HypertensionNCT01276197
Using Stories to Address Disparities in Hypertension
A study testing Story-Telling DVD and Non-Storytelling DVD in people with Hypertension, run by VA Office of Research and Development at 4 sites in United States.
Trial summary
The purpose of this study is to determine if patients with high blood pressure are better able to control their blood pressure after watching a DVD about blood pressure. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Story-Telling DVD and Non-Storytelling DVD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 618 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2013to Jan 2016
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African-American
- Diagnosis of HTN
- Uncontrolled BP as defined by BP >140/90 twice in the preceding 12 months
Who cannot join
- active substance abuse
- severe mental illness
- cognitive disabilities that might prevent them from actively or reliably participating in the interviews
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5799
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
Philadelphia VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study is to determine if patients with high blood pressure are better able to control their blood pressure after watching a DVD about blood pressure.
Read the detailed description
This project consists of two phases: (1) Collecting of stories and creating a stories DVD; and (2) delivering the DVD in a randomized control trial (RCT). Both phases are described below.
The investigators will make two DVDs of African-American Veterans who will tell their success stories with controlling hypertension (HTN). The investigators want to help African-American Veterans control their hypertension by showing them stories that are interesting and that they can identify with, as well as giving them information about ways they can manage hypertension in their everyday lives. This is important because a disproportionate number of minority patients, including Veterans, have poorly controlled blood pressure. By showing them stories, rather than using more traditional methods of health education, the investigators hope to overcome some typical barriers to HTN control among the African-American population, including: lower levels of health literacy and numeracy, less trust in the medical system, and different (non-medical) models to explain their illness.
The Veteran storytellers will come from three VA sites (Charleston, Chicago, and Philadelphia) and their stories will be chosen based on (1) the proven effectiveness of the strategies they suggest for controlling BP and (2) how authentic they are, or how much they will "ring true" with the experiences of other Veterans, including their struggles and lessons learned.
After the DVD is complete, the investigators will conduct a randomized control trial to evaluate how effective it is in helping vets control their hypertension: 780 African-American vets with uncontrolled hypertension, from the same three VA sites, will participate. Half of them will watch the "Stories" DVD the investigators created; and the other half will watch a control, a DVD with the same medical information but without the narrative component. The investigators will measure their blood pressure (BP) just before they watch the DVD and again six months later. The investigators hypothesize that, six months after enrollment, the Veterans who watched the "Stories" DVD will have greater reduction in BP, as compared with those who watch the control. The investigators will also test the "Stories" DVD's impact on medication adherence and HTN management behaviors.
- Conditions
- Hypertension
- Being tested
- Story-Telling DVD, Non-Storytelling DVD
- Keywords
- hypertension, healthcare disparities, minority health, health behavior
- Medical subject headings
- Hypertension, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Story-Telling DVDOther
DVD will contain both informational and story-telling components.
Non-Storytelling DVDOther
DVD will contain only informational component.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Story-Telling DVD | Experimental | Participant will receive a DVD with informational and story-telling components Receives: Other: Story-Telling DVD |
| Arm 2: Non-Storytelling DVD | Active comparator | Participant will receive an informational DVD Receives: Other: Non-Storytelling DVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic BP at Follow-up
Systolic Bp measurement at 6-month follow-up; we modeled the impact of Intervention assignment on SBP, adjusting for Baseline. Thus, baseline SBP was collected but not used as outcome; Baseline SBP us used as a covariate.
Measured: 6 months after intervention
Diastolic BP Measurement at Follow-up
Participants BP measurement at 6-month follow-up
Measured: 6-month following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startJan 2013
- Primary completionMay 2015
- Study completionJan 2016
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 618 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Thomas K Houston, MD MPH, Principal investigator, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276197
- Sponsor's protocol ID
- IIR 10-132
- Status last verified
- Oct 2016
- First submitted
- 11 Jan 2011
- Last updated
- 2 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We plan to report on our primary outcome
Publications
Houston TK, Cherrington A, Coley HL, Robinson KM, Trobaugh JA, Williams JH, Foster PH, Ford DE, Gerber BS, Shewchuk RM, Allison JJ. The art and science of patient storytelling-harnessing narrative communication for behavioral interventions: the ACCE project. J Health Commun. 2011 Aug;16(7):686-97. doi: 10.1080/10810730.2011.551997. Epub 2011 May 24.
PubMed 21541875Fix GM, Bokhour BG. Understanding the context of patient experiences in order to explore adherence to secondary prevention guidelines after heart surgery. Chronic Illn. 2012 Dec;8(4):265-77. doi: 10.1177/1742395312441037. Epub 2012 Mar 2.
PubMed 22387691Fix GM, Houston TK, Barker AM, Wexler L, Cook N, Volkman JE, Bokhour BG. A novel process for integrating patient stories into patient education interventions: incorporating lessons from theater arts. Patient Educ Couns. 2012 Sep;88(3):455-9. doi: 10.1016/j.pec.2012.06.012. Epub 2012 Jul 6.
PubMed 22770814Houston TK, Fix GM, Shimada SL, Long JA, Gordon HS, Pope C, Volkman J, Allison JJ, DeLaughter K, Orner M, Bokhour BG. African American Veterans Storytelling: A Multisite Randomized Trial to Improve Hypertension. Med Care. 2017 Sep;55 Suppl 9 Suppl 2:S50-S58. doi: 10.1097/MLR.0000000000000766.
PubMed 28806366
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Stories to Address Disparities in Hypertension
- ClinicalTrials.gov ID
- NCT01276197
- Acronym / sponsor ID
- IIR 10-132
- Conditions
- Hypertension
- Keywords
- hypertension, healthcare disparities, minority health, health behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 618 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jan 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Posted 30 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if patients with high blood pressure are better able to control their blood pressure after watching a DVD about blood pressure.
Detailed description
This project consists of two phases: (1) Collecting of stories and creating a stories DVD; and (2) delivering the DVD in a randomized control trial (RCT). Both phases are described below.
The investigators will make two DVDs of African-American Veterans who will tell their success stories with controlling hypertension (HTN). The investigators want to help African-American Veterans control their hypertension by showing them stories that are interesting and that they can identify with, as well as giving them information about ways they can manage hypertension in their everyday lives. This is important because a disproportionate number of minority patients, including Veterans, have poorly controlled blood pressure. By showing them stories, rather than using more traditional methods of health education, the investigators hope to overcome some typical barriers to HTN control among the African-American population, including: lower levels of health literacy and numeracy, less trust in the medical system, and different (non-medical) models to explain their illness.
The Veteran storytellers will come from three VA sites (Charleston, Chicago, and Philadelphia) and their stories will be chosen based on (1) the proven effectiveness of the strategies they suggest for controlling BP and (2) how authentic they are, or how much they will "ring true" with the experiences of other Veterans, including their struggles and lessons learned.
After the DVD is complete, the investigators will conduct a randomized control trial to evaluate how effective it is in helping vets control their hypertension: 780 African-American vets with uncontrolled hypertension, from the same three VA sites, will participate. Half of them will watch the "Stories" DVD the investigators created; and the other half will watch a control, a DVD with the same medical information but without the narrative component. The investigators will measure their blood pressure (BP) just before they watch the DVD and again six months later. The investigators hypothesize that, six months after enrollment, the Veterans who watched the "Stories" DVD will have greater reduction in BP, as compared with those who watch the control. The investigators will also test the "Stories" DVD's impact on medication adherence and HTN management behaviors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Story-Telling DVD | Experimental | Other: Story-Telling DVDParticipant will receive a DVD with informational and story-telling components |
| Arm 2: Non-Storytelling DVD | Active comparator | Other: Non-Storytelling DVDParticipant will receive an informational DVD |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- African-American
- Diagnosis of HTN
- Uncontrolled BP as defined by BP >140/90 twice in the preceding 12 months
Key exclusion criteria (3 listed)
- active substance abuse
- severe mental illness
- cognitive disabilities that might prevent them from actively or reliably participating in the interviews
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 |
|---|---|---|
| Story-Telling DVDDVD will contain both informational and story-telling components. | Other | Arm 1: Story-Telling DVD |
| Non-Storytelling DVDDVD will contain only informational component. | Other | Arm 2: Non-Storytelling DVD |
Primary outcome
Systolic BP at Follow-up
Time frame: 6 months after intervention
Systolic Bp measurement at 6-month follow-up; we modeled the impact of Intervention assignment on SBP, adjusting for Baseline. Thus, baseline SBP was collected but not used as outcome; Baseline SBP us used as a covariate.
Diastolic BP Measurement at Follow-up
Time frame: 6-month following intervention
Participants BP measurement at 6-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21541875Houston TK, Cherrington A, Coley HL, Robinson KM, Trobaugh JA, Williams JH, Foster PH, Ford DE, Gerber BS, Shewchuk RM, Allison JJ. The art and science of patient storytelling-harnessing narrative communication for behavioral interventions: the ACCE project. J Health Commun. 2011 Aug;16(7):686-97. doi: 10.1080/10810730.2011.551997. Epub 2011 May 24.
- Results publication: PubMed 22387691Fix GM, Bokhour BG. Understanding the context of patient experiences in order to explore adherence to secondary prevention guidelines after heart surgery. Chronic Illn. 2012 Dec;8(4):265-77. doi: 10.1177/1742395312441037. Epub 2012 Mar 2.
- Results publication: PubMed 22770814Fix GM, Houston TK, Barker AM, Wexler L, Cook N, Volkman JE, Bokhour BG. A novel process for integrating patient stories into patient education interventions: incorporating lessons from theater arts. Patient Educ Couns. 2012 Sep;88(3):455-9. doi: 10.1016/j.pec.2012.06.012. Epub 2012 Jul 6.
- Derived from this study: PubMed 28806366Houston TK, Fix GM, Shimada SL, Long JA, Gordon HS, Pope C, Volkman J, Allison JJ, DeLaughter K, Orner M, Bokhour BG. African American Veterans Storytelling: A Multisite Randomized Trial to Improve Hypertension. Med Care. 2017 Sep;55 Suppl 9 Suppl 2:S50-S58. doi: 10.1097/MLR.0000000000000766.
- Individual participant dataSharing planned: Yes. We plan to report on our primary outcome
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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.
Thomas K Houston, MD MPH principal investigator
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Story-Telling DVD and Non-Storytelling DVD in people with Hypertension, run by VA Office of Research and Development at 4 sites 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 3 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: finished, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 30 Sep 2016). 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?
Systolic BP at Follow-up (time frame: 6 months after intervention). 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?
On the ClinicalTrials.gov record for NCT01276197, which also lists 4 linked publications.
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 2 Dec 2016.