NCT01117675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
Last Updated

May 5, 2010

Status Verified

April 1, 2010

Enrollment Period

2.9 years

First QC Date

May 3, 2010

Last Update Submit

May 4, 2010

Conditions

Keywords

TelemedicineHome careChronic HIV infectionHIV-infected patients

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Arm I

OTHER

Arm I: HIV-infected patients controlled through Virtual Hospital

Other: Virtual Hospital

Arm II

OTHER

Arm II: HIV-infected patients controlled through Standard Care

Other: Standard of Care

Interventions

A new home care model using a telemedicine system (Virtual Hospital) to care chronic HIV-infected patients

Arm I

Standard of Care

Arm II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having access to a computer and to a broadband

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agata Leon

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (2)

  • 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.

    BACKGROUND
  • 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.

MeSH Terms

Conditions

HIV Infections

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2010

First Posted

May 5, 2010

Study Start

January 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

May 5, 2010

Record last verified: 2010-04

Locations