Health Services AdministrationHOROSCOPENCT04607239
The Impact of Telemonitoring in the Management of Hypertension
A study testing Telemonitoring in people with Health Services Administration and Telemedicine, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
Trial summary
Rater blinded, multi-center, prospective, randomized controlled study comparing mean 24 hour systolic blood pressure of eligible hypertensive patients in the TELEMONITORIN group versus the USUAL CARE group, at 6 months after inclusion. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Health Services Administration, Telemedicine, Hypertension
- What is being tested?
- Telemonitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteTunisia
- Study dates
- 4 Jul 2020to 30 Jul 2021
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Included are patients with:
- age ≥ 35 years old
- newly diagnosed hypertention
- uncontrolled hypertention
Who cannot join
- Excluded are patients with:
- orthostatic hypotension
- chronic renal failure (serum creatinine > 200 micromol / L)
- acute coronary syndrome
- coronary revascularization or stroke within the past 3 months
- known secondary causes of hypertension
Show all 9Show fewer
- pregnancy
- New York Heart Association Class III or IV heart failure or left ventricular ejection fraction < 30%
- dementia or another cause that prevents the application of remote monitoring
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Fattouma Bourguiba Hospital
Monastir
Semir NOUIRA, Prof, 0021673106085, semir.nouira@rns.tn
About this study
Official title: HOme telemonitoRing of Arterial hypertensiOn With antihypertenSive Treatment Titration: a Randomized COntrolled prosPEctive Trial
Rater blinded, multi-center, prospective, randomized controlled study comparing mean 24 hour systolic blood pressure of eligible hypertensive patients in the TELEMONITORIN group versus the USUAL CARE group, at 6 months after inclusion.
- Conditions
- Health Services Administration, Telemedicine, Hypertension
- Being tested
- Telemonitoring, Usual Care without Telemonitoring
- Keywords
- Telecommunication, Telecare, Teleconsult, Telemanagement, Telemonitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemonitoringProcedure or surgery
- A weekly telephone call by the CRA for the collection of home blood pressure measurements (which the patient measures twice a day everyday), for therapeutic education, and for treatment compliance assessment.
- A monthly call by the attending physician for treatment titration and side effects check.
Usual Care without TelemonitoringProcedure or surgery
- Attending the follow up visits after inclusion at Day 90 (D-90) \& Day 180 (D-180) for face to face consultation with the attending physician.
- Usual care without any phone calls for therapeutic education, treatment compliance assessment, treatment titration or side effects check.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring | Experimental | In addition to the usual care, this group benefits from a weekly telephone call by the Clinical Research Associate (CRA) for the collection of home blood pressure measurements (which the patient measures twice a day everyday), for therapeutic education, and for treatment compliance assessment.
This group will also benefit from a monthly call by the attending physician for treatment titration and side effects check. Receives: Procedure: Telemonitoring |
| Conventional | Other | This group will benefit form the usual care without any phone calls for therapeutic education, treatment compliance assessment, treatment titration or side effects check.
The usual care includes attending the follow up visits after inclusion at Day 90 (D-90) \& Day 180 (D-180) for face to face consultation with the attending physician. Receives: Procedure: Usual Care without Telemonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of 24h systolic blood pressure (SBP)
The change from baseline of mean 24-hour systolic blood pressure (SBP) at 6 months of follow-up
Measured: 0 - 180 days
Secondary outcomes (5)
Mean of 24h diastolic blood pressure (DBP)
The change from baseline of mean 24 hour diastolic blood pressure (DBP) at 6 months of follow-up
Measured: 0-180 days
percentage of blood pressure load
The change of blood pressure load's percentages between baseline and 6 months of follow-up
Measured: 0-180 days
percentage of Dipping
The change of dipping percentages between baseline and 6 months of follow-up
Measured: 0-180 days
Mean of the Short Form survey (SF-12) scores
The change in the mean of SF-12 scores between baseline and 6 months of follow-up
Measured: 0-180 days
frequency of cardiovascular complications
Clinical outcomes including hospitalization rate, emergency room admissions related to high blood pressure, adverse effects, or other reasons
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start4 Jul 2020
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health Services AdministrationStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The interventional group (Telemonitoring) in addition to the usual care group (conventional) will benefit from: * a weekly telephone call for collection of home Blood Pressure measurements , therapeutic education \& treatment compliance check * a monthly call for treatment titration and side effects check
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Les Laboratoires des Médicaments Stériles
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607239
- Sponsor's protocol ID
- HTA-TELEMED
- Acronym
- HOROSCOPE
- Status last verified
- Oct 2020
- First submitted
- 22 Oct 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saafi M, Bel Haj Ali K, Dhaoui R, Toumia M, Sassi S, Bendaya Y, Bouchoucha M, Hafaeidh SB, Trabelsi I, Sekma A, Bakir A, Jaballah R, Yaakoubi H, Youssef R, Zorgati A, Beltaief K, Mezgar Z, Khrouf M, Sghaier A, Jerbi N, Razgallah R, Bouida W, Grissa MH, Saad J, Boubaker H, Dridi Z, Boukef R, Msolli MA, Nouira S; HOROSCOPE study group. Phone-based telemonitoring of arterial hypertension versus usual care: the HOROSCOPE study. Hypertens Res. 2025 Mar;48(3):1135-1143. doi: 10.1038/s41440-024-02018-6. Epub 2024 Dec 18.
PubMed 39695330Ben Hafaiedh S, Ben Daya Y, Radoui AH, Bouchoucha M, Razgallah R, Nouira S. Home Telemonitoring of Arterial Hypertension With Antihypertensive Treatment Titration: Protocol for a Randomized Controlled Prospective Trial (HOROSCOPE Study). JMIR Res Protoc. 2022 Mar 1;11(3):e26184. doi: 10.2196/26184.
PubMed 35230254
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOme telemonitoRing of Arterial hypertensiOn With antihypertenSive Treatment Titration: a Randomized COntrolled prosPEctive Trial
- ClinicalTrials.gov ID
- NCT04607239
- Acronym / sponsor ID
- HOROSCOPE / HTA-TELEMED
- Conditions
- Health Services Administration, Telemedicine, Hypertension
- Keywords
- Telecommunication, Telecare, Teleconsult, Telemanagement, Telemonitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Les Laboratoires des Médicaments StérilesIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2020 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 29 Oct 2020 (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.
Rater blinded, multi-center, prospective, randomized controlled study comparing mean 24 hour systolic blood pressure of eligible hypertensive patients in the TELEMONITORIN group versus the USUAL CARE group, at 6 months after inclusion.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The interventional group (Telemonitoring) in addition to the usual care group (conventional) will benefit from: * a weekly telephone call for collection of home Blood Pressure measurements , therapeutic education \& treatment compliance check * a monthly call for treatment titration and side effects check
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring | Experimental | Procedure: TelemonitoringIn addition to the usual care, this group benefits from a weekly telephone call by the Clinical Research Associate (CRA) for the collection of home blood pressure measurements (which the patient measures twice a day everyday), for therapeutic education, and for treatment compliance assessment. This group will also benefit from a monthly call by the attending physician for treatment titration and side effects check. |
| Conventional | Other | Procedure: Usual Care without TelemonitoringThis group will benefit form the usual care without any phone calls for therapeutic education, treatment compliance assessment, treatment titration or side effects check. The usual care includes attending the follow up visits after inclusion at Day 90 (D-90) \& Day 180 (D-180) for face to face consultation with the attending physician. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥ 35 years old
- newly diagnosed hypertention
- uncontrolled hypertention
Key exclusion criteria (9 listed)
- orthostatic hypotension
- chronic renal failure (serum creatinine > 200 micromol / L)
- acute coronary syndrome
- coronary revascularization or stroke within the past 3 months
- known secondary causes of hypertension
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 |
|---|---|---|
| Telemonitoring* A weekly telephone call by the CRA for the collection of home blood pressure measurements (which the patient measures twice a day everyday), for therapeutic education, and for treatment compliance assessment. * A monthly call by the attending physician for treatment titration and side effects check. | Procedure or surgery | Telemonitoring |
| Usual Care without Telemonitoring* Attending the follow up visits after inclusion at Day 90 (D-90) \& Day 180 (D-180) for face to face consultation with the attending physician. * Usual care without any phone calls for therapeutic education, treatment compliance assessment, treatment titration or side effects check. | Procedure or surgery | Conventional |
Primary outcome
Mean of 24h systolic blood pressure (SBP)
Time frame: 0 - 180 days
The change from baseline of mean 24-hour systolic blood pressure (SBP) at 6 months of follow-up
5 secondary outcomes
Mean of 24h diastolic blood pressure (DBP)
Time frame: 0-180 days
percentage of blood pressure load
Time frame: 0-180 days
percentage of Dipping
Time frame: 0-180 days
Mean of the Short Form survey (SF-12) scores
Time frame: 0-180 days
frequency of cardiovascular complications
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Derived from this study: PubMed 39695330Saafi M, Bel Haj Ali K, Dhaoui R, Toumia M, Sassi S, Bendaya Y, Bouchoucha M, Hafaeidh SB, Trabelsi I, Sekma A, Bakir A, Jaballah R, Yaakoubi H, Youssef R, Zorgati A, Beltaief K, Mezgar Z, Khrouf M, Sghaier A, Jerbi N, Razgallah R, Bouida W, Grissa MH, Saad J, Boubaker H, Dridi Z, Boukef R, Msolli MA, Nouira S; HOROSCOPE study group. Phone-based telemonitoring of arterial hypertension versus usual care: the HOROSCOPE study. Hypertens Res. 2025 Mar;48(3):1135-1143. doi: 10.1038/s41440-024-02018-6. Epub 2024 Dec 18.
- Derived from this study: PubMed 35230254Ben Hafaiedh S, Ben Daya Y, Radoui AH, Bouchoucha M, Razgallah R, Nouira S. Home Telemonitoring of Arterial Hypertension With Antihypertensive Treatment Titration: Protocol for a Randomized Controlled Prospective Trial (HOROSCOPE Study). JMIR Res Protoc. 2022 Mar 1;11(3):e26184. doi: 10.2196/26184.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring in people with Health Services Administration and Telemedicine, run by Les Laboratoires des Médicaments Stériles at 1 site in Tunisia.
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 4 inclusion and 9 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 24 Nov 2020. 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 Tunisia. 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 Semir NOUIRA, Prof (0021673106085, semir.nouira@rns.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of 24h systolic blood pressure (SBP) (time frame: 0 - 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04607239, which also lists 2 linked publications.
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 24 Nov 2020.