Trial Outcomes & Findings for Using Stories to Address Disparities in Hypertension (NCT NCT01276197)
NCT ID: NCT01276197
Last Updated: 2016-12-02
Results Overview
Systolic Bp measurement at 6-month follow-up; we modeled the impact of Intervention assignment on SBP, adjusting for Baseline. Thus, baseline SBP was collected but not used as outcome; Baseline SBP us used as a covariate.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
618 participants
Primary outcome timeframe
6 months after intervention
Results posted on
2016-12-02
Participant Flow
Participant milestones
| Measure |
Arm 1: Story-Telling DVD
Participant will receive a DVD with informational and story-telling components
Story-Telling DVD: DVD will contain both informational and story-telling components.
|
Arm 2: Non-Storytelling DVD
Participant will receive an informational DVD
Non-Storytelling DVD: DVD will contain only informational component.
|
|---|---|---|
|
Overall Study
STARTED
|
308
|
310
|
|
Overall Study
COMPLETED
|
200
|
200
|
|
Overall Study
NOT COMPLETED
|
108
|
110
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using Stories to Address Disparities in Hypertension
Baseline characteristics by cohort
| Measure |
Arm 1: Story-Telling DVD
n=308 Participants
Participant will receive a DVD with informational and story-telling components
Story-Telling DVD: DVD will contain both informational and story-telling components.
|
Arm 2: Non-Storytelling DVD
n=310 Participants
Participant will receive an informational DVD
Non-Storytelling DVD: DVD will contain only informational component.
|
Total
n=618 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
190 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
376 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
118 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
282 Participants
n=5 Participants
|
285 Participants
n=7 Participants
|
567 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
308 Participants
n=5 Participants
|
310 Participants
n=7 Participants
|
618 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months after interventionPopulation: Our analyses was completed with those who completed follow-up visit and varies from participant flow as we are not able to include those lost to follow-up.
Systolic Bp measurement at 6-month follow-up; we modeled the impact of Intervention assignment on SBP, adjusting for Baseline. Thus, baseline SBP was collected but not used as outcome; Baseline SBP us used as a covariate.
Outcome measures
| Measure |
Arm 1: Story-Telling DVD
n=264 Participants
Participant will receive a DVD with informational and story-telling components
Story-Telling DVD: DVD will contain both informational and story-telling components.
|
Arm 2: Non-Storytelling DVD
n=270 Participants
Participant will receive an informational DVD
Non-Storytelling DVD: DVD will contain only informational component.
|
|---|---|---|
|
Systolic BP at Follow-up
|
137.9 mmHg
Standard Deviation 18.4
|
141.2 mmHg
Standard Deviation 17.8
|
PRIMARY outcome
Timeframe: 6-month following interventionParticipants BP measurement at 6-month follow-up
Outcome measures
| Measure |
Arm 1: Story-Telling DVD
n=264 Participants
Participant will receive a DVD with informational and story-telling components
Story-Telling DVD: DVD will contain both informational and story-telling components.
|
Arm 2: Non-Storytelling DVD
n=270 Participants
Participant will receive an informational DVD
Non-Storytelling DVD: DVD will contain only informational component.
|
|---|---|---|
|
Diastolic BP Measurement at Follow-up
|
80.1 mmHg
Standard Deviation 13.0
|
81.9 mmHg
Standard Deviation 13.1
|
Adverse Events
Arm 1: Story-Telling DVD
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Non-Storytelling DVD
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Story-Telling DVD
n=308 participants at risk
Participant will receive a DVD with informational and story-telling components
Story-Telling DVD: DVD will contain both informational and story-telling components.
|
Arm 2: Non-Storytelling DVD
n=310 participants at risk
Participant will receive an informational DVD
Non-Storytelling DVD: DVD will contain only informational component.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Death
|
0.65%
2/308 • Number of events 2
|
0.65%
2/310 • Number of events 2
|
|
Cardiac disorders
Hospitalization
|
3.2%
10/308 • Number of events 10
|
2.6%
8/310 • Number of events 8
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place