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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05594264
Other study ID # 1766419-7
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 14, 2022
Est. completion date August 30, 2023

Study information

Verified date May 2023
Source University of Delaware
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 30, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
HBPStories
A 6-week web-based study. Systolic blood pressure, diastolic blood pressure, and medication adherence will be measured at baseline and 6-weeks.

Locations

Country Name City State
United States University of Delaware Newark Delaware

Sponsors (1)

Lead Sponsor Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood Pressure Systolic and Diastolic Blood Pressure, Unit of Measure: Percentage of Individuals with Elevated or High Blood Pressure 6 weeks
Primary Medication Adherence Self-reported using the DOSE-Nonadherence Scale, Unit of Measure: Percentage of Individuals reporting low, moderate, or high adherence 6 weeks
Secondary 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 6 week
Secondary Physical Activity Self-reported using the Yale Physical Activity Scale, Unit of Measure: Rates of physical inactivity 6 week
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