Early Telemedicine Training in Patients With COPD

March 10, 2014 updated by: Lisbeth Rosenbek Minet, Odense University Hospital

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telemedicine training and counselling

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical COPD Questionnaire (CCQ)
Time Frame: Up to 3 weeks
A self-administered validated questionnaire measuring the health status of patients with COPD.
Up to 3 weeks
Timed Up & Go test (TUG)
Time Frame: Up to 3 weeks
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)
Time Frame: Up to 3 weeks
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
Time Frame: Up to 3 weeks
Up to 3 weeks
Need for acute contact to the general practitioner
Time Frame: Up to 3 weeks
Up to 3 weeks
Patient subjective perception
Time Frame: Up to 3 weeks
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
Time Frame: Up to 3 weeks
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
Time Frame: Up to 3 weeks
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
Time Frame: Up to 3 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Lilian Møllegård, Reg. Nurce, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

March 6, 2014

First Submitted That Met QC Criteria

March 10, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Estimate)

March 12, 2014

Last Update Submitted That Met QC Criteria

March 10, 2014

Last Verified

March 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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