Overview

This trial is active, not recruiting.

Condition pulmonary disease, chronic obstructive
Treatment home telehealth
Sponsor Catalan Agency for Health Information, Assessment and Quality
Collaborator Fundació TicSalut
Start date April 2012
End date October 2013
Trial size 380 participants
Trial identifier NCT01512992, EC Grant Agreement 250487, RH_pilotCAT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
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)

Primary Outcomes

Measure
Number of hospital readmissions
time frame: 3 months period

Secondary Outcomes

Measure
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)

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title Renewing Health RCT in Catalonia for the Evaluation of Home Telehealth Follow-up After Hospital Discharge for COPD Patients
Principal investigator Josep Roca Torrent, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Catalan Agency for Health Information, Assessment and Quality.