Hypertension
Conditions
Keywords
Storytelling, Hypertension
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.
Interventions
BEHAVIORALHBPStories
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.
Sponsors
National Institute of General Medical Sciences (NIGMS)
University of Delaware
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 6 weeks | Systolic and Diastolic Blood Pressure, Unit of Measure: Percentage of Individuals with Elevated or High Blood Pressure |
| Medication Adherence | 6 weeks | Self-reported medication adherence, Unit of Measure: Percentage of Individuals reporting low, moderate, or high adherence |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness and Engagement | 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. |
Countries
United States
Participant flow
Pre-assignment details
Participants were not recruited for the pilot study phase of the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| Feasibility Study 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. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Feasibility Study | Total | Pilot Study |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 6 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 0 Participants |
| Age, Continuous | 53 years STANDARD_DEVIATION 15 | 53 years STANDARD_DEVIATION 15 | — |
| Education Bachelors | 9 Participants | 9 Participants | — |
| Education Masters/Doctorate | 8 Participants | 8 Participants | — |
| Education Some College, Trade, Associates | 12 Participants | 12 Participants | — |
| Education some HS, HS, GED | 2 Participants | 2 Participants | — |
| Income >$100,000 | 5 Participants | 5 Participants | — |
| Income <$50,000 | 18 Participants | 18 Participants | — |
| Income $50,000-<$100,000 | 8 Participants | 8 Participants | — |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 26 Participants | 26 Participants | — |
| Sex: Female, Male Male | 5 Participants | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 31 |
| other Total, other adverse events | 0 / 0 | 0 / 31 |
| serious Total, serious adverse events | 0 / 0 | 0 / 31 |
Outcome results
Primary
Blood Pressure
Systolic and Diastolic Blood Pressure, Unit of Measure: Percentage of Individuals with Elevated or High Blood Pressure
Time frame: 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.
Primary
Medication Adherence
Self-reported medication adherence, Unit of Measure: Percentage of Individuals reporting low, moderate, or high adherence
Time frame: 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.
Other Pre-specified
Effectiveness and Engagement
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.
Time frame: baseline