HypertensionNCT01389037
Understanding Health Care Information for African Americans With High Blood Pressure
A study testing Health Literacy-focused Self-help in people with Hypertension, run by Johns Hopkins University at 1 site in United States.
Trial summary
This clinical trial focuses on helping African Americans with high blood pressure to manage their disease. The study will target their ability to read and understand health information (also called health literacy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Health Literacy-focused Self-help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jun 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identified as African American aged 18 years or older;
- Systolic BP >140 and/or Diastolic BP >90 mmHg or SBP >135 and/or DBP >85 mmHg for individuals with diabetes mellitus or chronic kidney disease or on HBP medication; and
- Has a land-based telephone in the home or a cellular phone.
Who cannot join
- Participation in another ongoing trial;
- Acute and/or terminal condition precluding participation, such as terminal cancer;
- Hospitalization for stroke, myocardial infarction, coronary artery vascularization in the past 3 months;
- Recipient of an organ transplant or on kidney dialysis; and
- Psychiatric diagnosis precluding participation, such as schizophrenia or cognitive impairment as measured by Mini-Mental State Exam (score < 24)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Health Literacy of African Americans With High Blood Pressure
This clinical trial focuses on helping African Americans with high blood pressure to manage their disease. The study will target their ability to read and understand health information (also called health literacy). The research method relies on community participation in equal partnership with the researchers to provide interactive workshops and home blood pressure self-monitoring with the assistance of telephone counseling by community health workers.
Read the detailed description
The purpose of this study is to develop a culturally sensitive intervention focused on health literacy that is designed to reduce high blood pressure (HBP) in a vulnerable African American (AA) population. A community-based participatory research approach delivered by community health workers (CHW) will be used to address the following specific aims: Aim 1. To examine the effect of health literacy on self-care skills, including HBP knowledge, adherence to HBP and substance abuse treatment recommendations, communication skills, health care utilization, and BP outcomes in AAs with HBP. Aim 2. To conduct a pilot randomized, controlled trial with a delayed intervention control group to test the effectiveness of a health literacy-focused self-help HBP intervention program using CHWs in 100 AAs who reside in Baltimore City.
- Conditions
- Hypertension
- Being tested
- Health Literacy-focused Self-help, Delayed Intervention Control
- Keywords
- African American, High blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Literacy-focused Self-helpBehavioural
Weekly 2-hour sessions over 6 weeks followed by 12 month follow-up with home blood pressure self monitoring with telephone counseling by community health workers.
Delayed Intervention ControlBehavioural
Given pamphlets on the importance of high blood pressure control and offered weekly workshops. This group will be offered the intervention at the conclusion of data collection.
| Study group | Role | What they receive |
|---|---|---|
| Health Literacy-focused Self-help | Experimental | Not described Receives: Behavioral: Health Literacy-focused Self-help |
| Delayed intervention control | Placebo comparator | Not described Receives: Behavioral: Delayed Intervention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased blood pressure
Measured: 12 months
Secondary outcomes (1)
Increase adherence to recommended blood pressure management
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Benita Walton-Moss, DNS, Principal investigator, Johns Hopkins University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389037
- Sponsor's protocol ID
- NA_00030713
- Other IDs
- 1P30NR011409
- Status last verified
- Dec 2017
- First submitted
- 5 Jul 2011
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Health Literacy of African Americans With High Blood Pressure
- ClinicalTrials.gov ID
- NCT01389037
- Acronym / sponsor ID
- NA_00030713
- Conditions
- Hypertension
- Keywords
- African American, High blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Oct 2011 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Jul 2011 (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.
This clinical trial focuses on helping African Americans with high blood pressure to manage their disease. The study will target their ability to read and understand health information (also called health literacy). The research method relies on community participation in equal partnership with the researchers to provide interactive workshops and home blood pressure self-monitoring with the assistance of telephone counseling by community health workers.
Detailed description
The purpose of this study is to develop a culturally sensitive intervention focused on health literacy that is designed to reduce high blood pressure (HBP) in a vulnerable African American (AA) population. A community-based participatory research approach delivered by community health workers (CHW) will be used to address the following specific aims: Aim 1. To examine the effect of health literacy on self-care skills, including HBP knowledge, adherence to HBP and substance abuse treatment recommendations, communication skills, health care utilization, and BP outcomes in AAs with HBP. Aim 2. To conduct a pilot randomized, controlled trial with a delayed intervention control group to test the effectiveness of a health literacy-focused self-help HBP intervention program using CHWs in 100 AAs who reside in Baltimore City.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Literacy-focused Self-help | Experimental | Behavioral: Health Literacy-focused Self-help |
| Delayed intervention control | Placebo comparator | Behavioral: Delayed Intervention Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-identified as African American aged 18 years or older;
- Systolic BP >140 and/or Diastolic BP >90 mmHg or SBP >135 and/or DBP >85 mmHg for individuals with diabetes mellitus or chronic kidney disease or on HBP medication; and
- Has a land-based telephone in the home or a cellular phone.
Key exclusion criteria (5 listed)
- Participation in another ongoing trial;
- Acute and/or terminal condition precluding participation, such as terminal cancer;
- Hospitalization for stroke, myocardial infarction, coronary artery vascularization in the past 3 months;
- Recipient of an organ transplant or on kidney dialysis; and
- Psychiatric diagnosis precluding participation, such as schizophrenia or cognitive impairment as measured by Mini-Mental State Exam (score < 24)
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 |
|---|---|---|
| Health Literacy-focused Self-helpWeekly 2-hour sessions over 6 weeks followed by 12 month follow-up with home blood pressure self monitoring with telephone counseling by community health workers. | Behavioural | Health Literacy-focused Self-help |
| Delayed Intervention ControlGiven pamphlets on the importance of high blood pressure control and offered weekly workshops. This group will be offered the intervention at the conclusion of data collection. | Behavioural | Delayed intervention control |
Primary outcome
Decreased blood pressure
Time frame: 12 months
1 secondary outcome
Increase adherence to recommended blood pressure management
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
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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.
Benita Walton-Moss, DNS principal investigator
Johns Hopkins University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Literacy-focused Self-help in people with Hypertension, run by Johns Hopkins University 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 3 inclusion and 5 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 11 Dec 2017. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decreased blood pressure (time frame: 12 months). 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 11 Dec 2017.