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Heart Failure; With DecompensationMONTEROSANCT04403659

Telemonitoring of Patients Admitted in Hospital at Home With Acute Decompensated Heart Failure - Pilot Study

A study testing Telemedicine/telemonitoring (TM) suite in people with Heart Failure; With Decompensation and Heart Failure，Congestive, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

"La Casa nel Parco" (CANP) Project is a multidisciplinary project funded by the European Union and Regione Piemonte aimed to explore innovative technology application in the care of older subjects. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Telemedicine/telemonitoring (TM) suite
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteItaly
Study dates
1 Jun 2020to 31 Jan 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient admitted in Hospital at Home with signs and/or symptoms of new-onset or decompensated heart failure, according with the definition of 2016 European Society of Cardiology (ESC) guidelines on Heart Failure
  • Written informed consent signed by both the patient and the main caregiver

Who cannot join

  • Main caregiver with low IT skills (e.g. unable to use a smartphone);
  • Patient in whom body weight or accurate daily urine output cannot be measured
  • Patient with history of neoplastic/degenerative disease and with estimated life expectancy less than 3 months
  • Patient with decompensated liver cirrhosis (Child-Pugh score B o C)

Trial locations and contacts

1 site in 1 country.

Renata Marinello, MD, PhD contact

0116334771 ext. +39

rmarinello@cittadellasalute.to.it

Italy1 site

  • S.C. Geriatria e Malattie Metaboliche dell'Osso U, A.O.U. Città della Salute e della Scienza di Torino

    Torino, TO, 10126

Other trials in Italy

About this study

Official title: Monitoraggio Telematico di Pazienti Ricoverati in Ospedalizzazione a Domicilio Per Scompenso Cardiaco Acuto - Studio Pilota

"La Casa nel Parco" (CANP) Project is a multidisciplinary project funded by the European Union and Regione Piemonte aimed to explore innovative technology application in the care of older subjects. In this context, MONTEROSA is a monocentric randomized controlled open-label clinical trial evaluating the use of a telemonitoring/telemedicine (TM) suite (including a sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph) as a support to the routine clinical care of patients admitted to a Hospital at Home service for acute decompensated heart failure.

The main objective of the study will be to evaluate the impact of TM on number of daily physician's visits. Secondary objectives will be to evaluate the impact of TM on number of daily nurse visits, on overall in-hospital mortality and on patient's and caregiver's quality of life.

Being tested
Telemedicine/telemonitoring (TM) suite
Keywords
Telemedicine, Telemonitoring, Hospital at Home, Home Hospitalization
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telemedicine/telemonitoring (TM) suiteDevice

    The couples patient/caregiver will receive and trained to use a suite of TM instruments including: sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph. During the intervention phase (i.e. from allocation to exit from the study), the caregiver/patient will be asked to measure twice daily, at prespecified times, the following parameters using TM devices: arterial blood pressure, peripheral arterial haemoglobin saturation, tympanic temperature. Body weight will be evaluated once daily.

    The TM glucometer and TM electrocardiograph will be used exclusively by healthcare staff in case of patients in need of capillary blood glucose testing and according to clinical needs, respectively. All data will be automatically sent to a central interface and made readily available to physicians and nurses, to enable a prompt clinical response. In case of malfunctioning, a technical support will be ensured.

Study groups in NCT04403659
Study groupRoleWhat they receive
InterventionExperimentalUse of a telemonitoring/telemedicine suite (including a sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph) as a support to the routine clinical care
Receives: Device: Telemedicine/telemonitoring (TM) suite
ControlNo interventionRoutine clinical care, following European Society of Cardiology 2016 Guidelines on Heart failure and Good Clinical Practice guidelines

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean daily number of physician visits

    Mean daily number of physician visits during Hospital at Home (HaH) stay, defined as total number of physician visits during HaH stay, divided by days of HaH stay, for every single patient

    Measured: From allocation through to HaH discharge, in mean 15 days

Secondary outcomes (6)

  1. Mean daily number of nurse visits

    Mean daily number of nurse visits during Hospital at Home (HaH) stay, defined as total number of nurse visits during HaH stay, divided by days of HaH stay, for every single patient

    Measured: From allocation through to HaH discharge, in mean 15 days

  2. Mean daily number of urgent physician visits

    Mean daily number of urgent physician visits during Hospital at Home (HaH) stay, defined as total number of urgent (i.e. unplanned) physician visits during HaH stay, divided by days of HaH stay, for every single patient

    Measured: From allocation through to HaH discharge, in mean 15 days

  3. Mean daily number of urgent nurse visits

    Mean daily number of urgent nurse visits during Hospital at Home (HaH) stay, defined as total number of urgent (i.e. unplanned) nurse visits during HaH stay, divided by days of HaH stay, for every single patient

    Measured: From allocation through to HaH discharge, in mean 15 days

  4. Overall mortality

    Death by any cause during Hospital at Home (HaH) stay

    Measured: From allocation through to HaH discharge, in mean 15 days

  5. Patient's quality of life evaluated through the 12-Item Short Form survey (SF-12)

    Patient's quality of life evaluated through the 12-Item Short Form survey (SF-12), stratified in Physical component summary (Pcs) and Mental component summary (Mcs), at Hospital at Home (HaH) discharge

    Measured: At HaH discharge, in mean 15 days after allocation

  6. Main caregiver's quality of life evaluated through the 12-Item Short Form survey (SF-12)

    Main caregiver's quality of life evaluated through the 12-Item Short Form survey (SF-12), stratified in Physical component summary (Pcs) and Mental component summary (Mcs), at Hospital at Home (HaH) discharge

    Measured: At patient's HaH discharge, in mean 15 days after allocation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2020
  2. Study start1 Jun 2020 (estimated)
  3. Primary completion31 Jan 2021 (estimated)
  4. Study completion31 Jan 2021 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04403659
Sponsor's protocol ID
MONTEROSA
Acronym
MONTEROSA
Status last verified
May 2020
First submitted
21 May 2020
Last updated
27 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tibaldi V, Isaia G, Scarafiotti C, Gariglio F, Zanocchi M, Bo M, Bergerone S, Ricauda NA. Hospital at home for elderly patients with acute decompensation of chronic heart failure: a prospective randomized controlled trial. Arch Intern Med. 2009 Sep 28;169(17):1569-75. doi: 10.1001/archinternmed.2009.267.

    PubMed 19786675

  • Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

    PubMed 27206819

  • Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

    PubMed 8628042

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine/telemonitoring (TM) suite in people with Heart Failure; With Decompensation and Heart Failure，Congestive, run by A.O.U. Città della Salute e della Scienza 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 2 inclusion and 4 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 27 May 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Renata Marinello, MD, PhD (0116334771 ext. +39, rmarinello@cittadellasalute.to.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean daily number of physician visits (time frame: From allocation through to HaH discharge, in mean 15 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 NCT04403659, which also lists 3 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 27 May 2020.

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