HypertensionNCT05594264
Storytelling Intervention for African Americans Living With Hypertension
A study testing HBPStories in people with Hypertension, run by University of Delaware at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- HBPStories
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2022to 24 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study inclusion criteria are as follows:
- self-reported hypertension
- race/ethnicity: Black or African American
- prescribed antihypertensive medication
- age ≥ 18 years
Who cannot join
- The exclusion criteria are:
- cognitive limitations that limit the ability to provide informed consent
- unable to speak or read English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing and Implementing a Storytelling Intervention for African Americans Living With Hypertension
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
- Being tested
- HBPStories
- Keywords
- Storytelling, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBPStoriesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Systolic and Diastolic Blood Pressure, Unit of Measure: Percentage of Individuals with Elevated or High Blood Pressure
Measured: 6 weeks
Medication Adherence
Self-reported medication adherence, Unit of Measure: Percentage of Individuals reporting low, moderate, or high adherence
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start14 Jul 2022
- Primary completion24 Jun 2023
- Study completion24 Jun 2023
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594264
- Sponsor's protocol ID
- 1766419-7
- Other IDs
- 2P20GM113125-06
- Status last verified
- Jun 2024
- First submitted
- 31 Aug 2022
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Implementing a Storytelling Intervention for African Americans Living With Hypertension
- ClinicalTrials.gov ID
- NCT05594264
- Acronym / sponsor ID
- 1766419-7
- Conditions
- Hypertension
- Keywords
- Storytelling, Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 24 Jun 2023 (actual)
- Study completion
- 24 Jun 2023 (actual)
- First posted
- 26 Oct 2022 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pilot Study | Experimental | Behavioral: HBPStoriesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- self-reported hypertension
- race/ethnicity: Black or African American
- prescribed antihypertensive medication
- age ≥ 18 years
Key exclusion criteria (3 listed)
- cognitive limitations that limit the ability to provide informed consent
- unable to speak or read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBPStoriesThe 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. | Behavioural | Pilot Study |
Primary outcome
Blood Pressure
Time frame: 6 weeks
Systolic and Diastolic Blood Pressure, Unit of Measure: Percentage of Individuals with Elevated or High Blood Pressure
Medication Adherence
Time frame: 6 weeks
Self-reported medication adherence, Unit of Measure: Percentage of Individuals reporting low, moderate, or high adherence
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBPStories in people with Hypertension, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.