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

This study has been completed.
Sponsor:
Collaborator:
Bioengineering and Telemedicine Unit.Universidad Politécnica de Madrid
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01117675
First received: May 3, 2010
Last updated: May 4, 2010
Last verified: April 2010
  Purpose

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 Intervention
HIV Infection
Other: Virtual Hospital
Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A New Telemedicine Approach for Chronic HIV/AIDS Patient Home Care

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Clinical evaluation of patients cared through Virtual Hospital [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 83
Study Start Date: January 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117675

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

Publications:
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Agata Leon/Physician, Hospital Clinic
ClinicalTrials.gov Identifier: NCT01117675     History of Changes
Other Study ID Numbers: Hospital Clinic, Universidad Politecnica Madrid
Study First Received: May 3, 2010
Last Updated: May 4, 2010
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
Telemedicine
Home care
Chronic HIV infection
HIV-infected patients

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 23, 2014