Behavioral Study to Control Blood Pressure

NCT01035554 | Completed Phase 2

• 2 other identifiers: 687R01HL089402-01A2
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypertension

Keywords

high blood pressure

Outcome Measures

Primary Outcomes (1)

• Decreased Arterial Blood Pressure

  3 months

Study Arms (4)

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.

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.

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.

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.

Other: Self-Paced Programmed Instruction (SPPI); Other: Home Blood Pressure Monitor

Interventions

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.

HBPM + SPPI; UC + Self-Paced Program Instruction (SPPI)

Home Blood Pressure Monitor OTHER

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.

Also known as: Carrera Upper Arm Blood Pressure Monitor (battery opperated)

HBPM + SPPI; Home Blood Pressure Monitor (HBPM) + PM

Usual Care OTHER

Standard care

UC + Self-Paced Program Instruction (SPPI); Usual Care (UC) + Printed Materials (PM)

Printed Materials OTHER

National Institutes of Health Printed Materials on hypertension

Also known as: NIH publications 96-4041, 4042, 4045, 4046, 4047

Home Blood Pressure Monitor (HBPM) + PM; Usual Care (UC) + Printed Materials (PM)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• No major kidney, heart, liver failure
• Ages 21-80
• Must be able to travel to Hershey Medical Center (Hershey, PA)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Christopher Sciamanna, MD, MPH

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 18, 2009
• Study Start: May 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 11, 2013

Record last verified: 2013-11

Locations

US (1)