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临床试验/NCT02815878
NCT02815878已完成不适用

Project Enhance for Adults Aging With Long-Term Physical Disability

University of Washington2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2014年5月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
2
主要终点
Questionnaire: Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form

研究概览

简要总结

This project is an adaptation trial, testing the efficacy of an evidence-based community wellness program, Enhance Wellness (http://www.projectenhance.org/enhancewellness.aspx), in a sample of middle and older-aged adults living with multiple sclerosis, spinal cord injury, post-polio syndrome and muscular dystrophy.

详细描述

This is a quasi-experimental project, comparing the effects of Enhance Wellness in a sample of adults aged 45 years or older and living with long-term physical disability, to two quasi-control groups: a sample of adults without long-term disability participating in Enhance Wellness, and a sample of adults with long-term disability not participating in Enhance Wellness. Outcomes are collected pre-intervention and post-intervention, approximately 6-months apart.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Multiple Sclerosis, Muscular Dystrophy, Post-Polio Syndrome, or Spinal Cord Injury diagnosis (Group 1 and 3)
  • Living in King County, Washington (Group 1 only)
  • Ability to read and understand English

排除标准

  • Active suicidal ideation
  • Requires the use of a mechanical ventilator to breathe or speak

研究组 & 干预措施

Group 1: Intervention with Disability

Experimental

Participants with a diagnosis of multiple sclerosis, spinal cord injury, muscular dystrophy, or post-polio syndrome aged 45 or older receive Enhance Wellness for 6 months and complete pre and post outcome assessments.

干预措施: Enhance Wellness (Behavioral)

Group 2: Intervention without Disability

Active Comparator

Participants without a diagnosis of multiple sclerosis, spinal cord injury, muscular dystrophy, or post-polio syndrome aged 45 or older receive Enhance Wellness for 6 months and complete pre and post outcome assessments.

干预措施: Enhance Wellness (Behavioral)

Group 3: No intervention

No Intervention

Participants with a diagnosis of multiple sclerosis, spinal cord injury, muscular dystrophy, or post-polio syndrome aged 45 or older complete pre and post outcome assessments.

结局指标

主要结局

Questionnaire: Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form

时间窗: 6-months

Self-reported measure of depression. Greater scores indicated greater depressive symptoms.

Questionnaire: Level of reported self-efficacy as measured by the University of Washington Self-Efficacy Scale Questionnaire

时间窗: 6-months

This is a self-reported measure of perceived efficacy to manage conditions or symptoms related to a person's physical disability or condition. Greater scores represent greater self-efficacy.

Questionnaire: Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form

时间窗: 6-months

Self-reported measure of pain interference. Greater score indicate greater pain interference.

次要结局

未报告次要终点

研究者

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

Ivan Molton

Associate Professor, Rehabilitation Medicine

University of Washington

研究点 (2)

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