Chronic Patients, Heart Failure
Conditions
Keywords
Chronic care, Chronic patients, Heart Failure, Telemonitoring, Remote monitoring, Remote care, Healthcare, Home care
Brief summary
Vitalera 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 vitalera'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.
Interventions
OTHERvitalera telemonitoring platform
Patients will be followed-up with measurements from medical devices and health questionnaires delivered through the app
Sponsors
humanITcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Scale Between Baseline and 3-months Follow-up | 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. |
| Change in the Proportion of Treatment Adherent Patients Between Baseline and 3-months Follow-up. | 3 months | Change in the proportion of patients adherent to treatment measured with SMAQ between start and end of the study. This questionnaire consists of six questions that evaluate different aspects of patient compliance with treatment: forgetfulness, routine, adverse effects, and a quantification of omissions. A patient is classified as non-compliant (non-adherent) if he/she responds to any of the questions with a non-adherence answer, and in terms of quantification, if the patient has lost more than two doses during the last week or has not taken medication during more than two complete days during the last three months. Then we compute the proportion of adherent patients at baseline and 3-months follow-up and compute the change in proportion. |
| Change in Sel-care Behaviour Scale Between Baseline and 3-months Follow-up | 3 months | Patient's self-care behavior measured with The European Heart Failure Self-Care Behavior Scale. Scale from 9 to 45. The higher the score the poorer self-care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality From Any Cause | 3 months | Number of deaths during the study period |
| Number of Emergency Visits for CV Causes | 3 months | Total number of visits due to cardiovascular causes |
| Number of Hospital Readmissions | 3 months | Total number of hospitalizations |
| Number of Visits to the Emergency Room Due to HF Decompensation | 3 months | Total number of visits with intravenous decongestive therapy |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 43 |
| Telemonitoring (TM) Patients in the TM arm will be followed up with the vitalera 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.
vitalera telemonitoring platform: Patients will be followed-up with measurements from medical devices and health questionnaires delivered through the app | 46 |
| Total | 89 |
Baseline characteristics
| Characteristic | Telemonitoring (TM) | Total | Usual Care (UC) |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 16 | 68 years STANDARD_DEVIATION 15 | 70 years STANDARD_DEVIATION 13 |
| Alcohol use No | 22 Participants | 45 Participants | 23 Participants |
| Alcohol use Yes | 5 Participants | 7 Participants | 2 Participants |
| Alcohol use Yes, occasionally | 19 Participants | 37 Participants | 18 Participants |
| Diabetes No | 32 Participants | 64 Participants | 32 Participants |
| Diabetes Yes | 14 Participants | 25 Participants | 11 Participants |
| Does the patient have caretaker? No | 29 Participants | 52 Participants | 23 Participants |
| Does the patient have caretaker? Yes | 17 Participants | 37 Participants | 20 Participants |
| Education level High level | 12 Participants | 21 Participants | 9 Participants |
| Education level No education | 4 Participants | 12 Participants | 8 Participants |
| Education level Primery | 10 Participants | 22 Participants | 12 Participants |
| Education level Secondary | 20 Participants | 34 Participants | 14 Participants |
| Employment status None | 2 Participants | 4 Participants | 2 Participants |
| Employment status Paid | 14 Participants | 27 Participants | 13 Participants |
| Employment status Retired | 28 Participants | 54 Participants | 26 Participants |
| Employment status Student | 0 Participants | 1 Participants | 1 Participants |
| Employment status Unemployed | 2 Participants | 2 Participants | 0 Participants |
| Employment status Voluntary work | 0 Participants | 1 Participants | 1 Participants |
| Heart disease history No | 11 Participants | 20 Participants | 9 Participants |
| Heart disease history Yes | 35 Participants | 69 Participants | 34 Participants |
| Hypertension No | 20 Participants | 36 Participants | 16 Participants |
| Hypertension Yes | 26 Participants | 53 Participants | 27 Participants |
| LVEF categorical < 40 | 32 Participants | 53 Participants | 21 Participants |
| LVEF categorical 40 - 50 | 5 Participants | 12 Participants | 7 Participants |
| LVEF categorical >= 50 | 9 Participants | 24 Participants | 15 Participants |
| Number of people living with the patient | 2 people STANDARD_DEVIATION 1 | 2 people STANDARD_DEVIATION 1 | 2 people STANDARD_DEVIATION 1 |
| NYHA class II | 22 Participants | 50 Participants | 28 Participants |
| NYHA class III | 19 Participants | 31 Participants | 12 Participants |
| NYHA class IV | 5 Participants | 8 Participants | 3 Participants |
| Race/Ethnicity, Customized Ethnicity Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Latino | 2 Participants | 8 Participants | 6 Participants |
| Race/Ethnicity, Customized Ethnicity White | 44 Participants | 80 Participants | 36 Participants |
| Region of Enrollment Spain | 46 participants | 89 participants | 43 participants |
| Sex: Female, Male Female | 11 Participants | 24 Participants | 13 Participants |
| Sex: Female, Male Male | 35 Participants | 65 Participants | 30 Participants |
| Smoker Ex-smoker | 22 Participants | 41 Participants | 19 Participants |
| Smoker No | 20 Participants | 35 Participants | 15 Participants |
| Smoker Yes | 4 Participants | 13 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 2 / 46 |
| other Total, other adverse events | 3 / 43 | 1 / 46 |
| serious Total, serious adverse events | 9 / 43 | 7 / 46 |
Outcome results
Primary
Change in Quality of Life Scale Between Baseline and 3-months Follow-up
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care (UC) | Change in Quality of Life Scale Between Baseline and 3-months Follow-up | -24 units on a scale |
| Telemonitoring (TM) | Change in Quality of Life Scale Between Baseline and 3-months Follow-up | -32.5 units on a scale |
p-value: 0.252Wilcoxon (Mann-Whitney)
Primary
Change in Sel-care Behaviour Scale Between Baseline and 3-months Follow-up
Patient's self-care behavior measured with The European Heart Failure Self-Care Behavior Scale. Scale from 9 to 45. The higher the score the poorer self-care.
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care (UC) | Change in Sel-care Behaviour Scale Between Baseline and 3-months Follow-up | -4 units on a scale |
| Telemonitoring (TM) | Change in Sel-care Behaviour Scale Between Baseline and 3-months Follow-up | -4 units on a scale |
p-value: 0.791Wilcoxon (Mann-Whitney)
Primary
Change in the Proportion of Treatment Adherent Patients Between Baseline and 3-months Follow-up.
Change in the proportion of patients adherent to treatment measured with SMAQ between start and end of the study. This questionnaire consists of six questions that evaluate different aspects of patient compliance with treatment: forgetfulness, routine, adverse effects, and a quantification of omissions. A patient is classified as non-compliant (non-adherent) if he/she responds to any of the questions with a non-adherence answer, and in terms of quantification, if the patient has lost more than two doses during the last week or has not taken medication during more than two complete days during the last three months. Then we compute the proportion of adherent patients at baseline and 3-months follow-up and compute the change in proportion.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care (UC) | Change in the Proportion of Treatment Adherent Patients Between Baseline and 3-months Follow-up. | 0.056 proportion of participants |
| Telemonitoring (TM) | Change in the Proportion of Treatment Adherent Patients Between Baseline and 3-months Follow-up. | 0.068 proportion of participants |
p-value: 1McNemar
Secondary
Mortality From Any Cause
Number of deaths during the study period
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care (UC) | Mortality From Any Cause | 0 Participants |
| Telemonitoring (TM) | Mortality From Any Cause | 2 Participants |
Secondary
Number of Emergency Visits for CV Causes
Total number of visits due to cardiovascular causes
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care (UC) | Number of Emergency Visits for CV Causes | 3 visits to emergency room |
| Telemonitoring (TM) | Number of Emergency Visits for CV Causes | 1 visits to emergency room |
Secondary
Number of Hospital Readmissions
Total number of hospitalizations
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care (UC) | Number of Hospital Readmissions | 7 hospitalizations |
| Telemonitoring (TM) | Number of Hospital Readmissions | 7 hospitalizations |
Secondary
Number of Visits to the Emergency Room Due to HF Decompensation
Total number of visits with intravenous decongestive therapy
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care (UC) | Number of Visits to the Emergency Room Due to HF Decompensation | 2 visits to emergency room |
| Telemonitoring (TM) | Number of Visits to the Emergency Room Due to HF Decompensation | 0 visits to emergency room |