COPDNCT01178879
Randomised Trial of Telehealth Consultations for Nursing Care of Chronic Obstructive Pulmonary Disease (COPD) Patients
A study testing Telehealth consultation in people with COPD, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether telehealth nursing consultations of chronic obstructive pulmonary disease (COPD) patients are superior to hospital readmissions. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Telehealth consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteDenmark
- Study dates
- May 2010to Feb 2012
- 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
- Chronic obstructive pulmonary disease (COPD) verified by spirometry.
- Exacerbation in COPD, defined as increased need for medicine, and increased dyspnea or increased expectorate or increased coughing.
- > or 40 years old
- Living on Funen and islands
- Signed informed consent.
Who cannot join
- Not able to communicate via telephone and/or computer screen
- Previously received "The COPD suitcase", or participated in this protocol
- Systolic BT is <100 mm Hg
- Saturation < 90
- Thorax x-ray shows signs of malignant changes or lobar pneumonia
- Diagnosed with cancer or recurrence of cancer within the last five years
Show all 9Show fewer
- Admitted with septic shock, acute myocardial infarction or other serious medical condition (for example renal disease)
- Diagnosed with heart failure (EF < 30%)
- Refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Nurse Lead Telehealth Consultations in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to determine whether telehealth nursing consultations of chronic obstructive pulmonary disease (COPD) patients are superior to hospital readmissions.
Read the detailed description
COPD is among the most common reasons for illness and fatality in adults worldwide, and it is expected that this trend will escalate radically by 2020 (1). Approximately 29% of patients admitted to Hospital with exacerbation will be readmitted within the first month (2), and after one year 46% of patients will have been readmitted on one or more occasions due to exacerbation (3).
Therefore, trials have been carried out using different forms of digitally supported distance health interventions (telehealth nurse consultations) (4) of patients with COPD with a view to reducing the number of readmissions in a reliable way, measured in relation to mortality. Thus in these trials there are a certain indication that use of telehealth nurse consultations of patients with COPD is a treatment initiative that reliably can reduce the number of COPD patients readmitted with exacerbation.
The number of randomized telehealth studies are however few (4;5), and there is a lack of documentation of the effect of telehealth monitoring.
Therefore, a large randomized telehealth study with a clear set up was necessary.
This study is a randomized multicenter trial that will take place at the acute admissions department and lung department at Odense University Hospital,Denmark
We hypothesized that in a period of 26 weeks:
- The total number of readmissions can be reduced with 14%
- The time to the first readmission will be prolonged
- The number of readmissions with exacerbation can be reduced after telehealth consultations as a supplement to the conventional treatment compared with conventional treatment
- The total number of readmission days can be reduced after telehealth consultations as a supplement to the conventional treatment compared with conventional treatment
- The total number of readmission days with exacerbation can be reduced after telehealth consultations as a supplement to the conventional treatment compared with conventional treatment
- The mortality rate will remain unchanged after the telehealth consultations as a supplement to the conventional treatment compared with conventional treatment
- Conditions
- COPD
- Being tested
- Telehealth consultation
- Keywords
- Telehealth, nurse consultation, outpatient clinic
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth consultationBehavioural
Also called Telehealth nurse consultation
The consultations are structured as outpatient sessions immediately after discharge. The content of the education deals with the regular treatment, prevention of exacerbation and how to live with the illness. The aim of the counseling is to increase the patient's empowerment and competence to take action. The patients have the consultations for 7 days followed by a telephone call. Each session is organized and individualised according to the patient's wishes and needs for education and counselling.
The equipment consists of a computer with web camera, microphone and measurement equipment. A button to contact to the nurse at the hospital, an alarm button and a volume button. The results are transferred to the hospital by a secure internet line.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth consultation | Experimental | Telehealth nurse consultation plus treatment as usual Receives: Behavioral: Telehealth consultation |
| Conventional | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of readmissions
Measured: at 26 weeks after discharge
Secondary outcomes (5)
The mortality rate
Measured: at 26 weeks weeks after discharge
The duration to the first readmission
Measured: at 26 weeks after discharge
The number of hospital readmissions with exacerbation
Measured: at 26 weeks after discharge
The number of days readmitted
Measured: days 26 weeks after discharge
The number of days readmitted with exacerbation
Measured: days 26 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Sygekassernes Helsefond, Danish Nurses Organisation
- Responsible party
- Principal investigator, Birte Oestergaard, University of Southern Denmark
- Investigators
- Anne Dichmann Sorknaes, PhD student, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178879
- Sponsor's protocol ID
- UNRS-20100030-2
- Status last verified
- Jun 2013
- First submitted
- 9 Aug 2010
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Murray CJ, Lopez AD. Alternative projections of mortality and disability by cause 1990-2020: Global Burden of Disease Study. Lancet. 1997 May 24;349(9064):1498-504. doi: 10.1016/S0140-6736(96)07492-2.
PubMed 9167458(2) Sundhedsstyrelsen. Genindlæggelser af ældre i Danmark 2008 - Nye tal fra Sundhedsstyrelsen. 1060. Ref Type: Internet Communication.
Eriksen N, Hansen EF, Munch EP, Rasmussen FV, Vestbo J. [Chronic obstructive pulmonary disease. Admission, course and prognosis]. Ugeskr Laeger. 2003 Sep 8;165(37):3499-502. Danish.
PubMed 14531348Casas A, Troosters T, Garcia-Aymerich J, Roca J, Hernandez C, Alonso A, del Pozo F, de Toledo P, Anto JM, Rodriguez-Roisin R, Decramer M; members of the CHRONIC Project. Integrated care prevents hospitalisations for exacerbations in COPD patients. Eur Respir J. 2006 Jul;28(1):123-30. doi: 10.1183/09031936.06.00063205. Epub 2006 Apr 12.
PubMed 16611656Finkelstein SM, Speedie SM, Potthoff S. Home telehealth improves clinical outcomes at lower cost for home healthcare. Telemed J E Health. 2006 Apr;12(2):128-36. doi: 10.1089/tmj.2006.12.128.
PubMed 16620167
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nurse Lead Telehealth Consultations in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01178879
- Acronym / sponsor ID
- UNRS-20100030-2
- Conditions
- COPD
- Keywords
- Telehealth, nurse consultation, outpatient clinic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Sygekassernes Helsefond, Danish Nurses Organisation
- Study start
- May 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 10 Aug 2010 (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.
The purpose of this study is to determine whether telehealth nursing consultations of chronic obstructive pulmonary disease (COPD) patients are superior to hospital readmissions.
Detailed description
COPD is among the most common reasons for illness and fatality in adults worldwide, and it is expected that this trend will escalate radically by 2020 (1). Approximately 29% of patients admitted to Hospital with exacerbation will be readmitted within the first month (2), and after one year 46% of patients will have been readmitted on one or more occasions due to exacerbation (3).
Therefore, trials have been carried out using different forms of digitally supported distance health interventions (telehealth nurse consultations) (4) of patients with COPD with a view to reducing the number of readmissions in a reliable way, measured in relation to mortality. Thus in these trials there are a certain indication that use of telehealth nurse consultations of patients with COPD is a treatment initiative that reliably can reduce the number of COPD patients readmitted with exacerbation.
The number of randomized telehealth studies are however few (4;5), and there is a lack of documentation of the effect of telehealth monitoring.
Therefore, a large randomized telehealth study with a clear set up was necessary.
This study is a randomized multicenter trial that will take place at the acute admissions department and lung department at Odense University Hospital,Denmark
We hypothesized that in a period of 26 weeks:
- The total number of readmissions can be reduced with 14%
- The time to the first readmission will be prolonged
- The number of readmissions with exacerbation can be reduced after telehealth consultations as a supplement to the conventional treatment compared with conventional treatment
- The total number of readmission days can be reduced after telehealth consultations as a supplement to the conventional treatment compared with conventional treatment
- The total number of readmission days with exacerbation can be reduced after telehealth consultations as a supplement to the conventional treatment compared with conventional treatment
- The mortality rate will remain unchanged after the telehealth consultations as a supplement to the conventional treatment compared with conventional treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth consultation | Experimental | Behavioral: Telehealth consultationTelehealth nurse consultation plus treatment as usual |
| Conventional | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic obstructive pulmonary disease (COPD) verified by spirometry.
- Exacerbation in COPD, defined as increased need for medicine, and increased dyspnea or increased expectorate or increased coughing.
- > or 40 years old
- Living on Funen and islands
- Signed informed consent.
Key exclusion criteria (9 listed)
- Not able to communicate via telephone and/or computer screen
- Previously received "The COPD suitcase", or participated in this protocol
- Systolic BT is <100 mm Hg
- Saturation < 90
- Thorax x-ray shows signs of malignant changes or lobar pneumonia
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 |
|---|---|---|
| Telehealth consultationAlso: Telehealth nurse consultationThe consultations are structured as outpatient sessions immediately after discharge. The content of the education deals with the regular treatment, prevention of exacerbation and how to live with the illness. The aim of the counseling is to increase the patient's empowerment and competence to take action. The patients have the consultations for 7 days followed by a telephone call. Each session is organized and individualised according to the patient's wishes and needs for education and counselling. The equipment consists of a computer with web camera, microphone and measurement equipment. A button to contact to the nurse at the hospital, an alarm button and a volume button. The results are transferred to the hospital by a secure internet line. | Behavioural | Telehealth consultation |
Primary outcome
The number of readmissions
Time frame: at 26 weeks after discharge
5 secondary outcomes
The mortality rate
Time frame: at 26 weeks weeks after discharge
The duration to the first readmission
Time frame: at 26 weeks after discharge
The number of hospital readmissions with exacerbation
Time frame: at 26 weeks after discharge
The number of days readmitted
Time frame: days 26 weeks after discharge
The number of days readmitted with exacerbation
Time frame: days 26 weeks after discharge
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 28 Jun 2013.
- Background: PubMed 9167458Murray CJ, Lopez AD. Alternative projections of mortality and disability by cause 1990-2020: Global Burden of Disease Study. Lancet. 1997 May 24;349(9064):1498-504. doi: 10.1016/S0140-6736(96)07492-2.
- Background(2) Sundhedsstyrelsen. Genindlæggelser af ældre i Danmark 2008 - Nye tal fra Sundhedsstyrelsen. 1060. Ref Type: Internet Communication.
- Background: PubMed 14531348Eriksen N, Hansen EF, Munch EP, Rasmussen FV, Vestbo J. [Chronic obstructive pulmonary disease. Admission, course and prognosis]. Ugeskr Laeger. 2003 Sep 8;165(37):3499-502. Danish.
- Background: PubMed 16611656Casas A, Troosters T, Garcia-Aymerich J, Roca J, Hernandez C, Alonso A, del Pozo F, de Toledo P, Anto JM, Rodriguez-Roisin R, Decramer M; members of the CHRONIC Project. Integrated care prevents hospitalisations for exacerbations in COPD patients. Eur Respir J. 2006 Jul;28(1):123-30. doi: 10.1183/09031936.06.00063205. Epub 2006 Apr 12.
- Background: PubMed 16620167Finkelstein SM, Speedie SM, Potthoff S. Home telehealth improves clinical outcomes at lower cost for home healthcare. Telemed J E Health. 2006 Apr;12(2):128-36. doi: 10.1089/tmj.2006.12.128.
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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.
Anne Dichmann Sorknaes, PhD student principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth consultation in people with COPD, run by University of Southern Denmark 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 9 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 28 Jun 2013. 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?
The number of readmissions (time frame: at 26 weeks after discharge). 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 NCT01178879, which also lists 5 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 28 Jun 2013.