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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01117675
Recruitment Status : Completed
First Posted : May 5, 2010
Last Update Posted : May 5, 2010
Bioengineering and Telemedicine Unit.Universidad Politécnica de Madrid
Information provided by:
Hospital Clinic of Barcelona

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infection Other: Virtual Hospital Other: Standard of Care Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A New Telemedicine Approach for Chronic HIV/AIDS Patient Home Care
Study Start Date : January 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Arm I
Arm I: HIV-infected patients controlled through Virtual Hospital
Other: Virtual Hospital
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
Other: Standard of Care
Standard of Care

Primary Outcome Measures :
  1. Clinical evaluation of patients cared through Virtual Hospital [ Time Frame: Two years ]
    The main goals were the definition, development, clinical routine installation and evaluation of a telemedicine service that compares standard care with telecare follow-up for attending stable HIV-infected patients in the chronic phase of their disease.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01117675

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Agata Leon
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Bioengineering and Telemedicine Unit.Universidad Politécnica de Madrid

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.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Agata Leon/Physician, Hospital Clinic Identifier: NCT01117675     History of Changes
Other Study ID Numbers: Hospital Clinic
Universidad Politecnica Madrid
First Posted: May 5, 2010    Key Record Dates
Last Update Posted: May 5, 2010
Last Verified: April 2010
Keywords provided by Hospital Clinic of Barcelona:
Home care
Chronic HIV infection
HIV-infected patients
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases