HypertensionInTakeCareNCT06229171
InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention
A study testing adherence support system based on a vocal assistant in people with Hypertension and Treatment Adherence and Compliance, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
Inadequate medication adherence (MA) in chronic conditions, including cardiovascular prevention, represents an important risk factor. The use of new IT technologies in this setting is supposed to be useful to improve patients' adherence, but currently available solutions have significant limitations, including lack of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Treatment Adherence and Compliance, Digital Health
- What is being tested?
- adherence support system based on a vocal assistant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult (>18 years old) patients
- History of essential hypertension
- Treatment with at least one antihypertensive drug for which dedicated plasma essay is available
- wireless internet connection available at patients' home
- stable clinical conditions
- written informed consent
Who cannot join
- insufficient technological literacy to manage vocal assistant
- dementia or significant psychiatric disorders
- conditions significantly limiting vocal communication (deafness, significant speech disorders, poor knowledge of Italian language)
- pregnancy or breastfeeding
- active cancer (except basal cell skin carcinoma)
- upper limb amputation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
San Luca Hospital, Istituto Auxologico Italiano IRCCS
Milan, 20149
Lucia Zanotti, +39 02 619112714, l.zanotti@auxologico.it
About this study
Inadequate medication adherence (MA) in chronic conditions, including cardiovascular prevention, represents an important risk factor. The use of new IT technologies in this setting is supposed to be useful to improve patients' adherence, but currently available solutions have significant limitations, including lack of personalization and reliance on expensive ad hoc systems.
This interdisciplinary project aims to verify the hypothesis that in patients on chronic antihypertensive treatment MA can be improved through the implementation of a novel digital health solution for MA monitoring and support, based on inexpensive and user-friendly, commercially available technology (voice assistant), connected with web interface for the physician. The intervention will be personalized based on the creation of Personas, intended as multidisciplinary-based representations of different user types. This approach will be tested in a randomized clinical trial.
- Being tested
- adherence support system based on a vocal assistant
- Keywords
- Personalized Medicine
- Medical subject headings
- Hypertension, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adherence support system based on a vocal assistantOther
Participants in the intervention group will receive a vocal assistant device and the instructions/support for the activation of the system at their homes. The device will remind the participant, at the times defined during set-up, which therapy should be taken and with what dosage. The participant will have 30 minutes from the first reminder to confirm vocally that the therapy has been taken, which will otherwise be considered as not having been taken.
Participants in the control group will receive verbal advice from the physician about the need to follow the treatment recommendations and simple indications on possible solutions to maintain adherence, as by the usual practice of the Centre.
| Study group | Role | What they receive |
|---|---|---|
| usual practice | No intervention | Not described |
| vocal assistant | Experimental | Not described Receives: Other: adherence support system based on a vocal assistant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence (plasma essay - 3m)
Percentage of adherent patients based on plasma essay at follow-up visit
Measured: after 3 months of randomized intervention
Secondary outcomes (9)
adherence (pill count - 3m)
percentage of adherent patients based on pill count adherence (AdhVA) at follow-up visit
Measured: after 3 months of randomized intervention
adherence (voice assistant - 3m)
percentage of adherent patients based on voice assistant adherence (AdhVA) at follow-up visit
Measured: after 3 months of randomized intervention
adherence (questionnaire - 3m)
percentage of adherent patients based on MARS-5I (Medication Adherence Report Scale-5 Italian version) at follow-up visit
Measured: after 3 months of randomized intervention
Adherence (plasma essay - 5m)
percentage of adherent patients based on plasma essay at final visit
Measured: after 5 months
adherence (pill count - 5m)
percentage of adherent patients based on pill count adherence (AdhVA) at final visit
Measured: after 5 months
adherence (voice assistant - 5m)
percentage of adherent patients based on voice assistant adherence (AdhVA) at final visit
Measured: after 5 months
adherence (questionnaire - 5m)
percentage of adherent patients based on MARS-5I at final visit
Measured: after 5 months
24h Systolic Blood Pressure (3m)
24-hour systolic blood pressure (ABPM) at follow-up visit
Measured: after 3 months of randomized intervention
24h Systolic Blood Pressure (5m)
24-hour systolic blood pressure (ABPM) at final visit
Measured: after 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Oct 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA, Politecnico di Milano
- Responsible party
- Sponsor
- Investigators
- Grzegorz Bilo, MD, PhD, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229171
- Sponsor's protocol ID
- 09M201
- Acronym
- InTakeCare
- Status last verified
- Aug 2025
- First submitted
- 19 Jan 2024
- Last updated
- 21 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention
- ClinicalTrials.gov ID
- NCT06229171
- Acronym / sponsor ID
- InTakeCare / 09M201
- Keywords
- Personalized Medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA, Politecnico di Milano
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 29 Jan 2024 (actual)
- 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.
Inadequate medication adherence (MA) in chronic conditions, including cardiovascular prevention, represents an important risk factor. The use of new IT technologies in this setting is supposed to be useful to improve patients' adherence, but currently available solutions have significant limitations, including lack of personalization and reliance on expensive ad hoc systems.
This interdisciplinary project aims to verify the hypothesis that in patients on chronic antihypertensive treatment MA can be improved through the implementation of a novel digital health solution for MA monitoring and support, based on inexpensive and user-friendly, commercially available technology (voice assistant), connected with web interface for the physician. The intervention will be personalized based on the creation of Personas, intended as multidisciplinary-based representations of different user types. This approach will be tested in a randomized clinical trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual practice | No intervention | – |
| vocal assistant | Experimental | Other: adherence support system based on a vocal assistant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult (>18 years old) patients
- History of essential hypertension
- Treatment with at least one antihypertensive drug for which dedicated plasma essay is available
- wireless internet connection available at patients' home
- stable clinical conditions
Key exclusion criteria (6 listed)
- insufficient technological literacy to manage vocal assistant
- dementia or significant psychiatric disorders
- conditions significantly limiting vocal communication (deafness, significant speech disorders, poor knowledge of Italian language)
- pregnancy or breastfeeding
- active cancer (except basal cell skin carcinoma)
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 |
|---|---|---|
| adherence support system based on a vocal assistantParticipants in the intervention group will receive a vocal assistant device and the instructions/support for the activation of the system at their homes. The device will remind the participant, at the times defined during set-up, which therapy should be taken and with what dosage. The participant will have 30 minutes from the first reminder to confirm vocally that the therapy has been taken, which will otherwise be considered as not having been taken. Participants in the control group will receive verbal advice from the physician about the need to follow the treatment recommendations and simple indications on possible solutions to maintain adherence, as by the usual practice of the Centre. | Other | vocal assistant |
Primary outcome
Adherence (plasma essay - 3m)
Time frame: after 3 months of randomized intervention
Percentage of adherent patients based on plasma essay at follow-up visit
9 secondary outcomes
adherence (pill count - 3m)
Time frame: after 3 months of randomized intervention
adherence (voice assistant - 3m)
Time frame: after 3 months of randomized intervention
adherence (questionnaire - 3m)
Time frame: after 3 months of randomized intervention
Adherence (plasma essay - 5m)
Time frame: after 5 months
adherence (pill count - 5m)
Time frame: after 5 months
adherence (voice assistant - 5m)
Time frame: after 5 months
adherence (questionnaire - 5m)
Time frame: after 5 months
24h Systolic Blood Pressure (3m)
Time frame: after 3 months of randomized intervention
24h Systolic Blood Pressure (5m)
Time frame: after 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Grzegorz Bilo, MD, PhD principal investigator
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adherence support system based on a vocal assistant in people with Hypertension and Treatment Adherence and Compliance, run by Istituto Auxologico Italiano at 1 site in Italy.
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: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grzegorz Bilo, MD, PhD (+390261911 ext. 2903, g.bilo@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (plasma essay - 3m) (time frame: after 3 months of randomized intervention). 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 21 Aug 2025.