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Home Telehealth Follow-up After Hospital Discharge for Chronic Obstructive Pulmonary Disease (COPD) Patients

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ClinicalTrials.gov Identifier: NCT01512992
Recruitment Status : Unknown
Verified September 2013 by Catalan Agency for Health Information, Assessment and Quality.
Recruitment status was:  Active, not recruiting
First Posted : January 20, 2012
Last Update Posted : September 5, 2013
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Procedure: Home telehealth

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Renewing Health RCT in Catalonia for the Evaluation of Home Telehealth Follow-up After Hospital Discharge for COPD Patients
Study Start Date : April 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Home telehealth Procedure: Home telehealth

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.
No Intervention: Usual care

Outcome Measures

Primary Outcome Measures :
  1. Number of hospital readmissions [ Time Frame: 3 months period ]

Secondary Outcome Measures :
  1. 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 ]
  2. Hospital anxiety and depression scale HADS [ Time Frame: 3 months - at baseline and study end ]
  3. Lung condition as measured by FEV1 [ Time Frame: 3 months - at baseline and study end ]
  4. Condition-related health status measured by COPD Assessment Test (CAT) [ Time Frame: 3 months - at baseline and study end ]
  5. Mortality [ Time Frame: 3 months period ]
  6. Patients' Acceptance-Satisfaction measured by the WSD Questionnaire [ Time Frame: at the 3rd month of the telehealth intervention ]
  7. Time in days to first readmission [ Time Frame: 3 months period ]
  8. Length of stay in days for each readmission [ Time Frame: 3 months period ]
  9. Number of emergency room visits [ Time Frame: at the 3rd month (end of trial) ]

Eligibility Criteria

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Exacerbation of COPD
  • Age > 40 years
  • Capability to use the devices provided
  • Willing to participate

Exclusion Criteria:

• Participation in a previous COPD home telehealth study

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512992

Hospital Germans Trias i Pujol
Badalona, Catalonia, Spain
Capio Hospital Universitari Sagrat Cor
Barcelona, Catalonia, Spain
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain
Hospital del Mar
Barcelona, Catalonia, Spain
Hospital Plató
Barcelona, Catalonia, Spain
Hospital de Mataró
Mataró, Catalonia, Spain
Hospital Parc Taulí
Sabadell, Catalonia, Spain
Consorci Sanitari de Terrassa
Terrassa, Catalonia, Spain
Sponsors and Collaborators
Catalan Agency for Health Information, Assessment and Quality
Fundació TicSalut
Hospital Clinic of Barcelona
Hospital de Mataró
Principal Investigator: Josep Roca Torrent, MD Pulmonary Department - Hospital Clinic of Barcelona
More Information

Responsible Party: Catalan Agency for Health Information, Assessment and Quality
ClinicalTrials.gov Identifier: NCT01512992     History of Changes
Other Study ID Numbers: RH_pilotCAT
EC Grant Agreement 250487 ( Other Grant/Funding Number: European Comission, Information Society and Media DG )
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes