An interventional study of mHealth platform in HIV Infections, sponsored by Hospital Clinic of Barcelona. Status unknown at 5 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-15.
Sponsored by Hospital Clinic of Barcelona · Not applicable, Interventional, and Health services research
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.
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.
4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 3,900 is above the median of 83 across 3,312 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Hospital Clinic of Barcelona is the lead sponsor of 326 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Changes in Patient Activation Measure (PAM-13) questionnaire from baseline
Time frame: months 12 and 24
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
Started Apr 2017 (actual). Primary completion is estimated for Sep 2019, 29 months after the start.
Of 549 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's planned 29 months is close to that.
Counting every sponsor, half of 559 studies reached it within 28 months; a quarter within 16 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Clinic of Barcelona →