NCT00237692

Brief Summary

There are 65 million Americans and over 8.5 million veterans who have been diagnosed with hypertension; yet only 31% of all hypertensive patients have their blood pressure (BP) under effective control (less than 140/90 mm/Hg). Uncontrolled hypertension greatly increases the risk of cerebral vascular accidents, coronary artery disease, myocardial infarction, renal failure, congestive heart failure, and mortality. Despite the damaging impact of hypertension and the availability of well-defined therapies and widely accepted target values for BP, interventions to improve BP control have had limited success.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
591

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

December 1, 2014

Completed
Last Updated

April 24, 2015

Status Verified

August 1, 2014

Enrollment Period

4.3 years

First QC Date

October 7, 2005

Results QC Date

August 29, 2014

Last Update Submit

April 6, 2015

Conditions

Hypertension

Keywords

TelemedicineAdherenceTailored Nurse InterventionHome Blood Pressure Monitoringcardiovascular disease

Outcome Measures

Primary Outcomes (6)

  • Estimated Percentage of Participants in Blood Pressure Control at Baseline

    When patients had multiple blood pressure readings during their baseline visit, means of their systolic and diastolic readings were used as the baseline blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \<140/90mmHg for non-diabetic patients and \< 130/80mmHg for diabetic patients

    Baseline

  • Estimated Percentage of Participants in Blood Pressure Control at 6 Months

    When patients had multiple blood pressure readings during their 6 month visit, means of their systolic and diastolic readings were used as the 6 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \<140/90mmHg for non-diabetic patients and \< 130/80mmHg for diabetic patients

    6month

  • Estimated Percentage of Participants in Blood Pressure Control at 12 Months

    When patients had multiple blood pressure readings during their 12 month visit, means of their systolic and diastolic readings were used as the 12 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \<140/90mmHg for non-diabetic patients and \< 130/80mmHg for diabetic patients

    12 month

  • Estimated Percentage of Participants in Blood Pressure Control at 18 Months

    When patients had multiple blood pressure readings during their 18 month visit, means of their systolic and diastolic readings were used as the 18 month blood pressure values; Using Joint National Committee 7 Report (JNC7) blood pressure guidelines for BP control: \<140/90mmHg for non-diabetic patients and \< 130/80mmHg for diabetic patients

    18 month

  • Blood Pressure Averages Systolic & Diastolic

    Blood pressure measured at Baseline. BP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model.

    Baseline

  • Blood Pressure Averages Systolic & Diastolic

    Blood pressure measured at 12 month. BP control estimates are marginalized probabilities with corresponding 95% confidence intervals derived from a logistic mixed effects regression model.

    12-month

Study Arms (4)

Arm 1

NO INTERVENTION

Control group - a group of hypertensive patient who receive usual care

Arm 2

EXPERIMENTAL

Nurse Behavioral intervention with Home BP Telemonitoring Nurse-administered tailored behavior intervention

Behavioral: Nurse Behavioral intervention with Home BP Telemonitoring

Arm 3

EXPERIMENTAL

Nurse Medication Management with Home BP Telemonitoring -- Nurse administer medication management according to hypertension decision support system

Behavioral: Nurse Medication Management with Home BP Telemonitoring

Arm 4

EXPERIMENTAL

Nurse Combined intervention with Home BP Telemonitoring - Combination of the nurse administered tailored behavioral \& medication management interventions

Behavioral: Nurse Combined intervention with Home BP Telemonitoring

Interventions

Nurse Behavioral intervention with Home BP TelemonitoringBEHAVIORAL

Nurse-administered behavior intervention

Arm 2
Nurse Medication Management with Home BP TelemonitoringBEHAVIORAL

Nurse administer medication management according to hypertension decision support

Arm 3
Nurse Combined intervention with Home BP TelemonitoringBEHAVIORAL

Combination of the nurse administered tailored behavioral \& medication management

Arm 4

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of uncontrolled hypertension,
  • prescribed a medication to lower blood pressure,
  • have a regular primary care physician at Durham VA Medical Center, and
  • be a veteran. For Sustainability portion the patient must have participated in an intervention arm of primary study.

You may not qualify if:

  • Hospitalized in past 3 months for stroke,
  • heart attack,
  • surgery for blocked arteries,
  • diagnosed with metastatic cancer or treated with dialysis,
  • have a diagnosis of dementia or a hearing impairment which prevents them from being able to hear/speak on the telephone, and
  • creatinine serum lab which exceed 2.5.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (13)

  • Bosworth HB, Olsen MK, McCant F, Harrelson M, Gentry P, Rose C, Goldstein MK, Hoffman BB, Powers B, Oddone EZ. Hypertension Intervention Nurse Telemedicine Study (HINTS): testing a multifactorial tailored behavioral/educational and a medication management intervention for blood pressure control. Am Heart J. 2007 Jun;153(6):918-24. doi: 10.1016/j.ahj.2007.03.004.

    PMID: 17540191BACKGROUND

  • Crowley MJ, Grubber JM, Olsen MK, Bosworth HB. Factors associated with non-adherence to three hypertension self-management behaviors: preliminary data for a new instrument. J Gen Intern Med. 2013 Jan;28(1):99-106. doi: 10.1007/s11606-012-2195-1. Epub 2012 Aug 28.

    PMID: 22926634RESULT

  • Jackson GL, Oddone EZ, Olsen MK, Powers BJ, Grubber JM, McCant F, Bosworth HB. Racial differences in the effect of a telephone-delivered hypertension disease management program. J Gen Intern Med. 2012 Dec;27(12):1682-9. doi: 10.1007/s11606-012-2138-x. Epub 2012 Aug 3.

    PMID: 22865016RESULT

  • Wang V, Smith VA, Bosworth HB, Oddone EZ, Olsen MK, McCant F, Powers BJ, Van Houtven CH. Economic evaluation of telephone self-management interventions for blood pressure control. Am Heart J. 2012 Jun;163(6):980-6. doi: 10.1016/j.ahj.2012.03.016. Epub 2012 May 21.

    PMID: 22709750RESULT

  • Crowley MJ, Smith VA, Olsen MK, Danus S, Oddone EZ, Bosworth HB, Powers BJ. Treatment intensification in a hypertension telemanagement trial: clinical inertia or good clinical judgment? Hypertension. 2011 Oct;58(4):552-8. doi: 10.1161/HYPERTENSIONAHA.111.174367. Epub 2011 Aug 15.

    PMID: 21844490RESULT

  • Bosworth HB, Powers BJ, Olsen MK, McCant F, Grubber J, Smith V, Gentry PW, Rose C, Van Houtven C, Wang V, Goldstein MK, Oddone EZ. Home blood pressure management and improved blood pressure control: results from a randomized controlled trial. Arch Intern Med. 2011 Jul 11;171(13):1173-80. doi: 10.1001/archinternmed.2011.276.

    PMID: 21747013RESULT

  • Powers BJ, Olsen MK, Smith VA, Woolson RF, Bosworth HB, Oddone EZ. Measuring blood pressure for decision making and quality reporting: where and how many measures? Ann Intern Med. 2011 Jun 21;154(12):781-8, W-289-90. doi: 10.7326/0003-4819-154-12-201106210-00005.

    PMID: 21690592RESULT

  • Powers BJ, Danus S, Grubber JM, Olsen MK, Oddone EZ, Bosworth HB. The effectiveness of personalized coronary heart disease and stroke risk communication. Am Heart J. 2011 Apr;161(4):673-80. doi: 10.1016/j.ahj.2010.12.021.

    PMID: 21473965RESULT

  • Zullig LL, Melnyk SD, Goldstein K, Shaw RJ, Bosworth HB. The role of home blood pressure telemonitoring in managing hypertensive populations. Curr Hypertens Rep. 2013 Aug;15(4):346-55. doi: 10.1007/s11906-013-0351-6.

    PMID: 23625207RESULT

  • Bowen ME, Bosworth HB, Roumie CL. Blood pressure control in a hypertension telemedicine intervention: does distance to primary care matter? J Clin Hypertens (Greenwich). 2013 Oct;15(10):723-30. doi: 10.1111/jch.12172. Epub 2013 Jul 23.

    PMID: 24088280RESULT

  • Bosworth HB, Olsen MK, Dudley T, Orr M, Goldstein MK, Datta SK, McCant F, Gentry P, Simel DL, Oddone EZ. Patient education and provider decision support to control blood pressure in primary care: a cluster randomized trial. Am Heart J. 2009 Mar;157(3):450-6. doi: 10.1016/j.ahj.2008.11.003. Epub 2009 Jan 10.

    PMID: 19249414RESULT

  • McCant F, McKoy G, Grubber J, Olsen MK, Oddone E, Powers B, Bosworth HB. Feasibility of blood pressure telemonitoring in patients with poor blood pressure control. J Telemed Telecare. 2009;15(6):281-5. doi: 10.1258/jtt.2009.090202.

    PMID: 19720764RESULT

  • Maciejewski ML, Bosworth HB, Olsen MK, Smith VA, Edelman D, Powers BJ, Kaufman MA, Oddone EZ, Jackson GL. Do the benefits of participation in a hypertension self-management trial persist after patients resume usual care? Circ Cardiovasc Qual Outcomes. 2014 Mar;7(2):269-75. doi: 10.1161/CIRCOUTCOMES.113.000309. Epub 2014 Mar 11.

    PMID: 24619321DERIVED

MeSH Terms

Conditions

HypertensionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Results Point of Contact

Title
Hayden B. Bosworth, PhD
Organization
Center for Primary Care, HSRD COIN
hayden.bosworth@va.gov
919-286-0411

Study Officials

  • Hayden B. Bosworth, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

May 1, 2006

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

April 24, 2015

Results First Posted

December 1, 2014

Record last verified: 2014-08

Locations

US(1)