Chronic Obstructive Pulmonary Disease (COPD)NCT02006082
Readmissions to Hospital Among Patients With COPD After Telemedicine Video Consultation - a Pilot Project
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Helse Stavanger HF at 1 site in Norway.
Trial summary
The purpose of this study was to evaluate the effects of telemedicine video-consultation (TVC) on the frequency of hospital re-admissions during 12 months follow-up after TVC among patients with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 88 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Telemedicine video-consultation (TVC)
- Type of treatment
- Medical device
- How many people
- 99 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2012to Dec 2012
- Phase
- Observational
- 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 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All COPD patients living in the southern part of Rogaland county in Western Norway, who were monitored at home by TVC following discharge after emergency hospitalization for COPD exacerbation at Stavanger University Hospital, or at Dalane Medical Center (DMC) in Egersund, or who had tele-monitoring at home under outpatient treatment for acute COPD deterioration during a pilot project period (16th April 2010 - 31st December 2011)
Who may be able to join
- All COPD patients living in the southern part of Rogaland county in Western Norway, with a habitual value of FEV1 < 50%, who were monitored at home by TVC following discharge after emergency hospitalization for COPD exacerbation at Stavanger University Hospital or DMC in Egersund, or who had tele-monitoring at home under outpatient treatment for acute COPD deterioration during the pilot project period
- Written informed consent was obtained
Who cannot join
- Previously inclusion in the study
- Unwillingness to participate
- Residence in service housing with care or in nursing homes
- Inability to communicate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Readmissions to Hospital and Patient Satisfaction Among Patients With Chronic Obstructive Pulmonary Disease After Telemedicine Video Consultation - a Pilot Project
The purpose of this study was to evaluate the effects of telemedicine video-consultation (TVC) on the frequency of hospital re-admissions during 12 months follow-up after TVC among patients with chronic obstructive pulmonary disease (COPD). Our secondary aims were to assess the impact of TVC on the length of recurrent hospital stays and time to re-admission within 12 months follow-up after TVC. We also wanted to evaluate the patient satisfaction related to TVC.
Read the detailed description
The study is conducted as a retrospective uni-center observation study of a population of COPD patients who after discharge from hospital for acute COPD exacerbation, or during outpatient treatment for acute COPD exacerbation, was monitored for 2 weeks by TVC during a pilot project period from 16 April 2010 to 31 December 2011. To study a possible change in amount of hospital admissions we have compared the frequencies and durations of such events before and after TVC in comparable time periods.
A detailed patient history comprising demographic data, social status, smoking habits, body mass index (BMI), use of medication, co-morbidity and the habitual lung function were registered. Dates of admittance and discharge were noted. Retrospectively, medical records were scrutinized for re-admissions due to COPD exacerbations at 12 months follow-up. Frequency of and date of re-admissions, length of hospital stay, and clinical data were recorded. Also frequency of admission due to COPD exacerbation and length of hospital stay(s) during the last 12 months prior to the TVC were recorded, and date of last discharge was noted. Finally, all patients were encouraged to complete a questionnaire concerning patient satisfaction and impact on patient's quality of life. All answers were registered anonymously.
Data were entered to a database by one trained nurse and monitored by another person, who compared data entered into the registry against predefined rules for range or consistency with other data fields in the registry. All patients who had been monitored by TVC during the pilot project period, gave informed consent to participate in the observational study, and no patient was lost to follow-up.
Continuously distributed variables of baseline characteristics were given as mean + SEM, while variables with more skewed distributions were given as median and upper and lower quartiles.
The Shapiro-Wilk test for normality was performed to study the distribution of parameters. A chi-square test was applied to compare the frequency of re-admissions during 12 months following TVC to the frequency of hospital admissions during the last 12 months prior to TVC. The total number of days in hospital during the last 12 months prior to TVC was compared to number of days in hospital during 12 months following TVC by a paired t-test. Differences in baseline characteristics between patients who were re-admitted and those who were not, were analyzed by a Two-sample Student's T-test, or in case of non-normality, by the Mann-Whitney Rank Sum test.
The number of days to re-admission following TVC as compared to number of days from last discharge to date of index admittance was displayed in a Kaplan Meier plot, with a hazard ratio (HR) calculation by a by a Cox regression analysis.
A statistically significant level of p < 0.05 was applied for all tests. All statistical analyses were performed using the statistical package of SigmaPlot Version 12.
Power calculations have not been performed for the purpose of this pilot study, because of too many unknown factors. The results of this study will form the basis of power calculations for a future prospective randomized study.
- Being tested
- Telemedicine video-consultation (TVC)
- Keywords
- Telemedicine video-consultation (TVC), Re-admission to hospital, Time to re-admission, Length if hospital stay, Patient satisfaction, Chronic obstructive pulmonary disease (COPD)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine video-consultation (TVC)Device
Also called Video-conferencing in Telemedicine
All patients enrolled in the study, were previously monitored by TVC, and the number and length of hospital stays within 6 and 12 months following TVC were compared to similar numbers before TVC in comparable time periods. Thus, TVC is actually not to be considered as an intervention.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients followed after TVC | All COPD patients living in the southern part of Rogaland county in Western Norway, with a habitual value of FEV1 < 50%, who were monitored at home by TVC following discharge after emergency hospitalization for COPD exacerbation at Stavanger University Hospital, or who had tele-monitoring at home under outpatient treatment for acute COPD deterioration during the pilot project period (16th April 2010 - 31st December 2011). The telemedicine equipment consisted of a computer with a web camera with a microphone, through which the patient at home and the specially trained nurse in hospital were able to communicate, and also comprised requisites to measure the patient's oxygen saturation and heart rate, and to perform a spirometry. Receives: Device: Telemedicine video-consultation (TVC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of hospital re-admissions due to COPD exacerbations during 12 months follow-up after TVC, as compared to admissions due to COPD exacerbations during 12 months pre-TVC
Number of re-admissions in hospital due to COPD exacerbations during 12 months follow-up after TVC, as compared to number of hospital admissions caused by COPD exacerbations the 12 months preceding TVC
Measured: 12 months from inclusion period 16th April 2010 to 31st December 2011
Secondary outcomes (1)
Length of hospital stays (days in hospital) when re-admitted during 12 months follow-up after TVC, as compered to length of hospital stays due to COPD the year preceding TVC
Measured: 12 months after inclusion period from 16th April 2010 to 31st December 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Heidi Grundt, MD PhD, Study chair, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006082
- Sponsor's protocol ID
- SUS-IDPVO2011/50
- Other IDs
- SUS-IDPVO2011/50COPD
- Status last verified
- Dec 2013
- First submitted
- 13 Sep 2013
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Readmissions to Hospital and Patient Satisfaction Among Patients With Chronic Obstructive Pulmonary Disease After Telemedicine Video Consultation - a Pilot Project
- ClinicalTrials.gov ID
- NCT02006082
- Acronym / sponsor ID
- SUS-IDPVO2011/50
- Keywords
- Telemedicine video-consultation (TVC), Re-admission to hospital, Time to re-admission, Length if hospital stay, Patient satisfaction, Chronic obstructive pulmonary disease (COPD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Dec 2013 (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 was to evaluate the effects of telemedicine video-consultation (TVC) on the frequency of hospital re-admissions during 12 months follow-up after TVC among patients with chronic obstructive pulmonary disease (COPD). Our secondary aims were to assess the impact of TVC on the length of recurrent hospital stays and time to re-admission within 12 months follow-up after TVC. We also wanted to evaluate the patient satisfaction related to TVC.
Detailed description
The study is conducted as a retrospective uni-center observation study of a population of COPD patients who after discharge from hospital for acute COPD exacerbation, or during outpatient treatment for acute COPD exacerbation, was monitored for 2 weeks by TVC during a pilot project period from 16 April 2010 to 31 December 2011. To study a possible change in amount of hospital admissions we have compared the frequencies and durations of such events before and after TVC in comparable time periods.
A detailed patient history comprising demographic data, social status, smoking habits, body mass index (BMI), use of medication, co-morbidity and the habitual lung function were registered. Dates of admittance and discharge were noted. Retrospectively, medical records were scrutinized for re-admissions due to COPD exacerbations at 12 months follow-up. Frequency of and date of re-admissions, length of hospital stay, and clinical data were recorded. Also frequency of admission due to COPD exacerbation and length of hospital stay(s) during the last 12 months prior to the TVC were recorded, and date of last discharge was noted. Finally, all patients were encouraged to complete a questionnaire concerning patient satisfaction and impact on patient's quality of life. All answers were registered anonymously.
Data were entered to a database by one trained nurse and monitored by another person, who compared data entered into the registry against predefined rules for range or consistency with other data fields in the registry. All patients who had been monitored by TVC during the pilot project period, gave informed consent to participate in the observational study, and no patient was lost to follow-up.
Continuously distributed variables of baseline characteristics were given as mean + SEM, while variables with more skewed distributions were given as median and upper and lower quartiles.
The Shapiro-Wilk test for normality was performed to study the distribution of parameters. A chi-square test was applied to compare the frequency of re-admissions during 12 months following TVC to the frequency of hospital admissions during the last 12 months prior to TVC. The total number of days in hospital during the last 12 months prior to TVC was compared to number of days in hospital during 12 months following TVC by a paired t-test. Differences in baseline characteristics between patients who were re-admitted and those who were not, were analyzed by a Two-sample Student's T-test, or in case of non-normality, by the Mann-Whitney Rank Sum test.
The number of days to re-admission following TVC as compared to number of days from last discharge to date of index admittance was displayed in a Kaplan Meier plot, with a hazard ratio (HR) calculation by a by a Cox regression analysis.
A statistically significant level of p < 0.05 was applied for all tests. All statistical analyses were performed using the statistical package of SigmaPlot Version 12.
Power calculations have not been performed for the purpose of this pilot study, because of too many unknown factors. The results of this study will form the basis of power calculations for a future prospective randomized study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients followed after TVC | – | Device: Telemedicine video-consultation (TVC)All COPD patients living in the southern part of Rogaland county in Western Norway, with a habitual value of FEV1 < 50%, who were monitored at home by TVC following discharge after emergency hospitalization for COPD exacerbation at Stavanger University Hospital, or who had tele-monitoring at home under outpatient treatment for acute COPD deterioration during the pilot project period (16th April 2010 - 31st December 2011). The telemedicine equipment consisted of a computer with a web camera with a microphone, through which the patient at home and the specially trained nurse in hospital were able to communicate, and also comprised requisites to measure the patient's oxygen saturation and heart rate, and to perform a spirometry. |
Who may qualify
- Ages
- 40 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All COPD patients living in the southern part of Rogaland county in Western Norway, who were monitored at home by TVC following discharge after emergency hospitalization for COPD exacerbation at Stavanger University Hospital, or at Dalane Medical Center (DMC) in Egersund, or who had tele-monitoring at home under outpatient treatment for acute COPD deterioration during a pilot project period (16th April 2010 - 31st December 2011)
Key inclusion criteria (2 listed)
- All COPD patients living in the southern part of Rogaland county in Western Norway, with a habitual value of FEV1 < 50%, who were monitored at home by TVC following discharge after emergency hospitalization for COPD exacerbation at Stavanger University Hospital or DMC in Egersund, or who had tele-monitoring at home under outpatient treatment for acute COPD deterioration during the pilot project period
- Written informed consent was obtained
Key exclusion criteria (4 listed)
- Previously inclusion in the study
- Unwillingness to participate
- Residence in service housing with care or in nursing homes
- Inability to communicate
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 video-consultation (TVC)Also: Video-conferencing in TelemedicineAll patients enrolled in the study, were previously monitored by TVC, and the number and length of hospital stays within 6 and 12 months following TVC were compared to similar numbers before TVC in comparable time periods. Thus, TVC is actually not to be considered as an intervention. | Device | COPD patients followed after TVC |
Primary outcome
Frequency of hospital re-admissions due to COPD exacerbations during 12 months follow-up after TVC, as compared to admissions due to COPD exacerbations during 12 months pre-TVC
Time frame: 12 months from inclusion period 16th April 2010 to 31st December 2011
Number of re-admissions in hospital due to COPD exacerbations during 12 months follow-up after TVC, as compared to number of hospital admissions caused by COPD exacerbations the 12 months preceding TVC
1 secondary outcome
Length of hospital stays (days in hospital) when re-admitted during 12 months follow-up after TVC, as compered to length of hospital stays due to COPD the year preceding TVC
Time frame: 12 months after inclusion period from 16th April 2010 to 31st December 2011
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 9 Dec 2013.
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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.
Heidi Grundt, MD PhD study chair
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Helse Stavanger HF at 1 site in Norway.
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 2 inclusion and 4 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 9 Dec 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 Norway. 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?
Frequency of hospital re-admissions due to COPD exacerbations during 12 months follow-up after TVC, as compared to admissions due to COPD exacerbations during 12 months pre-TVC (time frame: 12 months from inclusion period 16th April 2010 to 31st December 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2013.