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临床试验/NCT04750304
NCT04750304已完成不适用

Evaluation of the Use of an E-health Therapeutic Education Application for Osteoarthritis Patients

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
Excercie adherence

研究概览

简要总结

Osteoarthritis is the most common joint disease affecting the joint in a comprehensive and progressive manner. It leads to increasing disability.

The recommendations of recent years favor the non-pharmacological treatment of osteoarthritis including regular physical activity, therapeutic education and weight loss Osteoarthritis population has a low level of physical activity due to a lack of information, motivation and false beliefs related to physical activity and kinesiophobia (fear of movement) A preliminary qualitative study (ARTHe1) evaluating the barriers and levers of the use of an e-health therapeutic education application in patients with osteoarthritis was carried out in order to guide the development of the ARTHe application.

The objective of this study is to have the application tested on a panel of patients in order to assess the benefits of using the application in terms of adherence to the practice of physical activity but also in clinical terms on function and pain, and the satisfaction of the patient

详细描述

This is a prospective observational study including the evaluation of the use of the ARTH-e application after 3 weeks, 6 weeks and 3 months of use.

Patient recruitment will be done in the PRM department of Clermont-Ferrand University Hospital A subgroup of patients will receive a Garmin VivoSmart 4 connected wristband, which will record intrinsic stress measurement data during the test.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients older than 18 years
  • Patients with osteoarthritis according to the ACR (American College of Rheumatology) criteria, symptomatic and diagnosed before inclusion by a specialist or not.
  • Patients with least one knee impairment
  • Patients with a smartphone or tablet with at least Android 5 or iOS
  • Volunteer patients willing to participate in the study.

排除标准

  • Patients with no diagnostic criteria for ACR.
  • Patients with comprehension disorders making it impossible to interview and complete questionnaires or use the application.
  • Refusal to participate or being already included in a research protocol that could influence the current protocol.
  • Patients under guardianship, curatorship or deprived of liberty.

结局指标

主要结局

Excercie adherence

时间窗: 3 months

Measured with Exercice Adherence Rating Scale (EARS) on 5 point Likert scale, 0= totally agree, 5 = totally disagree

次要结局

  • Average weekly pain level(From day 1 to 3 months)
  • Daily number of steps(From day 1 to 3 months)
  • Daily heart rate(From day 1 to 3 months)
  • Pain with analogic visual scale(3 weeks, 6 weeks, 3 months)
  • Number of sessions carried out on a level before moving to the next level(From day 1 to 3 months)
  • Frequency of opening the application per week(From day 1 to 3 months)
  • Frequency of opening the application with on exercice session per week(From day 1 to 3 months)
  • Rating of exercice session (out of 5 stars)(From day 1 to 3 months)
  • Daily heart variability(From day 1 to 3 months)
  • Satisfaction questionnaire(3 months)
  • Rate of positive responses to questionnaires true / false(From day 1 to 3 months)
  • Functional evaluation(3 weeks, 6 weeks, 3 months)
  • Time spent on the application at each opening(From day 1 to 3 months)
  • Intensity of movement(From day 1 to 3 months)
  • Daily energy expenditure in calories(From day 1 to 3 months)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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