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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Procedure: Home telehealth


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home telehealth<br> | Procedure: Home telehealth<br>* 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.<br>|
| No Intervention: Usual care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospital readmissions |  | 3 months period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life of the patients as measured by the SF-36 v2 questionnaire |  | 3 months - at baseline and study end | 
| Hospital anxiety and depression scale HADS |  | 3 months - at baseline and study end | 
| Lung condition as measured by FEV1 |  | 3 months - at baseline and study end | 
| Condition-related health status measured by COPD Assessment Test (CAT) |  | 3 months - at baseline and study end | 
| Mortality |  | 3 months period | 
| Patients' Acceptance-Satisfaction measured by the WSD Questionnaire |  | at the 3rd month of the telehealth intervention | 
| Time in days to first readmission |  | 3 months period | 
| Length of stay in days for each readmission |  | 3 months period | 
| Number of emergency room visits |  | at the 3rd month (end of trial) |