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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)

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ClinicalTrials.gov Identifier: NCT02904733
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : December 15, 2017
Sponsor:
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
Information provided by (Responsible Party):
Agathe LEON, Fundacion Clinic per a la Recerca Biomédica

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.


Condition or disease Intervention/treatment Phase
HIV Infections Other: mHealth platform Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3900 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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)
Actual Study Start Date : April 7, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 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.
Other: mHealth platform
Use of a mHealth platform to inform and empower patient of hies/her own health




Primary Outcome Measures :
  1. Changes in Patient Activation Measure (PAM-13) questionnaire from baseline [ Time Frame: months 12 and 24 ]

Secondary Outcome Measures :
  1. Changes in Satisfaction System Usability Scale (SUS) [ Time Frame: months 12 and 24 ]
  2. Maintenance of virological suppression (HIV-1 RNA <50 c/ml) [ Time Frame: months 12 and 24 ]
  3. Change in CD4 count [ Time Frame: months 12 and 24 ]
  4. Change in blood lipid profile [ Time Frame: months 12 and 24 ]
  5. Changes in Quality of life (EQ-5D-5L questionnaire) from baseline [ Time Frame: months 12 and 24 ]
  6. Changes in Quality of life (PROQOL-HIV questionnaire) from baseline [ Time Frame: months 12 and 24 ]
  7. Changes in adherence quantified by Morisky-Green questionnaire [ Time Frame: months 12 and 24 ]
  8. Percentage of patients with changes in ART from baseline [ Time Frame: months 12 and 24 ]
  9. Changes on self-reported economic questionnaire aspects from baseline [ Time Frame: months 12 and 24 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02904733


Contacts
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Contact: Jennifer Whetham, MD +44 1273 523081 Jennifer.Whetham@bsuh.nhs.uk
Contact: Agathe León, MD +34932275400 ext 2447 aleon@clinic.ub.es

Locations
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Belgium
Prins Leopold Instituut Voor Tropische Geneeskunde Recruiting
Antwerp, Belgium, 2000
Contact: Ludgiw Aspers, MD         
Croatia
Klinika za Infektivne Bolesti Dr. Fran Mihaljevic Recruiting
Zagreb, Croatia, 10000
Contact: Josip Begovac, MD         
Portugal
Centro Hospitalar de Lisboa Central Recruiting
Lisboa, Portugal, 1169 097
Contact: Eugenio Teofilo, MD         
Spain
Hospital Clínic i Provincial Recruiting
Barcelona, Spain, 08036
Contact: Agathe Leon, MD    34.93.227.54.00      
Contact: Eva González, MD    34.93.227.54.00      
United Kingdom
University of Brighton Recruiting
Brighton, United Kingdom, BN2 4AT
Contact: Jennifer Whetham, MD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
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

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Responsible Party: Agathe LEON, Dr, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT02904733     History of Changes
Other Study ID Numbers: EMERGE
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases