Heart FailureNCT04071093
Home Telemonitoring System for Patients With Heart Failure
A study testing Home Telemonitoring System (HTS) in people with Heart Failure, run by Universidad Nacional de Tucuman at 1 site in Argentina.
Trial summary
This randomized controlled trial compares a home telemonitoring system (HTS) versus usual care during a 90 days follow-up of Heart Failure (HF) ambulatory patients, in order to evaluate if the use of the HTS improves self-care and treatment adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Home Telemonitoring System (HTS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Aug 2018to 30 Apr 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
- were over 18 years with a primary diagnosis of HF,
- had been hospitalized at least once time as a consequence of a HF decompensation,
- had a Smartphone,
- had access to WiFi,
- had access to a weight scale and to a blood-pressure monitor
Who cannot join
- illiterate patients,
- had learning difficulties,
- had a cognitive impairment sufficient to interfere with the use of the telemonitoring system, or had a severe depression that could interfere with their quality of life perception.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Zenón Santillán Health Center Hospital
San Miguel de Tucumán, Tucumán Province, 4000
About this study
Official title: Trial Clínico. Utilidad Del Telemonitoreo en Pacientes Con IC Como Medio de Apoyo Para la autogestión de la Enfermedad
This randomized controlled trial compares a home telemonitoring system (HTS) versus usual care during a 90 days follow-up of Heart Failure (HF) ambulatory patients, in order to evaluate if the use of the HTS improves self-care and treatment adherence. The study was reviewed and approved by the Methodological Committee and by the Research Ethics Committee from the Provincial Health System, according to the Declaration of Helsinki. Written informed consent was obtained before randomization.
- Conditions
- Heart Failure
- Being tested
- Home Telemonitoring System (HTS)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Telemonitoring System (HTS)Other
The HTS consists of an App that daily collects measurements of weight, blood pressure, heart rate and symptoms (checklist of symptoms questions). The HTS processes the data and generates and sends an alert to the physicians if a risk situation occurs (measurements are outside of normal ranges). The App has also an educational functionality that allows learning about lifestyle, self-care and healthy habits for HF patients. For this purpose, the application: a) has a section that answers frequent questions, b) has a question and answer game about HF, and c) sends educational messages to the patients every day.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring | Other | Not described Receives: Other: Home Telemonitoring System (HTS) |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in self-care
Changes in self-care at baseline and end line of the follow-up using the European Heart Self-care Behavior Questionnaire
Measured: 3-month
Changes in treatment adherence
Changes in treatment adherence at baseline and end line of the follow-up using the Morisky Modified Scale
Measured: 3-month
Secondary outcomes (1)
Rate of Rehospitalizations
Rehospitalizations rate during follow-up
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Aug 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Tucuman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucía María Yanicelli, Universidad Nacional de Tucuman
- Investigators
- Lucia M Yanicelli, PhD, Principal investigator, Universidad Nacional de Tucumán
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071093
- Sponsor's protocol ID
- 94
- Status last verified
- Aug 2019
- First submitted
- 22 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yanicelli LM, Goy CB, Gonzalez VDC, Palacios GN, Martinez EC, Herrera MC. Non-invasive home telemonitoring system for heart failure patients: A randomized clinical trial. J Telemed Telecare. 2021 Oct;27(9):553-561. doi: 10.1177/1357633X19899261. Epub 2020 Jan 23.
PubMed 31973633
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial Clínico. Utilidad Del Telemonitoreo en Pacientes Con IC Como Medio de Apoyo Para la autogestión de la Enfermedad
- ClinicalTrials.gov ID
- NCT04071093
- Acronym / sponsor ID
- 94
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Nacional de TucumanUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 28 Aug 2019 (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.
This randomized controlled trial compares a home telemonitoring system (HTS) versus usual care during a 90 days follow-up of Heart Failure (HF) ambulatory patients, in order to evaluate if the use of the HTS improves self-care and treatment adherence. The study was reviewed and approved by the Methodological Committee and by the Research Ethics Committee from the Provincial Health System, according to the Declaration of Helsinki. Written informed consent was obtained before randomization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring | Other | Other: Home Telemonitoring System (HTS) |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- were over 18 years with a primary diagnosis of HF,
- had been hospitalized at least once time as a consequence of a HF decompensation,
- had a Smartphone,
- had access to WiFi,
- had access to a weight scale and to a blood-pressure monitor
Key exclusion criteria (3 listed)
- illiterate patients,
- had learning difficulties,
- had a cognitive impairment sufficient to interfere with the use of the telemonitoring system, or had a severe depression that could interfere with their quality of life perception.
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 |
|---|---|---|
| Home Telemonitoring System (HTS)The HTS consists of an App that daily collects measurements of weight, blood pressure, heart rate and symptoms (checklist of symptoms questions). The HTS processes the data and generates and sends an alert to the physicians if a risk situation occurs (measurements are outside of normal ranges). The App has also an educational functionality that allows learning about lifestyle, self-care and healthy habits for HF patients. For this purpose, the application: a) has a section that answers frequent questions, b) has a question and answer game about HF, and c) sends educational messages to the patients every day. | Other | Telemonitoring |
Primary outcome
Changes in self-care
Time frame: 3-month
Changes in self-care at baseline and end line of the follow-up using the European Heart Self-care Behavior Questionnaire
Changes in treatment adherence
Time frame: 3-month
Changes in treatment adherence at baseline and end line of the follow-up using the Morisky Modified Scale
1 secondary outcome
Rate of Rehospitalizations
Time frame: 3-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Derived from this study: PubMed 31973633Yanicelli LM, Goy CB, Gonzalez VDC, Palacios GN, Martinez EC, Herrera MC. Non-invasive home telemonitoring system for heart failure patients: A randomized clinical trial. J Telemed Telecare. 2021 Oct;27(9):553-561. doi: 10.1177/1357633X19899261. Epub 2020 Jan 23.
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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.
Lucia M Yanicelli, PhD principal investigator
Universidad Nacional de Tucumán
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Telemonitoring System (HTS) in people with Heart Failure, run by Universidad Nacional de Tucuman at 1 site in Argentina.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 28 Aug 2019. 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 Argentina. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in self-care (time frame: 3-month). The study lists 2 primary outcomes in all. 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 NCT04071093, which also lists 1 linked publication.
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 28 Aug 2019.