Storytelling Intervention for African Americans Living With Hypertension
Primary Purpose
Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HBPStories
Sponsored by
About this trial
This is an interventional prevention trial for Hypertension focused on measuring Storytelling, Hypertension
Eligibility Criteria
Inclusion Criteria:
The study inclusion criteria are as follows:
- self-reported hypertension
- race/ethnicity: Black or African American
- prescribed antihypertensive medication
- age ≥ 18 years
Exclusion Criteria:
The exclusion criteria are:
- cognitive limitations that limit the ability to provide informed consent
- unable to speak or read English
Sites / Locations
- University of DelawareRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Web-based Storytelling
Arm Description
Participants will participate in a 6-week web-based storytelling study.
Outcomes
Primary Outcome Measures
Blood Pressure
Systolic and Diastolic Blood Pressure, Unit of Measure: Percentage of Individuals with Elevated or High Blood Pressure
Medication Adherence
Self-reported using the DOSE-Nonadherence Scale, Unit of Measure: Percentage of Individuals reporting low, moderate, or high adherence
Secondary Outcome Measures
Diet
Self-reported using the Assessment of Dietary Adherence and Identification of Barriers to Healthy Eating, Unit of Measure: Percent of participants reporting a healthy diet
Physical Activity
Self-reported using the Yale Physical Activity Scale, Unit of Measure: Rates of physical inactivity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05594264
Brief Title
Storytelling Intervention for African Americans Living With Hypertension
Official Title
Developing and Implementing a Storytelling Intervention for African Americans Living With Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Delaware
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Narrative communication (e.g., storytelling) is an approach that has contributed to behavioral change for individuals with conditions such as diabetes, breast cancer, and hypertension. The objective of this study is to conduct a feasibility and pilot study storytelling intervention for African Americans with hypertension. In the feasibility phase 30 African Americans with hypertension will be recruited to view nine patient stories and provide feedback on the effectiveness, usefulness, and satisfaction with the stories. Nine African Americans adults with hypertension were filmed, sharing experiences living with and managing hypertension; including, diet and exercise tips, suggestions for locating healthy foods, and motivational stories about successfully controlling hypertension. During the feasibility phase feedback will also be elicited from the participants about the best approaches for delivering a storytelling intervention, and obtain feedback on the resources and health information that would be helpful to an individual participating in a storytelling intervention. In the pilot study phase, 30 African Americans adults with hypertension will be recruited to participate in a 6-week trial, each week the participants will watch one story and review one module of health information accessible through the study specific website developed for the HBPStories study. Data will be collected at baseline and 6-weeks including systolic and diastolic blood pressure, medication adherence, health behaviors such as diet and physical activity, and psychosocial measures including positive affect and self-efficacy in the management of hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Storytelling, Hypertension
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Web-based Storytelling
Arm Type
Experimental
Arm Description
Participants will participate in a 6-week web-based storytelling study.
Intervention Type
Behavioral
Intervention Name(s)
HBPStories
Intervention Description
A 6-week web-based study. Systolic blood pressure, diastolic blood pressure, and medication adherence will be measured at baseline and 6-weeks.
Primary Outcome Measure Information:
Title
Blood Pressure
Description
Systolic and Diastolic Blood Pressure, Unit of Measure: Percentage of Individuals with Elevated or High Blood Pressure
Time Frame
6 weeks
Title
Medication Adherence
Description
Self-reported using the DOSE-Nonadherence Scale, Unit of Measure: Percentage of Individuals reporting low, moderate, or high adherence
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Diet
Description
Self-reported using the Assessment of Dietary Adherence and Identification of Barriers to Healthy Eating, Unit of Measure: Percent of participants reporting a healthy diet
Time Frame
6 week
Title
Physical Activity
Description
Self-reported using the Yale Physical Activity Scale, Unit of Measure: Rates of physical inactivity
Time Frame
6 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The study inclusion criteria are as follows:
self-reported hypertension
race/ethnicity: Black or African American
prescribed antihypertensive medication
age ≥ 18 years
Exclusion Criteria:
The exclusion criteria are:
cognitive limitations that limit the ability to provide informed consent
unable to speak or read English
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yendelela L Cuffee, PhD
Phone
302-831-1302
Email
ylcuffee@udel.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified participant data will be available one year after the last participant is recruited. Study protocol, informed consent, and study surveys will be available immediately after recruitment is completed.
IPD Sharing Time Frame
The de-identified study data will become available one year after the last participant is recruited, and will be available for three years. Supporting information will be available as soon as recruitment is completed.
IPD Sharing Access Criteria
Please email the PI for access to study data and supporting information.
Learn more about this trial
Storytelling Intervention for African Americans Living With Hypertension
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