Clinical trial NCT01117675: A New Telemedicine Approach for Chronic HIV/AIDS Patient Home Care
Official title: A New Telemedicine Approach for Chronic HIV/AIDS Patient Home Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Keywords: Telemedicine
Home care
Chronic HIV infection
HIV-infected patients
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Bioengineering and Telemedicine Unit.Universidad Politécnica de Madrid
First posted: 2010-05-05
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Clinical evaluation of patients cared through Virtual Hospital
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Agata Leon
Study officials:
References:
citation: 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.
citation: 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.