A Multidomain Intervention Program for Older People With Dementia

NCT04948450 | Completed Results DMC

• 1 other identifier: CB1.02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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

Conditions

Dementia; Alzheimer Disease; Dementia, Mixed

Keywords

Dementia; Multidomain intervention; Older people

Outcome Measures

Primary Outcomes (2)

• Adherence

  Percentageof sessions attended out of the total planned

  6 months

• Retention

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

  6 months

Secondary Outcomes (14)

• Global Cognition

  Baseline, 6 months

• Executive Function Via Clock Drawing Test

  Baseline, 6 months

• Attention Function Via Digit Span Forward

  Baseline, 6 months

• Atttention Function Will be Assessed Using Digit Span Backward.

  Baseline, 6 months

• Behavioral and Psychological Symptoms of Dementia (BPSD)

  Baseline, 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

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

Control group

NO INTERVENTION

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.

Interventions

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.

Intervention group

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.

Intervention group

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.

Intervention 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 %.

Intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Geriatric Hospital: lead

Study Sites (4)

Dien Hong nursing home

Hanoi, Vietnam

Location

National Geriatric Hospital

Hanoi, Vietnam

Location

Nhan Ai nursing home

Hanoi, Vietnam

Location

Orihome

Hanoi, Vietnam

Location

Related Publications (10)

• Duong S, Patel T, Chang F. Dementia: What pharmacists need to know. Can Pharm J (Ott). 2017 Feb 7;150(2):118-129. doi: 10.1177/1715163517690745. eCollection 2017 Mar-Apr. No abstract available.

  PMID: 28405256 BACKGROUND

• Prince M, Bryce R, Albanese E, Wimo A, Ribeiro W, Ferri CP. The global prevalence of dementia: a systematic review and metaanalysis. Alzheimers Dement. 2013 Jan;9(1):63-75.e2. doi: 10.1016/j.jalz.2012.11.007.

  PMID: 23305823 BACKGROUND

• Bich NN, Dung NTT, Vu T, Quy LT, Tuan NA, Binh NTT, Hung NT, Anh LV. Dementia and associated factors among the elderly in Vietnam: a cross-sectional study. Int J Ment Health Syst. 2019 Aug 23;13:57. doi: 10.1186/s13033-019-0314-7. eCollection 2019.

  PMID: 31462907 BACKGROUND

• GBD 2016 Dementia Collaborators. Global, regional, and national burden of Alzheimer's disease and other dementias, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 Jan;18(1):88-106. doi: 10.1016/S1474-4422(18)30403-4. Epub 2018 Nov 26.

  PMID: 30497964 BACKGROUND

• Wimo A, Guerchet M, Ali GC, Wu YT, Prina AM, Winblad B, Jonsson L, Liu Z, Prince M. The worldwide costs of dementia 2015 and comparisons with 2010. Alzheimers Dement. 2017 Jan;13(1):1-7. doi: 10.1016/j.jalz.2016.07.150. Epub 2016 Aug 29.

  PMID: 27583652 BACKGROUND

• Fink HA, Jutkowitz E, McCarten JR, Hemmy LS, Butler M, Davila H, Ratner E, Calvert C, Barclay TR, Brasure M, Nelson VA, Kane RL. Pharmacologic Interventions to Prevent Cognitive Decline, Mild Cognitive Impairment, and Clinical Alzheimer-Type Dementia: A Systematic Review. Ann Intern Med. 2018 Jan 2;168(1):39-51. doi: 10.7326/M17-1529. Epub 2017 Dec 19.

  PMID: 29255847 BACKGROUND

• Nguyen TA, Pham T, Dang TH, Hinton WL, Nguyen AT, Pham TL, Crotty M, Kurrle S, Bui QT, Nguyen H, Roughead EE. Towards the development of Vietnam's national dementia plan-the first step of action. Australas J Ageing. 2020 Jun;39(2):137-141. doi: 10.1111/ajag.12755. Epub 2019 Dec 9.

  PMID: 31814244 BACKGROUND

• Streater A, Spector A, Aguirre E, Hoe J, Hoare Z, Woods R, Russell I, Orrell M. Maintenance Cognitive Stimulation Therapy (CST) in practice: study protocol for a randomized controlled trial. Trials. 2012 Jun 26;13:91. doi: 10.1186/1745-6215-13-91.

  PMID: 22735077 BACKGROUND

• Mohs RC, Knopman D, Petersen RC, Ferris SH, Ernesto C, Grundman M, Sano M, Bieliauskas L, Geldmacher D, Clark C, Thal LJ. Development of cognitive instruments for use in clinical trials of antidementia drugs: additions to the Alzheimer's Disease Assessment Scale that broaden its scope. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S13-21.

  PMID: 9236948 BACKGROUND

• Kivipelto M, Solomon A, Ahtiluoto S, Ngandu T, Lehtisalo J, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Nissinen A, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER): study design and progress. Alzheimers Dement. 2013 Nov;9(6):657-65. doi: 10.1016/j.jalz.2012.09.012. Epub 2013 Jan 17.

  PMID: 23332672 BACKGROUND

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Mixed Dementias

Interventions

Social Work

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr Nguyen Xuan Thanh
• Organization: National Geriatric Hospital

xuanthanhbmlk@hmu.edu.vn

0983277646

Study Officials

• Anh T Nguyen, PhD

  National Geriatric Hospital

  STUDY DIRECTOR

• Thanh X Nguyen, MS

  National Geriatric Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head of Palliative care department

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: July 2, 2021
• Study Start: November 24, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: April 6, 2025
• Results First Posted: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

VN (4)