Trial Outcomes & Findings for Reducing Inequities in Care of Hypertension, Lifestyle Improvement for Everyone (RICH LIFE Project) (NCT NCT02674464)
NCT ID: NCT02674464
Last Updated: 2022-07-01
Results Overview
Number of participants with Controlled Blood Pressure (\<140/90 mm Hg).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1820 participants
Primary outcome timeframe
12 months
Results posted on
2022-07-01
Participant Flow
Using eligibility criteria, the study biostatistician screened participating health systems' electronic medical record (EMR) data to identify potentially eligible patients. Only patients seen within 6 months prior to the recruitment data pull were assessed for eligibility. Trained study staff recruited participants between August 1, 2017, and October 31, 2019. The baseline blood pressure measurement was included in the recruitment data.
Participants were considered enrolled upon completing the baseline survey. Whenever possible, trained study staff administered the baseline survey immediately after obtaining consent to participate.
Unit of analysis: Clusters
Participant milestones
| Measure |
Standard of Care Plus
Practices in the Standard of Care Plus (SCP) comparator group received interventions designed to reinforce and standardize evidence-based hypertension care best practices across both intervention and comparator practices. The "plus" in the standard care arm included integration of proper BP measurement techniques, hypertension care best practices, and audit and feedback of hypertension control performance, as "usual care" at each practice. Additionally, health-system- and practice-level leaders at SCP practices participated in a system-level leadership engagement intervention consisting of quarterly, one-hour calls.
|
Collaborative Care/Stepped Care (CC/SC)
The intensive Collaborative Care/Stepped Care (CC/SC) arm includes all components of the SCP arm and plus the establishment of a practice-based collaborative care team with a stepped-care approach; quarterly hypertension dashboard education and training; and twice quarterly "coaching calls" for system- and practice-level leaders, care managers (CM), and community health workers (CHWs) the CC/SC arm to discuss the interventions during their active intervention phase.
In the CC/SC approach, treatment for patients with prolonged uncontrolled hypertension is enhanced by adding a care manager and a community health worker (CHW) to deliver community-based contextualized care, or consultation with a panel of sub-specialists, or both, as necessary, to improve patient-centered outcomes and reduce disparities in hypertension control.
|
|---|---|---|
|
Overall Study
STARTED
|
927 15
|
893 15
|
|
Overall Study
6 Month Follow-up
|
771 15
|
806 15
|
|
Overall Study
COMPLETED
|
790 15
|
733 15
|
|
Overall Study
NOT COMPLETED
|
137 0
|
160 0
|
Reasons for withdrawal
| Measure |
Standard of Care Plus
Practices in the Standard of Care Plus (SCP) comparator group received interventions designed to reinforce and standardize evidence-based hypertension care best practices across both intervention and comparator practices. The "plus" in the standard care arm included integration of proper BP measurement techniques, hypertension care best practices, and audit and feedback of hypertension control performance, as "usual care" at each practice. Additionally, health-system- and practice-level leaders at SCP practices participated in a system-level leadership engagement intervention consisting of quarterly, one-hour calls.
|
Collaborative Care/Stepped Care (CC/SC)
The intensive Collaborative Care/Stepped Care (CC/SC) arm includes all components of the SCP arm and plus the establishment of a practice-based collaborative care team with a stepped-care approach; quarterly hypertension dashboard education and training; and twice quarterly "coaching calls" for system- and practice-level leaders, care managers (CM), and community health workers (CHWs) the CC/SC arm to discuss the interventions during their active intervention phase.
In the CC/SC approach, treatment for patients with prolonged uncontrolled hypertension is enhanced by adding a care manager and a community health worker (CHW) to deliver community-based contextualized care, or consultation with a panel of sub-specialists, or both, as necessary, to improve patient-centered outcomes and reduce disparities in hypertension control.
|
|---|---|---|
|
Overall Study
Death
|
10
|
21
|
|
Overall Study
Withdrawal by Subject
|
24
|
44
|
|
Overall Study
Lost to Follow-up
|
97
|
92
|
|
Overall Study
Outside survey window
|
6
|
3
|
Baseline Characteristics
Reducing Inequities in Care of Hypertension, Lifestyle Improvement for Everyone (RICH LIFE Project)
Baseline characteristics by cohort
| Measure |
Standard of Care Plus (SCP)
n=927 Participants
Practices in the Standard of Care Plus (SCP) comparator group received interventions designed to reinforce and standardize evidence-based hypertension care best practices across both intervention and comparator practices. The "plus" in the standard care arm included integration of proper BP measurement techniques, hypertension care best practices, and audit and feedback of hypertension control performance, as "usual care" at each practice. Additionally, health-system- and practice-level leaders at SCP practices participated in a system-level leadership engagement intervention consisting of quarterly, one-hour calls.
|
Collaborative Care/Stepped Care (CC/SC)
n=893 Participants
The intensive Collaborative Care/Stepped Care (CC/SC) arm includes all components of the SCP arm and plus the establishment of a practice-based collaborative care team with a stepped-care approach; quarterly hypertension dashboard education and training; and twice quarterly "coaching calls" for system- and practice-level leaders, care managers (CM), and community health workers (CHWs) the CC/SC arm to discuss the interventions during their active intervention phase.
In the CC/SC approach, treatment for patients with prolonged uncontrolled hypertension is enhanced by adding a care manager and a community health worker (CHW) to deliver community-based contextualized care, or consultation with a panel of sub-specialists, or both, as necessary, to improve patient-centered outcomes and reduce disparities in hypertension control.
|
Total
n=1820 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
60.3 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
534 Participants
n=5 Participants
|
547 Participants
n=7 Participants
|
1081 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
393 Participants
n=5 Participants
|
346 Participants
n=7 Participants
|
739 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
130 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
797 Participants
n=5 Participants
|
851 Participants
n=7 Participants
|
1648 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
463 Participants
n=5 Participants
|
566 Participants
n=7 Participants
|
1029 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
359 Participants
n=5 Participants
|
279 Participants
n=7 Participants
|
638 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
74 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
927 Participants
n=5 Participants
|
893 Participants
n=7 Participants
|
1820 Participants
n=5 Participants
|
|
Education, highest degree
Less than high school diploma
|
156 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
333 Participants
n=5 Participants
|
|
Education, highest degree
High school diploma/GED
|
434 Participants
n=5 Participants
|
428 Participants
n=7 Participants
|
862 Participants
n=5 Participants
|
|
Education, highest degree
Some college
|
113 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Education, highest degree
Bachelor's degree
|
115 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Education, highest degree
Graduate degree
|
105 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Education, highest degree
Missing (refused)
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Medicaid
Yes
|
218 Participants
n=5 Participants
|
264 Participants
n=7 Participants
|
482 Participants
n=5 Participants
|
|
Medicaid
No
|
703 Participants
n=5 Participants
|
624 Participants
n=7 Participants
|
1327 Participants
n=5 Participants
|
|
Medicaid
Missing
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Systolic Blood Pressure
|
151.9 mm Hg
STANDARD_DEVIATION 11.7 • n=5 Participants
|
152.7 mm Hg
STANDARD_DEVIATION 12.9 • n=7 Participants
|
152.3 mm Hg
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Diastolic Blood Pressure
|
84.4 mm Hg
STANDARD_DEVIATION 11.7 • n=5 Participants
|
86.6 mm Hg
STANDARD_DEVIATION 12.9 • n=7 Participants
|
85.5 mm Hg
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Diabetes
|
429 Participants
n=5 Participants
|
392 Participants
n=7 Participants
|
821 Participants
n=5 Participants
|
|
Hyperlipidemia
|
700 Participants
n=5 Participants
|
646 Participants
n=7 Participants
|
1346 Participants
n=5 Participants
|
|
Coronary heart disease
|
149 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
Depression
|
263 Participants
n=5 Participants
|
256 Participants
n=7 Participants
|
519 Participants
n=5 Participants
|
|
Smoker
|
267 Participants
n=5 Participants
|
280 Participants
n=7 Participants
|
547 Participants
n=5 Participants
|
|
Patient Activation Measure (PAM-13)
|
65.4 score on a scale
STANDARD_DEVIATION 16.2 • n=5 Participants
|
66.7 score on a scale
STANDARD_DEVIATION 15.9 • n=7 Participants
|
66.0 score on a scale
STANDARD_DEVIATION 16.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: We received BP data on 750 patients in the SCP arm and on 754 patients in the CC/SC arm from EMR's.
Number of participants with Controlled Blood Pressure (\<140/90 mm Hg).
Outcome measures
| Measure |
Standard of Care Plus (SCP)
n=750 Participants
Practices in the Standard of Care Plus (SCP) comparator group received interventions designed to reinforce and standardize evidence-based hypertension care best practices across both intervention and comparator practices. The "plus" in the standard care arm included integration of proper BP measurement techniques, hypertension care best practices, and audit and feedback of hypertension control performance, as "usual care" at each practice. Additionally, health-system- and practice-level leaders at SCP practices participated in a system-level leadership engagement intervention consisting of quarterly, one-hour calls.
|
Collaborative Care/Stepped Care (CC/SC)
n=754 Participants
The intensive Collaborative Care/Stepped Care (CC/SC) arm includes all components of the SCP arm and plus the establishment of a practice-based collaborative care team with a stepped-care approach; quarterly hypertension dashboard education and training; and twice quarterly "coaching calls" for system- and practice-level leaders, care managers (CM), and community health workers (CHWs) the CC/SC arm to discuss the interventions during their active intervention phase.
In the CC/SC approach, treatment for patients with prolonged uncontrolled hypertension is enhanced by adding a care manager and a community health worker (CHW) to deliver community-based contextualized care, or consultation with a panel of sub-specialists, or both, as necessary, to improve patient-centered outcomes and reduce disparities in hypertension control.
|
|---|---|---|
|
Number of Participants With Controlled Blood Pressure
|
462 Participants
|
442 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 monthsPopulation: 790 patients in the SCP arm completed the follow-up survey at 12-months, but 1 patient did not complete the PAM-13 (primary patient-reported outcome) questions in the survey resulting in 789 patients in the sample. 733 patients in the CC/SC arm competed the follow-up survey at 12-months, but 2 patients did not complete the PAM-13 (primary patient-reported outcome) questions in the survey resulting in 731 patients in the sample.
The Patient Activation Measure assesses knowledge, skills, and confidence in the management of one's health. It is comprised of 13 items and each item is on a 1-5 scale. Insignia health scores on a standardized overall score of 0-100 where higher scores indicate a better outcome.
Outcome measures
| Measure |
Standard of Care Plus (SCP)
n=789 Participants
Practices in the Standard of Care Plus (SCP) comparator group received interventions designed to reinforce and standardize evidence-based hypertension care best practices across both intervention and comparator practices. The "plus" in the standard care arm included integration of proper BP measurement techniques, hypertension care best practices, and audit and feedback of hypertension control performance, as "usual care" at each practice. Additionally, health-system- and practice-level leaders at SCP practices participated in a system-level leadership engagement intervention consisting of quarterly, one-hour calls.
|
Collaborative Care/Stepped Care (CC/SC)
n=731 Participants
The intensive Collaborative Care/Stepped Care (CC/SC) arm includes all components of the SCP arm and plus the establishment of a practice-based collaborative care team with a stepped-care approach; quarterly hypertension dashboard education and training; and twice quarterly "coaching calls" for system- and practice-level leaders, care managers (CM), and community health workers (CHWs) the CC/SC arm to discuss the interventions during their active intervention phase.
In the CC/SC approach, treatment for patients with prolonged uncontrolled hypertension is enhanced by adding a care manager and a community health worker (CHW) to deliver community-based contextualized care, or consultation with a panel of sub-specialists, or both, as necessary, to improve patient-centered outcomes and reduce disparities in hypertension control.
|
|---|---|---|
|
Patient Activation Measure (PAM-13)
Baseline
|
65.4 score on a scale
Interval 63.4 to 67.4
|
66.1 score on a scale
Interval 64.6 to 68.7
|
|
Patient Activation Measure (PAM-13)
12 months
|
66.7 score on a scale
Interval 64.6 to 68.7
|
67.9 score on a scale
Interval 65.8 to 70.0
|
SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: We received BP data on 750 patients in the SCP arm and on 754 patients in the CC/SC arm from EMR's.
Mean Systolic Blood Pressure in mm Hg at baseline and 12 months.
Outcome measures
| Measure |
Standard of Care Plus (SCP)
n=750 Participants
Practices in the Standard of Care Plus (SCP) comparator group received interventions designed to reinforce and standardize evidence-based hypertension care best practices across both intervention and comparator practices. The "plus" in the standard care arm included integration of proper BP measurement techniques, hypertension care best practices, and audit and feedback of hypertension control performance, as "usual care" at each practice. Additionally, health-system- and practice-level leaders at SCP practices participated in a system-level leadership engagement intervention consisting of quarterly, one-hour calls.
|
Collaborative Care/Stepped Care (CC/SC)
n=754 Participants
The intensive Collaborative Care/Stepped Care (CC/SC) arm includes all components of the SCP arm and plus the establishment of a practice-based collaborative care team with a stepped-care approach; quarterly hypertension dashboard education and training; and twice quarterly "coaching calls" for system- and practice-level leaders, care managers (CM), and community health workers (CHWs) the CC/SC arm to discuss the interventions during their active intervention phase.
In the CC/SC approach, treatment for patients with prolonged uncontrolled hypertension is enhanced by adding a care manager and a community health worker (CHW) to deliver community-based contextualized care, or consultation with a panel of sub-specialists, or both, as necessary, to improve patient-centered outcomes and reduce disparities in hypertension control.
|
|---|---|---|
|
Mean Systolic Blood Pressure
Baseline
|
151.8 mm Hg
Interval 150.3 to 153.3
|
152.5 mm Hg
Interval 151.0 to 154.0
|
|
Mean Systolic Blood Pressure
12 months
|
137.1 mm Hg
Interval 135.5 to 138.7
|
138.7 mm Hg
Interval 137.1 to 140.2
|
SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: We received BP data on 750 patients in the SCP arm and on 754 patients in the CC/SC arm from EMR's.
Mean Diastolic Blood Pressure in mm Hg at baseline and 12 months.
Outcome measures
| Measure |
Standard of Care Plus (SCP)
n=750 Participants
Practices in the Standard of Care Plus (SCP) comparator group received interventions designed to reinforce and standardize evidence-based hypertension care best practices across both intervention and comparator practices. The "plus" in the standard care arm included integration of proper BP measurement techniques, hypertension care best practices, and audit and feedback of hypertension control performance, as "usual care" at each practice. Additionally, health-system- and practice-level leaders at SCP practices participated in a system-level leadership engagement intervention consisting of quarterly, one-hour calls.
|
Collaborative Care/Stepped Care (CC/SC)
n=754 Participants
The intensive Collaborative Care/Stepped Care (CC/SC) arm includes all components of the SCP arm and plus the establishment of a practice-based collaborative care team with a stepped-care approach; quarterly hypertension dashboard education and training; and twice quarterly "coaching calls" for system- and practice-level leaders, care managers (CM), and community health workers (CHWs) the CC/SC arm to discuss the interventions during their active intervention phase.
In the CC/SC approach, treatment for patients with prolonged uncontrolled hypertension is enhanced by adding a care manager and a community health worker (CHW) to deliver community-based contextualized care, or consultation with a panel of sub-specialists, or both, as necessary, to improve patient-centered outcomes and reduce disparities in hypertension control.
|
|---|---|---|
|
Mean Diastolic Blood Pressure
Baseline
|
84.7 mm Hg
Interval 82.8 to 86.5
|
86.7 mm Hg
Interval 84.9 to 88.6
|
|
Mean Diastolic Blood Pressure
12 months
|
78.9 mm Hg
Interval 77.1 to 80.8
|
79.8 mm Hg
Interval 77.9 to 81.7
|
SECONDARY outcome
Timeframe: Baseline, 12, 24 monthsClinical Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12, 24 monthsClinical Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12, 24 monthsClinical Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12, 24 monthsClinical Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineClinical Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsClinical Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsClinical Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12, 24 monthsClinical Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineClinical Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsClinical Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsClinical Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12, 24 monthsPatient Reported Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsClinical Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsClinical Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsClinical Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsClinical Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsClinical Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12, 24 monthsPatient Reported Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline 12, 24 monthsPatient Reported Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12, 24 monthsPatient Reported Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12, 24 monthsPatient Reported Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12, 24 monthsPatient Reported Outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12, 24 monthsPatient Reported Outcome
Outcome measures
Outcome data not reported
Adverse Events
Standard of Care Plus (SCP)
Serious events: 0 serious events
Other events: 515 other events
Deaths: 21 deaths
Collaborative Care/Stepped Care (CC/SC)
Serious events: 0 serious events
Other events: 499 other events
Deaths: 34 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care Plus (SCP)
n=927 participants at risk
Practices in the Standard of Care Plus (SCP) comparator group received interventions designed to reinforce and standardize evidence-based hypertension care best practices across both intervention and comparator practices. The "plus" in the standard care arm included integration of proper BP measurement techniques, hypertension care best practices, and audit and feedback of hypertension control performance, as "usual care" at each practice. Additionally, health-system- and practice-level leaders at SCP practices participated in a system-level leadership engagement intervention consisting of quarterly, one-hour calls.
|
Collaborative Care/Stepped Care (CC/SC)
n=893 participants at risk
The intensive Collaborative Care/Stepped Care (CC/SC) arm includes all components of the SCP arm and plus the establishment of a practice-based collaborative care team with a stepped-care approach; quarterly hypertension dashboard education and training; and twice quarterly "coaching calls" for system- and practice-level leaders, care managers (CM), and community health workers (CHWs) the CC/SC arm to discuss the interventions during their active intervention phase.
In the CC/SC approach, treatment for patients with prolonged uncontrolled hypertension is enhanced by adding a care manager and a community health worker (CHW) to deliver community-based contextualized care, or consultation with a panel of sub-specialists, or both, as necessary, to improve patient-centered outcomes and reduce disparities in hypertension control.
|
|---|---|---|
|
Cardiac disorders
Self-reported stroke
|
2.5%
22/875 • Adverse events data were collected up to 1 year.
|
2.9%
24/835 • Adverse events data were collected up to 1 year.
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
9/875 • Adverse events data were collected up to 1 year.
|
2.3%
19/835 • Adverse events data were collected up to 1 year.
|
|
General disorders
Fall precipitating medical treatment
|
9.6%
84/875 • Adverse events data were collected up to 1 year.
|
9.8%
82/835 • Adverse events data were collected up to 1 year.
|
|
General disorders
Hospitalizations
|
25.9%
227/875 • Adverse events data were collected up to 1 year.
|
25.4%
212/835 • Adverse events data were collected up to 1 year.
|
|
Cardiac disorders
Hypotension
|
22.6%
197/873 • Adverse events data were collected up to 1 year.
|
22.1%
186/842 • Adverse events data were collected up to 1 year.
|
|
Cardiac disorders
Hypertension
|
16.8%
147/873 • Adverse events data were collected up to 1 year.
|
17.8%
150/842 • Adverse events data were collected up to 1 year.
|
|
Cardiac disorders
Bradycardia
|
0.34%
3/873 • Adverse events data were collected up to 1 year.
|
0.00%
0/842 • Adverse events data were collected up to 1 year.
|
|
General disorders
Hyponatremia
|
0.65%
6/927 • Adverse events data were collected up to 1 year.
|
1.3%
12/893 • Adverse events data were collected up to 1 year.
|
|
General disorders
Hypernatremia
|
0.11%
1/927 • Adverse events data were collected up to 1 year.
|
0.22%
2/893 • Adverse events data were collected up to 1 year.
|
|
General disorders
Hypokalemia
|
0.65%
6/927 • Adverse events data were collected up to 1 year.
|
0.90%
8/893 • Adverse events data were collected up to 1 year.
|
|
General disorders
Hyperkalemia
|
2.3%
21/927 • Adverse events data were collected up to 1 year.
|
3.2%
29/893 • Adverse events data were collected up to 1 year.
|
|
Renal and urinary disorders
Serum creatinine increase by at least 50% since previous measure
|
0.97%
9/927 • Adverse events data were collected up to 1 year.
|
1.7%
15/893 • Adverse events data were collected up to 1 year.
|
Additional Information
Dr. Lisa Cooper, Principal Investigator
Johns Hopkins University School of Medicine
Phone: 4106143659
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place