Effectiveness of Non-pharmacological Interventions for Dementia Prevention in Elderly Patients With Mild Cognitive Impairment
Effectiveness of Dementia Prevention in Elderly Patients With Mild Cognitive Impairment at Nhân dân Gia Định Hospital, Hồ Chí Minh City
1 other identifier
interventional
192
1 country
1
Brief Summary
The aims of this study is to evaluate the effectiveness of non-pharmacological interventions program in preventing progression from mild cognitive impairment to dementia in patients with mild cognitive impairment in the short term, at Nhân dân Gia Định Hospital, Hồ Chí Minh City.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2024
CompletedFirst Posted
Study publicly available on registry
June 12, 2024
CompletedStudy Start
First participant enrolled
August 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
September 19, 2024
September 1, 2024
2.1 years
May 31, 2024
September 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Effectiveness of Intervention Program
Evaluating the effectiveness of preventing progression from mild cognitive impairment to dementia using the Montreal Cognitive Assessment (The MoCA Test) in patients with mild cognitive impairment in the short term. Higher scores mean a better outcome. The following result ranges may indicate cognitive impairment: 18-25 points: Mild cognitive impairment. 10-17 points: Moderate cognitive impairment. Fewer than 10 points: Severe cognitive impairment.
Measured at month 3 and 6 after randomisation
Secondary Outcomes (5)
Change in Activities of Daily Living
Baseline, Week12, Week24
Change in physical fitness
Baseline, Week12, Week24
Change in mental health
Baseline, Week12, Week24
Patient Adherance
Week12
Patient Attendance
Week12
Study Arms (2)
Home-based cognitive training exercises
ACTIVE COMPARATORThe cognitive training exercises program includes a total of 19 exercises and activities. The 19 exercises are divided into 8 groups: (1) warm up and cool down (relaxation exercise), (2) episodic memory, (3) digit span and calculation, (4) language, (5) Linking Letters \& Numbers, (6) Imagery, (7) Visuoconstructional skills, (8) linking ADL/IADL tasks. Subjects are provided with 19 exercises and instructed to perform them at home. Home-based exercises will be assessed weekly. Subjects are provided with a logbook to track their progress with the home exercises and were given the opportunity to provide feedback, ask questions, and receive support for any difficulties encountered during the process. All cognitive training exercises are based on the Technical Procedure Instructions issued by the Vietnamese Ministry of Health.
Supervised cognitive training exercises
EXPERIMENTALThe cognitive training exercises program includes a total of 19 exercises and activities. The 19 exercises are divided into 8 groups: (1) warm up and cool down (relaxation exercise), (2) episodic memory, (3) digit span and calculation, (4) language, (5) Linking Letters \& Numbers, (6) Imagery, (7) Visuoconstructional skills, (8) linking ADL/IADL tasks. The subjects are given exercises at the hospital under the supervision of physiotherpist/ physiatrist, and are also instructed to do the exercises at home. Home-based exercises will be assessed weekly. Subjects are provided with a logbook to track their progress with the home exercises and were given the opportunity to provide feedback, ask questions, and receive support for any difficulties encountered during the process. All cognitive training exercises are based on the Technical Procedure Instructions issued by the Vietnamese Ministry of Health.
Interventions
The subjects received (i) education on lifestyle modification, (ii) home-based cognitive training exercises with physiotherapist/ physiatrist contact when needed and (iii) a physical training exercises conducted at hospital under the supervision of physiotherapist/ physiatrist (3 weekly session for 12 weeks). This arm has a duration of 12 weeks.
The subjects received (i) education on lifestyle modification, (ii) supervised cognitive training exercises at hospital (1 weekly session for 12 weeks) and (iii) a physical training exercises conducted in a hospital under the supervision of physiotherapist/ physiatrist (3 weekly session for 12 weeks). This arm has a duration of 12 weeks.
Eligibility Criteria
You may qualify if:
- Subjects diagnosed with mild cognitive impairment:
- Cognitive complaints from the subject or a family member.
- Report a decline in cognitive function compared to the subject's previous ability over the past year OR
- Evidence from clinical assessment, specifically here is MMSE screening with results of 24-29 points.
- Subjects did not suffer major impacts from cognitive complaints on daily life.
- No prior diagnosis of dementia.
- Ensure transportation from living location to hospital.
- Have at least one relative or caregiver who can supervise the subject's daily activities.
- Stable chronic underlying conditions (diabetes, hypertension).
- Consent to participate in the study.
You may not qualify if:
- Don't know Vietnamese writing.
- Audio-visual ability does not meet the requirements of assessment tests and prevention programs.
- Systemic diseases are contraindications/ restriction to participation in programs and/or cause secondary cognitive impairment (traumatic brain injury, stroke, brain tumor, parkinsonism, epilepsy, acute coronary artery disease, acute myocardial infarction, bone fractures...).
- The assessment score on the Geriatric Depression Scale (GDS-15) is ≥ 5 points.
- Diagnosed with other mental disorders that may limit the ability to understand, communicate and work in groups (schizophrenia, mania, bipolar disorder, dissociative disorder, generalized anxiety disorder).
- Currently participating in another research program on dementia prevention or a research program on medication to prevent dementia within the last 3 months.
- Taking medications that may affect cognitive function, such as benzodiazepines, hypnotics, and antipsychotics.
- Alcohol abuse: drinking alcohol daily or consuming more than 14 units of alcohol per week (equivalent to 10 grams of ethanol, as defined by the Ministry of Health); diagnosed with alcohol dependence or currently being treated for mental illness due to alcohol dependence.
- Do not agree to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nhân dân Gia Định Hospital
Ho Chi Minh City, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2024
First Posted
June 12, 2024
Study Start
August 26, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, ANALYTIC CODE
- Time Frame
- Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
- Access Criteria
- Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Data obtained through this study may be provided to qualified researchers with academic interest in dementia prevention. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.