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

Renewing Health RCT in Catalonia for the Evaluation of Home Telehealth Follow-up After Hospital Discharge for COPD Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01512992
Enrollment
380
Registered
2012-01-20
Start date
2012-04-30
Completion date
2013-12-31
Last updated
2013-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

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.

Interventions

PROCEDUREHome 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.

Sponsors

Fundació TicSalut
CollaboratorOTHER
Hospital Clinic of Barcelona
CollaboratorOTHER
Hospital de Mataró
CollaboratorOTHER
Catalan Agency for Health Information, Assessment and Quality
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Number of hospital readmissions3 months period

Secondary

MeasureTime frame
Hospital anxiety and depression scale HADS3 months - at baseline and study end
Lung condition as measured by FEV13 months - at baseline and study end
Condition-related health status measured by COPD Assessment Test (CAT)3 months - at baseline and study end
Mortality3 months period
Health related quality of life of the patients as measured by the SF-36 v2 questionnaire3 months - at baseline and study end
Time in days to first readmission3 months period
Length of stay in days for each readmission3 months period
Number of emergency room visitsat the 3rd month (end of trial)
Patients' Acceptance-Satisfaction measured by the WSD Questionnaireat the 3rd month of the telehealth intervention

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026