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Completed

NCT Number: NCT02085187

Early Telemedicine Training in Patients With COPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telemedicine training and counselling

Other

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.

Primary outcomes

  1. Clinical COPD Questionnaire (CCQ)

    Time frame: Up to 3 weeks

    A self-administered validated questionnaire measuring the health status of patients with COPD.

  2. 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

  3. 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.

  4. Patients' falls during training

    Time frame: Up to 3 weeks

  5. Need for acute contact to the general practitioner

    Time frame: Up to 3 weeks

  6. 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 … ".

  7. 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.

  8. 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).

  9. 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.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Region of Southern Denmark

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Mar 12, 2014
Registry last updated
Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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