Brain-Health Lifestyle Restructuring Intervention
Primary Purpose
Lifestyle, Cognitive Decline, Aging
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Lifestyle Intervention
social activity
Sponsored by

About this trial
This is an interventional treatment trial for Lifestyle focused on measuring lifestyle intervention, brain health, aging, cognitive impairment
Eligibility Criteria
Inclusion Criteria:
- Over 55 years old and living in the community
- Reported cognitive declines.
Exclusion Criteria:
- 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.
Sites / Locations
- National Cheng-Kung UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
No Intervention
Arm Label
Lifestyle Intervention
Social Activities
Passive Control
Arm Description
Subjects in the Lifestyle Intervention group will, in six months, receive sixteen group sessions and six individualized treatment sessions.
Social Activities Group will receive twenty-two group sessions
Control group will receive patient education materials with each assessment
Outcomes
Primary Outcome Measures
Cognitive function
Montreal Cognitive Assessment, with a value of 0-30. Higher scores mean a better outcome.
Cognitive function
Montreal Cognitive Assessment, with a value of 0-30. Higher scores mean a better outcome.
Cognitive function
Montreal Cognitive Assessment, with a value of 0-30. Higher scores mean a better outcome.
Activity participation
Canadian Performance of Occupational Performance, with a value of 0-10. Higher scores mean a better outcome.
Activity participation
Canadian Performance of Occupational Performance, with a value of 0-10. Higher scores mean a better outcome.
Change of activity participation
Canadian Performance of Occupational Performance, with a value of 0-10. Higher scores mean a better outcome.
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.
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.
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.
Secondary Outcome Measures
Physical function
Short Physical Performance Battery
Physical function
Short Physical Performance Battery has a scale of 0-12, higher score indicating a better outcome.
Physical function
Short Physical Performance Battery has a scale of 0-12, higher score indicating a better outcome.
Functional memory
Contextual Memory Test with a score of 0-20, with higher score indicating a better outcome.
Functional memory
Contextual Memory Test with a score of 0-20, with higher score indicating a better outcome.
Functional memory
Contextual Memory Test with a score of 0-20, with higher score indicating a better outcome.
Working memory
Digit Forward and Digit Backward with a score of 2-10, , with higher score indicating a better outcome.
Working memory
Digit Forward and Digit Backward with a score of 2-10, , with higher score indicating a better outcome.
Working memory
Digit Forward and Digit Backward with a score of 2-10, , with higher score indicating a better outcome.
Complex attention
The score of Color Trail Test-1 & 2 is the time spent to complete the test. The test will be terminated when 4 minute is up. Lesser time indicates a better outcome.
Complex attention
The score of Color Trail Test-1 & 2 is the time spent to complete the test. The test will be terminated when 4 minute is up. Lesser time indicates a better outcome.
Complex attention
The score of Color Trail Test-1 & 2 is the time spent to complete the test. The test will be terminated when 4 minute is up. Lesser time indicates a better outcome.
Processing speed
Symbol Digit Substitution Test takes 90 seconds to complete. The score is the number of correct responses. A higher score indicates a better outcome.
Processing speed
Symbol Digit Substitution Test takes 90 seconds to complete. The score is the number of correct responses. A higher score indicates a better outcome.
Processing speed
Symbol Digit Substitution Test takes 90 seconds to complete. The score is the number of correct responses. A higher score indicates a better outcome.
Full Information
NCT ID
NCT04576624
First Posted
September 8, 2020
Last Updated
September 29, 2020
Sponsor
National Cheng Kung University
Collaborators
Ministry of Science and Technology, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT04576624
Brief Title
Brain-Health Lifestyle Restructuring Intervention
Official Title
A Brain-Health Lifestyle Restructuring Intervention for Older Adults With Mild Cognitive Decline : Feasibility, Effectiveness, and Experiences With the Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University
Collaborators
Ministry of Science and Technology, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
With population aging, the number of older persons in Taiwan with cognitive impairments increases. Recent years witnessed an expansion of governmental policies and services dedicated to improve long-term care. It is critical to develop an effective cognitive intervention that can prevent, delay, or slow down cognitive decline. Although literature support a multi-modal approach to preserve the cognitive capacity of older adults with cognitive impairments, there is inadequate attention to facilitate the integration of cognitively therapeutic activities to daily routines, nor to the establishment of a lifestyle that promote brain health. Therefore, the adherence to the intervention program was low after the program ended.
Literature support the effectiveness of a lifestyle approach to promote the health of and reduce medical cost for persons with chronic diseases, such as cardiovascular diseases and diabetes. Empirical evidence also supports the effectiveness of 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 brain health of older persons with cognitive impairments. The goals of this project are thus three-folds:
To develop a contextualized lifestyle restructuring intervention that facilitates the integration of cognition-promoting activities into daily routines and examine the feasibility of this intervention.
To compare the effectiveness of a brain-health lifestyle restructuring intervention, social activity, and passive control in (1) general cognition, activity participation, activities of daily living function, and quality of life, and (2)physical function and cognitive function at the end of the intervention, 6 months after, and one year after.
To qualitatively explore the experiences of the participants with the intervention, perceived effectiveness, and its contextual influences.
This is a three-year project using a combined pragmatic randomized controlled clinical trial and multiple case studies mixed-method research design. One hundred twenty-two older adults with cognitive impairments and residing in community will be recruited and randomly assigned to the groups of Lifestyle Intervention, Social Activities, and Passive Control. Subjects in the Lifestyle Intervention group will, in six months, receive sixteen group sessions and six individualized treatment sessions. Social Activities Group will receive twenty-two group sessions. Control group will receive patient education materials with each assessment. All participants will receive pre- and post-intervention, 6-month, and 12-month follow-up evaluations. Primary outcomes include cognitive function, activity participation, daily activity functions , and quality of life. Secondary outcomes include physical function, functional memory, working memory, complex attention, and processing speed.
Descriptive statistics, inferential statistics, factorial ANNOVA, and Generalized Estimating Equation will be used to evaluate and compare the effectiveness of the Lifestyle Restructuring Intervention. This study will also use multiple case studies to qualitatively understand the experiences of eight participants about their participation in the intervention, cognitive decline, and the contextual factors that affects their participation. Sequential interviews and participant observation will be used to do qualitative data collection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lifestyle, Cognitive Decline, Aging
Keywords
lifestyle intervention, brain health, aging, cognitive impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
three-year project using a combined pragmatic randomized controlled clinical trial and multiple case studies mixed-method research design
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Intervention
Arm Type
Experimental
Arm Description
Subjects in the Lifestyle Intervention group will, in six months, receive sixteen group sessions and six individualized treatment sessions.
Arm Title
Social Activities
Arm Type
Sham Comparator
Arm Description
Social Activities Group will receive twenty-two group sessions
Arm Title
Passive Control
Arm Type
No Intervention
Arm Description
Control group will receive patient education materials with each assessment
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
social activity
Intervention Description
24 social gathering events
Primary Outcome Measure Information:
Title
Cognitive function
Description
Montreal Cognitive Assessment, with a value of 0-30. Higher scores mean a better outcome.
Time Frame
pre-intervention
Title
Cognitive function
Description
Montreal Cognitive Assessment, with a value of 0-30. Higher scores mean a better outcome.
Time Frame
6 months after the intervention begins
Title
Cognitive function
Description
Montreal Cognitive Assessment, with a value of 0-30. Higher scores mean a better outcome.
Time Frame
6 month after the end of intervention
Title
Activity participation
Description
Canadian Performance of Occupational Performance, with a value of 0-10. Higher scores mean a better outcome.
Time Frame
pre-intervention
Title
Activity participation
Description
Canadian Performance of Occupational Performance, with a value of 0-10. Higher scores mean a better outcome.
Time Frame
6 months after the intervention begins
Title
Change of activity participation
Description
Canadian Performance of Occupational Performance, with a value of 0-10. Higher scores mean a better outcome.
Time Frame
6 month after the end of intervention
Title
QOL (Quality of Life)
Description
COOP/WONCA is the full title of the assessment. The assessment has a value of 6-30. Higher scores mean a poorer outcome.
Time Frame
pre-intervention
Title
QOL (Quality of Life)
Description
COOP/WONCA is the full title of the assessment. The assessment has a value of 6-30. Higher scores mean a poorer outcome.
Time Frame
6 months after the intervention begins
Title
QOL (Quality of Life)
Description
COOP/WONCA is the full title of the assessment. The assessment has a value of 6-30. Higher scores mean a poorer outcome.
Time Frame
6 month after the end of intervention
Secondary Outcome Measure Information:
Title
Physical function
Description
Short Physical Performance Battery
Time Frame
pre-intervention
Title
Physical function
Description
Short Physical Performance Battery has a scale of 0-12, higher score indicating a better outcome.
Time Frame
6 months after the intervention begins
Title
Physical function
Description
Short Physical Performance Battery has a scale of 0-12, higher score indicating a better outcome.
Time Frame
6 month after the end of intervention
Title
Functional memory
Description
Contextual Memory Test with a score of 0-20, with higher score indicating a better outcome.
Time Frame
pre-intervention
Title
Functional memory
Description
Contextual Memory Test with a score of 0-20, with higher score indicating a better outcome.
Time Frame
6 months after the intervention begins
Title
Functional memory
Description
Contextual Memory Test with a score of 0-20, with higher score indicating a better outcome.
Time Frame
6 months after the end of intervention
Title
Working memory
Description
Digit Forward and Digit Backward with a score of 2-10, , with higher score indicating a better outcome.
Time Frame
pre-intervention
Title
Working memory
Description
Digit Forward and Digit Backward with a score of 2-10, , with higher score indicating a better outcome.
Time Frame
6 months after the intervention begins
Title
Working memory
Description
Digit Forward and Digit Backward with a score of 2-10, , with higher score indicating a better outcome.
Time Frame
6 months after the end of intervention
Title
Complex attention
Description
The score of Color Trail Test-1 & 2 is the time spent to complete the test. The test will be terminated when 4 minute is up. Lesser time indicates a better outcome.
Time Frame
pre-intervention
Title
Complex attention
Description
The score of Color Trail Test-1 & 2 is the time spent to complete the test. The test will be terminated when 4 minute is up. Lesser time indicates a better outcome.
Time Frame
6 months after the intervention begins
Title
Complex attention
Description
The score of Color Trail Test-1 & 2 is the time spent to complete the test. The test will be terminated when 4 minute is up. Lesser time indicates a better outcome.
Time Frame
6 months after the end of intervention
Title
Processing speed
Description
Symbol Digit Substitution Test takes 90 seconds to complete. The score is the number of correct responses. A higher score indicates a better outcome.
Time Frame
pre-intervention
Title
Processing speed
Description
Symbol Digit Substitution Test takes 90 seconds to complete. The score is the number of correct responses. A higher score indicates a better outcome.
Time Frame
6 months after the intervention begins
Title
Processing speed
Description
Symbol Digit Substitution Test takes 90 seconds to complete. The score is the number of correct responses. A higher score indicates a better outcome.
Time Frame
6 months after the end of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over 55 years old and living in the community
Reported cognitive declines.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ling Hui Chang, Ph.D
Phone
+886918214428
Email
lhchang@mail.ncku.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling-Hui Chang
Organizational Affiliation
Department of Occupational Therapy, NCKU
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng-Kung University
City
Tainan
ZIP/Postal Code
701
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling-Hui Chang, Ph.D
Phone
88662353535
Ext
5907
Email
lhchang@mail.ncku.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
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Brain-Health Lifestyle Restructuring Intervention
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