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

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.

Study Overview

• Status: Recruiting
• Conditions: Aging; Cognitive Decline; Lifestyle
• Intervention / Treatment: Behavioral: Lifestyle Intervention; Behavioral: social activity

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.

• Study Type: Interventional
• Enrollment (Anticipated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ling Hui Chang, Ph.D; Phone Number: +886918214428; Email: lhchang@mail.ncku.edu.tw

Study Locations

• Taiwan
  • Tainan, Taiwan, 701
    • Recruiting
    • National Cheng-Kung University
    • Contact: Ling-Hui Chang, Ph.D; Phone Number: 5907 88662353535; Email: lhchang@mail.ncku.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle Intervention; Subjects in the Lifestyle Intervention group will, in six months, receive sixteen group sessions and six individualized treatment sessions.	Behavioral: 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.
Sham Comparator: Social Activities; Social Activities Group will receive twenty-two group sessions	Behavioral: social activity; 24 social gathering events
No Intervention: Passive Control; Control group will receive patient education materials with each assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical function	Short Physical Performance Battery	pre-intervention
Physical function	Short Physical Performance Battery has a scale of 0-12, higher score indicating a better outcome.	6 months after the intervention begins
Physical function	Short Physical Performance Battery has a scale of 0-12, higher score indicating a better outcome.	6 month after the end of intervention
Functional memory	Contextual Memory Test with a score of 0-20, with higher score indicating a better outcome.	pre-intervention
Functional memory	Contextual Memory Test with a score of 0-20, with higher score indicating a better outcome.	6 months after the intervention begins
Functional memory	Contextual Memory Test with a score of 0-20, with higher score indicating a better outcome.	6 months after the end of intervention
Working memory	Digit Forward and Digit Backward with a score of 2-10, , with higher score indicating a better outcome.	pre-intervention
Working memory	Digit Forward and Digit Backward with a score of 2-10, , with higher score indicating a better outcome.	6 months after the intervention begins
Working memory	Digit Forward and Digit Backward with a score of 2-10, , with higher score indicating a better outcome.	6 months after the end of intervention
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.	pre-intervention
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.	6 months after the intervention begins
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.	6 months after the end of intervention
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.	pre-intervention
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.	6 months after the intervention begins
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.	6 months after the end of intervention

Collaborators and Investigators

• Sponsor: National Cheng Kung University
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Principal Investigator: Ling-Hui Chang, Department of Occupational Therapy, NCKU

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: aging; lifestyle intervention; cognitive impairment; brain health
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: National Cheng-Kung University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No