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

Primary Purpose

Subjective Cognitive Decline

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Cognitive strategy training
group interactive game
Sponsored by
National Cheng Kung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subjective Cognitive Decline

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Occupational Therapy, College of Medicine, National Cheng Kung University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive strategy training

group interactive game

Arm Description

The experimental group will receive the Cognitive strategy training (CST), which includes awareness enhancement, cognitive-related education, discussion of everyday cognitive difficulties, generation of cognitive strategies, cognitive strategy practice, and homework assignments.

The active control group will receive group interactive game, including table games and games using songs, balloons, newspapers and so on.

Outcomes

Primary Outcome Measures

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

Change from Baseline General Self-Efficacy Scale (GSE) at post-intervention, and 3-month follow-up.
General Self-Efficacy Scale (GSE) is a self-reported questionnaire used to assess individual beliefs of how effective they are in facing stress and challenges. The scale scores range from 10 to 40, with higher scores indicating better self-efficacy.
Change from Baseline Contemplation ladder at post-intervention, and 3-month follow-up.
Contemplation ladder is an 11-point scale used to assess readiness and motivation for change before action. The scale score is between 0 and 10, with higher scores indicating greater motivation for change.
Change from Baseline COOP/WONCA (World Organization of Family Doctors) charts at post-intervention, and 3-month follow-up.
COOP/WONCA (World Organization of Family Doctors) is a self-reported chart used to assess health-related quality of life. The scale scores range from 6 to 30, with lower scores indicating better quality of life.

Full Information

First Posted
December 22, 2019
Last Updated
March 30, 2020
Sponsor
National Cheng Kung University
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1. Study Identification

Unique Protocol Identification Number
NCT04330404
Brief Title
Effects of Cognitive Strategy Training on Daily Function in People With Subjective Cognitive Decline
Official Title
Effects of Cognitive Strategy Training on Daily Function in People With Subjective Cognitive Decline
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Cognitive Decline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The experimental group will receive the Cognitive strategy training. The active control group will receive group interactive game.
Masking
Outcomes Assessor
Masking Description
For the interventionist, it is important to build relationships with participants through baseline interviews. The pre-test will be conducted by the interventionist. Assessors at post-intervention, and 3-month follow-up will be blind to the group allocation.
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive strategy training
Arm Type
Experimental
Arm Description
The experimental group will receive the Cognitive strategy training (CST), which includes awareness enhancement, cognitive-related education, discussion of everyday cognitive difficulties, generation of cognitive strategies, cognitive strategy practice, and homework assignments.
Arm Title
group interactive game
Arm Type
Active Comparator
Arm Description
The active control group will receive group interactive game, including table games and games using songs, balloons, newspapers and so on.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive strategy training
Intervention Description
The Cognitive strategy training, including awareness enhancement, cognitive-related education, discussion of everyday cognitive difficulties, generation of cognitive strategies, cognitive strategy practice, and homework assignments
Intervention Type
Behavioral
Intervention Name(s)
group interactive game
Intervention Description
The active control group will receive group interactive game, including table games and games using songs, balloons, newspapers and so on.
Primary Outcome Measure Information:
Title
Change from Baseline Canadian Occupational Performance Measure-Chinese version (COPM-C) at post-intervention, and 3-month follow-up.
Description
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.
Time Frame
Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention. .
Secondary Outcome Measure Information:
Title
Change from Baseline General Self-Efficacy Scale (GSE) at post-intervention, and 3-month follow-up.
Description
General Self-Efficacy Scale (GSE) is a self-reported questionnaire used to assess individual beliefs of how effective they are in facing stress and challenges. The scale scores range from 10 to 40, with higher scores indicating better self-efficacy.
Time Frame
Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention.
Title
Change from Baseline Contemplation ladder at post-intervention, and 3-month follow-up.
Description
Contemplation ladder is an 11-point scale used to assess readiness and motivation for change before action. The scale score is between 0 and 10, with higher scores indicating greater motivation for change.
Time Frame
Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention.
Title
Change from Baseline COOP/WONCA (World Organization of Family Doctors) charts at post-intervention, and 3-month follow-up.
Description
COOP/WONCA (World Organization of Family Doctors) is a self-reported chart used to assess health-related quality of life. The scale scores range from 6 to 30, with lower scores indicating better quality of life.
Time Frame
Assessments will be performed at baseline, within one week after the intervention, and 3-month follow-up after the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuchen Liu
Organizational Affiliation
Department of Occupational Therapy, College of Medicine, National Cheng Kung University, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Occupational Therapy, College of Medicine, National Cheng Kung University
City
Tainan
ZIP/Postal Code
701
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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