is critical in the face of population growth and increased living standards resulting in longer lifespan. In the first Vietnam National Dementia Conference, dementia was recognized as a public health priority in Vietnam.26 The number of older people living in nursing homes is increasing in Vietnam, in which the percentage of people with dementia accounts for the majority. However, there was limited evidence on multifactorial intervention program for people with dementia in nursing homes in Vietnam. In order to improve treatment effectiveness, reduce symptoms and improve the quality of life of patients with dementia and their caregivers, we plan to conduct a pilot study to investigate the feasibility of a multidomain intervention program (physical; cognitive; social and management of metabolic and vascular risk factors) for older people with dementia in nursing homes.

Objectives

Primary

To assess the feasibility of a multidomain intervention program (physical, cognitive, social and management of metabolic and vascular risk factors) for older people with dementia in nursing homes.

Secondary

To investigate the effect of a multidomain intervention program on behavioral and psychological symptoms, quality of life, functional ability, falls and sleep, frailty, global cognition and the specific cognitive domains of attention, memory, fluency and executive function; utilization of healthcare services, and death rate for older people with dementia.

Method

Trial Design and Participants

This is a two-armed 12-month, multicenter, randomized controlled pilot study, based in nursing homes in Hanoi, Vietnam.

Inclusion Criteria

We aim to enroll participants aged over 60 years, living in nursing homes who have a diagnosis of major neurocognitive disorder (according to DSM 5 criteria),27 stage mild to moderate (according to Clinical Dementia Rating).28 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 (eg, advanced cancers, end-stage chronic diseases, acute myocardial infarction, stroke)
  2. Symptomatic cardiovascular disease or coronary revascularization within 1 year
  3. Clinical evidence of schizophrenia, severe depression, psychiatric or bipolar disorder (according to DSM-V TR criteria)29
  4. Alcoholism or substance dependence (according to DSM-5 criteria),30 currently, or within the past 2 years
  5. Severe loss of vision, hearing or communicative ability (according to the interRAI Community Health Assessment)31
  6. Participant or family unwilling to participate in the study.

Recruitment

Participants will be recruited from November 2022 until December 2023.

Research Team

The research team consists of 5 researchers, 2 research assistants, 2 neurologists and 2 physiotherapy experts. Prior to recruiting participants, the research assistants will complete a training program in screening and data collection using the specific measures to be used in the study.

Sample Size Estimates

Assuming a standardised effect sizes (ES) of 0.232 for a pilot randomised trial, with 90% power and two-sided 5% significance, and allowing for a 10% dropout rate and 5% mortality, the final sample size to be recruited is 60 (30 per study arm).

Randomisation, Concealment, and Allocation

A concealed, computer-generated sequence of randomly permuted blocks (block size = 8), stratified by age (60–69, 70–79, 80 and over) and disease severity (mild or moderate) will be generated by a statistician not otherwise involved in the study. Randomization will occur at the completion of the entire baseline assessment.

Blinding

Participants will be informed that they will be randomly assigned to one of the two treatment groups by the research assistants. Investigators will be blinded to the intervention allocation. All outcome measures will be administered by blinded assessors.

Study Procedure

The study PI and/or researchers in the research team will contact adults aged 60 years and older in the nursing homes (Orihome, Nhan Ai, Dien Hong) 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 will be evaluated for capacity to give informed consent. If participants have the capacity to consent to the research project, they will receive a complete explanation of the purpose, risks, and procedures of the study and sign a written informed consent. Otherwise, a family member will consent for them.

A screening log will be kept to document number and reasons of participants who do not meet the inclusion criteria, decline to participate, or any other reasons.

Participants who agreed to participate in the study will be randomized into two equal groups, to receive either a 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.

The patients in the intervention group and the control group will be still participating in the usual care and activity, which were consistent across all three nursing homes in the study. The activities including quizzes and movement games will be held every 3 months. They will also be doing 15-minute morning exercise every day with light intensity. Participants in both the intervention and the control groups will be treated for dementia according to the recommendations of the Vietnam Alzheimer 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, and hip and waist circumference), blood pressure determination, pulse rate and rhythm check, assessment for cardiovascular risk factors 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). Blood pressure measurements will be made on the left arm of the seated participants with a sphygmomanometer and an appropriately sized cuff; the average of 2 physician-obtained measures constitute the examination blood pressure. Metabolic and vascular risk factors will be ascertained by self-report (or caregivers report/nursing home report). Diabetes is defined as fasting glucose >7 mmol/l or use of insulin or oral hypoglycemic medications. Hypertension is defined as a systolic blood pressure of 140 mm Hg or more, or a diastolic blood pressure of 90 mm Hg or more, or taking antihypertensive medication. Dyslipidemia is defined as having an increased level of triglycerides, total cholesterol, or low-density lipoprotein cholesterol (LDL-C) or decreased level of high-density lipoprotein cholesterol (HDL-C). Results will be provided to participants and their doctors.

Interventions

The Intervention Group

In addition to what is given to both groups, the participants in the intervention group will receive three intervention components in 6 months: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions.

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 (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.

The exercise program consists of progressive resistance training. Participants will progress through the 6-month intervention, guided by daily ratings of perceived exertion (15–18) on the Borg Scale.33

People with dementia and their care staff will be instructed to follow the prescribed PRT exercises for the rest of the week. Participants will be encouraged to exercise daily. Physiotherapists will determine progress subjectively based on the ability of the person with dementia. Training volume will be monitored by adding up the total minutes of participation during each day of the prescribed program.

Cognitive Intervention

The study subjects will receive cognitive intervention based on Cognitive Stimulation Therapy34 with rehabilitation experts. The intervention involves 14 sessions of themed activities, which typically run twice weekly. The sessions will be organized in groups (10 patients/group).

Each session lasts about 45 minutes. To make sure that there is continuity between the sessions they will follow the same structure: introduction (10 minutes), main activity (25 minutes) and conclusion (10 minutes). A total set of 14 exercises will be selected including physical games, sounds, childhood, food, current affairs, word association, being creative, categorising objects, orientation, using money, number game, word games, team quiz, which will be culturally adapted in Vietnam. Necessary activities related to daily lives will also be included. 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 in a separate room. Training volume (multiplying the number of repetitions performed/day by the number of days) will be monitored using a training diary.

Social Intervention

Social intervention will be combined with physical and cognitive interventions through doing these interventions in a group, ie, playing group games during exercises (eg, dancing, throwing ball to each other) or doing cognitive stimulation therapy in a group.

Management of Metabolic and Vascular Risk Factors

In the intervention group, metabolic and vascular risk factors will be evaluated by cardiologists and endocrinologists in the study.

Study physicians will assess change in blood pressure, weight and BMI, and hip and waist circumference, blood tests (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 the cardiologists and endocrinologists. The target for blood pressure is less than 120/90 mmHg and the target for HbA1c is less than 8%.

The Control Group

The control group will receive general health advice every 3 months based on their physical examination and blood findings. They will be provided usual care plus health education materials.

Outcome Measurements

All outcome measures will be administered at baseline, 6 months and extended follow-up at 12 months. The outcomes are shown in Table 1.

Table 1 Primary and Secondary Outcome Measures for Patients

Primary Outcome

The primary outcome of the study is the feasibility of the intervention which will be assessed via the recruitment, adherence and retention.

Secondary Outcomes

Cognitive Function

Global cognition will be measured by Alzheimer’s Disease Assessment Scale-Cognitive (ADAS-Cog) 13-item version.35 Dementia severity will be assessed by the sum of boxes method of the Clinical Dementia Rating scale (CDR).36 Cognition will be assessed globally by the Mini-Mental State Examination (MMSE)37; executive function by the Clock drawing plus Trails B38; and attention by digit span forward39 and Trials A test.40

Behavioral and Psychological Symptoms of Dementia (BPSD) (Agitation, Aggression, Depression)

Researchers will interview care staff using the Neuropsychiatric Inventory (NPI) questionnaire to assess BPSD.41

Functional Ability

Functional ability will be assessed by using the Activities of Daily Living Scale (ADL), the Instrumental Activities of Daily Living Scale (IADL),42 the Short Physical Performance Battery (SPPB),43 handgrip strength, Timed Up & Go (TUG) test.44

Falls

Falls will be assessed by number of falls within the previous 12 months at baseline and during the study period.

Sleep Problem

Sleep Problem will be assessed with the Pittsburgh Sleep Quality Index.45

Health-Related Quality of Life

Health-related quality of life will be assessed with the Quality of Life in Alzheimer’s Disease scale (QoL-AD).46

Use of Healthcare Services

Use of healthcare services will be assessed through the number of admissions to hospital and visits to the emergency department.

Death

Death will be assessed through caregiver reports or nursing home records.

Statistical Analysis

The adherence rate for each intervention will be calculated by adding the number of sessions completed and dividing by the total number of intervention sessions assigned to each intervention component: physical activity intervention, cognitive intervention, vascular and metabolic risk factor management. The total adherence rate will be calculated by adding the number of sessions completed across all intervention components and dividing by the total number of intervention sessions assigned without modifying the weight of each intervention component. Regarding the participants who drop out of the study, adherence rates will be calculated until the dropout point. Chi-square test will used for categorical variables and a one-way analysis of variance for continuous variables to compare baseline characteristics between the groups. The chi-square test will be used to compare the retention rates between the intervention and control groups.

The secondary outcomes will be analyzed using a mITT population. Simple and multivariate linear and logistic regression models will be used to assess the relationships and risk factors for changes in secondary outcomes. Statistical analyses were performed using SPSS 26.0 (SPSS, Chicago, IL, USA). P < 0.05 was considered significant.

Discussion

This is the first study to evaluate the feasibility of a multidomain intervention program for older people with dementia in nursing homes in Vietnam. Participants will be followed-up for 6 months after the end of the 6-month intervention; and longer if further funding becomes available. The results from the trial will inform clinicians and the public of the possibility of comprehensive treatment beyond simple drug treatments for dementia. This will pave the way for further studies to evaluate the long-term effects of multidomain interventions in dementia patients. Furthermore, the research results will provide information on the effectiveness of multidomain interventions which will inform policy development on dementia.

Data Sharing Statement

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Ethical Approval and Consent

Ethical approval has been performed in accordance with the Declaration of Helsinki and have been approved from the Hanoi Medical university (IRB00003121) on December 31, 2020. Participants will be evaluated for capacity to give informed consent. If participants have the capacity to consent to the research project, they will receive a complete explanation of the purpose, risks, and procedures of the study and sign a written informed consent. Otherwise, a family member will consent for them. The trial is registered with ClinicalTrials.gov identifier: NCT04948450 registered on 02/07/2021.

Acknowledgments

Research is supported and helped by the Board of Directors and medical staff at the Dien Hong, Nhan Ai and Orihome nursing care in Vietnam. We are grateful to Hoa L. Nguyen for valuable suggestions on this manuscript.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Funding

Thanh Xuan Nguyen was funded by Vingroup JSC and supported by the Master, PhD Scholarship Programme of Vingroup Innovation Foundation (VINIF), Institute of Big Data, code VINIF.2021.TS.139. Research reported in this publication was supported by the National Institute of Aging (NIA) of the National Institutes of Health (NIH) under award number R01AG064688 (Hinton/Nguyen MPI). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIA and the NIH. The sponsors had no role in the design and conduct of the study, in the collection, analysis, and interpretation of data, in the preparation of the manuscript or in the review or approval of the manuscript.

Disclosure

Professor Henry Brodaty reports personal fees from Biogen, Eisai, Roche, Skin2Neuron, and Cranbrook Care, outside the submitted work. All authors declare no other conflicts of interest in this work.

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