Trial Outcomes & Findings for Evaluating Efficacy of Digital Health Technology in the Treatment of Congestive Heart Failure (NCT NCT04394754)
NCT ID: NCT04394754
Last Updated: 2023-05-18
Results Overview
Assessed by the change in score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) survey between baseline scoring (at enrollment) and at 90 days post-enrollment. This survey is a 23 item self-administered instrument used to quantify a patient's perception of health status. For each domain reported, an overall summary scored is derived and transformed to a score range of 0-100. The Total Symptom score is the mean of the Symptom Frequency and Symptom Burden scores. The Overall Summary Score is the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation Scores. The Clinical Summary score is the mean of the Physical Limitation and Total Symptom scores. All KCCQ scores are summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
182 participants
Primary outcome timeframe
Day 90 after enrollment
Results posted on
2023-05-18
Participant Flow
Participant milestones
| Measure |
Control
Patients will receive usual care and no digital health device.
|
BodyPort
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
44
|
46
|
46
|
46
|
|
Overall Study
COMPLETED
|
36
|
39
|
38
|
38
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
8
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating Efficacy of Digital Health Technology in the Treatment of Congestive Heart Failure
Baseline characteristics by cohort
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
59 years
n=7 Participants
|
62 years
n=5 Participants
|
62.5 years
n=4 Participants
|
61 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Non-hispanic white
|
24 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Non-hispanic black
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Insurance Coverage
Commericial
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Insurance Coverage
Medicare
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Insurance Coverage
Medicaid
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Insurance Coverage
Uninsured
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Heart Failure Classification
(Heart failure with reduced ejection fraction HFrEF)
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
|
Heart Failure Classification
Heart failure with preserved ejection fraction (HFpEF)
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Ejection Fraction, median
|
32 Percent of ventricular ejection
n=5 Participants
|
29.5 Percent of ventricular ejection
n=7 Participants
|
43.5 Percent of ventricular ejection
n=5 Participants
|
40 Percent of ventricular ejection
n=4 Participants
|
36 Percent of ventricular ejection
n=21 Participants
|
|
New York Heart Association (NYHA) classification
Class I
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
New York Heart Association (NYHA) classification
Class II
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
New York Heart Association (NYHA) classification
Class III
|
19 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
|
New York Heart Association (NYHA) classification
Unknown
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Cardiac Device
Pacemaker
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Cardiac Device
Implantable cardioverter defibrillator (ICD)
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Cardiac Device
CardioMEMS
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Cardiac Device
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Cardiac Device
No device
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Comorbidities
Diabetes Mellitus
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Comorbidities
Chronic Kidney Disease (CKD)
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Comorbidities
Chronic obstructive pulmonary disease (COPD)
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Comorbidities
Hypertension
|
23 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
131 Participants
n=21 Participants
|
|
Comorbidities
Malignancy
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Comorbidities
Depression
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Comorbidities
Liver Disease
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Comorbidities
Coronary artery disease (CAD)
|
11 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Comorbidities
Hyperlipidemia
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Comorbidities
Obesity
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Medications
Beta Blocker
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
164 Participants
n=21 Participants
|
|
Medications
ACEi/ARB/ARNI
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
|
Medications
MRA
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Medications
SGLT2i
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Creatinine
|
1.08 mg/dL
n=5 Participants
|
1.18 mg/dL
n=7 Participants
|
1.15 mg/dL
n=5 Participants
|
1.09 mg/dL
n=4 Participants
|
1.1 mg/dL
n=21 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR)
|
60 mL/min/1.73m2
n=5 Participants
|
59 mL/min/1.73m2
n=7 Participants
|
60 mL/min/1.73m2
n=5 Participants
|
60 mL/min/1.73m2
n=4 Participants
|
60 mL/min/1.73m2
n=21 Participants
|
|
Potassium
|
4.3 mmol/L
n=5 Participants
|
4.2 mmol/L
n=7 Participants
|
4.4 mmol/L
n=5 Participants
|
4.4 mmol/L
n=4 Participants
|
4.3 mmol/L
n=21 Participants
|
|
Hemoglobin
|
12.7 g/dL
n=5 Participants
|
12.7 g/dL
n=7 Participants
|
11.9 g/dL
n=5 Participants
|
12.8 g/dL
n=4 Participants
|
12.7 g/dL
n=21 Participants
|
|
White Blood Cell (WBC) Count
|
7.1 10^3 cells/µL
n=5 Participants
|
7 10^3 cells/µL
n=7 Participants
|
6.9 10^3 cells/µL
n=5 Participants
|
7.5 10^3 cells/µL
n=4 Participants
|
7.1 10^3 cells/µL
n=21 Participants
|
|
Brain Natriuretic Peptide (BNP)
|
995.5 pg/mL
n=5 Participants
|
876.5 pg/mL
n=7 Participants
|
737.5 pg/mL
n=5 Participants
|
914.2 pg/mL
n=4 Participants
|
858 pg/mL
n=21 Participants
|
|
Platelet count
|
234 10^3 cells/µL
n=5 Participants
|
261.5 10^3 cells/µL
n=7 Participants
|
218 10^3 cells/µL
n=5 Participants
|
230 10^3 cells/µL
n=4 Participants
|
234 10^3 cells/µL
n=21 Participants
|
|
Aspartate aminotransferase (AST)
|
27 U/L
n=5 Participants
|
25 U/L
n=7 Participants
|
25 U/L
n=5 Participants
|
28 U/L
n=4 Participants
|
26 U/L
n=21 Participants
|
|
Alanine transaminase (ALT)
|
31 U/L
n=5 Participants
|
22 U/L
n=7 Participants
|
24 U/L
n=5 Participants
|
25 U/L
n=4 Participants
|
25 U/L
n=21 Participants
|
|
Total Bilirubin
|
0.5 Mg/dL
n=5 Participants
|
0.3 Mg/dL
n=7 Participants
|
0.5 Mg/dL
n=5 Participants
|
0.4 Mg/dL
n=4 Participants
|
0.5 Mg/dL
n=21 Participants
|
|
International Normalized Ratio (INR)
|
1.1 Ratio
n=5 Participants
|
1.1 Ratio
n=7 Participants
|
1.1 Ratio
n=5 Participants
|
1.1 Ratio
n=4 Participants
|
1.1 Ratio
n=21 Participants
|
|
Prothrombin time (PT)
|
11.3 seconds
n=5 Participants
|
11.9 seconds
n=7 Participants
|
12.1 seconds
n=5 Participants
|
11.7 seconds
n=4 Participants
|
11.9 seconds
n=21 Participants
|
|
Partial Thromboplastin Time (PTT)
|
30.8 seconds
n=5 Participants
|
25.6 seconds
n=7 Participants
|
27.1 seconds
n=5 Participants
|
27.5 seconds
n=4 Participants
|
27.2 seconds
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 90 after enrollmentAssessed by the change in score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) survey between baseline scoring (at enrollment) and at 90 days post-enrollment. This survey is a 23 item self-administered instrument used to quantify a patient's perception of health status. For each domain reported, an overall summary scored is derived and transformed to a score range of 0-100. The Total Symptom score is the mean of the Symptom Frequency and Symptom Burden scores. The Overall Summary Score is the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation Scores. The Clinical Summary score is the mean of the Physical Limitation and Total Symptom scores. All KCCQ scores are summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Outcome measures
| Measure |
Control
n=36 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=39 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=38 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=38 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Change in Quality of Life at 90 Days Post Enrollment
Physical Limitation
|
-4.2 Scores on a scale (difference)
Interval -14.6 to 4.2
|
-4.2 Scores on a scale (difference)
Interval -12.5 to 4.2
|
0 Scores on a scale (difference)
Interval -4.2 to 10.4
|
-4.2 Scores on a scale (difference)
Interval -16.7 to 0.0
|
|
Change in Quality of Life at 90 Days Post Enrollment
Symptom Stability
|
0 Scores on a scale (difference)
Interval -25.0 to 0.0
|
0 Scores on a scale (difference)
Interval -25.0 to 0.0
|
0 Scores on a scale (difference)
Interval -25.0 to 25.0
|
0 Scores on a scale (difference)
Interval 0.0 to 0.0
|
|
Change in Quality of Life at 90 Days Post Enrollment
Total Symptom Score
|
-1 Scores on a scale (difference)
Interval -13.5 to 7.8
|
0 Scores on a scale (difference)
Interval -4.2 to 14.6
|
4.2 Scores on a scale (difference)
Interval -1.0 to 16.7
|
1 Scores on a scale (difference)
Interval -6.2 to 12.5
|
|
Change in Quality of Life at 90 Days Post Enrollment
Self-Efficacy
|
0 Scores on a scale (difference)
Interval 0.0 to 12.5
|
0 Scores on a scale (difference)
Interval 0.0 to 12.5
|
0 Scores on a scale (difference)
Interval -12.5 to 12.5
|
0 Scores on a scale (difference)
Interval 0.0 to 12.5
|
|
Change in Quality of Life at 90 Days Post Enrollment
Social Limitation
|
0 Scores on a scale (difference)
Interval -16.7 to 8.3
|
0 Scores on a scale (difference)
Interval -12.5 to 18.8
|
0 Scores on a scale (difference)
Interval -6.3 to 25.0
|
0 Scores on a scale (difference)
Interval -12.5 to 6.3
|
|
Change in Quality of Life at 90 Days Post Enrollment
Quality of Life
|
8.3 Scores on a scale (difference)
Interval -16.7 to 25.0
|
8.3 Scores on a scale (difference)
Interval -8.3 to 25.0
|
4.2 Scores on a scale (difference)
Interval -8.3 to 16.7
|
0 Scores on a scale (difference)
Interval -8.4 to 16.7
|
|
Change in Quality of Life at 90 Days Post Enrollment
Clinical Summary Score
|
-3.1 Scores on a scale (difference)
Interval -10.2 to 3.0
|
0 Scores on a scale (difference)
Interval -6.2 to 7.3
|
2.8 Scores on a scale (difference)
Interval -1.0 to 14.6
|
-1.6 Scores on a scale (difference)
Interval -10.4 to 6.3
|
|
Change in Quality of Life at 90 Days Post Enrollment
Overall Summary Score
|
0.3 Scores on a scale (difference)
Interval -9.2 to 9.4
|
2.1 Scores on a scale (difference)
Interval -7.8 to 14.6
|
3.4 Scores on a scale (difference)
Interval -2.8 to 15.1
|
2.1 Scores on a scale (difference)
Interval -9.1 to 6.8
|
|
Change in Quality of Life at 90 Days Post Enrollment
Symptom Frequency
|
-2.1 Scores on a scale (difference)
Interval -13.5 to 10.4
|
0 Scores on a scale (difference)
Interval -8.3 to 10.4
|
0 Scores on a scale (difference)
Interval -4.2 to 18.8
|
3.1 Scores on a scale (difference)
Interval -4.2 to 12.5
|
|
Change in Quality of Life at 90 Days Post Enrollment
Symptom Burden
|
0 Scores on a scale (difference)
Interval -8.3 to 8.3
|
0 Scores on a scale (difference)
Interval -8.3 to 16.7
|
8.3 Scores on a scale (difference)
Interval 0.0 to 16.7
|
0 Scores on a scale (difference)
Interval -8.3 to 16.7
|
SECONDARY outcome
Timeframe: 180 days post enrollmentAssessed by the change in score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) survey between day 90 post enrollment and at day 180 post enrollment. This survey is a 23 item self-administered instrument used to quantify a patient's perception of health status. For each domain reported, an overall summary scored is derived and transformed to a score range of 0-100. The Total Symptom score is the mean of the Symptom Frequency and Symptom Burden scores. The Overall Summary Score is the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation Scores. The Clinical Summary score is the mean of the Physical Limitation and Total Symptom scores. All KCCQ scores are summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Change in Quality of Life at 180 Days Post Enrollment
Physical Limitation
|
-4.2 Scores on a scale (difference)
Interval -12.5 to 4.2
|
-8.3 Scores on a scale (difference)
Interval -18.8 to 0.0
|
-2.1 Scores on a scale (difference)
Interval -10.4 to 8.3
|
-2.1 Scores on a scale (difference)
Interval -8.3 to 8.3
|
|
Change in Quality of Life at 180 Days Post Enrollment
Clinical Summary Score
|
-1 Scores on a scale (difference)
Interval -10.4 to 4.2
|
-3.1 Scores on a scale (difference)
Interval -8.3 to 1.0
|
1 Scores on a scale (difference)
Interval -4.2 to 15.5
|
-1 Scores on a scale (difference)
Interval -10.4 to 10.4
|
|
Change in Quality of Life at 180 Days Post Enrollment
Symptom Burden
|
0 Scores on a scale (difference)
Interval -8.3 to 16.7
|
0 Scores on a scale (difference)
Interval -16.7 to 16.7
|
0 Scores on a scale (difference)
Interval -8.3 to 16.7
|
0 Scores on a scale (difference)
Interval -16.7 to 8.3
|
|
Change in Quality of Life at 180 Days Post Enrollment
Total Symptom Score
|
0 Scores on a scale (difference)
Interval -8.3 to 10.4
|
0 Scores on a scale (difference)
Interval -10.4 to 6.2
|
7.3 Scores on a scale (difference)
Interval 0.0 to 18.7
|
0 Scores on a scale (difference)
Interval -18.8 to 10.4
|
|
Change in Quality of Life at 180 Days Post Enrollment
Self- Efficacy
|
0 Scores on a scale (difference)
Interval 0.0 to 12.5
|
0 Scores on a scale (difference)
Interval 0.0 to 12.5
|
0 Scores on a scale (difference)
Interval 0.0 to 12.5
|
0 Scores on a scale (difference)
Interval 0.0 to 12.5
|
|
Change in Quality of Life at 180 Days Post Enrollment
Quality of Life
|
8.3 Scores on a scale (difference)
Interval 0.0 to 16.7
|
0 Scores on a scale (difference)
Interval -8.3 to 8.3
|
0 Scores on a scale (difference)
Interval -16.7 to 16.7
|
0 Scores on a scale (difference)
Interval -8.3 to 25.0
|
|
Change in Quality of Life at 180 Days Post Enrollment
Overall Summary Score
|
3.6 Scores on a scale (difference)
Interval -4.2 to 9.8
|
0 Scores on a scale (difference)
Interval -9.6 to 6.8
|
-1 Scores on a scale (difference)
Interval -7.3 to 16.1
|
0 Scores on a scale (difference)
Interval -7.8 to 10.4
|
|
Change in Quality of Life at 180 Days Post Enrollment
Symptom Stability
|
0 Scores on a scale (difference)
Interval -25.0 to 0.0
|
0 Scores on a scale (difference)
Interval 0.0 to 0.0
|
0 Scores on a scale (difference)
Interval -25.0 to 0.0
|
0 Scores on a scale (difference)
Interval -25.0 to 0.0
|
|
Change in Quality of Life at 180 Days Post Enrollment
Symptom Frequency
|
0 Scores on a scale (difference)
Interval -8.3 to 8.3
|
0 Scores on a scale (difference)
Interval -8.3 to 4.2
|
6.3 Scores on a scale (difference)
Interval -4.2 to 29.2
|
0 Scores on a scale (difference)
Interval -4.2 to 12.5
|
|
Change in Quality of Life at 180 Days Post Enrollment
Social Limitation
|
0 Scores on a scale (difference)
Interval -9.4 to 12.5
|
0 Scores on a scale (difference)
Interval -12.5 to 12.5
|
-3.1 Scores on a scale (difference)
Interval -18.8 to 5.2
|
0 Scores on a scale (difference)
Interval -12.5 to 16.7
|
SECONDARY outcome
Timeframe: 90 days post enrollmentVia medical record review. Number of patients with a hospital admission between enrollment to day 90 post enrollment.
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of Participants With Hospital Admission at 90 Days Post Enrollment
Participants with hospital admission
|
11 Participants
|
16 Participants
|
14 Participants
|
17 Participants
|
|
Number of Participants With Hospital Admission at 90 Days Post Enrollment
Participants with hospital admission related to congestive heart failure (CHF)
|
4 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 180 days post enrollmentVia medical record review. This measure is calculated as the number of participants with a hospital admission from day 90 to day 180 post enrollment.
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of Participants With Hospital Admission at 180 Days Post Enrollment
Participants with hospital admission
|
10 Participants
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Hospital Admission at 180 Days Post Enrollment
Participants with hospital admission related to CHF
|
3 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 90 days post enrollmentPopulation: Surescripts data was not made available to investigators, thus we are unable to collect prescription-related data to assess this outcome.
Documented prescription or change in dosing of any one of the following medication classes: beta blockers, ACEi/ARBs, and/or spironolactone; assessed via Surescripts data collection.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 180 days post enrollmentPopulation: Surescripts data was not made available to investigators, thus we are unable to collect prescription-related data to assess this outcome.
Documented prescription or change in dosing of any one of the following medication classes: beta blockers, ACEi/ARBs, and/or spironolactone; assessed via Surescripts data collection.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 days post enrollmentNumber of patients having documented prescription of all of the following medication classes between enrollment and day 90 post enrollment: beta blockers, angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARBs)/angiotensin receptor-neprilysin inhibitors (ARNI), sodium/glucose cotransporter-2 inhibitors (SGLT2i) and aldosterone receptor antagonists (MRAs); assessed via Surescripts data collection.
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment
Beta-blocker
|
42 Participants
|
39 Participants
|
41 Participants
|
42 Participants
|
|
Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment
ACEi/ARB/ARNI
|
32 Participants
|
36 Participants
|
33 Participants
|
30 Participants
|
|
Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment
MRA
|
25 Participants
|
25 Participants
|
26 Participants
|
21 Participants
|
|
Number of Subjects Using Guideline-directed Medical Therapy at 90 Days Post Enrollment
SGLT2i
|
15 Participants
|
13 Participants
|
18 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 180 days post enrollmentNumber of patients having documented prescription of all of the following medication classes between day 90 post enrollment and day 180 post enrollment: beta blockers, angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARBs)/angiotensin receptor-neprilysin inhibitors (ARNI), sodium/glucose cotransporter-2 inhibitors (SGLT2i) and aldosterone receptor antagonists (MRAs); assessed via Surescripts data collection.
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment
ACEi/ARB/ARNI
|
34 Participants
|
35 Participants
|
32 Participants
|
32 Participants
|
|
Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment
Beta Blocker
|
40 Participants
|
38 Participants
|
40 Participants
|
40 Participants
|
|
Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment
MRA
|
23 Participants
|
24 Participants
|
24 Participants
|
25 Participants
|
|
Number of Subjects Using Guideline-directed Medical Therapy at 180 Days Post Enrollment
SGLT2i
|
17 Participants
|
13 Participants
|
17 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 90 days post enrollmentVia medical record review. Number of participants with an emergency department visit between enrollment and day 90 post enrollment.
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of Participants With Emergency Department (ED) Visits at 90 Days Post Enrollment
Participants with ED visit
|
10 Participants
|
12 Participants
|
10 Participants
|
14 Participants
|
|
Number of Participants With Emergency Department (ED) Visits at 90 Days Post Enrollment
Participants with ED visit related to CHF
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 180 days post enrollmentVia medical record review. Number of participants with an emergency department visit between day 90 and day 180 post enrollment.
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of Participants With Emergency Department Visits at 180 Days Post Enrollment
Participants with ED visit
|
8 Participants
|
12 Participants
|
13 Participants
|
13 Participants
|
|
Number of Participants With Emergency Department Visits at 180 Days Post Enrollment
Participants with ED visit related to CHF
|
4 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 90 days post enrollmentVia medical record review, defined as an increase in serum creatinine by 50% over baseline (pre-enrollment creatinine) at any point between enrollment day 90 post enrollment.
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of Participants With Acute Kidney Injury (AKI) Development at 90 Days Post Enrollment
|
4 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 180 days post enrollmentVia medical record review, defined as an increase in serum creatinine by 50% over baseline (pre-enrollment creatinine) at any point between day 90 and day 180 post enrollment.
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of Participants With Acute Kidney Injury (AKI) Development at 180 Days Post Enrollment
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 90 days post enrollmentVia medical record review. Number of deaths between enrollment and 90 days post enrollment.
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Mortality Rate at 90 Days Post Enrollment
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 180 days post enrollmentVia medical record review. Number of deaths between day 90 and day 180 post enrollment.
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Mortality Rates at 180 Days Post Enrollment
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 90 days post enrollmentVia medical record review; number of participants with at least one clinic no show between enrollment and day 90 post enrollment.
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of Participants With at Least One Clinic No-show at 90 Days Post Enrollment
|
12 Participants
|
12 Participants
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 90 days post enrollmentVia medical record review. Number of visits between enrollment and 90 days post enrollment.
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of In-person and Remote Clinic Visits at 90 Days Post Enrollment
Number of in-person clinic visits
|
2 Clinic visits
Interval 1.0 to 3.0
|
2 Clinic visits
Interval 1.0 to 3.0
|
2 Clinic visits
Interval 1.0 to 3.0
|
2 Clinic visits
Interval 1.0 to 3.0
|
|
Number of In-person and Remote Clinic Visits at 90 Days Post Enrollment
Number of virtual/phone clinic visits
|
1 Clinic visits
Interval 1.0 to 1.0
|
1 Clinic visits
Interval 1.0 to 2.0
|
2 Clinic visits
Interval 1.0 to 4.0
|
1 Clinic visits
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: 180 days post enrollmentVia medical record review. Number of visits between day 90 and day 180 post enrollment.
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of In-person and Remote Clinic Visits at 180 Days Post Enrollment
Number of in-person clinic visits
|
1 Clinic visits
Interval 0.0 to 1.0
|
0 Clinic visits
Interval 0.0 to 1.0
|
1 Clinic visits
Interval 0.0 to 2.0
|
0 Clinic visits
Interval 0.0 to 1.0
|
|
Number of In-person and Remote Clinic Visits at 180 Days Post Enrollment
Number of virtual/phone clinic visits
|
0 Clinic visits
Interval 0.0 to 0.0
|
0 Clinic visits
Interval 0.0 to 0.0
|
0 Clinic visits
Interval 0.0 to 0.0
|
0 Clinic visits
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 90 days post enrollmentVia medical record review
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of Remote Device Checks by Providers at 90 Days Post Enrollment
|
17 Remote device checks
Interval 5.0 to 29.0
|
1 Remote device checks
Interval 1.0 to 3.0
|
3 Remote device checks
Interval 3.0 to 3.0
|
6 Remote device checks
Interval 5.0 to 8.0
|
SECONDARY outcome
Timeframe: 180 days post enrollmentVia medical record review
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of Remote Device Checks by Providers at 180 Days Post Enrollment
|
0 Remote device checks
Interval 0.0 to 0.0
|
0 Remote device checks
Interval 0.0 to 0.0
|
0 Remote device checks
Interval 0.0 to 0.0
|
0 Remote device checks
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 90 days post enrollmentVia medical record review of telephone logs between enrollment and day 90 post enrollment.
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment
Number of calls to clinic with questions/inquiry for provider
|
1 Provider-Participant calls
Interval 1.0 to 4.0
|
1 Provider-Participant calls
Interval 1.0 to 2.0
|
1 Provider-Participant calls
Interval 1.0 to 2.0
|
2 Provider-Participant calls
Interval 1.0 to 3.0
|
|
Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment
Number of calls by provider/clinic to patient for check-in
|
2 Provider-Participant calls
Interval 1.0 to 4.0
|
2 Provider-Participant calls
Interval 1.0 to 3.0
|
2 Provider-Participant calls
Interval 1.0 to 3.0
|
2 Provider-Participant calls
Interval 1.0 to 5.0
|
|
Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment
Number of calls by provider/clinic to patient with test results
|
2 Provider-Participant calls
Interval 1.0 to 2.0
|
2 Provider-Participant calls
Interval 1.0 to 2.0
|
1 Provider-Participant calls
Interval 1.0 to 2.0
|
1 Provider-Participant calls
Interval 1.0 to 2.0
|
|
Number of Phone Calls Between Provider and Participant at 90 Days Post Enrollment
Number of appointment reminder calls made to patient
|
3 Provider-Participant calls
Interval 1.0 to 4.0
|
2 Provider-Participant calls
Interval 1.0 to 3.0
|
2 Provider-Participant calls
Interval 1.0 to 2.0
|
2 Provider-Participant calls
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: 180 days post enrollmentVia medical record review of telephone logs
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment
Number of calls to clinic with questions/inquiry for provider
|
0 Patient-provider calls
Interval 0.0 to 0.0
|
0 Patient-provider calls
Interval 0.0 to 1.0
|
0 Patient-provider calls
Interval 0.0 to 0.0
|
0 Patient-provider calls
Interval 0.0 to 1.0
|
|
Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment
Number of calls by provider/clinic to patient for check-in
|
0 Patient-provider calls
Interval 0.0 to 1.0
|
0 Patient-provider calls
Interval 0.0 to 1.0
|
0 Patient-provider calls
Interval 0.0 to 1.0
|
0 Patient-provider calls
Interval 0.0 to 1.0
|
|
Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment
Number of calls by provider/clinic to patient with test results
|
0 Patient-provider calls
Interval 0.0 to 0.0
|
0 Patient-provider calls
Interval 0.0 to 0.0
|
0 Patient-provider calls
Interval 0.0 to 0.0
|
0 Patient-provider calls
Interval 0.0 to 0.0
|
|
Number of Phone Calls Between Provider and Participant at 180 Days Post Enrollment
Number of appointment reminder calls made to patient
|
0 Patient-provider calls
Interval 0.0 to 1.0
|
0 Patient-provider calls
Interval 0.0 to 1.0
|
0 Patient-provider calls
Interval 0.0 to 1.0
|
0 Patient-provider calls
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 90 days post enrollmentPopulation: Current EHR infrastructure does not capture chart openings, thus outcome cannot be assessed because data not collected.
Via medical record review of chart openings per patient
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 180 days post enrollmentPopulation: Current EHR infrastructure does not capture chart openings, thus outcome cannot be assessed because data not collected.
Via medical record review of chart openings per patient
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within one week of consentCollected from patient enrollment platform
Outcome measures
| Measure |
Control
n=44 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
n=46 Participants
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of Subjects Who Complete on Boarding and Baseline Assessments
|
44 Participants
|
46 Participants
|
46 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: 90 days post enrollmentAssessed as number of subjects who used device at least once during their duration in the study, up to 90 days post enrollment.
Outcome measures
| Measure |
Control
n=46 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of Subjects Who Complete Digital Health Product Set up
|
43 Participants
|
23 Participants
|
33 Participants
|
—
|
SECONDARY outcome
Timeframe: 90 days post enrollmentInformation collected from device metrics to assess frequency of use
Outcome measures
| Measure |
Control
n=46 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of Weekly Interactions With the Device
Week 1
|
4 Weekly interactions with device
Standard Deviation 2.2
|
6.9 Weekly interactions with device
Standard Deviation 5.5
|
1.8 Weekly interactions with device
Standard Deviation 0.5
|
—
|
|
Number of Weekly Interactions With the Device
Week 2
|
8.1 Weekly interactions with device
Standard Deviation 5.9
|
6.1 Weekly interactions with device
Standard Deviation 1.8
|
1 Weekly interactions with device
Standard Deviation .2
|
—
|
|
Number of Weekly Interactions With the Device
Week 3
|
7.7 Weekly interactions with device
Standard Deviation 5.4
|
5.7 Weekly interactions with device
Standard Deviation 2.2
|
1 Weekly interactions with device
Standard Deviation 0
|
—
|
|
Number of Weekly Interactions With the Device
Week 4
|
8.3 Weekly interactions with device
Standard Deviation 7.5
|
5.9 Weekly interactions with device
Standard Deviation 2.1
|
1 Weekly interactions with device
Standard Deviation .2
|
—
|
|
Number of Weekly Interactions With the Device
Week 5
|
6.8 Weekly interactions with device
Standard Deviation 3.7
|
5.7 Weekly interactions with device
Standard Deviation 2.2
|
1 Weekly interactions with device
Standard Deviation .2
|
—
|
|
Number of Weekly Interactions With the Device
Week 6
|
6.5 Weekly interactions with device
Standard Deviation 3
|
6.6 Weekly interactions with device
Standard Deviation 1.4
|
1 Weekly interactions with device
Standard Deviation .2
|
—
|
|
Number of Weekly Interactions With the Device
Week 7
|
6.5 Weekly interactions with device
Standard Deviation 2.7
|
6 Weekly interactions with device
Standard Deviation 1.9
|
1 Weekly interactions with device
Standard Deviation 0.2
|
—
|
|
Number of Weekly Interactions With the Device
Week 8
|
6.3 Weekly interactions with device
Standard Deviation 3.1
|
6.8 Weekly interactions with device
Standard Deviation .6
|
1.1 Weekly interactions with device
Standard Deviation .3
|
—
|
|
Number of Weekly Interactions With the Device
Week 9
|
5.7 Weekly interactions with device
Standard Deviation 3.3
|
5.4 Weekly interactions with device
Standard Deviation 2.5
|
1 Weekly interactions with device
Standard Deviation .2
|
—
|
|
Number of Weekly Interactions With the Device
Week 10
|
5.9 Weekly interactions with device
Standard Deviation 3.6
|
5.5 Weekly interactions with device
Standard Deviation 2.5
|
1 Weekly interactions with device
Standard Deviation .2
|
—
|
|
Number of Weekly Interactions With the Device
Week 11
|
6.3 Weekly interactions with device
Standard Deviation 2.8
|
6.4 Weekly interactions with device
Standard Deviation 1.9
|
1.1 Weekly interactions with device
Standard Deviation 0.3
|
—
|
|
Number of Weekly Interactions With the Device
Week 12
|
6.3 Weekly interactions with device
Standard Deviation 3.2
|
5.8 Weekly interactions with device
Standard Deviation 2.4
|
1 Weekly interactions with device
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: 180 days post enrollmentInformation collected from device metrics to assess frequency of use
Outcome measures
| Measure |
Control
n=46 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Number of Weekly Interactions With the Device
Week 13
|
6 Weekly interactions with device
Standard Deviation 3.2
|
6.5 Weekly interactions with device
Standard Deviation 1.5
|
1 Weekly interactions with device
Standard Deviation .2
|
—
|
|
Number of Weekly Interactions With the Device
Week 14
|
6.9 Weekly interactions with device
Standard Deviation 3.6
|
5.8 Weekly interactions with device
Standard Deviation 2.2
|
1 Weekly interactions with device
Standard Deviation .2
|
—
|
|
Number of Weekly Interactions With the Device
Week 15
|
6.3 Weekly interactions with device
Standard Deviation 2.3
|
6.6 Weekly interactions with device
Standard Deviation 1.3
|
1 Weekly interactions with device
Standard Deviation 0
|
—
|
|
Number of Weekly Interactions With the Device
Week 16
|
5.5 Weekly interactions with device
Standard Deviation 2.7
|
6.7 Weekly interactions with device
Standard Deviation .9
|
1.2 Weekly interactions with device
Standard Deviation .5
|
—
|
|
Number of Weekly Interactions With the Device
Week 17
|
6.1 Weekly interactions with device
Standard Deviation 2.9
|
5.8 Weekly interactions with device
Standard Deviation 2.1
|
1.1 Weekly interactions with device
Standard Deviation .3
|
—
|
|
Number of Weekly Interactions With the Device
Week 18
|
5.6 Weekly interactions with device
Standard Deviation 2.8
|
6.8 Weekly interactions with device
Standard Deviation .4
|
1.1 Weekly interactions with device
Standard Deviation .3
|
—
|
|
Number of Weekly Interactions With the Device
Week 19
|
5.9 Weekly interactions with device
Standard Deviation 3.3
|
6.5 Weekly interactions with device
Standard Deviation 1.8
|
1 Weekly interactions with device
Standard Deviation .2
|
—
|
|
Number of Weekly Interactions With the Device
Week 20
|
6.3 Weekly interactions with device
Standard Deviation 2.8
|
6.8 Weekly interactions with device
Standard Deviation .7
|
1 Weekly interactions with device
Standard Deviation .2
|
—
|
|
Number of Weekly Interactions With the Device
Week 21
|
5.2 Weekly interactions with device
Standard Deviation 2.5
|
6.4 Weekly interactions with device
Standard Deviation 1.3
|
1.1 Weekly interactions with device
Standard Deviation .3
|
—
|
|
Number of Weekly Interactions With the Device
Week 22
|
5.5 Weekly interactions with device
Standard Deviation 2.6
|
6.4 Weekly interactions with device
Standard Deviation 1.8
|
1.2 Weekly interactions with device
Standard Deviation .4
|
—
|
|
Number of Weekly Interactions With the Device
Week 23
|
5.2 Weekly interactions with device
Standard Deviation 3.3
|
6.3 Weekly interactions with device
Standard Deviation 1.6
|
1 Weekly interactions with device
Standard Deviation .2
|
—
|
|
Number of Weekly Interactions With the Device
Week 24
|
5.2 Weekly interactions with device
Standard Deviation 3.3
|
6.3 Weekly interactions with device
Standard Deviation 1.6
|
1 Weekly interactions with device
Standard Deviation .2
|
—
|
SECONDARY outcome
Timeframe: 90 days post enrollmentInformation collected from device metric to assess frequency of use
Outcome measures
| Measure |
Control
n=46 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Average Number of Daily Interactions With the Device
|
.7 Interactions per day with device
Standard Deviation .4
|
.5 Interactions per day with device
Standard Deviation .4
|
.1 Interactions per day with device
Standard Deviation .04
|
—
|
SECONDARY outcome
Timeframe: 180 days post enrollmentInformation collected from device metric to assess frequency of use
Outcome measures
| Measure |
Control
n=46 Participants
Patients will receive usual care and no digital health device.
|
BodyPort
n=46 Participants
Patients will receive the BodyPort device.
BodyPort: Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
|
Noom
n=46 Participants
Patients will receive a subscription to the Noom platform.
Noom: Patients will receive a subscription to use Noom, a personalized diet and weight management application.
|
Conversa
Patients will receive a subscription to the Conversa platform.
Conversa: patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
|
|---|---|---|---|---|
|
Average Number of Daily Interactions With the Device
|
.6 Daily interactions with device
Standard Deviation .4
|
.9 Daily interactions with device
Standard Deviation .8
|
.2 Daily interactions with device
Standard Deviation .09
|
—
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
BodyPort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Noom
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conversa
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place