- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02085187
Early Telemedicine Training in Patients With COPD
Early Telemedicine Training and Counselling After Hospitalization in Patients With Severe Chronic Obstructive Pulmonary Disease: A Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Odense, Denmark, 5000
- Odense University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Study Chair: Lilian Møllegård, Reg. Nurce, Odense University Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-20110036
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.
Clinical Trials on Chronic Obstructive Pulmonary Disease (COPD)
-
University College, LondonUniversity of Cambridge; National Institute for Health Research, United Kingdom and other collaboratorsUnknownChronic Obstructive Pulmonary Disease (COPD).United Kingdom
-
Reham Mohammed ElmorshedyCompletedChronic Obstructive Pulmonary Disease(COPD)Egypt
-
AstraZenecaCompletedChronic Obstructive Pulmonary Disease (COPD).United Kingdom
-
Ryme Medical, Inc.Not yet recruitingCOPD | Lung Disease, Chronic Obstructive | COPD Patients | COPD Acute Exacerbation | COPD (Chronic Obstructive Pulmonary Disease) | Lung Disease Airways | COPD Exacerbations
-
Virginia Commonwealth UniversityFisher and Paykel HealthcareCompletedChronic Obstructive Pulmonary Disease(COPD)United States
-
Beaumont HospitalAerogenCompletedChronic Obstructive Pulmonary Disease | COPD | COPD Exacerbation | Copd Exacerbation AcuteIreland
-
Morair Medtech, LLCRecruitingEmphysema | COPD | Emphysema or COPD | COPD (Chronic Obstructive Pulmonary Disease) | Emphysema, PulmonaryAustria, Germany, Netherlands
-
Medtronic BRCUnknownCOPD | COPD Exacerbation
-
Barron Associates, Inc.National Heart, Lung, and Blood Institute (NHLBI); University of VirginiaNot yet recruitingCOPD | COPD - Chronic Obstructive Pulmonary DiseaseUnited States
-
Elpen Pharmaceutical Co. Inc.Completed
Clinical Trials on Telemedicine training and counselling
-
Karolinska InstitutetCompleted
-
UKK InstituteFinland's Slot Machine Association (RAY); Ministry of Education; Scientific Advisory...Completed
-
Air Liquide Healthcare SpainHospital Sant Joan de DeuCompleted
-
Huashan HospitalUnknown
-
Universita di VeronaAzienda Ospedaliera Universitaria Integrata Verona; University of PadovaRecruitingType 2 Diabetes MellitusItaly
-
Region Örebro CountyKarolinska Institutet; Örebro University, SwedenNot yet recruitingUnintended Pregnancy Prevention
-
Queen's University, BelfastRecruiting
-
Umeå UniversityVastra Gotaland Region; Region Östergötland; Region Stockholm; Region Örebro County and other collaboratorsCompletedDiabetes Mellitus, Type 2Sweden
-
University of California, San FranciscoNational Cancer Institute (NCI)CompletedSmoking Cessation | Second Hand Tobacco SmokeUnited States
-
RWTH Aachen UniversityNot yet recruitingBlended-care Counselling | Digital and Mental Literacy Training | App STEPSGermany