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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Home telehealth
Sponsored by
Catalan Agency for Health Information, Assessment and Quality
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Germans Trias i Pujol
  • Capio Hospital Universitari Sagrat Cor
  • Hospital Clinic de Barcelona
  • Hospital del Mar
  • Hospital Plató
  • Hospital de Mataró
  • Hospital Parc Taulí
  • Consorci Sanitari de Terrassa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Home telehealth

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Number of hospital readmissions

Secondary Outcome Measures

Health related quality of life of the patients as measured by the SF-36 v2 questionnaire
Hospital anxiety and depression scale HADS
Lung condition as measured by FEV1
Condition-related health status measured by COPD Assessment Test (CAT)
Mortality
Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
Time in days to first readmission
Length of stay in days for each readmission
Number of emergency room visits

Full Information

First Posted
January 16, 2012
Last Updated
September 4, 2013
Sponsor
Catalan Agency for Health Information, Assessment and Quality
Collaborators
Fundació TicSalut, Hospital Clinic of Barcelona, Hospital de Mataró
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1. Study Identification

Unique Protocol Identification Number
NCT01512992
Brief Title
Home Telehealth Follow-up After Hospital Discharge for Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
Renewing Health RCT in Catalonia for the Evaluation of Home Telehealth Follow-up After Hospital Discharge for COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catalan Agency for Health Information, Assessment and Quality
Collaborators
Fundació TicSalut, Hospital Clinic of Barcelona, Hospital de Mataró

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home telehealth
Arm Type
Experimental
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Home telehealth
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of hospital readmissions
Time Frame
3 months period
Secondary Outcome Measure Information:
Title
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
Title
Hospital anxiety and depression scale HADS
Time Frame
3 months - at baseline and study end
Title
Lung condition as measured by FEV1
Time Frame
3 months - at baseline and study end
Title
Condition-related health status measured by COPD Assessment Test (CAT)
Time Frame
3 months - at baseline and study end
Title
Mortality
Time Frame
3 months period
Title
Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
Time Frame
at the 3rd month of the telehealth intervention
Title
Time in days to first readmission
Time Frame
3 months period
Title
Length of stay in days for each readmission
Time Frame
3 months period
Title
Number of emergency room visits
Time Frame
at the 3rd month (end of trial)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Roca Torrent, MD
Organizational Affiliation
Pulmonary Department - Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Catalonia
Country
Spain
Facility Name
Capio Hospital Universitari Sagrat Cor
City
Barcelona
State/Province
Catalonia
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
State/Province
Catalonia
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
State/Province
Catalonia
Country
Spain
Facility Name
Hospital Plató
City
Barcelona
State/Province
Catalonia
Country
Spain
Facility Name
Hospital de Mataró
City
Mataró
State/Province
Catalonia
Country
Spain
Facility Name
Hospital Parc Taulí
City
Sabadell
State/Province
Catalonia
Country
Spain
Facility Name
Consorci Sanitari de Terrassa
City
Terrassa
State/Province
Catalonia
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
16611656
Citation
Casas A, Troosters T, Garcia-Aymerich J, Roca J, Hernandez C, Alonso A, del Pozo F, de Toledo P, Anto JM, Rodriguez-Roisin R, Decramer M; members of the CHRONIC Project. Integrated care prevents hospitalisations for exacerbations in COPD patients. Eur Respir J. 2006 Jul;28(1):123-30. doi: 10.1183/09031936.06.00063205. Epub 2006 Apr 12.
Results Reference
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PubMed Identifier
16620167
Citation
Finkelstein SM, Speedie SM, Potthoff S. Home telehealth improves clinical outcomes at lower cost for home healthcare. Telemed J E Health. 2006 Apr;12(2):128-36. doi: 10.1089/tmj.2006.12.128.
Results Reference
background
PubMed Identifier
20197355
Citation
Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE. Home telehealth for chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Telemed Telecare. 2010;16(3):120-7. doi: 10.1258/jtt.2009.090812. Epub 2010 Mar 2.
Results Reference
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Home Telehealth Follow-up After Hospital Discharge for Chronic Obstructive Pulmonary Disease (COPD) Patients

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