HypertensionPhase 2/3NCT01035554
Behavioral Study to Control Blood Pressure
A Phase 2/3 study testing Self-Paced Programmed Instruction (SPPI), Home Blood Pressure Monitor and Printed Materials in people with Hypertension, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
We propose to test an intervention to increase patients' understanding of the causes, consequences, and the rationale for treatment, of their hypertension (HTN), as a strategy for increasing blood pressure (BP) control. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Self-Paced Programmed Instruction (SPPI), Home Blood Pressure Monitor and Printed Materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to May 2012
- Phase
- Phase 2/3
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- Has been diagnosed by physician has having hypertension/high blood pressure
- Has been prescribed medications to treat hypertension
- Has a blood pressure reading at the Screening Visit of either above 140/90
- If previously diagnosed with cancer, must be in remission
- Not currently pregnant or trying to become pregnant within next three months
Show all 9Show fewer
- No major kidney, heart, liver failure
- Ages 21-80
- Must be able to travel to Hershey Medical Center (Hershey, PA)
Who cannot join
- Cannot read and speak English fluently
- Has not been diagnosed with hypertension
- Is not currently taking medications for hypertension
- Has blood pressure that is below 140 and 90
- Has blood pressure that is above 180 or 120
- Has cancer that is not in remission
Show all 9Show fewer
- Is currently pregnant of plans to become pregnant in the next 3 months
- Has had major kidney, heart or liver failure
- Is less than 21 or greater than 80 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Effect of a Novel Behavioral Intervention on Blood Pressure Control in Hypertension Patients
We propose to test an intervention to increase patients' understanding of the causes, consequences, and the rationale for treatment, of their hypertension (HTN), as a strategy for increasing blood pressure (BP) control. The focus is on the interaction between a behavioral intervention to reduce BP - home BP monitoring (HBPM) - and patient knowledge, which, we propose, moderates the effect of the HBPM intervention. We hypothesize that patients who have a better understanding of their illness and its prescribed treatment will be more adherent to the treatment regimen, and thus will exhibit improved outcomes compared to those who have been exposed to the same intervention, but who do not have a clear understanding of these elements.
Read the detailed description
According to the National Health and Nutrition Examination Survey, more than 31% of adults in the U.S. population have hypertension (HTN). HTN is a major risk factor for heart disease and stroke, which are the 1st and 3rd leading causes of death in the U.S. and impose an enormous financial and social burden on Americans with more than $352 billion spent in direct and indirect costs. Behavioral interventions to control blood pressure (BP) have exhibited, on average, positive but relatively modest effects on blood pressure control. We and others have studied the effects of one such intervention - home BP monitoring - on BP control in hypertensive patients, and found reliable, albeit modest effects. We have found similar effects for another behavioral intervention, Motivational Interviewing, on BP control. We hypothesize that the effects of such interventions will be augmented when accompanied by a systematic approach to patient education concerning their illness and its treatment. The literature suggests that patient education is "necessary but not sufficient"(an implicit interaction) to produce behavioral changes; however, the "necessary" part tends to be ignored by interventionalists. The implication of the interaction is that when patients lack the necessary knowledge, any intervention is likely to be less effective (as any value multiplied by zero - i.e., no knowledge - is zero). In spite of this, we have found no trials that have tested the interaction between patient knowledge and a lifestyle or drug intervention.
We propose to test an intervention to increase patients' understanding of the causes, consequences, and the rationale for treatment, of their HTN, as a strategy for increasing BP control. The focus is on the interaction between a behavioral intervention to reduce BP - home BP monitoring (HBPM) - and patient knowledge, which, we propose, moderates the effect of the HBPM intervention. We hypothesize that patients who have a better understanding of their illness and its prescribed treatment will be more adherent to the treatment regimen, and thus will exhibit improved outcomes compared to those who have been exposed to the same intervention, but who do not have a clear understanding of these elements.
We propose to pilot test the effect of the HBPM intervention using a 2 X 2 independent groups randomized design, to allow us to compare the effects of Usual Care (UC) + Printed Materials (PM) compared to Usual Care (UC) and Self-Paced Programmed Instruction (SPPI) compared to Home Blood Pressure Monitoring (HBPM) + Printed Materials (PM) compared to Home Blood Pressure Monitoring (HBPM) + Self-Paced Programmed Instruction (SPPI).
Our primary hypothesis is:
Decreased ABP at 3 months will be ordered thusly:
HBPM+SPPI > HBPM+PM > UC+SPPI > UC+PM
- Conditions
- Hypertension
- Being tested
- Self-Paced Programmed Instruction (SPPI), Home Blood Pressure Monitor, Usual Care, Printed Materials
- Keywords
- 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.
Self-Paced Programmed Instruction (SPPI)Other
If participants are assigned to SPPI, they will be asked to complete a series of educational modules at their own pace on the laptop that is provided. They will be informed that there is no grading and that the program is set up so that they can go at their own pace. The SPPI modules will be designed directly from the information provided on the Printed Materials (PM) from the National Institutes of Health.
Home Blood Pressure MonitorOther
Also called Carrera Upper Arm Blood Pressure Monitor (battery opperated)
The home blood pressure monitor will allow the participant to measure their blood pressure anytime and anywhere precisely, quickly and easily on their upper arm.
Usual CareOther
Standard care
Printed MaterialsOther
Also called NIH publications 96-4041, 4042, 4045, 4046, 4047
National Institutes of Health Printed Materials on hypertension
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (UC) + Printed Materials (PM) | Active comparator | If the participant is assigned to UC, they will receive standard care. They will not receive a HBPM to use for the study, but will be given one to keep at the 3 month Follow-Up Visit. If they are also assigned to PM, they will then be given written materials (pamphlets from the NIH) and will be asked to review the information in its entirety. The coordinator will be available to answer any questions they might have. Receives: Other: Usual Care; Other: Printed Materials |
| UC + Self-Paced Program Instruction (SPPI) | Experimental | If the participant is assigned to UC, they will receive standard care. They will not receive a HBPM to use for the study, but will be given one to keep at the 3 month Follow-Up Visit. If they are also assigned to SPPI, they will be asked to complete a series of educational modules at their own pace on the laptop that is provided. They will be informed that there is no grading and that the program is set up so that they can go at their own pace. The SPPI modules will be designed directly from the information provided on the Printed Materials from the National Institutes of Health. Receives: Other: Self-Paced Programmed Instruction (SPPI); Other: Usual Care |
| Home Blood Pressure Monitor (HBPM) + PM | Experimental | If the participant is assigned to HBPM, they will be asked to use the monitor once a day in the morning and once before they go to bed any 3 days of the week, each week of the study (total = 12 weeks). They will be asked to record their BP values in diaries they will be given to take home with them. If they are also assigned to PM, they will then be given written materials (pamphlets from the NIH) regarding hypertension education and will be asked to review the information in its entirety. The coordinator will be available to answer any questions they might have. Receives: Other: Home Blood Pressure Monitor; Other: Printed Materials |
| HBPM + SPPI | Experimental | If the participant is assigned to HBPM, they will be asked to use the monitor once a day in the morning and once before they go to bed any 3 days of the week, each week of the study (total = 12 weeks). They will be asked to record their BP values in diaries they will be given to take home with them.
If they are also assigned to SPPI, they will be asked to complete a series of educational modules at their own pace on the laptop that is provided. They will be informed that there is no grading and that the program is set up so that they can go at their own pace. The SPPI modules will be designed directly from the information provided on the PM from the National Institutes of Health. Receives: Other: Self-Paced Programmed Instruction (SPPI); Other: Home Blood Pressure Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased Arterial Blood Pressure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startMay 2010
- Primary completionMay 2012
- Study completionMay 2012
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
- Investigators
- Christopher Sciamanna, MD, MPH, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035554
- Sponsor's protocol ID
- 687
- Other IDs
- R01HL089402-01A2
- Status last verified
- Nov 2013
- First submitted
- 17 Dec 2009
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Novel Behavioral Intervention on Blood Pressure Control in Hypertension Patients
- ClinicalTrials.gov ID
- NCT01035554
- Acronym / sponsor ID
- 687
- Conditions
- Hypertension
- Keywords
- high blood pressure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 18 Dec 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.
We propose to test an intervention to increase patients' understanding of the causes, consequences, and the rationale for treatment, of their hypertension (HTN), as a strategy for increasing blood pressure (BP) control. The focus is on the interaction between a behavioral intervention to reduce BP - home BP monitoring (HBPM) - and patient knowledge, which, we propose, moderates the effect of the HBPM intervention. We hypothesize that patients who have a better understanding of their illness and its prescribed treatment will be more adherent to the treatment regimen, and thus will exhibit improved outcomes compared to those who have been exposed to the same intervention, but who do not have a clear understanding of these elements.
Detailed description
According to the National Health and Nutrition Examination Survey, more than 31% of adults in the U.S. population have hypertension (HTN). HTN is a major risk factor for heart disease and stroke, which are the 1st and 3rd leading causes of death in the U.S. and impose an enormous financial and social burden on Americans with more than $352 billion spent in direct and indirect costs. Behavioral interventions to control blood pressure (BP) have exhibited, on average, positive but relatively modest effects on blood pressure control. We and others have studied the effects of one such intervention - home BP monitoring - on BP control in hypertensive patients, and found reliable, albeit modest effects. We have found similar effects for another behavioral intervention, Motivational Interviewing, on BP control. We hypothesize that the effects of such interventions will be augmented when accompanied by a systematic approach to patient education concerning their illness and its treatment. The literature suggests that patient education is "necessary but not sufficient"(an implicit interaction) to produce behavioral changes; however, the "necessary" part tends to be ignored by interventionalists. The implication of the interaction is that when patients lack the necessary knowledge, any intervention is likely to be less effective (as any value multiplied by zero - i.e., no knowledge - is zero). In spite of this, we have found no trials that have tested the interaction between patient knowledge and a lifestyle or drug intervention.
We propose to test an intervention to increase patients' understanding of the causes, consequences, and the rationale for treatment, of their HTN, as a strategy for increasing BP control. The focus is on the interaction between a behavioral intervention to reduce BP - home BP monitoring (HBPM) - and patient knowledge, which, we propose, moderates the effect of the HBPM intervention. We hypothesize that patients who have a better understanding of their illness and its prescribed treatment will be more adherent to the treatment regimen, and thus will exhibit improved outcomes compared to those who have been exposed to the same intervention, but who do not have a clear understanding of these elements.
We propose to pilot test the effect of the HBPM intervention using a 2 X 2 independent groups randomized design, to allow us to compare the effects of Usual Care (UC) + Printed Materials (PM) compared to Usual Care (UC) and Self-Paced Programmed Instruction (SPPI) compared to Home Blood Pressure Monitoring (HBPM) + Printed Materials (PM) compared to Home Blood Pressure Monitoring (HBPM) + Self-Paced Programmed Instruction (SPPI).
Our primary hypothesis is:
Decreased ABP at 3 months will be ordered thusly:
HBPM+SPPI > HBPM+PM > UC+SPPI > UC+PM
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual Care (UC) + Printed Materials (PM) | Active comparator | Other: Usual Care, Other: Printed MaterialsIf the participant is assigned to UC, they will receive standard care. They will not receive a HBPM to use for the study, but will be given one to keep at the 3 month Follow-Up Visit. If they are also assigned to PM, they will then be given written materials (pamphlets from the NIH) and will be asked to review the information in its entirety. The coordinator will be available to answer any questions they might have. |
| UC + Self-Paced Program Instruction (SPPI) | Experimental | Other: Self-Paced Programmed Instruction (SPPI), Other: Usual CareIf the participant is assigned to UC, they will receive standard care. They will not receive a HBPM to use for the study, but will be given one to keep at the 3 month Follow-Up Visit. If they are also assigned to SPPI, they will be asked to complete a series of educational modules at their own pace on the laptop that is provided. They will be informed that there is no grading and that the program is set up so that they can go at their own pace. The SPPI modules will be designed directly from the information provided on the Printed Materials from the National Institutes of Health. |
| Home Blood Pressure Monitor (HBPM) + PM | Experimental | Other: Home Blood Pressure Monitor, Other: Printed MaterialsIf the participant is assigned to HBPM, they will be asked to use the monitor once a day in the morning and once before they go to bed any 3 days of the week, each week of the study (total = 12 weeks). They will be asked to record their BP values in diaries they will be given to take home with them. If they are also assigned to PM, they will then be given written materials (pamphlets from the NIH) regarding hypertension education and will be asked to review the information in its entirety. The coordinator will be available to answer any questions they might have. |
| HBPM + SPPI | Experimental | Other: Self-Paced Programmed Instruction (SPPI), Other: Home Blood Pressure MonitorIf the participant is assigned to HBPM, they will be asked to use the monitor once a day in the morning and once before they go to bed any 3 days of the week, each week of the study (total = 12 weeks). They will be asked to record their BP values in diaries they will be given to take home with them. If they are also assigned to SPPI, they will be asked to complete a series of educational modules at their own pace on the laptop that is provided. They will be informed that there is no grading and that the program is set up so that they can go at their own pace. The SPPI modules will be designed directly from the information provided on the PM from the National Institutes of Health. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- English speaking
- Has been diagnosed by physician has having hypertension/high blood pressure
- Has been prescribed medications to treat hypertension
- Has a blood pressure reading at the Screening Visit of either above 140/90
- If previously diagnosed with cancer, must be in remission
Key exclusion criteria (9 listed)
- Cannot read and speak English fluently
- Has not been diagnosed with hypertension
- Is not currently taking medications for hypertension
- Has blood pressure that is below 140 and 90
- Has blood pressure that is above 180 or 120
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 |
|---|---|---|
| Self-Paced Programmed Instruction (SPPI)If participants are assigned to SPPI, they will be asked to complete a series of educational modules at their own pace on the laptop that is provided. They will be informed that there is no grading and that the program is set up so that they can go at their own pace. The SPPI modules will be designed directly from the information provided on the Printed Materials (PM) from the National Institutes of Health. | Other | HBPM + SPPI, UC + Self-Paced Program Instruction (SPPI) |
| Home Blood Pressure MonitorAlso: Carrera Upper Arm Blood Pressure Monitor (battery opperated)The home blood pressure monitor will allow the participant to measure their blood pressure anytime and anywhere precisely, quickly and easily on their upper arm. | Other | HBPM + SPPI, Home Blood Pressure Monitor (HBPM) + PM |
| Usual CareStandard care | Other | UC + Self-Paced Program Instruction (SPPI), Usual Care (UC) + Printed Materials (PM) |
| Printed MaterialsAlso: NIH publications 96-4041, 4042, 4045, 4046, 4047National Institutes of Health Printed Materials on hypertension | Other | Home Blood Pressure Monitor (HBPM) + PM, Usual Care (UC) + Printed Materials (PM) |
Primary outcome
Decreased Arterial Blood Pressure
Time frame: 3 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 Nov 2013.
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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.
Christopher Sciamanna, MD, MPH principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Self-Paced Programmed Instruction (SPPI), Home Blood Pressure Monitor and Printed Materials in people with Hypertension, run by Milton S. Hershey Medical Center 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 9 inclusion and 9 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 Nov 2013. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Arterial Blood Pressure (time frame: 3 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 Nov 2013; AzTrials last refreshed its copy on 30 Oct 2026.