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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Fundació TicSalut
Hospital Clinic of Barcelona
Hospital de Mataró
Information provided by (Responsible Party):
Catalan Agency for Health Information, Assessment and Quality
ClinicalTrials.gov Identifier:
NCT01512992
First received: January 16, 2012
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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 Intervention
Pulmonary Disease, Chronic Obstructive
Procedure: Home telehealth

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Catalan Agency for Health Information, Assessment and Quality:

Primary Outcome Measures:
  • Number of hospital readmissions [ Time Frame: 3 months period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Hospital anxiety and depression scale HADS [ Time Frame: 3 months - at baseline and study end ] [ Designated as safety issue: No ]
  • Lung condition as measured by FEV1 [ Time Frame: 3 months - at baseline and study end ] [ Designated as safety issue: No ]
  • Condition-related health status measured by COPD Assessment Test (CAT) [ Time Frame: 3 months - at baseline and study end ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 3 months period ] [ Designated as safety issue: No ]
  • Patients' Acceptance-Satisfaction measured by the WSD Questionnaire [ Time Frame: at the 3rd month of the telehealth intervention ] [ Designated as safety issue: No ]
  • Time in days to first readmission [ Time Frame: 3 months period ] [ Designated as safety issue: No ]
  • Length of stay in days for each readmission [ Time Frame: 3 months period ] [ Designated as safety issue: No ]
  • Number of emergency room visits [ Time Frame: at the 3rd month (end of trial) ] [ Designated as safety issue: No ]

Estimated Enrollment: 380
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512992

Locations
Spain
Hospital Germans Trias i Pujol
Badalona, Catalonia, Spain
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain
Hospital Plató
Barcelona, Catalonia, Spain
Capio Hospital Universitari Sagrat Cor
Barcelona, Catalonia, Spain
Hospital del Mar
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
Investigators
Principal Investigator: Josep Roca Torrent, MD Pulmonary Department - Hospital Clinic of Barcelona
  More Information

Publications:
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
Study First Received: January 16, 2012
Last Updated: September 4, 2013
Health Authority: Spain: Ethics Committee

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

ClinicalTrials.gov processed this record on September 16, 2014