跳至主要内容
临床试验/NCT03335150
NCT03335150已完成不适用

Cognitive Rehabilitation for Individuals With Parkinson's Disease and MCI

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2015年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
2
主要终点
Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test Total Scaled Score

研究概览

简要总结

To investigate the effectiveness of a novel compensatory cognitive rehabilitation program for individuals with Parkinson's disease (PD) and mild cognitive impairment (MCI).

详细描述

Eligible study participants will be randomly assigned to one of two interventions: 1) Cognitive Rehabilitation (Cognitive Symptom Management and Rehabilitation Therapy for Parkinson's disease; CogSMART-PD) or 2) Supportive Care. Interventions are held within a group format consisting of approximately 5 individuals with PD. Groups will meet once per week for 1.5 hours over a 10-week period. Neuropsychological testing will be administered pre- and post-intervention as well as 6- and 12-months after the intervention.

研究设计

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

盲法说明

Investigator and Assessor are blinded to group assignment.

入排标准

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

入选标准

  • Diagnosis of Parkinson's disease
  • Mild Cognitive Impairment
  • Over 40 years of age
  • Fluent English speaker

排除标准

  • Other neurological conditions (e.g., stroke) besides Parkinson's disease

结局指标

主要结局

Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test Total Scaled Score

时间窗: Baseline and Week 10

The WAIS-IV Matrix Reasoning test is a validated, objective measure of executive function. Scaled scores range from 0 to 26. Higher scores indicate better executive function. Scores reported below are change scores.

次要结局

  • Cognitive Problems and Strategies Assessment (CPSA) Memory Strategies Use Score(Baseline and Week 10)
  • Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Total Score(Baseline and Week 10)
  • Memory for Intention Test (MIST) Total Score(Baseline and Week 10)
  • World Health Organization Quality of Life (WHOQOL)-BREF Psychological Domain Transformed Score(Baseline and Week 10)
  • Delis-Kaplan Executive Functioning System (D-KEFS): 20 Questions Test Total Questions Asked Scaled Score(Baseline and Week 10)
  • Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score(Baseline and Week 10)
  • Neuropsychiatric Inventory-Questionnaire (NPI-Q) Total Month Score(Baseline and Week 10)
  • Informant Questionnaire on Cognitive Decline in the Elderly-Self Report (IQCODE-SR) Total Score(Baseline and Week 10)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验