Brain-Health Lifestyle Restructuring Intervention
A Brain-Health Lifestyle Restructuring Intervention for Older Adults With Mild Cognitive Decline : Feasibility, Effectiveness, and Experiences With the Intervention
1 other identifier
interventional
125
1 country
1
Brief Summary
With population aging, the number of older persons with cognitive impairments increases. Literature support the effectiveness of a lifestyle approach to promote the health of persons with cognitive impairment, as well as a Lifestyle Redesign intervention to improve the general health and quality of life of frail older adults. The investigators propose to combine a multi-modal cognitive intervention and lifestyle redesign approach to improve the cognitive health of older persons with cognitive impairments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
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
Study Start
First participant enrolled
August 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 8, 2020
CompletedFirst Posted
Study publicly available on registry
October 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2023
CompletedOctober 6, 2020
September 1, 2020
3 years
September 8, 2020
September 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Cognitive function
Montreal Cognitive Assessment, with a value of 0-30. Higher scores mean a better outcome.
pre-intervention
Cognitive function
Montreal Cognitive Assessment, with a value of 0-30. Higher scores mean a better outcome.
6 months after the intervention begins
Cognitive function
Montreal Cognitive Assessment, with a value of 0-30. Higher scores mean a better outcome.
6 month after the end of intervention
Activity participation
Canadian Performance of Occupational Performance, with a value of 0-10. Higher scores mean a better outcome.
pre-intervention
Activity participation
Canadian Performance of Occupational Performance, with a value of 0-10. Higher scores mean a better outcome.
6 months after the intervention begins
Change of activity participation
Canadian Performance of Occupational Performance, with a value of 0-10. Higher scores mean a better outcome.
6 month after the end of intervention
QOL (Quality of Life)
COOP/WONCA is the full title of the assessment. The assessment has a value of 6-30. Higher scores mean a poorer outcome.
pre-intervention
QOL (Quality of Life)
COOP/WONCA is the full title of the assessment. The assessment has a value of 6-30. Higher scores mean a poorer outcome.
6 months after the intervention begins
QOL (Quality of Life)
COOP/WONCA is the full title of the assessment. The assessment has a value of 6-30. Higher scores mean a poorer outcome.
6 month after the end of intervention
Secondary Outcomes (15)
Physical function
pre-intervention
Physical function
6 months after the intervention begins
Physical function
6 month after the end of intervention
Functional memory
pre-intervention
Functional memory
6 months after the intervention begins
- +10 more secondary outcomes
Study Arms (3)
Lifestyle Intervention
EXPERIMENTALSubjects in the Lifestyle Intervention group will, in six months, receive sixteen group sessions and six individualized treatment sessions.
Social Activities
SHAM COMPARATORSocial Activities Group will receive twenty-two group sessions
Passive Control
NO INTERVENTIONControl group will receive patient education materials with each assessment
Interventions
A combined approach of a lifestyle structuring intervention to improve the general health and quality of life of persons with cognitive impairments. The investigators propose to combine a multi-modal cognitive intervention and lifestyle redesign approach to improve the cognitive health of older persons with cognitive impairments.
Eligibility Criteria
You may qualify if:
- Over 55 years old and living in the community
- Reported cognitive declines.
You may not qualify if:
- Within normal cognition, determined by scoring more than 24 in the Taiwanese version of the Montreal Cognitive Assessment
- Having any medical, neurological, psychiatric conditions, and depression by scoring above 10 in the Brief Symptom Rating Scale
- Having severe visual, auditory, speech or physical problems that limit them to follow instructions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cheng-Kung University
Tainan, 701, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ling-Hui Chang
Department of Occupational Therapy, NCKU
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 8, 2020
First Posted
October 6, 2020
Study Start
August 1, 2020
Primary Completion
July 31, 2023
Study Completion
July 31, 2023
Last Updated
October 6, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share