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临床试验/NCT04552561
NCT04552561已完成不适用

My MS Toolkit + Coaching: A Guided Web-based Symptom Self-Management Program for People With MS

University of Michigan1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2020年10月19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
5
试验地点
1
主要终点
Acceptability/Feasibility of the the coached version of My MS Toolkit

研究概览

简要总结

My MS Toolkit is a web-based symptom self-management program for persons with multiple sclerosis (MS).

This study is evaluating various aspects of My MS Toolkit plus coaching and how it impacts symptom self-management in multiple sclerosis. The research team believe that the toolkit will be feasible, acceptable, and beneficial to participants.

详细描述

Study participants will be asked to use a newly developed web-based symptom self-management program, called the My MS Toolkit, for 8 weeks.

The My MS Toolkit includes 8 modules that describe symptom self-management strategies. Participants will explore the My MS Toolkit, following the prompts and guides built into the program, and meet with a study coach weekly for 15 to 30-minute telephone-delivered coaching sessions. Participants are encouraged to practice and apply the skills learned.

The study can be done from participants' homes using a reliable internet-connected device. No travel is required.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • •Multiple Sclerosis
  • •Have access to a reliable, internet-connected device (e.g. computer, tablet). (Note: this study is conducted electronically and is not location dependent.)
  • •One or more of the following:
  • •Moderate/moderately severe depressive symptoms
  • •Chronic pain
  • •Presence of significant fatigue symptoms
  • •Read, speak and understand English.

排除标准

  • •Significant cognitive impairment
  • •Current psychotherapy for symptoms

研究组 & 干预措施

My MS Toolkit

Experimental

10 Participants asked to use My MS Toolkit and meet weekly with a study coach via telephone.

干预措施: My MS Toolkit (Behavioral)

结局指标

主要结局

Acceptability/Feasibility of the the coached version of My MS Toolkit

时间窗: Post-treatment, approximately week 8

Assessed by the Participant Satisfaction Evaluation Survey. This survey is a 17 item scale with one free text item and 16 items with scores ranging from 1-4 (lowest to highest) with total scores ranging from 16-64. Higher scores indicate greater levels of acceptability.

次要结局

  • Impact My MS Toolkit: Change in depressive symptoms as measured by the Patient Health Questionnaire depression scale(Pre-treatment and Post-treatment, approximately week 8)
  • Impact My MS Toolkit: Change in pain interference as measured by The Brief Pain Inventory Short Form(Pre-treatment and Post-treatment, approximately week 8)
  • Change in self-efficacy for managing symptoms as measured by the University of Washington Self-Efficacy Scale(Pre-treatment and Post-treatment, approximately week 8)
  • Impact of My MS Toolkit: Change in fatigue(Pre-treatment and Post-treatment, approximately week 8)
  • Participant perception of change(Post-treatment, approximately week 8)

研究者

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

Anna Kratz

Associate Professor of Physical Medicine and Rehabilitation

University of Michigan

研究点 (1)

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