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Clinical Trials/NCT04330404
NCT04330404
Unknown
N/A

Effects of Cognitive Strategy Training on Daily Function in People With Subjective Cognitive Decline

National Cheng Kung University1 site in 1 country80 target enrollmentNovember 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Subjective Cognitive Decline
Sponsor
National Cheng Kung University
Enrollment
80
Locations
1
Primary Endpoint
Change from Baseline Canadian Occupational Performance Measure-Chinese version (COPM-C) at post-intervention, and 3-month follow-up.
Last Updated
6 years ago

Overview

Brief Summary

Subjective cognitive decline (SCD) is the transitional state between normal aging and mild cognitive impairment. SCD is defined as having self-perceived declines in any cognitive domain over time; having normal performance on cognitive testing; no dementia or depression. Cognitive difficulties can lead to a decline on daily function and quality of life. Early intervention can prevent SCD from developing into dementia.

Cognitive strategy training (CST) aims to generate individualized strategies to solve cognitive problems, which can be effective to improve daily functions and performances. However, there is limited clinical research aimed at improving daily functions for SCD. Most non-pharmacological studies have conducted objective cognitive training, which may not enhance daily performance. Previous studies also seldom examine the effectiveness of the intervention to improve daily function, quality of life, self-efficacy and motivation.

This study adopts a quasi-experimental design. The investigators will recruit 80 community-dwelling people with SCD who are aged 55 and older. There will be 40 participants in each group. The experimental group will receive the CST. The active control group will receive group interactive game. Both groups will have 8 sessions for one hour per week for a total of 8 weeks. Outcome measures include daily function, self-efficacy, motivation for change, and quality of life. Assessments will be performed at baseline, post-intervention, and 3-month follow-up. The demographic data of the two groups will be compared using the independent sample t-test and chi-square test. Changes on outcomes between the two groups will be analyzed by two-way ANOVA. This study was approved by the Human Research Ethics Committee at National Cheng Kung University. All participants provided written informed consent before testing.

This study aims to (1) examine the feasibility of the CST in community-dwelling people with SCD; (2) explore the efficacy of the CST on daily function, self-efficacy, motivation for change, and quality of life.

Registry
clinicaltrials.gov
Start Date
November 1, 2019
End Date
December 31, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shu-Chen Liu

Graduate student, Department of Occupational Therapy, College of Medicine

National Cheng Kung University

Eligibility Criteria

Inclusion Criteria

  • aged 55 and above
  • live in community
  • self-perceived decline in cognition compared to five years ago
  • subjective cognitive decline, Cognitive Failure Questionnaire (CFQ) score above zero.

Exclusion Criteria

  • objective cognitive impairment, Taiwanese version of the Montreal Cognitive Assessment (MoCA-T) scores below 24
  • any medical, neurological or psychiatric disorders, Brief Symptom Rating Scale (BSRS-5) scores 10 or more
  • severe visual, auditory, verbal or physical impairments interfere with communication, command compliance, and strategy execution
  • participate in other research related to cognitive strategy at the same time.

Outcomes

Primary Outcomes

Change from Baseline Canadian Occupational Performance Measure-Chinese version (COPM-C) at post-intervention, and 3-month follow-up.

Time Frame: Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention. .

Canadian Occupational Performance Measure-Chinese version (COPM-C) is a semi-structured interview questionnaire used to assess self-perceived problems in occupational performance areas. Participants need to identify cognitive-related occupational performance problems, then score the importance from 1 to 10. The higher the score, the more important it is. Participants also need to score their performance and satisfaction from 1 to 10 on the first five important issues. Higher scores mean a better outcome.

Secondary Outcomes

  • Change from Baseline General Self-Efficacy Scale (GSE) at post-intervention, and 3-month follow-up.(Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention.)
  • Change from Baseline COOP/WONCA (World Organization of Family Doctors) charts at post-intervention, and 3-month follow-up.(Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention.)
  • Change from Baseline Contemplation ladder at post-intervention, and 3-month follow-up.(Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention.)

Study Sites (1)

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