Trial Outcomes & Findings for Multicenter Trial for the Validation of Vitalera Platform (NCT NCT05825755)
NCT ID: NCT05825755
Last Updated: 2025-03-19
Results Overview
Quality of life measured with the Minnesota Living with Heart Failure scale. Scale from 0 to 105. The lower the score the better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
97 participants
Primary outcome timeframe
3 months
Results posted on
2025-03-19
Participant Flow
Participant milestones
| Measure |
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. In addition, patients will use the app only to answer to health questionnaires in order to stardardize the responses from both group and evaluate the outcomes of the study.
The number of pre-planned contacts will be defined according to the particular clinical practice of each recruitment center.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
52
|
|
Overall Study
COMPLETED
|
43
|
44
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multicenter Trial for the Validation of Vitalera Platform
Baseline characteristics by cohort
| Measure |
Usual Care (UC)
n=43 Participants
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.
|
Telemonitoring (TM)
n=46 Participants
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
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 13 • n=5 Participants
|
66 years
STANDARD_DEVIATION 16 • n=7 Participants
|
68 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
36 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
43 participants
n=5 Participants
|
46 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
NYHA class
II
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
NYHA class
III
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
NYHA class
IV
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
LVEF categorical
< 40
|
21 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
LVEF categorical
40 - 50
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
LVEF categorical
>= 50
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Employment status
Retired
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Employment status
Paid
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Employment status
None
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Employment status
Unemployed
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Employment status
Voluntary work
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Employment status
Student
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education level
Primery
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Education level
Secondary
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Education level
High level
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Education level
No education
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Does the patient have caretaker?
Yes
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Does the patient have caretaker?
No
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Number of people living with the patient
|
2 people
STANDARD_DEVIATION 1 • n=5 Participants
|
2 people
STANDARD_DEVIATION 1 • n=7 Participants
|
2 people
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Smoker
Yes
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Smoker
No
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Smoker
Ex-smoker
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Alcohol use
Yes
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Alcohol use
Yes, occasionally
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Alcohol use
No
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Diabetes
Yes
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Diabetes
No
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Hypertension
Yes
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Hypertension
No
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Heart disease history
Yes
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Heart disease history
No
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsQuality of life measured with the Minnesota Living with Heart Failure scale. Scale from 0 to 105. The lower the score the better outcome.
Outcome measures
| Measure |
Usual Care (UC)
n=38 Participants
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. In addition, patients will use the app only to answer to health questionnaires in order to stardardize the responses from both group and evaluate the outcomes of the study.
The number of pre-planned contacts will be defined according to the particular clinical practice of each recruitment center.
|
Telemonitoring (TM)
n=40 Participants
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
|
|---|---|---|
|
Change in Quality of Life Scale Between Baseline and 3-months Follow-up
|
-24 units on a scale
Interval -24.5 to -8.0
|
-32.5 units on a scale
Interval -33.5 to -9.5
|
PRIMARY outcome
Timeframe: 3 monthsChange 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.
Outcome measures
| Measure |
Usual Care (UC)
n=36 Participants
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. In addition, patients will use the app only to answer to health questionnaires in order to stardardize the responses from both group and evaluate the outcomes of the study.
The number of pre-planned contacts will be defined according to the particular clinical practice of each recruitment center.
|
Telemonitoring (TM)
n=39 Participants
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
|
|---|---|---|
|
Change in the Proportion of Treatment Adherent Patients Between Baseline and 3-months Follow-up.
|
0.056 proportion of participants
|
0.068 proportion of participants
|
PRIMARY outcome
Timeframe: 3 monthsPatient'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.
Outcome measures
| Measure |
Usual Care (UC)
n=39 Participants
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. In addition, patients will use the app only to answer to health questionnaires in order to stardardize the responses from both group and evaluate the outcomes of the study.
The number of pre-planned contacts will be defined according to the particular clinical practice of each recruitment center.
|
Telemonitoring (TM)
n=39 Participants
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
|
|---|---|---|
|
Change in Sel-care Behaviour Scale Between Baseline and 3-months Follow-up
|
-4 units on a scale
Interval -7.0 to 0.0
|
-4 units on a scale
Interval -7.0 to -1.0
|
SECONDARY outcome
Timeframe: 3 monthsNumber of deaths during the study period
Outcome measures
| Measure |
Usual Care (UC)
n=43 Participants
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. In addition, patients will use the app only to answer to health questionnaires in order to stardardize the responses from both group and evaluate the outcomes of the study.
The number of pre-planned contacts will be defined according to the particular clinical practice of each recruitment center.
|
Telemonitoring (TM)
n=46 Participants
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
|
|---|---|---|
|
Mortality From Any Cause
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 monthsTotal number of hospitalizations
Outcome measures
| Measure |
Usual Care (UC)
n=43 Participants
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. In addition, patients will use the app only to answer to health questionnaires in order to stardardize the responses from both group and evaluate the outcomes of the study.
The number of pre-planned contacts will be defined according to the particular clinical practice of each recruitment center.
|
Telemonitoring (TM)
n=46 Participants
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
|
|---|---|---|
|
Number of Hospital Readmissions
|
7 hospitalizations
|
7 hospitalizations
|
SECONDARY outcome
Timeframe: 3 monthsTotal number of visits with intravenous decongestive therapy
Outcome measures
| Measure |
Usual Care (UC)
n=43 Participants
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. In addition, patients will use the app only to answer to health questionnaires in order to stardardize the responses from both group and evaluate the outcomes of the study.
The number of pre-planned contacts will be defined according to the particular clinical practice of each recruitment center.
|
Telemonitoring (TM)
n=46 Participants
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
|
|---|---|---|
|
Number of Visits to the Emergency Room Due to HF Decompensation
|
2 visits to emergency room
|
0 visits to emergency room
|
SECONDARY outcome
Timeframe: 3 monthsTotal number of visits due to cardiovascular causes
Outcome measures
| Measure |
Usual Care (UC)
n=43 Participants
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. In addition, patients will use the app only to answer to health questionnaires in order to stardardize the responses from both group and evaluate the outcomes of the study.
The number of pre-planned contacts will be defined according to the particular clinical practice of each recruitment center.
|
Telemonitoring (TM)
n=46 Participants
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
|
|---|---|---|
|
Number of Emergency Visits for CV Causes
|
3 visits to emergency room
|
1 visits to emergency room
|
Adverse Events
Usual Care (UC)
Serious events: 9 serious events
Other events: 3 other events
Deaths: 0 deaths
Telemonitoring (TM)
Serious events: 7 serious events
Other events: 1 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Usual Care (UC)
n=43 participants at risk
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. In addition, patients will use the app only to answer to health questionnaires in order to stardardize the responses from both group and evaluate the outcomes of the study.
The number of pre-planned contacts will be defined according to the particular clinical practice of each recruitment center.
|
Telemonitoring (TM)
n=46 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
All-cause hospitalizaton
|
16.3%
7/43 • Number of events 7 • During 3-month follow-up
|
15.2%
7/46 • Number of events 7 • During 3-month follow-up
|
|
Cardiac disorders
Urgent visit with intravenous decongestive therapy
|
4.7%
2/43 • Number of events 2 • During 3-month follow-up
|
0.00%
0/46 • During 3-month follow-up
|
Other adverse events
| Measure |
Usual Care (UC)
n=43 participants at risk
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. In addition, patients will use the app only to answer to health questionnaires in order to stardardize the responses from both group and evaluate the outcomes of the study.
The number of pre-planned contacts will be defined according to the particular clinical practice of each recruitment center.
|
Telemonitoring (TM)
n=46 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Visit to medical emergencies
|
7.0%
3/43 • Number of events 3 • During 3-month follow-up
|
2.2%
1/46 • Number of events 1 • During 3-month follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place