Short summary

In this research project we test the effect of early, supervised, telemedical training across sectors for patients with severe and very severe COPD (a randomized controlled trial) and research into the significance of this practice for those involved and their everyday lives: patients, peers and health professionals (a qualitative study).

The research project is a collaboration between University Hospital Odense and Svendborg (OUH), and the municipalities of Svendborg and Odense.

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Rationale

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
• 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

Aim:

The aim is to study the effect of telemedical training on activities of daily living, quality of life and physical performance in patients with severe or very severe COPD and to explore the significance of the practice for the patients, their peers and the health professionals.

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 and STS (Science Technology Studies).

A LEAN consultant from OUH will be involved in developing the best clinical pathway for the patients and the professionals.

Timetable: August 1 ^st 2015 - August 1 ^st 2018. 

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Description of the cohort

Patients who take part in the study have been admitted to OUH because of a worsening of their COPD. The criteria for inclusion are 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. 

Data and biological material

Primary outcome:

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. Whether patients continue rehabilitation training in the municipal sphere, after telemedical training is completed is also noted.

Secondary outcomes:

The Clinical COPD Questionnaire (CCQ) is a validated questionnaire, measuring the health status for patients with COPD by using a standardized self-administered questionnaire about COPD. CCQ is useful for comparing measurements of health status at group level. In addition for quantifying changes in health after treatment and correlating with CAT and SGRQ

ADL - Q is a questionnaire, completed by the patient that measures the individual's perception of their own abilities to carry out daily activities.

FAS is a validated questionnaire, completed by the patient that measures the extent of a participant's physical activity on an average 24 hour period.

Compliance: It is registered whether the patients in the municipal sphere continue the rehabilitating training after the telemedical training has ended.

The following parameters describe the participating patient group: Sex, age, civil status, socio - economic status, BMI, FEV₁ of expected value, FEV₁ /FVC, MRC- dyspnea score, oxygen treatment in the home, treatment with atomizer, the usual inhaled COPD treatment (grouped), oral prednisolone treatment, home care, use of tobacco.

Whether telemedical training has an effect on readmissions for patients with COPD will be examined by comparing the number of admissions for the intervention group and the control group. Data will be requisitioned from the Region's IT.

Qualitative study: Method:

The general approach to the qualitative study is critical psychological and STS (Science Technology Studies).

Patients, relatives and health professionals are involved in the study in that they participate as players in telemedicial training in each their own significant way, thus illuminating telemedicial training in a broad manner: how the patients feel about this service, their mutual relations with the health professionals and what it means to them in their daily lives.

The researcher will do participant observations of patients in their homes and at the physiotherapists during training and daily tasks. Semi-structured interviews will be conducted with the patients and their families.

Group interviewing will be done with occupational - and physiotherapists, who train with the patients - regionally as well as municipally - to grasp the cross sectorial perspective as well. 

Collaborating researchers and departments

Svendborg Municipality

• Souchef Ulla Arlofelt
• Physiotherapist Lene Buur-Jensen

Odense Municipality

• Chief consultant Asger Kudahl
• Physiotherapist Lena Ellegaard

Department of Respiratory Medicine, Odense University Hospital, Svendborg

• Head nurse Jette Krøjgaard
• Charge nurse Britta Aaes
• Nurse Hanne Svenningsen

Department of Rehabilitation, Odense University Hospital, Svendborg

• Chief therapist Anne Lise Zilmer
• Physiotherapist Eva Kamelaczyk
• Physiotherapist Magnus Fuglerud

Department of Lung Medicine, Odense University Hospital, Odense

• Consultant Ingrid Titlestad
• Head nurse Bent Schwarz
• Nurse Bente Grøn

Department of Rehabilitation, Odense University Hospital, Odense

• Co-supervisor and adjunct Lisbeth Rosenbek Minet, PhD
• Head therapist Rober Elbek Juul
• Line Willads Hansen

Department of Public Health, University of Southern Denmark

• Main supervisor and lecturer Lotte Huniche, PhD

Department of Lung Medicine, Gentofte Hospital and Manchester Academic Health Science Centre, University of Manchester

• Co-supervisor and professor Jørgen Vestbo

Centre for Innovative Medical Technology (CIMT)

• Co-supervisor and MTV-consultant Kristian Kidholm
• Co-supervisor and chief consultant Claus Duedal Pedersen