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

Primary Purpose

HIV Infections

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

mHealth platform

About this trial

This is an interventional health services research trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Documented HIV-1 infection
Aged at least 18 years old
Able to give informed consent
In possession of a smartphone, tablet, or similar technology supporting the mHealth platform
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.
Clinically stable from an HIV perspective: Defined as without opportunistic infection or AIDS related cancers within the previous 12 months

Exclusion Criteria:

Aged less than 18 years
Pregnant
Participating in a clinical trial or receiving an investigational medication
Unable to comprehend the patient information sheet
Unable to comprehend the instructions for using the mHealth platform
Considered for any other reason by their regular physician to be unsuitable for study participation.

Sites / Locations

Prins Leopold Instituut Voor Tropische GeneeskundeRecruiting
Klinika za Infektivne Bolesti Dr. Fran MihaljevicRecruiting
Centro Hospitalar de Lisboa CentralRecruiting
Hospital Clínic i ProvincialRecruiting
University of BrightonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mHealth platform

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes in Patient Activation Measure (PAM-13) questionnaire from baseline

Secondary Outcome Measures

Changes in Satisfaction System Usability Scale (SUS)

Maintenance of virological suppression (HIV-1 RNA <50 c/ml)

Change in CD4 count

Change in blood lipid profile

Changes in Quality of life (EQ-5D-5L questionnaire) from baseline

Changes in Quality of life (PROQOL-HIV questionnaire) from baseline

Changes in adherence quantified by Morisky-Green questionnaire

Percentage of patients with changes in ART from baseline

Changes on self-reported economic questionnaire aspects from baseline

Full Information

NCT ID

NCT02904733

First Posted

July 7, 2016

Last Updated

December 14, 2017

Sponsor

Hospital Clinic of Barcelona

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02904733

Brief Title

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

Acronym

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

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 7, 2017 (Actual)

Primary Completion Date

September 2019 (Anticipated)

Study Completion Date

September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Clinic of Barcelona

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mHealth platform

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

mHealth platform

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in Patient Activation Measure (PAM-13) questionnaire from baseline

Time Frame

months 12 and 24

Secondary Outcome Measure Information:

Title

Changes in Satisfaction System Usability Scale (SUS)

Time Frame

months 12 and 24

Title

Maintenance of virological suppression (HIV-1 RNA <50 c/ml)

Time Frame

months 12 and 24

Title

Change in CD4 count

Time Frame

months 12 and 24

Title

Change in blood lipid profile

Time Frame

months 12 and 24

Title

Changes in Quality of life (EQ-5D-5L questionnaire) from baseline

Time Frame

months 12 and 24

Title

Changes in Quality of life (PROQOL-HIV questionnaire) from baseline

Time Frame

months 12 and 24

Title

Changes in adherence quantified by Morisky-Green questionnaire

Time Frame

months 12 and 24

Title

Percentage of patients with changes in ART from baseline

Time Frame

months 12 and 24

Title

Changes on self-reported economic questionnaire aspects from baseline

Time Frame

months 12 and 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Documented HIV-1 infection Aged at least 18 years old Able to give informed consent In possession of a smartphone, tablet, or similar technology supporting the mHealth platform 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. Clinically stable from an HIV perspective: Defined as without opportunistic infection or AIDS related cancers within the previous 12 months Exclusion Criteria: Aged less than 18 years Pregnant Participating in a clinical trial or receiving an investigational medication Unable to comprehend the patient information sheet Unable to comprehend the instructions for using the mHealth platform Considered for any other reason by their regular physician to be unsuitable for study participation.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jennifer Whetham, MD

Phone

+44 1273 523081

Jennifer.Whetham@bsuh.nhs.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Agathe León, MD

Phone

+34932275400

Ext

2447

aleon@clinic.ub.es

Facility Information:

Facility Name

Prins Leopold Instituut Voor Tropische Geneeskunde

City

Antwerp

ZIP/Postal Code

2000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ludgiw Aspers, MD

Facility Name

Klinika za Infektivne Bolesti Dr. Fran Mihaljevic

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Josip Begovac, MD

Facility Name

Centro Hospitalar de Lisboa Central

City

Lisboa

ZIP/Postal Code

1169 097

Country

Portugal

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eugenio Teofilo, MD

Facility Name

Hospital Clínic i Provincial

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Agathe Leon, MD

Phone

34.93.227.54.00

First Name & Middle Initial & Last Name & Degree

Eva González, MD

Phone

34.93.227.54.00

Facility Name

University of Brighton

City

Brighton

ZIP/Postal Code

BN2 4AT

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer Whetham, MD

12. IPD Sharing Statement

Learn more about this trial

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

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