Clinical trial NCT05594264: 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
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Keywords: Storytelling
Hypertension
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2022-10-26
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The two phase study, included a feasibility phase. During the feasibility phase 30 participants would be recruited to provide feedback on the design of the website, the impact of the study, and preferences for future study designs. The second phase of the study was the pilot study. The objective of the 6-week study was to explore the impact of a web-based storytelling program on medication adherence and blood pressure.
Primary purpose: PREVENTION

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 High Blood Pressure Stories (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.


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

Primary outcomes:
measure: Blood Pressure
timeFrame: 6 weeks
measure: Medication Adherence
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
measure: Effectiveness and Engagement
timeFrame: baseline
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
References: