search
Back to results

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

Primary Purpose

HIV Infection

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Virtual Hospital
Standard of Care
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV Infection focused on measuring Telemedicine, Home care, Chronic HIV infection, HIV-infected patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Agata Leon

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Arm I

Arm II

Arm Description

Arm I: HIV-infected patients controlled through Virtual Hospital

Arm II: HIV-infected patients controlled through Standard Care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 3, 2010
Last Updated
May 4, 2010
Sponsor
Hospital Clinic of Barcelona
Collaborators
Bioengineering and Telemedicine Unit.Universidad Politécnica de Madrid
search

1. Study Identification

Unique Protocol Identification Number
NCT01117675
Brief Title
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

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Bioengineering and Telemedicine Unit.Universidad Politécnica de Madrid

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
Telemedicine, Home care, Chronic HIV infection, HIV-infected patients

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Other
Arm Description
Arm I: HIV-infected patients controlled through Virtual Hospital
Arm Title
Arm II
Arm Type
Other
Arm Description
Arm II: HIV-infected patients controlled through Standard Care
Intervention Type
Other
Intervention Name(s)
Virtual Hospital
Intervention Description
A new home care model using a telemedicine system (Virtual Hospital) to care chronic HIV-infected patients
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care
Primary Outcome Measure Information:
Title
Clinical evaluation of patients cared through Virtual Hospital
Description
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.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Agata Leon
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
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.
Results Reference
background
PubMed Identifier
21283736
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs