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Clinical Trials/NCT02085187
NCT02085187CompletedNot Applicable

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

Odense University Hospital1 site in 1 country50 target enrollmentStarted: January 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Clinical COPD Questionnaire (CCQ)

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Telemedicine training and counselling

Experimental

Intervention: Telemedicine training and counselling (Other)

Outcomes

Primary Outcomes

Clinical COPD Questionnaire (CCQ)

Time Frame: Up to 3 weeks

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

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

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.

Need for acute contact to the general practitioner

Time Frame: 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 ... ".

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.

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).

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.

Patients' falls during training

Time Frame: Up to 3 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lisbeth Rosenbek Minet

Assistent Professor

Odense University Hospital

Study Sites (1)

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