Telemedical Training for Chronically Ill COPD Patients: a Cross Sectoral Study
Telemedical Training for Chronically Ill COPD Patients: a Cross Sectoral Study
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.
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:

 -  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 patients' journey in and across sector borders by using Lean methods.

 The projects relevance for the clinic and target group:

 The study is expected to contribute to improving the treatment of severely ill patients with
 COPD cross-sectorally by generating knowledge for the physical and occupational therapists'
 practice. 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 includes patients with severe COPD in Odense and Svendborg. It is anticipated that
 similar patient groups with similar difficulties, nationally as well as internationally, will
 benefit from the findings.

 Background:

 More than 430.000 people in Denmark have Chronic Obstructive Pulmonary Disease (COPD) (Hansen
 et al., 2008). Characteristic for COPD is respiratory tract obstruction, which is not
 completely reversible and worsens as time passes. Complications of COPD are: loss of muscle
 mass, weight loss and an increasing social isolation (The National Board of Health, 2007).

 It is well documented that a systematic individually composed rehabilitation program,
 including training, has an effect on patients' functional level and quality of life (National
 board of Health, 2007). Early rehabilitation after hospitalization may break the vicious
 circle, which can arise for patients with COPD. In this cycle, hospitalization can entail
 inactivity and loss of muscular strength, thus increasing the risk of new aggravations with
 re-admittance to hospital as a result (National board of Health, 2014). In addition, at this
 time no studies examine the effect of training on daily activities (ibid).

 To offer these severely ill patients rehabilitation is a regional task. However, the patients
 with severe COPD often decline training, as the transport to and from hospital is too
 exhausting for them. The result is no training for this group. The same dilemma exists in
 other countries (Burkow et al., 2013). Inactivity can mean stagnation in daily life, which
 affects functioning (Williams et al., 2011) for both patients and their families (Wong et
 al., 2005) Patients with COPD, who cannot take part in the usual rehabilitation program due
 to the degree of their illness, are now recommended to take part in strength training as a
 replacement. The recommendation is based solely on consensus of good clinical practice.
 Research is lacking (National Board of Health, 2014).

 Few studies examine telemedicine, COPD and supervised training. Two studies with supervised
 team training for, among others, patients with COPD showed great patient satisfaction and an
 increased experience of social support (Nield and Hoo, 2012, Burkow et al., 2013). One of the
 studies showed a significantly decreased occurrence of dyspnoea in the intervention group
 (Nield and Hoo, 2012).

 In 2010-2012 OUH did a feasibility study in an attempt to develop a training program for
 patients with severe or very severe COPD who reject the established rehabilitation program at
 the hospital. The study, which encompassed 50 patients in a year, tested and developed an
 early effort using an individually tailored home-training program based on telemedical
 training.

 The results showed potential in relation to previous telemedical training of patients with
 COPD. Considering the scanty knowledge in the field, a contribution to produce knowledge of
 greater variation is relevant.

 Project type:

 An randomised controlled Study (RCT) is needed to reveal the effect of telemedical training
 and muscle strength related to doing every day chores and to see how this affects their daily
 activities and quality of life.

 The RCT study:

 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.

 Hypotheses:

 This study is designed to assess the hypothesis that patients with severe or very severe
 COPD, who have thanked no to training at the hospital, receiving telemedical training will
 experience greater satisfaction doing daily activities, increase their quality of life and
 increase their physical performance than patients who do not receive telemedical training.

 Place and project participants:

 Patients who take part in the study have been admitted to OUH because of a worsening of their
 COPD. The criteria for inclusion and exclusion criteria will be submitted elsewhere.

 Design and method:

 The project participants are included consecutively in the intervention group or the control
 group for two years. A power calculation shows the study can, with a random sampling size of
 100 patients, 50 in each group, show a difference of 2,7 seconds in FTSST(Stand up - sit down
 five times). The strength is set to 80 %. The calculation is based on a standard deviation of
 4,8 for FTSST and a 5 % to-sided significance level. If a dropout rate of 20 % is allowed
 for, it will mean that 128 persons must be included.

 The patients are randomized to the intervention group or the control group by baseline after
 an informed consent. Measurements are made at baseline, post-intervention and follow-up,
 which are 3 and 6 months after post-intervention.

 Patients in the intervention group will receive telemedical training in teams of up to 4, 21
 times, three times weekly for seven weeks. During the first three weeks the regional
 physiotherapists will be responsible for the training. Municipal occupational -and
 physiotherapists will manage the last four weeks' training.

 Patients in the control-group will receive no training as they have refused the offer. They
 will be discharged to the municipal sphere with a rehabilitation plan.

 Data generation method:

 Function tests and questionnaires will be included in the quantitative study of the
 telemedicial training's importance for physical ability, daily activities and health related
 quality of life for patients with severe or very severe COPD.

 Outcome measures will be submitted elsewhere. The following parameters describe the
 participating patient group: Sex, age, civil status, socio - economic status, Body Mass Index
 (BMI), forced expiratory volume in one 1 second (FEV1) of expected value, FEV1 / forced vital
 capacity (FVC), Medical Research Council Breathlessness Scale (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.

 Analysis:

 The data will be continuously keyed into an Access database. Calculation of the analysis will
 be done using the software program STATA (abbreviation of Statistic and Data). The data will
 be analyzed according to the principle 'intention to treat'. The level of significance α will
 be placed at 0,05 and power β = 0,8. Descriptive statistics and regression analysis will be
 used.

 Ethical considerations:

 The patients will be informed of the project's goal, form and content both orally and in
 written form and that participation is voluntary. Written consent must be had before
 inclusion. Participants will be informed that they can leave the study at any time. The
 project leader will file inclusion numbers and corresponding personal data securely according
 to the applicable rules. The project is registered and approved of by The Danish Data
 Protection Agency and the Danish Council of Ethics.

 Documentation of results, knowledge sharing and distribution:

 Three articles will be published in relevant international peer-reviewed journals. The Danish
 Lung Association will be continuously informed of the study's status. The results will be
 distributed to national and international conferences, and studies abroad. These include
 health professional forums during the Ph.D. study - depending on the results of the study.

 Database:

 Data from the project will be stored via Odense Patient Explorative Network (OPEN)- more
 specifically Redcap as the data management system. Redcap is approved of by God Clinical
 practice (GCP).
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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).