Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
125 participants
INTERVENTIONAL
2020-08-01
2023-07-31
Brief Summary
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Detailed Description
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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:
1. 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.
2. 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.
3. 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Lifestyle Intervention
Subjects in the Lifestyle Intervention group will, in six months, receive sixteen group sessions and six individualized treatment sessions.
Lifestyle Intervention
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.
Social Activities
Social Activities Group will receive twenty-two group sessions
social activity
24 social gathering events
Passive Control
Control group will receive patient education materials with each assessment
No interventions assigned to this group
Interventions
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Lifestyle Intervention
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.
social activity
24 social gathering events
Eligibility Criteria
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Inclusion Criteria
* Reported cognitive declines.
Exclusion Criteria
* 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.
50 Years
ALL
No
Sponsors
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Ministry of Science and Technology, Taiwan
OTHER_GOV
National Cheng Kung University
OTHER
Responsible Party
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Ling-Hui Chang
Associate Professor
Principal Investigators
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Ling-Hui Chang
Role: PRINCIPAL_INVESTIGATOR
Department of Occupational Therapy, NCKU
Locations
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National Cheng-Kung University
Tainan City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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National Cheng-Kung University
Identifier Type: -
Identifier Source: org_study_id
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