Clinical trial NCT02904733: Validation Study of mHealth Technology in HIV to Improve Empowerment and Healthcare Utilisation: Research and Innovation to Generate Evidence for Personalised Care (EmERGE)
Official title: Validation Study of mHealth Technology in HIV to Improve Empowerment and Healthcare Utilisation: Research and Innovation to Generate Evidence for Personalised Care (EmERGE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Brighton and Sussex University Hospitals NHS Trust
name: Instituut Voor Tropische Geneeskunde (ITM), Antwerp, Belgium.
name: Klinika za infektivne bolesti (KIB), Zagreb, Croatia
name: Centro Hospitalar de Lisboa Central
name: Fundacion Clinic per a la Recerca Biomédica
name: University of Brighton
name: Podmedics, ( POD), Northwood, United Kingdom
name: Universidad Politecnica de Madrid
name: National Prospective Monitoring System HIV Health-economics Collaboration, (NPMS), Richmond, United Kingdom
name: European Aids Treatment Group (EATG), Brussels, Belgium
name: mHealth Futures LTD, Brighton, United Kingdom
First posted: 2016-09-19
Enrollment: 3900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A large (3900 patients) cohort study, undertaken in five European sites to validate in a mHealth platform to enable self-management of HIV in patients with stable disease using a tailored HTA process, Model for Assessment of Telemedicine Applications (MAST), specifically developed for the assessment of mHealth solutions.

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: Number of Study Centres: 5 Duration of Study: 35 Months Criteria for Evaluation: Usability of the mHealth platform, patient self-management and empowerment, clinical safety (virological suppression maintenance, CD4 count, laboratory parameters, adverse events and adherence), quality of life and self-economy will be assessed by questionnaires and laboratory parameters.

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.

Eligibility criteria: Inclusion Criteria:

1. Documented HIV-1 infection
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:

1. Aged less than 18 years
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.

Primary outcomes:
measure: Changes in Patient Activation Measure (PAM-13) questionnaire from baseline
timeFrame: months 12 and 24
Secondary outcomes:
measure: Changes in Satisfaction System Usability Scale (SUS)
timeFrame: months 12 and 24
measure: Maintenance of virological suppression (HIV-1 RNA <50 c/ml)
timeFrame: months 12 and 24
measure: Change in CD4 count
timeFrame: months 12 and 24
measure: Change in blood lipid profile
timeFrame: months 12 and 24
measure: Changes in Quality of life (EQ-5D-5L questionnaire) from baseline
timeFrame: months 12 and 24
measure: Changes in Quality of life (PROQOL-HIV questionnaire) from baseline
timeFrame: months 12 and 24
measure: Changes in adherence quantified by Morisky-Green questionnaire
timeFrame: months 12 and 24
measure: Percentage of patients with changes in ART from baseline
timeFrame: months 12 and 24
measure: Changes on self-reported economic questionnaire aspects from baseline
timeFrame: months 12 and 24
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Prins Leopold Instituut Voor Tropische Geneeskunde
city: Zagreb
country: Croatia
facility: Klinika za Infektivne Bolesti Dr. Fran Mihaljevic
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Central
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial
city: Brighton
country: United Kingdom
facility: University of Brighton
Study officials:
References: