A New Telemedicine Approach for Chronic HIV/AIDS Patient Home Care

NCT ID: NCT01117675

Last Updated: 2010-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-12-31

Brief Summary

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Background: Antiretroviral therapy has changed the natural history of the HIV infection in developed countries becoming a chronic disease. This clinical scenario would need a new approach to control patients, simplifying the follow-up visits and the accessibility to the healthcare professionals. A new home care model using a telemedicine system (Virtual Hospital) was developed.

Detailed Description

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Stable HIV-infected patients with access to a computer and broadband were randomized to: arm I, patients monitored by Virtual Hospital the first year and arm II patients monitored in the hospital the first year (standard of care). After 1 year of follow up, patients were crossed into the other arm. A "Virtual Hospital" was developed to integrate the control of patient in a multidisciplinary telecare team, allowing the patient to be remotely followed-up by the healthcare professionals through Internet. Virtual Hospital had four main services: Virtual Consultations, Telepharmacy, Virtual Library and Virtual Community. A technical and a clinical evaluation of Virtual Hospital were made.

Conditions

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HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I

Arm I: HIV-infected patients controlled through Virtual Hospital

Group Type OTHER

Virtual Hospital

Intervention Type OTHER

A new home care model using a telemedicine system (Virtual Hospital) to care chronic HIV-infected patients

Arm II

Arm II: HIV-infected patients controlled through Standard Care

Group Type OTHER

Standard of Care

Intervention Type OTHER

Standard of Care

Interventions

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Virtual Hospital

A new home care model using a telemedicine system (Virtual Hospital) to care chronic HIV-infected patients

Intervention Type OTHER

Standard of Care

Standard of Care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Stable patients (CD4 \>250 cells/mm3 during at least the 3 months before inclusion to the study)
* Having access to a computer and to a broadband

Exclusion Criteria

* HIV infected adults with current therapy failure (defined by detectable viral load on treatment or CD4 cell count \< 250 cells/ml)
* Tumors
* Opportunistic infections
* Pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bioengineering and Telemedicine Unit.Universidad Politécnica de Madrid

UNKNOWN

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Hospital Clinic

Locations

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Agata Leon

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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Caceres C, et al. A telemedicine system for chronic HIV/AIDS patient home care through the Internet. Telemedicine and e-Health 2005; 11: 219-220. Caceres C, et al. A Home Integral Telecare System for HIV/AIDS Patients. Stud Health Technol Inform. 2005;114:23-9. Caceres C, et al. An integral care telemedicine system for HIV/AIDS patients. Int J Med Inform. 2006; 75:638-42.

Reference Type BACKGROUND

Leon A, Caceres C, Fernandez E, Chausa P, Martin M, Codina C, Rousaud A, Blanch J, Mallolas J, Martinez E, Blanco JL, Laguno M, Larrousse M, Milinkovic A, Zamora L, Canal N, Miro JM, Gatell JM, Gomez EJ, Garcia F. A new multidisciplinary home care telemedicine system to monitor stable chronic human immunodeficiency virus-infected patients: a randomized study. PLoS One. 2011 Jan 21;6(1):e14515. doi: 10.1371/journal.pone.0014515.

Reference Type DERIVED
PMID: 21283736 (View on PubMed)

Other Identifiers

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Universidad Politecnica Madrid

Identifier Type: -

Identifier Source: secondary_id

Hospital Clinic

Identifier Type: -

Identifier Source: org_study_id

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