A New Telemedicine Approach for Chronic HIV/AIDS Patient Home Care
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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 |
- 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 |
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 More Information
Publications:
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 June 17, 2013