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Early Telemedicine Training in Patients With COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Telemedicine training and counselling

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Pulmonary rehabilitation, Training, Counselling, Telemedicine, Videoconference, COPD, Chronic disease, Internet.

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Odense University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telemedicine training and counselling

Arm Description

Outcomes

Primary Outcome Measures

Clinical COPD Questionnaire (CCQ)

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

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

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.

Patients' falls during training

Need for acute contact to the general practitioner

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 … ".

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.

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).

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02085187

First Posted

March 6, 2014

Last Updated

March 10, 2014

Sponsor

Odense University Hospital

Collaborators

Region of Southern Denmark

1. Study Identification

Unique Protocol Identification Number

NCT02085187

Brief Title

Early Telemedicine Training in Patients With COPD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Odense University Hospital

Collaborators

Region of Southern Denmark

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Pulmonary rehabilitation, Training, Counselling, Telemedicine, Videoconference, COPD, Chronic disease, Internet.

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Telemedicine training and counselling

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Telemedicine training and counselling

Intervention Description

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 Outcome Measure Information:

Title

Clinical COPD Questionnaire (CCQ)

Description

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

Time Frame

Up to 3 weeks

Title

Timed Up & Go test (TUG)

Description

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

Time Frame

Up to 3 weeks

Title

The five time sit to stand test (FTSST)

Description

Measures functional lower limb muscle strength, where the time in seconds (2 decimals) used for 5 times rising from a chair is measured.

Time Frame

Up to 3 weeks

Title

Patients' falls during training

Time Frame

Up to 3 weeks

Title

Need for acute contact to the general practitioner

Time Frame

Up to 3 weeks

Title

Patient subjective perception

Description

Time Frame

Up to 3 weeks

Title

Costs per patient participating in the telemedicine rehabilitation

Description

This included renting of the "patient briefcase", establishing of a safe line for data transmission and use of hospital staff.

Time Frame

Up to 3 weeks

Title

Reimbursement to the hospital

Description

Time Frame

Up to 3 weeks

Title

Focus Group interview

Description

Time Frame

Up to 3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lilian Møllegård, Reg. Nurce

Organizational Affiliation

Odense University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Odense University Hospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

33511633

Citation

Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

Results Reference

derived

PubMed Identifier

25886014

Citation

Rosenbek Minet L, Hansen LW, Pedersen CD, Titlestad IL, Christensen JK, Kidholm K, Rayce K, Bowes A, Mollegard L. Early telemedicine training and counselling after hospitalization in patients with severe chronic obstructive pulmonary disease: a feasibility study. BMC Med Inform Decis Mak. 2015 Feb 7;15:3. doi: 10.1186/s12911-014-0124-4.

Results Reference

derived

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Early Telemedicine Training in Patients With COPD

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