Early Telemedicine Training in Patients With COPD

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085187
• Other study ID #: S-20110036
• Status: Completed
• Phase: N/A
• First received: March 6, 2014
• Last updated: March 10, 2014
• Start date: January 2012
• Est. completion date: January 2013

Study information

• Verified date: March 2014
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	Region of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical COPD Questionnaire (CCQ)	A self-administered validated questionnaire measuring the health status of patients with COPD.	Up to 3 weeks	No
Primary	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	No
Primary	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	No
Primary	Patients' falls during training		Up to 3 weeks	Yes
Primary	Need for acute contact to the general practitioner		Up to 3 weeks	Yes
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No