ISe-santé, a Study Evaluating a Model for Implementing E-health in the Management of HIV Patients

NCT ID: NCT05025891

Last Updated: 2021-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-04
• Study Completion Date: 2023-03-01

Brief Summary

It is a randomized, controlled, open-label, parallel group study of 3 arms, among patients followed for chronic HIV infection at Cayenne hospital. The main objective of the study is to evaluate the effectiveness of follow-up of these patients by teleconsultation associated or not with health mediation.

Detailed Description

The COVID-19 pandemic crisis has strained health systems, and chronic disease monitoring has often been put on hold, without yet really measuring the resulting health impact. In this context, e-Health has benefited from considerable momentum to overcome the shortcomings that have arisen, to allow remote monitoring of patients infected with COVID 19, to protect patients and caregivers and avoid nosocomial infections. Telemedicine is all the more relevant in Guyana as there are issues of geographic isolation, lack of specialists and critical mass of health professionals. In French Guiana, faced with the arrival of teleconsultation tools, a fear of professionals is their applicability for the most vulnerable populations, not knowing how to read or speak French and having restricted access to digital technology. Moreover HIV infection is an ever stigmatizing infection affecting populations that are often extremely precarious, requiring specialist monitoring and lifelong treatment.

The study team propose to carry out a randomized, controlled, open-label, parallel group study of 3 arms, among patients followed for chronic HIV infection at Cayenne hospital : 1/ Control group with classic follow-up at Cayenne hospital. 2/Teleconsultation only group: patients referred to the remote monitoring platform without specific support. 3/Teleconsulation group + mediator: patients referred to the remote monitoring platform with support from a health mediator Patients will be followed every 3 months or 6 months depending on the judgment of the investigating physician for 12 months in the study (primary endpoint evaluated at 1 year). Number of patients to be included: 450 patients.

Conditions

HIV; Telemedicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Arm 1: control

Patients continue consultations as usual in HDJA or at UMIT.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm 2: teleconsultation alone

Patients are directed to the tele-monitoring platform without specific accompaniment.

Group Type: EXPERIMENTAL

Teleconsultation

Intervention Type: OTHER

Patients are randomized into groups in which there are either teleconsultations alone or with the help of a mediator to carry out their follow-up care

Arm 3: teleconsultation and mediation

Patients are referred to the tele-monitoring platform with specific support with mediation.

Group Type: EXPERIMENTAL

Teleconsultation

Intervention Type: OTHER

Patients are randomized into groups in which there are either teleconsultations alone or with the help of a mediator to carry out their follow-up care

Interventions

Teleconsultation

Patients are randomized into groups in which there are either teleconsultations alone or with the help of a mediator to carry out their follow-up care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with chronic HIV infection.
• Patient with a regular follow-up for more than three months in the adult day hospital or in the infectious diseases department of the Cayenne Hospital Center.
• Patient of legal age.
• Patient having signed the consent form..

Exclusion Criteria

• Pregnant patient
• Patient with a severe neurological or psychiatric history (significant cognitive disorders, intellectual disability).
• Patient with a physical disability that prevents communication via the e-Health platform (mute patient, visually and hearing impaired, specific manual motor disability, bedridden patient).
• Patient who does not master one of the languages available at the mediation.
• Patients under guardianship or trusteeship, people under protective measures

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier de Cayenne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

General Hospital of Cayenne

Cayenne, , French Guiana

Site Status: RECRUITING

Countries

French Guiana

Central Contacts

LUCARELLI Aude, Dr

Role: CONTACT

aude.lucarelli@ch-cayenne.fr

0594395541

BOUTROU Mathilde, Dr

Role: CONTACT

mathilde.buotrou@ch-cayenne.fr

Facility Contacts

Mathieu Nacher, Pr

Role: primary

mathieu.nacher@ch-cayenne.fr

0594395385

Other Identifiers

ISe-SANTE

Identifier Type: -

Identifier Source: org_study_id