Chronic Obstructive Pulmonary Disease (COPD)NCT02085187
Early Telemedicine Training in Patients With COPD
A study testing Telemedicine training and counselling in people with Chronic Obstructive Pulmonary Disease (COPD), run by Odense University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Telemedicine training and counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Telemedicine Training and Counselling After Hospitalization in Patients With Severe Chronic Obstructive Pulmonary Disease: A Feasibility Study
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.
- Being tested
- Telemedicine training and counselling
- Keywords
- Pulmonary rehabilitation, Training, Counselling, Telemedicine, Videoconference, COPD, Chronic disease, Internet.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine training and counsellingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine training and counselling | Experimental | Not described Receives: Other: Telemedicine training and counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical COPD Questionnaire (CCQ)
A self-administered validated questionnaire measuring the health status of patients with COPD.
Measured: Up to 3 weeks
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
Measured: Up to 3 weeks
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.
Measured: Up to 3 weeks
Patients' falls during training
Measured: Up to 3 weeks
Need for acute contact to the general practitioner
Measured: Up to 3 weeks
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 … ".
Measured: Up to 3 weeks
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.
Measured: Up to 3 weeks
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).
Measured: Up to 3 weeks
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.
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark
- Responsible party
- Principal investigator, Lisbeth Rosenbek Minet, Odense University Hospital
- Investigators
- Lilian Møllegård, Reg. Nurce, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085187
- Sponsor's protocol ID
- S-20110036
- Status last verified
- Mar 2014
- First submitted
- 6 Mar 2014
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 33511633Rosenbek 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.
PubMed 25886014
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Telemedicine Training and Counselling After Hospitalization in Patients With Severe Chronic Obstructive Pulmonary Disease: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02085187
- Acronym / sponsor ID
- S-20110036
- Keywords
- Pulmonary rehabilitation, Training, Counselling, Telemedicine, Videoconference, COPD, Chronic disease, Internet.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Region of Southern Denmark
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemedicine training and counselling | Experimental | Other: Telemedicine training and counselling |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine training and counsellingTraining 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. | Other | Telemedicine training and counselling |
Primary outcome
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.
Patients' falls during training
Time frame: Up to 3 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
- Derived from this study: PubMed 33511633Cox 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.
- Derived from this study: PubMed 25886014Rosenbek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilian Møllegård, Reg. Nurce study chair
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine training and counselling in people with Chronic Obstructive Pulmonary Disease (COPD), run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical COPD Questionnaire (CCQ) (time frame: Up to 3 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02085187, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2014.