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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
Sponsor:
Collaborators:
Fundació TicSalut
Hospital Clinic of Barcelona
Hospital de Mataró
Information provided by (Responsible Party):
Catalan Agency for Health Information, Assessment and Quality

Tracking Information
First Submitted Date  ICMJE January 16, 2012
First Posted Date  ICMJE January 20, 2012
Last Update Posted Date September 5, 2013
Study Start Date  ICMJE April 2012
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2012)
Number of hospital readmissions [ Time Frame: 3 months period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01512992 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2012)
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Home Telehealth Follow-up After Hospital Discharge for Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title  ICMJE Renewing Health RCT in Catalonia for the Evaluation of Home Telehealth Follow-up After Hospital Discharge for COPD Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Home telehealth
    Intervention: Procedure: Home telehealth
  • No Intervention: Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 19, 2012)
380
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01512992
Other Study ID Numbers  ICMJE RH_pilotCAT
EC Grant Agreement 250487 ( Other Grant/Funding Number: European Comission, Information Society and Media DG )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Catalan Agency for Health Information, Assessment and Quality
Study Sponsor  ICMJE Catalan Agency for Health Information, Assessment and Quality
Collaborators  ICMJE
  • Fundació TicSalut
  • Hospital Clinic of Barcelona
  • Hospital de Mataró
Investigators  ICMJE
Principal Investigator: Josep Roca Torrent, MD Pulmonary Department - Hospital Clinic of Barcelona
PRS Account Catalan Agency for Health Information, Assessment and Quality
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP