Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2P20GM113125-06 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Funding ended before the second phase of the study could be started. Additionally, the second phase of the study will be a part of the PIs K01 study.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline |
Inclusion Criteria:
The study inclusion criteria are as follows:
Exclusion Criteria:
The exclusion criteria are:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Delaware | Newark | Delaware | 19713 | United States |
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.
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.
Please email the PI for access to study data and supporting information.
Not provided
Participants were not recruited for the pilot study phase of the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pilot Study Phase | 6-week trial of the web-based storytelling study |
| FG001 | Feasibility Phase | The objective of the feasibility phase of the study was to recruit 30 participants to view the video stories and provide feedback on engagement and satisfaction with the stories and recommendations for the design of a future research study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Due to the delay in recruiting for the feasibility phase of the study, we were unable to conduct the 6-week trial. The PI was funded for a K01 and has incorporated the 6-week trial into the design of the K01 research.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Feasibility Study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Pressure | Systolic and Diastolic Blood Pressure, Unit of Measure: Percentage of Individuals with Elevated or High Blood Pressure | 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. | Posted | 6 weeks |
|
There were two phases of the study, the feasibility phase and the pilot study. During the feasibility phase participants viewed the website and stories, and completed surveys during one visit. Adverse events were collected within 24 hours of participating in the feasibility phase. The second phase, the pilot study was not initiated due to funding ending; therefore, no adverse events were collected.
The definition of adverse events or serious adverse events does not differ from the clinicaltrials.gov definition.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pilot Study | Participants will participate in a 6-week web-based storytelling study. Systolic blood pressure, diastolic blood pressure, and medication adherence will be measured at baseline and 6-weeks. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yendelela Cuffee | University of Delaware | (302) 831-1302 | ylcuffee@udel.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 27, 2023 | Aug 22, 2024 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Income | Count of Participants | Participants |
|
|
| Primary | Medication Adherence | Self-reported medication adherence, Unit of Measure: Percentage of Individuals reporting low, moderate, or high adherence | 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. | Posted | 6 weeks |
|
|
| 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. | Not Posted | baseline | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Feasibility Phase | Participants will review study website and stories, and provide feedback on effectiveness of the stories, engagement with the website, and preferences for lifestyle intervention study design. | 0 | 31 | 0 | 31 | 0 | 31 |
Not provided
Not provided
Not provided
| Bachelors |
|
| Masters/Doctorate |
|
| >$100,000 |
|