Trial Outcomes & Findings for A Study of Cardiovascular Disparities in the Greater Mankato Somali Community to Prevent Hypertension (NCT NCT05873153)
NCT ID: NCT05873153
Last Updated: 2026-07-24
Results Overview
Number of subjects to follow up with a primary care provider
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
3 months
Results posted on
2026-07-24
Participant Flow
Recruitment occurred from February 2023 through November 2024.
Participant milestones
| Measure |
Intervention Group
The intervention groups received Directed health education By community health workers, received a personal use blood pressure monitor, and referral to the primary care provider available PCP.
|
Control Group
participants were referred to their primary care provider or an available PCP.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
|
Overall Study
COMPLETED
|
15
|
8
|
|
Overall Study
NOT COMPLETED
|
6
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
age data were pre-specified to not be collected for this study
Baseline characteristics by cohort
| Measure |
Intervention Group
n=15 Participants
The intervention groups received Directed health education By community health workers, received a personal use blood pressure monitor, and referral to the primary care provider available PCP.
|
Control Group
n=9 Participants
participants were referred to their primary care provider or an available PCP.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
age data were pre-specified to not be collected for this study
|
0 Participants
age data were pre-specified to not be collected for this study
|
0 Participants
age data were pre-specified to not be collected for this study
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
age data were pre-specified to not be collected for this study
|
0 Participants
age data were pre-specified to not be collected for this study
|
0 Participants
age data were pre-specified to not be collected for this study
|
|
Age, Categorical
>=65 years
|
0 Participants
age data were pre-specified to not be collected for this study
|
0 Participants
age data were pre-specified to not be collected for this study
|
0 Participants
age data were pre-specified to not be collected for this study
|
|
Sex: Female, Male
Female
|
6 Participants
n=15 Participants
|
3 Participants
n=9 Participants
|
9 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=15 Participants
|
6 Participants
n=9 Participants
|
15 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=15 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=15 Participants
|
9 Participants
n=9 Participants
|
24 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=15 Participants
|
9 Participants
n=9 Participants
|
24 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=15 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
|
PCP at baseline
|
12 participants
n=15 Participants
|
7 participants
n=9 Participants
|
19 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Many patients were unable to contacted or moved out of study area during study.
Number of subjects to follow up with a primary care provider
Outcome measures
| Measure |
Intervention Group
n=15 Participants
The intervention groups received Directed health education By community health workers, received a personal use blood pressure monitor, and referral to the primary care provider available PCP.
|
Control Group
n=9 Participants
participants were referred to their primary care provider or an available PCP.
|
|---|---|---|
|
PCP Follow up
|
15 participant
0
|
8 participant
1
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 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