跳至主要内容
临床试验/NCT04330404
NCT04330404Unknown不适用

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

National Cheng Kung University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Change from Baseline Canadian Occupational Performance Measure-Chinese version (COPM-C) at post-intervention, and 3-month follow-up.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Cognitive strategy training

Experimental

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.

干预措施: Cognitive strategy training (Behavioral)

group interactive game

Active Comparator

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

干预措施: group interactive game (Behavioral)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shu-Chen Liu

Graduate student, Department of Occupational Therapy, College of Medicine

National Cheng Kung University

研究点 (1)

Loading locations...

相似试验