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临床试验/NCT02754232
NCT02754232撤回不适用

Telemedical Training in a Daily Perspective for Chronically Ill COPD Patients: a Cross Sectoral Study

Odense University Hospital0 个研究点开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
The Stand up - sit down five times test (FTSST)

研究概览

简要总结

Problem:

Training is an important part of the treatment and rehabilitation of patients with chronic obstructive pulmonary disease (COPD) because training can increase the patient's muscle mass, lead to higher physical performance, reduce difficulties in breathing and hereby increase the patients' capacity to make use of the medical treatment.

Rehabilitation is provided by hospitals training centres/outpatient clinics. However, the transport is too tiring for the patients, which is why they decline taking part in it. This can mean a worsening of their condition and an increase in readmissions.

Solution:

  • To develop a better treatment for patients with severe COPD: Telemedical training of patients with COPD in teams.
  • To develop a cross-sectoral practice for the telemedical training patients will use, thus decreasing the readmissions of OUH's patients with severe COPD
  • To optimize the patient's journey in and across sector borders by using Lean methods.

Perspective:

The study is expected to contribute to improving treatment of severely ill patients with COPD cross-sectorally. The results are expected to contribute to reducing readmissions and raising the level of evidence in telemedical research on training patients with severe COPD. The study's findings may be of use in relation to other patient groups who have difficulties coming to training.

Background:

This research project has its starting point in a pilot project. Its goal was to determine whether severely ill COPD patients could train at home and earlier than normal. Evaluation showed patients found it reassuring to train with the help of the COPD briefcase. They found it increased their physical and mental well-being.

Method:

To gain knowledge of the effect of telemedical training. The patient's strength, daily activity level and quality of life will be measured by conducting a randomized controlled trial including 125 patients - 62 in the intervention group and 62 in the control group.

Qualitative research methods will be used to explore the user perspective concerning patients, family and health professionals. The method is critical psychological practice research.

A Lean method consultant from University Hospital Odense (OUH) will be involved in developing the best clinical pathway for the patients and the professionals.

详细描述

Project Description:

Problem:

Training is an important part of the treatment and rehabilitation of patients with Chronic Obstructive Pulmonary Disease (COPD) because training can increase the patients' muscle mass, lead to higher physical performance, reduce difficulties in breathing and hereby improve the patient's ability to make use of the medical treatment.

Rehabilitation is provided by hospitals training centres/outpatient clinics. However, the transport is too tiring for the patients, which is why they decline taking part in it. This can mean a worsening of their condition and an increase in readmissions.

Solution:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • patients with severe and very severe COPD, that is FEV1/FVC under 0,7, FEV1 under 50 % of the expected value and grade three and above on the Medical Research Council Dyspnoea Scale (MRC- Dyspnoea Scale).
  • The patients have rejected OUH's offer of training at the hospital.
  • The patients must be mobile enough to complete the training.
  • The patients are motivated to participate in individual adjusted telemedical training in teams.
  • The patients have at the same time been offered Telemedical consultations by a nurse
  • The patients biggest problem concerning physical activity has to be their shortness of breath
  • The patients live in either Svendborg or Odense

排除标准

  • patients with lacking ability to communicate via telephone and/or computer screen, severe kidney insufficiency or cardiac insufficiency, saturation less than 88 % and possibly malignant changes in lung(s).

结局指标

主要结局

The Stand up - sit down five times test (FTSST)

时间窗: 7 weeks

The FTSST test (Stand up - sit down five times) is a function test, which measures lower body strength. It gives a picture of the ability to get up from a chair, which is a daily activity. The smallest relevant change is 2,7 seconds (Reuben and Siu, 1990). Whether patients continue rehabilitation training in the municipal sphere, after telemedical training is completed is also noted.

次要结局

  • Physical Activity Scale(3 and 7 weeks, 3 and 6 months)
  • The Stand up - sit down five times test (FTSST)(3 weeks, 3 and 6 months)
  • The Activities of Daily Living Questionnaire (ADL - Q)(7 weeks, 3 and 6 months)
  • Walking distance(3 and 7 weeks, 3 and 6 months)
  • European Quality of Life-5 Dimensions (EQ5D)(3 and 7 weeks, 3 and 6 months)
  • The Clinical COPD Questionnaire (CCQ)(3 and 7 weeks, 3 and 6 months)
  • Readmissions(3 and 6 months)

研究者

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

Kathrine Rayce

Ph.d. student

Odense University Hospital

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