Clinical trial NCT04576624: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Lifestyle
Cognitive Decline
Aging
Keywords: lifestyle intervention
brain health
aging
cognitive impairment
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2020-10-06
Enrollment: 125
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: three-year project using a combined pragmatic randomized controlled clinical trial and multiple case studies mixed-method research design
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: Cognitive function
timeFrame: pre-intervention
measure: Cognitive function
timeFrame: 6 months after the intervention begins
measure: Cognitive function
timeFrame: 6 month after the end of intervention
measure: Activity participation
timeFrame: pre-intervention
measure: Activity participation
timeFrame: 6 months after the intervention begins
measure: Change of activity participation
timeFrame: 6 month after the end of intervention
measure: QOL (Quality of Life)
timeFrame: pre-intervention
measure: QOL (Quality of Life)
timeFrame: 6 months after the intervention begins
measure: QOL (Quality of Life)
timeFrame: 6 month after the end of intervention
Secondary outcomes:
measure: Physical function
timeFrame: pre-intervention
measure: Physical function
timeFrame: 6 months after the intervention begins
measure: Physical function
timeFrame: 6 month after the end of intervention
measure: Functional memory
timeFrame: pre-intervention
measure: Functional memory
timeFrame: 6 months after the intervention begins
measure: Functional memory
timeFrame: 6 months after the end of intervention
measure: Working memory
timeFrame: pre-intervention
measure: Working memory
timeFrame: 6 months after the intervention begins
measure: Working memory
timeFrame: 6 months after the end of intervention
measure: Complex attention
timeFrame: pre-intervention
measure: Complex attention
timeFrame: 6 months after the intervention begins
measure: Complex attention
timeFrame: 6 months after the end of intervention
measure: Processing speed
timeFrame: pre-intervention
measure: Processing speed
timeFrame: 6 months after the intervention begins
measure: Processing speed
timeFrame: 6 months after the end of intervention
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University
Study officials:
affiliation: Department of Occupational Therapy, NCKU
name: Ling-Hui Chang
role: PRINCIPAL_INVESTIGATOR
References: