Pulmonary Disease, Chronic ObstructiveNCT01512992
Home Telehealth Follow-up After Hospital Discharge for Chronic Obstructive Pulmonary Disease (COPD) Patients
A study testing Home telehealth in people with Pulmonary Disease, Chronic Obstructive, run by Catalan Agency for Health Information, Assessment and Quality at 8 sites in Spain.
Trial summary
The purpose of this study is to assess the effects of a complex telemedicine intervention as a part of an integrated care program for patients with chronic obstructive pulmonary disease (COPD) discharged from the hospital after disease exacerbation. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Home telehealth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 8 sitesSpain
- Study dates
- Apr 2012to Dec 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
- Exacerbation of COPD
- Age > 40 years
- Capability to use the devices provided
- Willing to participate
Who cannot join
- Participation in a previous COPD home telehealth study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Hospital Germans Trias i Pujol
Badalona, Catalonia
Capio Hospital Universitari Sagrat Cor
Barcelona, Catalonia
Hospital Clinic de Barcelona
Barcelona, Catalonia
Hospital del Mar
Barcelona, Catalonia
Hospital Plató
Barcelona, Catalonia
Hospital de Mataró
Mataró, Catalonia
Hospital Parc Taulí
Sabadell, Catalonia
Consorci Sanitari de Terrassa
Terrassa, Catalonia
About this study
Official title: Renewing Health RCT in Catalonia for the Evaluation of Home Telehealth Follow-up After Hospital Discharge for COPD Patients
The purpose of this study is to assess the effects of a complex telemedicine intervention as a part of an integrated care program for patients with chronic obstructive pulmonary disease (COPD) discharged from the hospital after disease exacerbation. Will be evaluated whether the intervention produces benefits in terms of mortality, reduction in hospital readmissions and health-related quality of life. In addition, the trial evaluates the economical and organizational impact of the new service and examines its acceptability by patients and health professionals.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Home telehealth
- 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.
Home telehealthProcedure or surgery
Patients receive tailored intervention according to their clinical complexity.
All patients in the intervention group receive:
- Personalised care plan
- Education on self-management
- Access to a personalized online health folder
- Access to Call center
- Access to primary care and hospital specialists; follow-up visits for evaluation of clinical recovery and care plan adjustments (if needed).
Patients with LOW complexity additionally receive:
- Daily videoconferences for the 1st week after discharge
- Remote monitoring for respiratory parameters. Sensors are selected on an individual basis by the medical specialists.
Patients with HIGH complexity additionally receive:
- Videoconferences for at least 1 month after discharge, scheduled on an individual basis.
- Remote monitoring for respiratory parameters.
- One monthly phone call from the call centre to promote and assess patient self-management.
| Study group | Role | What they receive |
|---|---|---|
| Home telehealth | Experimental | Not described Receives: Procedure: Home telehealth |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospital readmissions
Measured: 3 months period
Secondary outcomes (9)
Health related quality of life of the patients as measured by the SF-36 v2 questionnaire
Measured: 3 months - at baseline and study end
Hospital anxiety and depression scale HADS
Measured: 3 months - at baseline and study end
Lung condition as measured by FEV1
Measured: 3 months - at baseline and study end
Condition-related health status measured by COPD Assessment Test (CAT)
Measured: 3 months - at baseline and study end
Mortality
Measured: 3 months period
Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
Measured: at the 3rd month of the telehealth intervention
Time in days to first readmission
Measured: 3 months period
Length of stay in days for each readmission
Measured: 3 months period
Number of emergency room visits
Measured: at the 3rd month (end of trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catalan Agency for Health Information, Assessment and Quality
- Sponsor type
- Other government
- Collaborators
- Fundació TicSalut, Hospital Clinic of Barcelona, Hospital de Mataró
- Responsible party
- Sponsor
- Investigators
- Josep Roca Torrent, MD, Principal investigator, Pulmonary Department - Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512992
- Sponsor's protocol ID
- RH_pilotCAT
- Other IDs
- EC Grant Agreement 250487
- Status last verified
- Sep 2013
- First submitted
- 16 Jan 2012
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Casas 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 16620167Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE. Home telehealth for chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Telemed Telecare. 2010;16(3):120-7. doi: 10.1258/jtt.2009.090812. Epub 2010 Mar 2.
PubMed 20197355
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renewing Health RCT in Catalonia for the Evaluation of Home Telehealth Follow-up After Hospital Discharge for COPD Patients
- ClinicalTrials.gov ID
- NCT01512992
- Acronym / sponsor ID
- RH_pilotCAT
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Catalan Agency for Health Information, Assessment and QualityOther government
- Collaborators
- Fundació TicSalut, Hospital Clinic of Barcelona, Hospital de Mataró
- Study start
- Apr 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 20 Jan 2012 (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 assess the effects of a complex telemedicine intervention as a part of an integrated care program for patients with chronic obstructive pulmonary disease (COPD) discharged from the hospital after disease exacerbation. Will be evaluated whether the intervention produces benefits in terms of mortality, reduction in hospital readmissions and health-related quality of life. In addition, the trial evaluates the economical and organizational impact of the new service and examines its acceptability by patients and health professionals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home telehealth | Experimental | Procedure: Home telehealth |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Exacerbation of COPD
- Age > 40 years
- Capability to use the devices provided
- Willing to participate
Key exclusion criteria (1 listed)
- Participation in a previous COPD home telehealth study
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 |
|---|---|---|
| Home telehealthPatients receive tailored intervention according to their clinical complexity. All patients in the intervention group receive: * Personalised care plan * Education on self-management * Access to a personalized online health folder * Access to Call center * Access to primary care and hospital specialists; follow-up visits for evaluation of clinical recovery and care plan adjustments (if needed). Patients with LOW complexity additionally receive: * Daily videoconferences for the 1st week after discharge * Remote monitoring for respiratory parameters. Sensors are selected on an individual basis by the medical specialists. Patients with HIGH complexity additionally receive: * Videoconferences for at least 1 month after discharge, scheduled on an individual basis. * Remote monitoring for respiratory parameters. * One monthly phone call from the call centre to promote and assess patient self-management. | Procedure or surgery | Home telehealth |
Primary outcome
Number of hospital readmissions
Time frame: 3 months period
9 secondary outcomes
Health related quality of life of the patients as measured by the SF-36 v2 questionnaire
Time frame: 3 months - at baseline and study end
Hospital anxiety and depression scale HADS
Time frame: 3 months - at baseline and study end
Lung condition as measured by FEV1
Time frame: 3 months - at baseline and study end
Condition-related health status measured by COPD Assessment Test (CAT)
Time frame: 3 months - at baseline and study end
Mortality
Time frame: 3 months period
Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
Time frame: at the 3rd month of the telehealth intervention
Time in days to first readmission
Time frame: 3 months period
Length of stay in days for each readmission
Time frame: 3 months period
Number of emergency room visits
Time frame: at the 3rd month (end of trial)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
- 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.
- Background: PubMed 20197355Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE. Home telehealth for chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Telemed Telecare. 2010;16(3):120-7. doi: 10.1258/jtt.2009.090812. Epub 2010 Mar 2.
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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.
Josep Roca Torrent, MD principal investigator
Pulmonary Department - Hospital Clinic of Barcelona
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home telehealth in people with Pulmonary Disease, Chronic Obstructive, run by Catalan Agency for Health Information, Assessment and Quality at 8 sites in Spain.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. 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?
Results are not available in the source record.
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?
Number of hospital readmissions (time frame: 3 months period). 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 NCT01512992, which also lists 3 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 5 Sep 2013.