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

September 4, 2013 updated by: Catalan Agency for Health Information, Assessment and Quality

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

380

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • Badalona, Catalonia, Spain
        • Hospital Germans Trias i Pujol
      • Barcelona, 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
      • Mataró, Catalonia, Spain
        • Hospital de Mataro
      • Sabadell, Catalonia, Spain
        • Hospital Parc Tauli
      • Terrassa, Catalonia, Spain
        • Consorci Sanitari de Terrassa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Usual care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of hospital readmissions
Time Frame: 3 months period
3 months period

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 months - at baseline and study end
Hospital anxiety and depression scale HADS
Time Frame: 3 months - at baseline and study end
3 months - at baseline and study end
Lung condition as measured by FEV1
Time Frame: 3 months - at baseline and study end
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
3 months - at baseline and study end
Mortality
Time Frame: 3 months period
3 months period
Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
Time Frame: at the 3rd month of the telehealth intervention
at the 3rd month of the telehealth intervention
Time in days to first readmission
Time Frame: 3 months period
3 months period
Length of stay in days for each readmission
Time Frame: 3 months period
3 months period
Number of emergency room visits
Time Frame: at the 3rd month (end of trial)
at the 3rd month (end of trial)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalan Agency for Health Information, Assessment and Quality

Collaborators

Hospital Clinic of Barcelona
Hospital de Mataró
Fundació TicSalut

Investigators

  • Principal Investigator: Josep Roca Torrent, MD, Pulmonary Department - Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ANTICIPATED)

October 1, 2013

Study Completion (ANTICIPATED)

December 1, 2013

Study Registration Dates

First Submitted

January 16, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (ESTIMATE)

January 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RH_pilotCAT
  • EC Grant Agreement 250487 (Other Grant/Funding Number: European Commission CIP/PSP-ICT Grant Agreement 250487)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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