Multidomain Intervention Programs for Older People With Dementia With Dementia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 July 2021
• Main ID: NCT04948450
• Date of registration: 04/06/2021
• Prospective Registration: Yes
• Primary sponsor: National Geriatric Hospital
• Public title: Multidomain Intervention Programs for Older People With Dementia With Dementia
• Scientific title: Multidomain Intervention Programs for Older People With Dementia
• Date of first enrolment: August 1, 2021
• Target sample size: 152
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT04948450
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Vietnam

Contacts

• Name: Thanh X Nguyen, Master

• Name: Nguyen X Thanh, Master

• Name: Anh T Nguyen, PhD
• Affiliation: National Geriatric Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- aged 60-79 years old

- living in the community

- who have a diagnosis of mild-moderate vascular dementia or mixed dementia according to
DSM 5 criteria.

- receiving pharmacological treatment for dementia (cholinesterase inhibitors,
memantine), must be on a stable dose for at least 3 months prior to the study.

- must be able to mobilise independently with or without a mobility aid and without
physical assistance.

- must have a caregiver who either lives with the participant or visits for at least
four hours per week.

Exclusion Criteria:

- acute and malignant diseases (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-IV TR criteria) [12]

- Alcoholism or substance dependence (according to DSM-5 criteria) [13], currently, or
within the past 2 years

- Severe loss of vision, hearing or communicative ability (according to the interRAI
Community Health Assessment) [14]

- Participant or family unwilling to participate in the study



Age minimum: 60 Years
Age maximum: 79 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dementia, Mixed

Dementia, Vascular

Intervention(s)

Behavioral: Cognitive stimulation intervention

Behavioral: Physical activity intervention

Other: Reduce of metabolic and vascular risk factors

Primary Outcome(s)

Cognitive performance [Time Frame: Change from Baseline Cognitive performance at 12 months]

Secondary Outcome(s)

Attention function [Time Frame: Change from Baseline Attention function at 12 months]

Behaviours (agitation, aggression) [Time Frame: Change from Baseline Behaviours at 12 months]

Caregiver burden [Time Frame: Change from Baseline Caregiver burden at 12 months]

Caregiver depression [Time Frame: Change from Baseline Caregiver depression at 12 months]

Caregiver quality of life [Time Frame: Change from Baseline Caregiver quality of life at 12 months]

Completers [Time Frame: 12 months]

Dementia severity [Time Frame: Change from Baseline Dementia severity at 12 months]

Excutive function using Clock drawing test [Time Frame: Change from Baseline Clock drawing test at 12 months]

Excutive function using Trails B test [Time Frame: Change from Baseline Trails B test at 12 months]

Fall risks [Time Frame: Change from Baseline Fall risks at 12 months]

Functional ability [Time Frame: Change from Baseline Functional ability at 12 months]

Memory function [Time Frame: Change from Baseline Memory function at 12 months]

Prevalence of fall [Time Frame: Change from Baseline Prevalence of fall at 12 months]

Quality of sleep [Time Frame: Change from Baseline Quality of sleep at 12 months]

Secondary ID(s)

AG064688

CB1.02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors