Storytelling Intervention for African Americans Living With Hypertension

NCT05594264 | Terminated Results

• 2 other identifiers: 1766419-72P20GM113125-06
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Storytelling; Hypertension

Outcome Measures

Primary Outcomes (2)

• Blood Pressure

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

  6 weeks

• Medication Adherence

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

  6 weeks

Other Outcomes (1)

• Effectiveness and Engagement

  baseline

Study Arms (2)

Pilot Study

EXPERIMENTAL

The objective of the second phase of the study was to conduct a 6-week pilot study of the web-based storytelling approach

Behavioral: HBPStories

Feasibility Phase

NO INTERVENTION

The objective of the feasibility phase was to assess participant views of the stories and the study website, and obtain feedback for the design of a future trial.

Interventions

HBPStories BEHAVIORAL

The objective of this arm was to pilot test the web-based storytelling program to determine the preliminary impact on blood pressure and medication adherence, and if the web-based approach was an engaging approach for individuals managing hypertension.

Pilot Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-reported hypertension
• race/ethnicity: Black or African American
• prescribed antihypertensive medication
• age ≥ 18 years

You may not qualify if:

• cognitive limitations that limit the ability to provide informed consent
• unable to speak or read English

Sponsors & Collaborators

• University of Delaware: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Recruitment for the feasibility study was delayed and we were able to recruit participants for the first phase of the study. The second phase of the study was not completed, the 6-week trial. However, the study was recently funded and the 6 week trial will be conducted as a part of a pilot study.

Results Point of Contact

• Title: Dr. Yendelela Cuffee
• Organization: University of Delaware

ylcuffee@udel.edu

(302) 831-1302

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: October 26, 2022
• Study Start: July 14, 2022
• Primary Completion: June 24, 2023
• Study Completion: June 24, 2023
• Last Updated: October 8, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: Please email the PI for access to study data and supporting information.

Locations

US (1)