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

Study Overview
=================
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.

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.

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

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Other: Virtual Hospital
* Other: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm I<br>Arm I: HIV-infected patients controlled through Virtual Hospital | Other: Virtual Hospital<br>* A new home care model using a telemedicine system (Virtual Hospital) to care chronic HIV-infected patients<br>|
| Other: Arm II<br>Arm II: HIV-infected patients controlled through Standard Care | Other: Standard of Care<br>* Standard of Care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation of patients cared through Virtual Hospital | 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. | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telemedicine, Home care, Chronic HIV infection, HIV-infected patients