Validation Study of mHealth Technology in HIV to Improve Empowerment and Healthcare Utilisation: Research and Innovation to Generate Evidence for Personalised Care (EmERGE)
NCT ID: NCT02904733
Last Updated: 2017-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
3900 participants
INTERVENTIONAL
2017-04-07
2019-09-30
Brief Summary
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As site recruitment will be sequential and the recruitment period will last 18 months, a maximum follow-up of 35 Months will be undertaken. Study visits will take place at baseline defined as the time of mHealth introduction, months 6, 12, 18, 24 and 30.
Detailed Description
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Routine data on patient demographics, treatment and investigations which will include viral load, CD4, haematology, biochemistry and urine sample. Patient Activation Measure, Quality of life, adherence questionnaire and economic questionnaires will be performed at baseline and at months 12 and 24. Satisfaction System Usability Scale will be evaluated at month 12 and 24.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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mHealth platform
Stable HIV-1 infected subjects will be followed-up using an mHealth platform. The platform will provide users with web based and mobile device applications which interface securely with relevant medical data and facilitate remote access to healthcare providers. The minimum length of follow-up will be 12 months and the maximum 35 months.
mHealth platform
Use of a mHealth platform to inform and empower patient of hies/her own health
Interventions
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mHealth platform
Use of a mHealth platform to inform and empower patient of hies/her own health
Eligibility Criteria
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Inclusion Criteria
2. Aged at least 18 years old
3. Able to give informed consent
4. In possession of a smartphone, tablet, or similar technology supporting the mHealth platform
5. Stable on ART: Defined as ART should be unchanged for at least 3 months and viral load undetectable (\<50 copies/ml) for at least 6 months.
6. Clinically stable from an HIV perspective: Defined as without opportunistic infection or AIDS related cancers within the previous 12 months
Exclusion Criteria
2. Pregnant
3. Participating in a clinical trial or receiving an investigational medication
4. Unable to comprehend the patient information sheet
5. Unable to comprehend the instructions for using the mHealth platform
6. Considered for any other reason by their regular physician to be unsuitable for study participation.
18 Years
ALL
No
Sponsors
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Brighton and Sussex University Hospitals NHS Trust
OTHER
Instituut Voor Tropische Geneeskunde (ITM), Antwerp, Belgium.
UNKNOWN
Klinika za infektivne bolesti (KIB), Zagreb, Croatia
UNKNOWN
Centro Hospitalar de Lisboa Central
OTHER
Fundacion Clinic per a la Recerca Biomédica
OTHER
University of Brighton
OTHER
Podmedics, ( POD), Northwood, United Kingdom
UNKNOWN
Universidad Politecnica de Madrid
OTHER
National Prospective Monitoring System HIV Health-economics Collaboration, (NPMS), Richmond, United Kingdom
UNKNOWN
European Aids Treatment Group (EATG), Brussels, Belgium
UNKNOWN
mHealth Futures LTD, Brighton, United Kingdom
UNKNOWN
Hospital Clinic of Barcelona
OTHER
Responsible Party
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Agathe LEON
Dr
Locations
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Prins Leopold Instituut Voor Tropische Geneeskunde
Antwerp, , Belgium
Klinika za Infektivne Bolesti Dr. Fran Mihaljevic
Zagreb, , Croatia
Centro Hospitalar de Lisboa Central
Lisbon, , Portugal
Hospital Clínic i Provincial
Barcelona, , Spain
University of Brighton
Brighton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Ludgiw Aspers, MD
Role: primary
Josip Begovac, MD
Role: primary
Eugenio Teofilo, MD
Role: primary
Agathe Leon, MD
Role: primary
Eva González, MD
Role: backup
Jennifer Whetham, MD
Role: primary
Other Identifiers
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EMERGE
Identifier Type: -
Identifier Source: org_study_id