Multicenter Trial for the Validation of HumanITcare Platform

Sponsor

humanITcare (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05825755

Collaborator

(none)

250

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

HumanITcare has implemented a cloud platform for the telemonitoring of chronic patients through portable medical devices and an alarm-based system that issues health alerts when a patient's biomedical measurement is outside a predefined clinical range. The platform frees doctors and caregivers from reviewing individual patient data for abnormalities, speeding up the decision-making process and reducing hospital visits. With this study we intend to validate the efficacy of the app for patients and digital platform for medical professionals, evaluating the increase in the quality of life of patients and measuring the reduction in the incidence of the main critical events of HF. In addition, the study will validate the new API interoperability standards and platform architecture and will assess the usability of the platform by delivering satisfaction questionnaires to patients and professionals at the end of the study.

This study is being carried out within the framework of a European project promoted by the European Innovation Council (EIC).

Condition or Disease	Intervention/Treatment	Phase
Chronic Patients Heart Failure	Other: HumanITcare telemonitoring platform	N/A

Detailed Description

This is a randomized controlled trial involving a Spanish network of hospitals. The study consists of continuous remote patient monitoring using HumanITcare's digital platform and the supplied devices (blood pressure monitor, wearable, scale and oximeter). For 3 months, a total of 250 patients suffering from HF will have their physiological constants monitored.

Patients will be included in the study based on the eligibility criteria and must complete the informed consent provided. Each hospital will decide when to include their patients according to their particular clinical practice. The recruitment period is defined as 3 months. That means patients will be incorporated into the study from its start until the third month. The last subject included in the study will then finish the study after six months from the first day of the study. Medical professionals from each hospital will be in charge of recruiting the participants. The recruitment rate is specific for each hospital, and it may vary depending on the month.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Randomized Controlled Multicenter Trial for the Validation of HumanITcare Platform

Anticipated Study Start Date :

Apr 15, 2023

Anticipated Primary Completion Date :

Oct 15, 2023

Anticipated Study Completion Date :

Oct 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual care (UC) The follow-up of the patients in the UC arm will be carried out in accordance with the usual clinical practice of each recruitment center. All recruiting centers have active and mature HF programs in place and therefore each center will decide how to follow up the patient. However, medical professionals will be required to register each patient on the platform, enter their baseline data (sociodemographics and risk factors) and enter all possible clinical events (death, non-fatal HF event, hospitalization or emergency room visit). that the patient could suffer during the entire follow-up period. The number of pre-planned contacts will be defined according to the particular clinical practice of each recruitment center.
Experimental: Telemonitoring (TM) Patients in the TM arm will be followed up with the HumanITcare platform and app. Physiological parameters (measured periodically), socio-demographic data, risk factors, medication tracking, symptomatology questionnaire for patients, NYHA-class, clinical interventions, health questionnaire answers, classified alarms with their respective timestamp and annotation by the MD, and measurement ranges for each personalized alarm and their changes.	Other: HumanITcare telemonitoring platform Patients will be followed-up with measurements from medical devices and health questionnaires delivered through the app

Arm

Intervention/Treatment

No Intervention: Usual care (UC)

The follow-up of the patients in the UC arm will be carried out in accordance with the usual clinical practice of each recruitment center. All recruiting centers have active and mature HF programs in place and therefore each center will decide how to follow up the patient. However, medical professionals will be required to register each patient on the platform, enter their baseline data (sociodemographics and risk factors) and enter all possible clinical events (death, non-fatal HF event, hospitalization or emergency room visit). that the patient could suffer during the entire follow-up period. The number of pre-planned contacts will be defined according to the particular clinical practice of each recruitment center.

Experimental: Telemonitoring (TM)

Patients in the TM arm will be followed up with the HumanITcare platform and app. Physiological parameters (measured periodically), socio-demographic data, risk factors, medication tracking, symptomatology questionnaire for patients, NYHA-class, clinical interventions, health questionnaire answers, classified alarms with their respective timestamp and annotation by the MD, and measurement ranges for each personalized alarm and their changes.

Other: HumanITcare telemonitoring platform

Patients will be followed-up with measurements from medical devices and health questionnaires delivered through the app

Outcome Measures

Primary Outcome Measures

Change in the combination of the normalized and weighted quality of life, self-care and adherence to treatment scales by the patient [3 months]
Composite of change in the value of the combined value of the normalized and weighted scales of each questionnaire: the Minnesota Living with Heart Failure scale, The European Heart Failure Self-care behaviour scale and Morisky-Green scale

Secondary Outcome Measures

Mortality from cardiovascular (CV) causes [3 months]
Number of deaths
Mortality from any cause [3 months]
Number of deaths
Acute decompensation of HF (first and recurrent) during the follow-up period [3 months]
Number of total decompensations
Hospital readmission due to HF decompensation [3 months]
Total number of hospitalizations
Hospital readmission for CV causes [3 months]
Total number of hospitalizations
Visits to the emergency room due to HF decompensation [3 months]
Total number of visits
Emergency visits for CV causes [3 months]
Total number of visits
Quality of life scale [3 months]
Quality of life measured with the Minnesota Living with Heart Failure scale. Scale from 0 to 105. The lower the score the better outcome.
Treatment adherence [3 months]
Adherence to treatment measured with Morisky-Green scale. Scale from 0 to 8. The higher the score the better outcome.
Self-care [3 months]
Patient's self-care measured with The European Heart Failure Self-Care Behavior Scale scale. Scale from 0 to 100. The higher the score the better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Heart failure (HF) patients with NYHA Functional Class >= II (according to 2021 EU guidelines).
Patients older than 18 years old.
Patients who have suffered an acute decompensation of HF (first and recurrent) in the 30 days prior to enrollment in the study.
NT-pro BNP ≥300 pg/ml at the moment of hospitalization for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter, NT-pro BNP must be ≥600 pg/mL
Patients must have had an echocardiogram during their HF hospitalization or in the previous 12 months.
Prior to initiating any procedures, the hospital will ensure that the patient obtains an informed consent document, if applicable.
All patients will be eligible regardless of the level of LVEF: HFrEF, HFmrEF, and HFpEF.

Exclusion Criteria:

Oncology patients with metastasis or with chemotherapy treatment ongoing
Patients participating in other studies or trials.
Patients not willing to participate.
Patients over 150 kg
Patients who do not use Catalan, Spanish, English, Portuguese, Italian, Dutch, German, Swedish, Hungarian, Romanian or French.
Patients without a mobile phone
Patients without internet connexion
Patients with moderate or severe cognitive impairment without a competent caregiver
Patients with serious psychiatric illness
Patients with planned cardiac surgery
Patients with planned heart transplantation or LVAD implant