HIV InfectionsEMERGENCT02904733
Validation Study of mHealth Technology in HIV to Improve Empowerment and Healthcare Utilisation: Research and Innovation to Generate Evidence for Personalised Care (EmERGE)
A study testing mHealth platform in people with HIV Infections, run by Hospital Clinic of Barcelona at 5 sites in 5 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- mHealth platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,900 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 7 Apr 2017to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Belgium1 site, 1 recruiting
- Recruiting
Prins Leopold Instituut Voor Tropische Geneeskunde
Antwerp, 2000
Ludgiw Aspers, MD
Croatia1 site, 1 recruiting
- Recruiting
Klinika za Infektivne Bolesti Dr. Fran Mihaljevic
Zagreb, 10000
Josip Begovac, MD
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar de Lisboa Central
Lisbon, 1169 097
Eugenio Teofilo, MD
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic i Provincial
Barcelona, 08036
Agathe Leon, MD, 34.93.227.54.00
Eva González, MD, 34.93.227.54.00
United Kingdom1 site, 1 recruiting
- Recruiting
University of Brighton
Brighton, BN2 4AT
Jennifer Whetham, MD
About this study
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- mHealth platform
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth platformOther
Use of a mHealth platform to inform and empower patient of hies/her own health
| Study group | Role | What they receive |
|---|---|---|
| mHealth platform | Experimental | 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. Receives: Other: mHealth platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Patient Activation Measure (PAM-13) questionnaire from baseline
Measured: months 12 and 24
Secondary outcomes (9)
Changes in Satisfaction System Usability Scale (SUS)
Measured: months 12 and 24
Maintenance of virological suppression (HIV-1 RNA <50 c/ml)
Measured: months 12 and 24
Change in CD4 count
Measured: months 12 and 24
Change in blood lipid profile
Measured: months 12 and 24
Changes in Quality of life (EQ-5D-5L questionnaire) from baseline
Measured: months 12 and 24
Changes in Quality of life (PROQOL-HIV questionnaire) from baseline
Measured: months 12 and 24
Changes in adherence quantified by Morisky-Green questionnaire
Measured: months 12 and 24
Percentage of patients with changes in ART from baseline
Measured: months 12 and 24
Changes on self-reported economic questionnaire aspects from baseline
Measured: months 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start7 Apr 2017
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Brighton and Sussex University Hospitals NHS Trust, Instituut voor Tropische Geneeskunde, 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
- Responsible party
- Principal investigator, Agathe LEON, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904733
- Sponsor's protocol ID
- EMERGE
- Acronym
- EMERGE
- Status last verified
- Dec 2017
- First submitted
- 7 Jul 2016
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02904733
- Acronym / sponsor ID
- EMERGE / EMERGE
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,900 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Brighton and Sussex University Hospitals NHS Trust, Instituut voor Tropische Geneeskunde, 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
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mHealth platform | Experimental | Other: mHealth platformStable 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth platformUse of a mHealth platform to inform and empower patient of hies/her own health | Other | mHealth platform |
Primary outcome
Changes in Patient Activation Measure (PAM-13) questionnaire from baseline
Time frame: months 12 and 24
9 secondary outcomes
Changes in Satisfaction System Usability Scale (SUS)
Time frame: months 12 and 24
Maintenance of virological suppression (HIV-1 RNA <50 c/ml)
Time frame: months 12 and 24
Change in CD4 count
Time frame: months 12 and 24
Change in blood lipid profile
Time frame: months 12 and 24
Changes in Quality of life (EQ-5D-5L questionnaire) from baseline
Time frame: months 12 and 24
Changes in Quality of life (PROQOL-HIV questionnaire) from baseline
Time frame: months 12 and 24
Changes in adherence quantified by Morisky-Green questionnaire
Time frame: months 12 and 24
Percentage of patients with changes in ART from baseline
Time frame: months 12 and 24
Changes on self-reported economic questionnaire aspects from baseline
Time frame: months 12 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth platform in people with HIV Infections, run by Hospital Clinic of Barcelona at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Croatia, Portugal, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Whetham, MD (+44 1273 523081, Jennifer.Whetham@bsuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Patient Activation Measure (PAM-13) questionnaire from baseline (time frame: months 12 and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2017.