Brain-Health Lifestyle Restructuring Intervention

• ClinicalTrials.gov Identifier: NCT04576624
• Recruitment Status: Recruiting
• First Posted: October 6, 2020
• Last Update Posted: October 6, 2020
• Sponsor: National Cheng Kung University
• Collaborator: Ministry of Science and Technology, Taiwan
• Information provided by (Responsible Party): Ling-Hui Chang, National Cheng Kung University

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.

Condition or disease	Intervention/treatment	Phase
Lifestyle; Cognitive Decline; Aging	Behavioral: Lifestyle Intervention; Behavioral: social activity	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 125 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: three-year project using a combined pragmatic randomized controlled clinical trial and multiple case studies mixed-method research design
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Brain-Health Lifestyle Restructuring Intervention for Older Adults With Mild Cognitive Decline : Feasibility, Effectiveness, and Experiences With the Intervention
• Actual Study Start Date: August 1, 2020
• Estimated Primary Completion Date: July 31, 2023
• Estimated Study Completion Date: July 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Cognitive function [ Time Frame: pre-intervention ]
   Montreal Cognitive Assessment, with a value of 0-30. Higher scores mean a better outcome.
2. Cognitive function [ Time Frame: 6 months after the intervention begins ]
   Montreal Cognitive Assessment, with a value of 0-30. Higher scores mean a better outcome.
3. Cognitive function [ Time Frame: 6 month after the end of intervention ]
   Montreal Cognitive Assessment, with a value of 0-30. Higher scores mean a better outcome.
4. Activity participation [ Time Frame: pre-intervention ]
   Canadian Performance of Occupational Performance, with a value of 0-10. Higher scores mean a better outcome.
5. Activity participation [ Time Frame: 6 months after the intervention begins ]
   Canadian Performance of Occupational Performance, with a value of 0-10. Higher scores mean a better outcome.
6. Change of activity participation [ Time Frame: 6 month after the end of intervention ]
   Canadian Performance of Occupational Performance, with a value of 0-10. Higher scores mean a better outcome.
7. QOL (Quality of Life) [ Time Frame: pre-intervention ]
   COOP/WONCA is the full title of the assessment. The assessment has a value of 6-30. Higher scores mean a poorer outcome.
8. QOL (Quality of Life) [ Time Frame: 6 months after the intervention begins ]
   COOP/WONCA is the full title of the assessment. The assessment has a value of 6-30. Higher scores mean a poorer outcome.
9. QOL (Quality of Life) [ Time Frame: 6 month after the end of intervention ]
   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 :

1. Physical function [ Time Frame: pre-intervention ]
   Short Physical Performance Battery
2. Physical function [ Time Frame: 6 months after the intervention begins ]
   Short Physical Performance Battery has a scale of 0-12, higher score indicating a better outcome.
3. Physical function [ Time Frame: 6 month after the end of intervention ]
   Short Physical Performance Battery has a scale of 0-12, higher score indicating a better outcome.
4. Functional memory [ Time Frame: pre-intervention ]
   Contextual Memory Test with a score of 0-20, with higher score indicating a better outcome.
5. Functional memory [ Time Frame: 6 months after the intervention begins ]
   Contextual Memory Test with a score of 0-20, with higher score indicating a better outcome.
6. Functional memory [ Time Frame: 6 months after the end of intervention ]
   Contextual Memory Test with a score of 0-20, with higher score indicating a better outcome.
7. Working memory [ Time Frame: pre-intervention ]
   Digit Forward and Digit Backward with a score of 2-10, , with higher score indicating a better outcome.
8. Working memory [ Time Frame: 6 months after the intervention begins ]
   Digit Forward and Digit Backward with a score of 2-10, , with higher score indicating a better outcome.
9. Working memory [ Time Frame: 6 months after the end of intervention ]
   Digit Forward and Digit Backward with a score of 2-10, , with higher score indicating a better outcome.
10. Complex attention [ Time Frame: pre-intervention ]
    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.
11. Complex attention [ Time Frame: 6 months after the intervention begins ]
    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.
12. Complex attention [ Time Frame: 6 months after the end of intervention ]
    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.
13. Processing speed [ Time Frame: pre-intervention ]
    Symbol Digit Substitution Test takes 90 seconds to complete. The score is the number of correct responses. A higher score indicates a better outcome.
14. Processing speed [ Time Frame: 6 months after the intervention begins ]
    Symbol Digit Substitution Test takes 90 seconds to complete. The score is the number of correct responses. A higher score indicates a better outcome.
15. Processing speed [ Time Frame: 6 months after the end of intervention ]
    Symbol Digit Substitution Test takes 90 seconds to complete. The score is the number of correct responses. A higher score indicates a better outcome.

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Ling Hui Chang, Ph.D; +886918214428; lhchang@mail.ncku.edu.tw

Locations

Taiwan

National Cheng-Kung University; Recruiting

Tainan, Taiwan, 701

Contact: Ling-Hui Chang, Ph.D 88662353535 ext 5907 lhchang@mail.ncku.edu.tw

Sponsors and Collaborators

National Cheng Kung University

Ministry of Science and Technology, Taiwan

Investigators

• Principal Investigator: Ling-Hui Chang; Department of Occupational Therapy, NCKU

More Information

• Responsible Party: Ling-Hui Chang, Associate Professor, National Cheng Kung University
• ClinicalTrials.gov Identifier: NCT04576624
• Other Study ID Numbers: National Cheng-Kung University
• First Posted: October 6, 2020
• Last Update Posted: October 6, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ling-Hui Chang, National Cheng Kung University:

lifestyle intervention; brain health; aging; cognitive impairment

Additional relevant MeSH terms:

Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders