Clinical trial NCT05351723: Effectiveness of Non-pharmacological Interventions for Dementia Among Elderly in Hai Duong Province, Vietnam
Official title: Effectiveness of Non-pharmacological Interventions for Dementia Among Elderly in Hai Duong Province, Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Non-pharmacological interventions
Dementia
Elderly
Randomized Control
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
Collaborators: name: National Geriatric Hospital
First posted: 2022-04-28
Enrollment: 88
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Before the intervention, the research team will record the video for each group:

  * Intervention group: each session comprises (1) 50 min of physical exercise, (2) 20 min of break time or education on dementia and lifestyle habits, and (3) 50 min of cognitive training.
  * Control group: education on dementia and lifestyle habits.
* Prior to intervening, patients who agree to participate will be screened and evaluated cognitive function, physical function, assessment of Activities of Daily Living, quality of life, depression, anxiety, stress, and sleep quality.
* We will randomly divide the patients into the intervention-control group at each commune. Each group will attend an "intervention program" once a week within six months.
* We will evaluate the participants in two groups twice after 3 months and after 6 months of intervention.
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled intervention aimed at improving cognitive decline in patients with dementia. The program includes exercise, cognitive training, and dementia education. The output index is expected to be an improvement in cognition, accompanied by an improvement in fitness, sleep quality, reduction in depression levels, and an improvement in quality of life. This is a program that is expected to be effective, inexpensive, easy to apply and does not require high expertise. A total of 50 dementia patients diagnosed and managed by the National Geriatric Hospital, Hai Duong Province General Hospital will be included in the study for 6 months. Patients were randomly assigned to an intervention group and received a program of physical exercise, cognitive training, dementia lecture, and long-term follow-up, or entered a control group to hear a lecture. about dementia. Cognition and fitness will be assessed after follow-up at 0, 3, and 6 months. This work is sponsored by Vingroup Joint Stock Company and supported by domestic Masters/Ph.D. The scholarship program of Vingroup Innovation Fund (VINIF), Vingroup Big Data Institute (VINBIGDATA).

Detailed description: Dementia is a syndrome including memory impairment and other cognitive disorders; that interfere with social and/or professional functioning. The number of people with dementia globally is estimated to increase from 25 million in 2000 to 63 million in 2030. In 2016, dementia was the fifth leading cause of death globally, with approximately 2.4 million people, and one of the leading causes of disability and dependency in the elderly. This affects not only people with dementia but also carers, families, communities, and society; thus, it increases the financial burden on the health system. Healthcare costs for dementia amounted to about $800 billion (accounting for 1% of global GDP) in 2015 and are expected to reach $2 trillion by 2030. Study design: Cluster randomized controlled trial

Study location, time, and subject:

* Location: communes of Thanh Mien district and Gia Loc district of Hai Duong province, Vietnam - the exact location of the REACH Project.
* Time: From 1st January 2021 to 12th December 2022. The investigators started the intervention 6 months after the end of the care capacity-building arm of the REACH project.
* Participants: elderly who are diagnosed with mild and moderate dementia from the aim 1

  * Inclusive criteria: (1) elderly (aged 60 years or above) who are living in Thanh Mien district and Gia Loc district of Hai Duong province; (2) Diagnosed with very mild, mild, and moderate dementia by the Clinical Dementia Assessment (CDR) Questionnaire, corresponding to CDR = 0.5, CDR = 1 and CDR = 2.
  * Exclusive criteria: (1) Not physically fit to participate in physical exercises; (2) Having cardiovascular diseases.

Sample size and sampling process:

* Using the formula for the difference between the 2 ratios, the expected sample size is 25 people in the intervention group and 25 people in the control group.
* Sampling process: randomized cluster sampling

  * Based on the list of patients with dementia diagnosed by a specialist in the initial investigation, The investigators will divide the patients into clusters (communal units) according to where they live.
  * At each research unit (commune), The investigators will randomly divide patients into 2 groups: intervention and control.

Study variables and instruments:

* Outcome variable: The prevalence of mild and moderate dementia pre-and post-intervention are assessed by the Clinical Dementia Assessment (CDR) Questionnaire in Vietnamese
* Independent variables: Daily activity level is assessed using a set of ADLs questionnaires (activities of daily living); Sleep quality according to the PSQI (The Pittsburgh Sleep Quality Index PITTSBURGH); Geriatric depression level according to Geriatric Depression Scale 15 (Geriatric Depression Scale-15); Quality of life according to the Vietnam Quality of Life Scale EQ-5D-5L (European Quality of Life).

Study process:

* The investigators will apply the intervention content based on prior valid evidence by the author "Minoru Kouzuk et al".
* Before the intervention, the research team will record the video for each group:

  * Intervention group: each session comprises (1) 50 min of physical exercise, (2) 20 min of break time or education on dementia and lifestyle habits, and (3) 50 min of cognitive training.
  * Control group: education on dementia and lifestyle habits.
* The research team will recruit and train the technicians at the National Geriatrics Hospital within 1 week.
* Prior to intervening, patients who agree to participate will be screened and evaluated for cognitive function, physical function, assessment of Activities of Daily Living, quality of life, depression, anxiety, stress, and sleep quality.
* The investigators will randomly divide the patients into the intervention-control group at each commune. Each group will attend an "intervention program" once a week for six months. Technicians will record every training session, monitor participants' health, and ensure that those in the intervention group do the exercises correctly.
* The investigators will evaluate the participants in two groups twice after 3 months and after 6 months of intervention.

Data analysis plan and power

* Data entry: The investigators use Kobotoolbox for data entry and management. The investigators use STATA 16.1 and R to clean, process, and analyze data.
* Qualitative variables are calculated by frequency and percentage. The investigators use Fisher Exact Test to determine the differences for qualitative variables and logistic regression to assess the association between outcome and independent variables with odds ratios (OR) and 95% Confidence Interval (95%CI).

Eligibility criteria: Inclusion Criteria:

* Elderly (aged 60 years or above).
* Living in Thanh Mien district and Gia Loc district of Hai Duong province.
* Diagnosed with very mild, mild and moderate dementia by the Clinical Dementia Assessment (CDR) Questionnaire, corresponding to CDR = 0.5, CDR = 1 and CDR = 2.

Exclusion Criteria:

* Not physically fit to participate in physical exercises.
* Having cardiovascular diseases.

Primary outcomes:
measure: Changes from Clinical Dementia Rating Questionnaire at 3, and 6 months
timeFrame: Baseline, 3, and 6 months post intervention
Secondary outcomes:
measure: Changes from International Physical Activity Questionnaire - Short Form at 3, and 6 months
timeFrame: Baseline, 3, and 6 months post intervention
measure: Changes from Pittsburgh sleep quality index at 3, and 6 months
timeFrame: Baseline, 3, and 6 months post intervention
measure: Changes from Geriatric Depression Scale-15 at 3, and 6 months
timeFrame: Baseline, 3, and 6 months post intervention
measure: Changes from EuroQoL-5 dimensions-5 levels at 3, and 6 months
timeFrame: Baseline, 3, and 6 months post intervention
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi Medical University
Study officials:
References: