HypertensionCSI BirminghamNCT00875225
Using Multimedia Technology for Hypertension Control for Low-Income African Americans
A study testing DVD and Intervention DVD in people with Hypertension, run by Cooper Green Mercy Hospital at 1 site in United States.
Trial summary
The purpose of this study is to test an interactive DVD intervention to encourage patients to stick to their blood pressure medication in order to achieve blood pressure control for African American patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- DVD and Intervention DVD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American
- Clinical Diagnosis of Hypertension
- Patient at Cooper Green Hospital
- Provided Informed Consent
- Age 18 or older
Who cannot join
- Pregnant
- Diagnosed with dementia, schizophrenia, bipolar illness, or other serious acute or chronic medical co-morbidity
Trial locations and contacts
1 site in 1 country.
United States1 site
Cooper Green Mercy Hospital
Birmingham, Alabama, 35233
About this study
Official title: Culturally Sensitive Intervention: CSI Birmingham
The purpose of this study is to test an interactive DVD intervention to encourage patients to stick to their blood pressure medication in order to achieve blood pressure control for African American patients. The intervention will convey health messages through personal patient stories who have dealt with or continue to struggle with high blood pressure.
Hypothesis 1: At the end of 9 months a higher proportion of patients randomized to the intervention group will achieve appropriate blood pressure control.
Hypothesis 2: At the end of 9 months a higher proportion of patients who randomized to the intervention group will report high adherence to their hypertension medications.
- Conditions
- Hypertension
- Being tested
- DVD, Intervention DVD
- Keywords
- Hypertension, Adherence to medications
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVDBehavioural
Control group will receive usual care DVD from health professionals
Intervention DVDBehavioural
Intervention group will receive intervention DVD with patient stories and information from health care professionals
| Study group | Role | What they receive |
|---|---|---|
| Control DVD | Active comparator | Control DVD with usual care information Receives: Behavioral: DVD |
| Intervention DVD | Active comparator | Intervention group will receive DVD with patient stories and information from health care professionals Receives: Behavioral: Intervention DVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure control
Measured: Two years
Secondary outcomes (1)
Adherence to hypertension medications
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startDec 2006
- Primary completionMay 2009 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooper Green Mercy Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Investigators
- Sandral Hullett, MD, Principal investigator, Cooper Green Mercy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875225
- Sponsor's protocol ID
- 59741 - Finding Answers
- Acronym
- CSI Birmingham
- Status last verified
- Apr 2009
- First submitted
- 2 Apr 2009
- Last updated
- 3 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Houston TK, Allison JJ, Sussman M, Horn W, Holt CL, Trobaugh J, Salas M, Pisu M, Cuffee YL, Larkin D, Person SD, Barton B, Kiefe CI, Hullett S. Culturally appropriate storytelling to improve blood pressure: a randomized trial. Ann Intern Med. 2011 Jan 18;154(2):77-84. doi: 10.7326/0003-4819-154-2-201101180-00004.
PubMed 21242364
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Sensitive Intervention: CSI Birmingham
- ClinicalTrials.gov ID
- NCT00875225
- Acronym / sponsor ID
- CSI Birmingham / 59741 - Finding Answers
- Conditions
- Hypertension
- Keywords
- Hypertension, Adherence to medications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Cooper Green Mercy HospitalUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- Dec 2006
- Primary completion
- May 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Not posted in the source record
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 test an interactive DVD intervention to encourage patients to stick to their blood pressure medication in order to achieve blood pressure control for African American patients. The intervention will convey health messages through personal patient stories who have dealt with or continue to struggle with high blood pressure.
Hypothesis 1: At the end of 9 months a higher proportion of patients randomized to the intervention group will achieve appropriate blood pressure control.
Hypothesis 2: At the end of 9 months a higher proportion of patients who randomized to the intervention group will report high adherence to their hypertension medications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control DVD | Active comparator | Behavioral: DVDControl DVD with usual care information |
| Intervention DVD | Active comparator | Behavioral: Intervention DVDIntervention group will receive DVD with patient stories and information from health care professionals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- African American
- Clinical Diagnosis of Hypertension
- Patient at Cooper Green Hospital
- Provided Informed Consent
- Age 18 or older
Key exclusion criteria (2 listed)
- Pregnant
- Diagnosed with dementia, schizophrenia, bipolar illness, or other serious acute or chronic medical co-morbidity
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 |
|---|---|---|
| DVDControl group will receive usual care DVD from health professionals | Behavioural | Control DVD |
| Intervention DVDIntervention group will receive intervention DVD with patient stories and information from health care professionals | Behavioural | Intervention DVD |
Primary outcome
Blood pressure control
Time frame: Two years
1 secondary outcome
Adherence to hypertension medications
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2009.
- Derived from this study: PubMed 21242364Houston TK, Allison JJ, Sussman M, Horn W, Holt CL, Trobaugh J, Salas M, Pisu M, Cuffee YL, Larkin D, Person SD, Barton B, Kiefe CI, Hullett S. Culturally appropriate storytelling to improve blood pressure: a randomized trial. Ann Intern Med. 2011 Jan 18;154(2):77-84. doi: 10.7326/0003-4819-154-2-201101180-00004.
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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.
Sandral Hullett, MD principal investigator
Cooper Green Mercy Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DVD and Intervention DVD in people with Hypertension, run by Cooper Green Mercy Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 3 Apr 2009. 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?
Results are not available in the source record.
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 control (time frame: Two years). 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 NCT00875225, which also lists 1 linked publication.
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 3 Apr 2009.