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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117675
• Other study ID #: Hospital Clinic
• Secondary ID: Universidad Poli
• Status: Completed
• Phase: N/A
• First received: May 3, 2010
• Last updated: May 4, 2010
• Start date: January 2005
• Est. completion date: December 2007

Study information

• Verified date: April 2010
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

Other:
• Virtual Hospital
A new home care model using a telemedicine system (Virtual Hospital) to care chronic HIV-infected patients
• Standard of Care
Standard of Care

Locations

Country	Name	City	State
Spain	Agata Leon	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Bioengineering and Telemedicine Unit.Universidad Politécnica de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes