Validation Study of mHealth Technology in HIV to Improve Empowerment and Healthcare Utilisation: Research and Innovation to Generate Evidence for Personalised Care (EmERGE)

HIV Infections Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02904733
• Other study ID #: EMERGE
• Status: Recruiting
• Phase: N/A
• First received: July 7, 2016
• Last updated: December 14, 2017
• Start date: April 7, 2017
• Est. completion date: September 2019

Study information

• Verified date: December 2017
• Source: Hospital Clinic of Barcelona
• Contact: Jennifer Whetham, MD
• Phone: +44 1273 523081
• Email: Jennifer.Whetham[@]bsuh.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3900
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Other:
• mHealth platform
Use of a mHealth platform to inform and empower patient of hies/her own health

Locations

Country	Name	City	State
Belgium	Prins Leopold Instituut Voor Tropische Geneeskunde	Antwerp
Croatia	Klinika za Infektivne Bolesti Dr. Fran Mihaljevic	Zagreb
Portugal	Centro Hospitalar de Lisboa Central	Lisboa
Spain	Hospital Clínic i Provincial	Barcelona
United Kingdom	University of Brighton	Brighton

Sponsors (12)

Lead Sponsor

Collaborator

Hospital Clinic of Barcelona

Brighton and Sussex University Hospitals NHS Trust, Centro Hospitalar de Lisboa Central, European Aids Treatment Group (EATG), Brussels, Belgium, Fundacion Clinic per a la Recerca Biomédica, Instituut Voor Tropische Geneeskunde (ITM), Antwerp, Belgium., Klinika za infektivne bolesti (KIB), Zagreb, Croatia, mHealth Futures LTD, Brighton, United Kingdom, National Prospective Monitoring System HIV Health-economics Collaboration, (NPMS), Richmond, United Kingdom, Podmedics, ( POD), Northwood, United Kingdom, Universidad Politecnica de Madrid, University of Brighton

Countries where clinical trial is conducted

Belgium,  Croatia,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Patient Activation Measure (PAM-13) questionnaire from baseline		months 12 and 24
Secondary	Changes in Satisfaction System Usability Scale (SUS)		months 12 and 24
Secondary	Maintenance of virological suppression (HIV-1 RNA <50 c/ml)		months 12 and 24
Secondary	Change in CD4 count		months 12 and 24
Secondary	Change in blood lipid profile		months 12 and 24
Secondary	Changes in Quality of life (EQ-5D-5L questionnaire) from baseline		months 12 and 24
Secondary	Changes in Quality of life (PROQOL-HIV questionnaire) from baseline		months 12 and 24
Secondary	Changes in adherence quantified by Morisky-Green questionnaire		months 12 and 24
Secondary	Percentage of patients with changes in ART from baseline		months 12 and 24
Secondary	Changes on self-reported economic questionnaire aspects from baseline		months 12 and 24