Trial Outcomes & Findings for Continuing the Conversation: Using Narrative Communication to Support Hypertension Self-management in African American Veterans (NCT NCT03970590)
NCT ID: NCT03970590
Last Updated: 2025-04-03
Results Overview
Blood Pressure (H1), will be calculated / performed to detect a difference in the change in both Diastolic and Systolic BP, comparing intervention and control.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
600 participants
Primary outcome timeframe
From enrollment to the time of follow-up, up to 8 months
Results posted on
2025-04-03
Participant Flow
Participant milestones
| Measure |
CTC Intervention
An integrated peer narrative-based intervention (VIEW \> SELECT \> GET), beginning with VIEW In-person viewing of VA Stories narratives, followed by SELECT a favorite Veteran Storyteller, and then GET favorite Storyteller "narrative-aligned" text messages over 6 months
|
Control
6-month HTN management assessment text messages without narrative component
Control: 6-month HTN management assessment text messages without narrative component
|
|---|---|---|
|
Overall Study
STARTED
|
300
|
300
|
|
Overall Study
COMPLETED
|
289
|
262
|
|
Overall Study
NOT COMPLETED
|
11
|
38
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Some participants declined to answer certain questions.
Baseline characteristics by cohort
| Measure |
CTC Intervention
n=300 Participants
An integrated peer narrative-based intervention (VIEW \> SELECT \> GET), beginning with VIEW In-person viewing of VA Stories narratives, followed by SELECT a favorite Veteran Storyteller, and then GET favorite Storyteller "narrative-aligned" text messages over 6 months
|
Control
n=300 Participants
6-month HTN management assessment text messages without narrative component
Control: 6-month HTN management assessment text messages without narrative component
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=288 Participants • Some participants declined to answer certain questions.
|
0 Participants
n=298 Participants • Some participants declined to answer certain questions.
|
0 Participants
n=586 Participants • Some participants declined to answer certain questions.
|
|
Age, Categorical
Between 18 and 65 years
|
148 Participants
n=288 Participants • Some participants declined to answer certain questions.
|
150 Participants
n=298 Participants • Some participants declined to answer certain questions.
|
298 Participants
n=586 Participants • Some participants declined to answer certain questions.
|
|
Age, Categorical
>=65 years
|
140 Participants
n=288 Participants • Some participants declined to answer certain questions.
|
148 Participants
n=298 Participants • Some participants declined to answer certain questions.
|
288 Participants
n=586 Participants • Some participants declined to answer certain questions.
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 9 • n=288 Participants • Some participants declined to answer.
|
64 years
STANDARD_DEVIATION 9 • n=298 Participants • Some participants declined to answer.
|
64 years
STANDARD_DEVIATION 9 • n=586 Participants • Some participants declined to answer.
|
|
Sex: Female, Male
Female
|
70 Participants
n=299 Participants • Some participants declined to answer.
|
58 Participants
n=298 Participants • Some participants declined to answer.
|
128 Participants
n=597 Participants • Some participants declined to answer.
|
|
Sex: Female, Male
Male
|
229 Participants
n=299 Participants • Some participants declined to answer.
|
240 Participants
n=298 Participants • Some participants declined to answer.
|
469 Participants
n=597 Participants • Some participants declined to answer.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=300 Participants
|
0 Participants
n=300 Participants
|
0 Participants
n=600 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=300 Participants
|
0 Participants
n=300 Participants
|
0 Participants
n=600 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=300 Participants
|
0 Participants
n=300 Participants
|
0 Participants
n=600 Participants
|
|
Race (NIH/OMB)
Black or African American
|
300 Participants
n=300 Participants
|
300 Participants
n=300 Participants
|
600 Participants
n=600 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=300 Participants
|
0 Participants
n=300 Participants
|
0 Participants
n=600 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=300 Participants
|
0 Participants
n=300 Participants
|
0 Participants
n=600 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=300 Participants
|
0 Participants
n=300 Participants
|
0 Participants
n=600 Participants
|
|
Region of Enrollment
United States
|
300 Participants
n=300 Participants
|
300 Participants
n=300 Participants
|
600 Participants
n=600 Participants
|
PRIMARY outcome
Timeframe: From enrollment to the time of follow-up, up to 8 monthsPopulation: Participants who completed study follow-up.
Blood Pressure (H1), will be calculated / performed to detect a difference in the change in both Diastolic and Systolic BP, comparing intervention and control.
Outcome measures
| Measure |
CTC Intervention
n=262 Participants
An integrated peer narrative-based intervention (VIEW \> SELECT \> GET), beginning with VIEW In-person viewing of VA Stories narratives, followed by SELECT a favorite Veteran Storyteller, and then GET favorite Storyteller "narrative-aligned" text messages over 6 months
|
Control
n=264 Participants
6-month HTN management assessment text messages without narrative component
Control: 6-month HTN management assessment text messages without narrative component
|
|---|---|---|
|
BP Measurement Change at Follow-up
Systolic
|
132 mmHg
Standard Deviation 17
|
133 mmHg
Standard Deviation 15
|
|
BP Measurement Change at Follow-up
Diastolic
|
80 mmHg
Standard Deviation 11
|
78 mmHg
Standard Deviation 12
|
Adverse Events
CTC Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sarah Cutrona, MD
VA Bedford Healthcare System Center for Health Organization and Implementation Research
Phone: 781-687-2861
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place