Trial Outcomes & Findings for Storytelling Intervention for African Americans Living With Hypertension (NCT NCT05594264)

NCT ID: NCT05594264

Last Updated: 2024-10-08

Results Overview

Systolic and Diastolic Blood Pressure, Unit of Measure: Percentage of Individuals with Elevated or High Blood Pressure

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

6 weeks

Results posted on

2024-10-08

Participant Flow

Participants were not recruited for the pilot study phase of the study.

Participant milestones

Participant milestones
Measure
Pilot Study Phase
6-week trial of the web-based storytelling study
Feasibility Phase
The objective of the feasibility phase of the study was to recruit 30 participants to view the video stories and provide feedback on engagement and satisfaction with the stories and recommendations for the design of a future research study.
Overall Study
STARTED
0
31
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
0
31

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pilot Study
Participants will participate in a 6-week web-based storytelling study. A 6-week web-based study. Systolic blood pressure, diastolic blood pressure, and medication adherence will be measured at baseline and 6-weeks.
Feasibility Study
n=31 Participants
Participants were invited to provide feedback on the effectiveness of the storytellers, engagement with the website and health information, and preferences for the design of a future intervention.
Total
n=31 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
0 Participants
n=31 Participants
0 Participants
n=31 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
25 Participants
n=31 Participants
25 Participants
n=31 Participants
Age, Categorical
>=65 years
0 Participants
6 Participants
n=31 Participants
6 Participants
n=31 Participants
Age, Continuous
53 years
STANDARD_DEVIATION 15 • n=31 Participants
53 years
STANDARD_DEVIATION 15 • n=31 Participants
Sex: Female, Male
Female
26 Participants
n=31 Participants
26 Participants
n=31 Participants
Sex: Female, Male
Male
5 Participants
n=31 Participants
5 Participants
n=31 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Education
some HS, HS, GED
2 Participants
n=31 Participants
2 Participants
n=31 Participants
Education
Some College, Trade, Associates
12 Participants
n=31 Participants
12 Participants
n=31 Participants
Education
Bachelors
9 Participants
n=31 Participants
9 Participants
n=31 Participants
Education
Masters/Doctorate
8 Participants
n=31 Participants
8 Participants
n=31 Participants
Income
<$50,000
18 Participants
n=31 Participants
18 Participants
n=31 Participants
Income
$50,000-<$100,000
8 Participants
n=31 Participants
8 Participants
n=31 Participants
Income
>$100,000
5 Participants
n=31 Participants
5 Participants
n=31 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Blood pressure was an outcome measure for the pilot study only. The pilot study was not initiated due to the funding ending before the study could begin. Blood pressure was not collected for either arm and there was no data to assess.

Systolic and Diastolic Blood Pressure, Unit of Measure: Percentage of Individuals with Elevated or High Blood Pressure

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 weeks

Population: Medication adherence was an outcome for the pilot study, not the feasibility study. The pilot study was not initiated due to the end of funding. Medication adherence data was not collected for any participants and there was no data to analyze.

Self-reported medication adherence, Unit of Measure: Percentage of Individuals reporting low, moderate, or high adherence

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline

Effectiveness and engagement were measured in the cross-section survey for the feasibility phase of the study. These measures were used to explore participants perceptions of the stories, participants self reported if the stories were engaging and effective in promoting lifestyle change.

Outcome measures

Outcome data not reported

Adverse Events

Pilot Study

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Feasibility Phase

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

Dr. Yendelela Cuffee

University of Delaware

Phone: (302) 831-1302

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place