Back to resultsMulticenter Trial for the Validation of HumanITcare Platform
Primary Purpose
Chronic Patients, Heart Failure
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HumanITcare telemonitoring platform
Sponsored by
About this trial
This is an interventional other trial for Chronic Patients focused on measuring Chronic care, Chronic patients, Heart Failure, Telemonitoring, Remote monitoring, Remote care, Healthcare, Home care
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual care (UC)
Telemonitoring (TM)
Arm Description
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.
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.
Outcomes
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
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 the Simplified Medication Adherence Questionnaire.
Secondary Outcome Measures
Mortality from cardiovascular (CV) causes
Number of deaths
Mortality from any cause
Number of deaths
Acute decompensation of HF (first and recurrent) during the follow-up period
Number of total decompensations
Hospital readmission due to HF decompensation
Total number of hospitalizations
Hospital readmission for CV causes
Total number of hospitalizations
Visits to the emergency room due to HF decompensation
Total number of visits
Emergency visits for CV causes
Total number of visits
Quality of life scale
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
Adherence to treatment measured with SMAQ. Scale from 0 to 5. The higher the score the better outcome.
Self-care
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05825755
Brief Title
Multicenter Trial for the Validation of HumanITcare Platform
Official Title
Randomized Controlled Multicenter Trial for the Validation of HumanITcare Platform
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
humanITcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Patients, Heart Failure
Keywords
Chronic care, Chronic patients, Heart Failure, Telemonitoring, Remote monitoring, Remote care, Healthcare, Home care
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual care (UC)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Telemonitoring (TM)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
HumanITcare telemonitoring platform
Intervention Description
Patients will be followed-up with measurements from medical devices and health questionnaires delivered through the app
Primary Outcome Measure Information:
Title
Change in the combination of the normalized and weighted quality of life, self-care and adherence to treatment scales by the patient
Description
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 the Simplified Medication Adherence Questionnaire.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mortality from cardiovascular (CV) causes
Description
Number of deaths
Time Frame
3 months
Title
Mortality from any cause
Description
Number of deaths
Time Frame
3 months
Title
Acute decompensation of HF (first and recurrent) during the follow-up period
Description
Number of total decompensations
Time Frame
3 months
Title
Hospital readmission due to HF decompensation
Description
Total number of hospitalizations
Time Frame
3 months
Title
Hospital readmission for CV causes
Description
Total number of hospitalizations
Time Frame
3 months
Title
Visits to the emergency room due to HF decompensation
Description
Total number of visits
Time Frame
3 months
Title
Emergency visits for CV causes
Description
Total number of visits
Time Frame
3 months
Title
Quality of life scale
Description
Quality of life measured with the Minnesota Living with Heart Failure scale. Scale from 0 to 105. The lower the score the better outcome.
Time Frame
3 months
Title
Treatment adherence
Description
Adherence to treatment measured with SMAQ. Scale from 0 to 5. The higher the score the better outcome.
Time Frame
3 months
Title
Self-care
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ricard Sanjosé Alemany
Phone
0034644499760
Email
ricard.sanjose@humanitcare.com
First Name & Middle Initial & Last Name or Official Title & Degree
Joan Perramon Llussà
Email
joan.perramon@humanitcare.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta MD Farrero
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Multicenter Trial for the Validation of HumanITcare Platform
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