此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Use of the SMART COPD Physical Activity App in Pulmonary Rehabilitation

Use of the SMART COPD Physical Activity App in Pulmonary Rehabilitation: a Randomised Feasibility Study

The investigators are carrying out a feasibility study to explore whether an app for physical activity in Chronic Obstructive Pulmonary Disease (COPD) is acceptable to people with the condition and to healthcare professionals who help patients manage the condition.

研究概览

详细说明

Chronic Obstructive Pulmonary Disease (COPD) is a long term lung condition which causes breathlessness, tiredness, coughing and chest infections. People with the condition often find it difficult to carry out day to day activities and to live a normal life. In recent years people with COPD have been encouraged to self-manage their condition, for example by increasing their physical activity, which could help them to live their life to the full. Recent advances in technology have the potential to help people do this. The SMART COPD 'app' which is being used in this study has been developed, based on previous research and the views of people living with the condition, to help people with COPD increase their physical activity. Physical activity is known to be important in helping people with COPD to enjoy better health and to carry out activities. The current study will investigate whether or not the app could be used alongside existing health services, and whether or not people with COPD, as well as healthcare professionals, find the 'app' acceptable and easy to use.

The investigators are working with three Pulmonary Rehabilitation (PR) teams in South Yorkshire (from Sheffield, Rotherham and Doncaster). PR is an education and exercise programme for people with lung conditions, which aims to teach people the skills to help them self-manage their condition. The first part of this feasibility study will investigate how PR is currently being delivered, and whether there would be any scope to include the app during and after PR to help people increase (or at least maintain) their physical activity levels longer term. This will be done by observing PR sessions, looking at how PR is delivered and referrals to the service, and through interactive workshops with healthcare professionals who deliver PR. The second part of the project will involve 'trying out' the app with a small group of people with COPD who are attending PR, to investigate whether the app is easy to use, whether any changes are needed, and the best way to use the app in the future. In order to determine whether the app successfully helps people with COPD to increase their physical activity levels, the investigators will need to carry out a much larger study in the future which compares use of the app with not having the app. The current feasibility project will help with planning this much larger study.

研究类型

介入性

注册 (实际的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Doncaster、英国
        • Doncaster and Bassetlaw Hospitals NHS Foundation Trust
      • Rotherham、英国
        • The Rotherham NHS Foundation Trust
      • Sheffield、英国
        • Sheffield Teaching Hospitals NHS Foundation Trust

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • A formal diagnosis of COPD;
  • Attending a Pulmonary Rehabilitation (PR) course in Sheffield, Rotherham or Doncaster;
  • Reasonable understanding of written and verbal English.

Exclusion Criteria:

  • Not formally diagnosed with COPD;
  • Deemed unable to attend standard PR;
  • A cognitive impairment which prevents an individual giving informed consent;
  • Does not understand written and verbal English.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention

Use of the app and Fitbit alongside 5-7 week pulmonary rehabilitation programme (plus goal-setting help from physiotherapist), and then app and Fitbit plus intermittent contact with physiotherapist for 8 weeks after pulmonary rehabilitation

NB Randomisation is being deployed to test the practicality / acceptability of randomising for a larger RCT. It is not being used to assess the efficacy of the intervention in the current study

An app which allows users to set physical activity goals, monitors progress towards those goals, and provides feedback to users. Several options for types of physical activity (daily walk, daily step count, and aerobic / strengthening exercises) which can be tailored to the individual user. Designed to be used in consultation with a physiotherapist initially, and then used independently by the individual with COPD. The app will first be used alongside pulmonary rehabilitation (PR), with physiotherapist advice on exercises and setting goals. After PR the individual with COPD will receive weekly contact from a physiotherapist for the first 4 weeks, and then no contact for the second 4 weeks
其他名称:
  • The app has been developed by the research team and is not commercially available. A Fitbit® Charge pedometer will be used
其他:Control

Attend 5-7 week pulmonary rehabilitation programme (usual care) and wear blinded Fitbit during pulmonary rehabilitation and for 8 weeks afterwards

NB Randomisation is being deployed to test the practicality / acceptability of randomising for a larger RCT. It is not being used to assess the efficacy of the intervention in the current study

Participants will follow the (usual care) PR programme. They will be asked to wear a blinided (cannot see step count) Fitbit Charge during the time they are on PR and then for 8 weeks afterwards
其他名称:
  • A Fitbit® Charge pedometer will be used

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Usability and Acceptability of the intervention, as measured using qualitative interviews with staff and patient participants
大体时间:Two years
Thematic analysis of interviews will be used to explore participants' views on the usability and acceptability of the intervention.
Two years
Usability and Acceptability of the intervention, as measured using the System Usability Scale (SUS) (questionnaire with Likert-style questions)
大体时间:Two years
The SUS will provide an overall usability score for the intervention which will be comparable to other interventions which have used this scale.
Two years
Usability and Acceptability of the intervention, as measured using data on patterns of use for the app and Fitbit which are automatically logged by these devices.
大体时间:Two years
Data on patterns of use of the devices will help us determine whether there are parts of the intervention which are not used, or how different parts of the system are used (e.g. goal-setting strategies).
Two years

次要结果测量

结果测量
措施说明
大体时间
Feasibility of conducting an RCT, including which outcome measures are of most relevance to people with COPD and healthcare professionals, whether those outcome measures would be feasible to use, and how feasible / acceptable randomisation would be
大体时间:Two years
As part of the feasibility study we will investigate a number of outcome measure options for a future large scale RCT, including physical activity logged by the devices (e.g. number of steps, whether goals are reached etc). We will also investigate a number of scales / questionnaires which measure different concepts which are potentially of interest (e.g. St George's Respiratory Questionnaire for quality of life, Exercise Self-Regulatory Efficacy Scale, EuroQol 5 Dimensions questionnaire for cost effectiveness etc), and acceptability of different outcomes measures. Acceptability of randomisation will be assessed through thematic analysis qualitative interviews
Two years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年1月1日

初级完成 (实际的)

2018年9月1日

研究完成 (实际的)

2018年9月1日

研究注册日期

首次提交

2016年2月12日

首先提交符合 QC 标准的

2016年2月19日

首次发布 (估计)

2016年2月25日

研究记录更新

最后更新发布 (实际的)

2018年9月27日

上次提交的符合 QC 标准的更新

2018年9月25日

最后验证

2018年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • STH19149

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅