Early Telemedicine Training in Patients With COPD

Study Overview
=================
Brief Summary
-----------------
Chronic obstructive pulmonary disease (COPD) is a widespread disease that can have a major impact on the lives of individuals. An essential element in the treatment of COPD is rehabilitation of which supervised training is an important part. However, not all individuals with severe COPD can participate in the rehabilitation provided by hospitals and municipal training centres due to distance to the training venues and transportation difficulties. The aim of the feasibility study was to evaluate an individualised home based training and counselling programme via video conference to patients with severe COPD after hospitalization with regard to safety, clinical outcomes, patients' perception, organisational aspects and economic aspects.

Official Title
-----------------
Early Telemedicine Training and Counselling After Hospitalization in Patients With Severe Chronic Obstructive Pulmonary Disease: A Feasibility Study

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Other: Telemedicine training and counselling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe and very severe COPD (i.e. with an FEV1 (forced expiratory volume in 1 second) value under 50% of the predicted value, an FEV1/FVC (forced vital capacity) ratio < 70%, MRC (Medical Research Council Dyspnoea Scale) grade 3) ≥40 years hospitalization with exacerbation of COPD declined participation in the hospital based rehabilitation participation in videoconference sessions with a nurse for one week immediately after discharge. Exclusion Criteria: inability to communicate via telephone and computer systolic BP <100mm Hg X-rays of the thorax showing abnormalities suspicious of thoracic malignancy or lobar pneumonia a diagnosis of cancer or recurrence of cancer within the last 5 years hospitalization with septic shock, acute myocardial infarction (AMI) or other serious medical conditions (e.g. kidney disorder) heart failure (EF<30%) if the patient did not wish to participate.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine training and counselling<br> | Other: Telemedicine training and counselling<br>* Training and counselling by the physiotherapist consisted of 3 weekly sessions, lasting 30-45 minutes, over a 3 week period, i.e. a total of 9 supervised sessions. Heart rate and oxygen saturation were monitored during the exercise training. This included thoracic mobilization exercises, cardio training, strength training and breathing exercises. The training intensity was progressed continuously. There were 1-2 sessions with the occupational therapist, which consisted of training and counselling on energy conservation techniques. The first session was 60 minutes long and included assessment, counselling and training. This session was delivered in the second week of the intervention. The intervention concluded in the third week, with sessions of 30 minutes as required.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical COPD Questionnaire (CCQ) | A self-administered validated questionnaire measuring the health status of patients with COPD. | Up to 3 weeks | 
| Timed Up & Go test (TUG) | Measuring the time in seconds (with 2 decimals), it takes a person to rise from an ordinary chair (with back and armrest), walk 3 meters, turn around and walk back to the chair and sit down again | Up to 3 weeks | 
| The five time sit to stand test (FTSST) | Measures functional lower limb muscle strength, where the time in seconds (2 decimals) used for 5 times rising from a chair is measured. | Up to 3 weeks | 
| Patients' falls during training |  | Up to 3 weeks | 
| Need for acute contact to the general practitioner |  | Up to 3 weeks | 
| Patient subjective perception | The patients submitted a postcard with information about their experience. The postcard was an open ended question and was printed with the text Dear Department of rehabilitation. My experience of training and counselling by use of the Patient briefcase was … . | Up to 3 weeks | 
| Costs per patient participating in the telemedicine rehabilitation | This included renting of the patient briefcase, establishing of a safe line for data transmission and use of hospital staff. | Up to 3 weeks | 
| Reimbursement to the hospital | Estimated as the DRG (Diagnose Related Groups) value of the rehabilitation activity similar to the payment for the activity from the regional health system (The Region of Southern Denmark) to the hospital in accordance with health care financing system). | Up to 3 weeks | 
| Focus Group interview | The perception of the hospital staff of the telemedicine intervention programme was assessed by a focus group interview with the occupational- and physiotherapists who carried out the telemedicine rehabilitation training and thus were familiar with the programme. | Up to 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary rehabilitation, Training, Counselling, Telemedicine, Videoconference, COPD, Chronic disease, Internet.