A Multidomain Intervention Program for Older People With Dementia

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04948450
• Other study ID #: CB1.02
• Secondary ID: R01AG064688
• Status: Completed
• Phase: N/A
• Start date: November 24, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: National Geriatric Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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.

Description:

This is a two-armed, 12 month, 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, and extended follow-up at 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia, Mixed

Intervention

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 (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
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 (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
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 7.5 %.

Locations

Country	Name	City	State
Vietnam	Dien Hong nursing home	Hanoi
Vietnam	National Geriatric Hospital	Hanoi
Vietnam	Nhan Ai nursing home	Hanoi
Vietnam	Orihome	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
National Geriatric Hospital

Country where clinical trial is conducted

Vietnam, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence (the day and time)	Attendance (the day and time) at each visit will be recorded for each component of the intervention.	6 months
Primary	Adherence (training diary)	Researchers also assess adherence by checking the participant's training diary.	6 months
Primary	Retention	The retention rate will be calculated as the percentage of participants in each group who did not discontinue the study.	6 months
Primary	Reasons for dropouts	Reasons for dropouts will be documented.	6 months
Secondary	Global cognition	Global cognition will be measured by Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) 13-item version; a higher score indicates poorer performance and greater impairment.	Baseline, 6 months, and 12 months
Secondary	Dementia severity via CDR	Dementia severity will be assessed by using Clinical Dementia Rating (CDR). The CDR score ranges from 0-3 (no dementia (CDR = 0), questionable dementia (CDR = 0.5), mild dementia (CDR = 1), moderate dementia (CDR = 2), and severe dementia (CDR = 3)	Baseline, 6 months, and 12 months
Secondary	Dementia severity via MMSE	Dementia severity will be assessed using Mini-Mental State Examination (MMSE), a low score being indicative of cognitive deterioration	Baseline, 6 months, and 12 months
Secondary	Executive function via Clock drawing test	Excutive function will be assessed using Clock drawing test.	Baseline, 6 months, and 12 months
Secondary	Executive function via Trails B test	Executive function will be assessed using Trails B test, higher scores reveal greater impairment	Baseline, 6 months, and 12 months
Secondary	Attention function via digit span forward	Attention function will be assessed using digit span forward.	Baseline, 6 months, and 12 months
Secondary	Attention function via Trials A	Attention function will be assessed using Trials A, higher scores reveal greater impairment	Baseline, 6 months, and 12 months
Secondary	Behavioral and psychological symptoms of dementia (BPSD)	Behavioral and psychological symptoms of dementia (BPSD) (e.g., agitation, aggression, depression) will be measured by interviewing staff using the Neuropsychiatric Inventory (NPI) questionnaire to assess the BPSD. The severity scale has scores ranging from 1 to 3 points (1=mild; 2=moderate; and 3=severe) and the scale for assessing caregiver distress has scores ranging from 0 to 5 points (0=no distress; 5=extreme distress).	Baseline, 6 months, and 12 months
Secondary	Functional ability via Barthel index	Functional ability will be assessed using Barthel index, lower scores indicating increased disability	Baseline, 6 months, and 12 months
Secondary	Functional ability via SPPB	Functional ability will be assessed using the Short Physical Performance Battery (SPPB), lower scores indicating increased disability	Baseline, 6 months, and 12 months
Secondary	Functional ability via the handgrip strength	Functional ability will be assessed via the handgrip strength.	Baseline, 6 months, and 12 months
Secondary	Functional ability via Timed Up & Go test	Fall risks will be assessed using Timed Up & Go test.	Baseline, 6 months, and 12 months
Secondary	Prevalence of falls	Falls will be assessed by asking the participants, caregivers, and care staff the number of falls in the 12 months prior baseline and in the 12 months during the study period.	Baseline, 6 months, and 12 months
Secondary	Quality of sleep	Quality of sleep will be assessed using Pittsburgh Sleep Quality Index. A global PSQI score greater than 5 distinguishing good and poor sleepers	Baseline, 6 months, and 12 months
Secondary	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), a higher score indicates better quality of life.	Baseline, 6 months, and 12 months
Secondary	Utilization of health services	Use of healthcare services will be assessed though number of admissions to hospital, visits to the emergency department.	Baseline, 6 months, and 12 months
Secondary	Death	Death will be assessed through reports from care staff, nursing home records.	6 months and 12 months