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临床试验/NCT02554474
NCT02554474已完成不适用

Effective of Online Physical Activity Monitoring in Inflammatory Arthritis (OPAM-IA): A New Model of Care

University of British Columbia2 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2017年1月1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
118
试验地点
2
主要终点
Daily Time in Moderate/Vigorous Physical Activity

研究概览

简要总结

Being physically active can reduce pain and fatigue, improve mobility and enhance quality of life in people with arthritis, but adherence to an active lifestyle is poor, with less than half of people with arthritis being active. The primary goal of this randomized controlled trial is to assess the efficacy of a physical activity coaching model to improve physical activity participation and reduce sedentary time in patients with Rheumatoid Arthritis and Systemic Lupus Erythematosus. This model combines the use of a Fitbit Flex (wireless physical activity tracker) paired with a FitViz application, a group education session, and telephone counselling by a physiotherapist.

详细描述

Patient self-management is a fundamental component in arthritis care that is often neglected. Physical activity is an essential part of self-management, however, less than half of people with arthritis are active. There are several factors that are associated with low physical activity participation such as motivation, doubts about the effectiveness of prescribed exercises, and lack of health professional advice on ways to progress physical activity. The variety of risk factors highlights the need for a multifaceted approach that provides support in terms of knowledge, skill development and timely advice from health professionals, as well as motivational support to stay active.

Our primary objective is to assess the efficacy of a physical activity counselling model, involving the use of a Fitbit Flex (wireless physical activity tracker) paired with a FitViz application (app), a group education session, and telephone counselling by a physiotherapist, to improve physical activity participation in patients with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Our secondary objective is to assess the effect of the intervention on reducing patients' sedentary time, and improving fatigue, mood, pain, and self-efficacy in arthritis management. We will carry out three aims: 1) To develop the FitViz app to pair with Fitbit to enhance user experience, 2) To conduct a pilot test for the Fitbit/FitViz intervention, 3) To evaluate the effect of the physical activity coaching model in patients with RA and SLE. In this proof-of-concept randomized controlled trial (RCT), the investigators hypothesize that compared to a control group (i.e. the Delayed Intervention group), participants in the Immediate Intervention Group will 1) increase moderate/vigorous physical activity (MVPA), 2) reduce sedentary time, 3) improve in fatigue, mood, and pain levels, and 4) improve in their self-efficacy in disease management.

The investigators will use a mixed-methods approach, involving a RCT and in-depth interviews. The proof-of-concept study will employ a stepped wedge RCT design, whereby the intervention will be sequentially rolled out to participants over a number of time periods. The order in which individuals receive the intervention will be determined at random. The strength of this design is that it can properly address the efficacy question, while avoiding the dilemma of withholding the intervention to some participants, as in a parallel group design.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Have a physician confirmed diagnosis of RA or SLE.
  • Have an email address and daily access to a computer with internet connection.
  • Be able to attend a 1.5-hour education session at Mary Pack Arthritis Centre, Arthritis Research Centre, or a Fraser Health site.

排除标准

  • Have previously used any physical activity wearables.
  • Face a level of risk by exercising as identified by the Physical Activity Readiness Questionnaire (PAR-Q).

结局指标

主要结局

Daily Time in Moderate/Vigorous Physical Activity

时间窗: Baseline, 9 weeks, 18 weeks, 27 weeks

Time spent in Moderate/Vigorous Physical Activity (MVPA) was measured with a SenseWear Mini sensor over a 7-day period. The mean time was calculated in bouted MVPA per day. A bout is defined as \>= 10 consecutive minutes or more at the level of \>= 3 METs (i.e., the lower bound of MVPA), with allowance for interruption of up to two minutes below the threshold.

次要结局

  • Partners In Health Scale(Baseline, 9 weeks, 18 weeks, 27 weeks)
  • The Self-Reported Habit Index (SRHI) - Sitting at Work Index(Baseline, 9 weeks, 18 weeks, 27 weeks)
  • Time Spent in Sedentary Activity(Baseline, 9 weeks, 18 weeks, 27 weeks)
  • Fatigue Severity Scale(Baseline, 9 weeks, 18 weeks, 27 weeks)
  • McGill Pain Questionnaire Short Form (MPQ-SF)(Baseline, 9 weeks, 18 weeks, 27 weeks)
  • The Patient Health Questionnaire-9 (PHQ-9)(Baseline, 9 weeks, 18 weeks, 27 weeks)
  • The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index(Baseline, 9 weeks, 18 weeks, 27 weeks)
  • The Self-Reported Habit Index (SRHI) - Walking Index(Baseline, 9 weeks, 18 weeks, 27 weeks)

研究者

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

Linda Li

Professor

University of British Columbia

研究点 (2)

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