Clinical trial NCT00237692: Hypertension Intervention Nurse Telemedicine Study (HINTS)
Official title: Behavioral/Pharmacological Telemedicine Interventions for BP Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Telemedicine
Adherence
Tailored Nurse Intervention
Home Blood Pressure Monitoring
cardiovascular disease
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-10-12
Enrollment: 591
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Detailed description: Detailed

Description Background:

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 (\<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.

Objectives:

The study is one of the first to compare three interventions designed to improve BP control: a behavioral educational intervention, an evidence-based medication management intervention, and combined intervention for patients with poor BP control defined by home BP monitoring. The primary hypotheses are: 1) Patients who receive only the behavioral intervention will show improved rates of BP control as compared to the control group over 18 months of follow-up; 2) Patients who receive only the hypertension medication management intervention will show improved rates of BP control as compared to the control group over 18 months of follow-up; and, 3) Patients who receive the combined intervention will show higher rates of BP control as compared to all other patients over the 18 months of follow-up.

Methods:

A three-year randomized controlled trial among veterans with poor BP control testing three interventions in three VA primary care clinics is proposed to improve BP control. We will test these interventions using home BP monitoring in a four group design administered via the telephone: 1) control group - a group of hypertensive patients who receive usual care; 2) Nurse-administered tailored behavioral intervention previously tested (HSR\&D grant IIR 20-034); 3) Nurse-administered medication management according to a hypertension decision support system that uses the VA's Computerized Medical Record System (VA HSR\&D grant CPI 99275); 4) combination of the tailored behavioral and medication management interventions.

A random sample of hypertensive patients with poor BP control at baseline were consented and randomly allocated to one of four arms. The interventions will activate only when home BP monitoring indicates inadequate BP control. Patients assigned to the behavioral intervention will receive a tailored self-management intervention to promote adherence with medication, information on the risks of hypertension and health behaviors at periodic telephone contacts. Patients will receive feedback about their recent BP values, continuous patient education, and will be monitored and supported to enhance treatment adherence. Patients randomized to the medication management arm will have their hypertension regimen changed by a nurse using a hypertension decision support system developed and validated in the VA. Medication recommendations generated are based on JNC 7 and the VA's hypertension treatment guidelines and are also individualized to patients' comorbid illnesses, laboratory values, and other elements of patients' clinical status. Medication management will be based on home BP monitoring and delivered by telephone. The nurse is part of an extended primary care team and communicates changes to the patients' primary care providers via a study physician.

The primary outcome will be a dichotomous measure representing whether or not the patient's BP is in control: \>140/90 mm/Hg (non-diabetic) and \>130/80 mm/Hg (diabetics). Measures will be made at six-month intervals over 18 months (4 total measurements). We will model the outcome measures and evaluate the interventions using a mixed effects model for dichotomous outcomes.

Status:

Primary study enrollment began May 5, 2006 and was completed November 2007. We randomized 591 participants in the study. Baseline recruitment was completed in November 2007. Participants' completed the six month follow-up interviews in June 2008 and 12 month follow-up in December 2008. 18 month follow-up was completed June 2009.

Study was granted an extension to complete two goals: 1) investigate the sustainability of BP control after completion of intervention, and , 2) examine what aspects of the intervention worked or did not work using qualitative interviews.

Background/Rationale:

Despite the impact of hypertension and the availability of well-defined therapies and widely accepted target values for blood pressure (BP), interventions to improve BP control have had limited success.

Objectives:

The study is one of the first to compare three interventions designed to improve BP control: a behavioral educational intervention, an evidence-based medication management intervention, and combined intervention for patients with poor BP control defined by home BP monitoring. We received an 11 month extension to evaluate 3 key components of the study (sustainability of BP effects, qualitative evaluation of the intervention, evaluation of the supporting materials used to ensure literacy levels and cultural sensitivity.)

Methods:

A 4-arm randomized trial with 18-month follow-up. Patents were selected from primary care clinics at the Durham VA Medical Center. Of the eligible patients, 591 individuals were randomized to either usual care or one of three telephone-based intervention groups. The intervention phone calls were triggered based on home BP values transmitted via telemonitoring devices. Patients were instructed to take their BP three times a week and transmit to study team. Behavioral management involved promoting health behaviors. Medication management involved adjustment of hypertension medications by a study physician and nurse based on hypertension treatment guidelines. The primary outcome was changes in BP control measured at six-month intervals over 18 months. For the sustainability extension of the study, in additional to collection of BP values, we will use qualitative analysis to examine the audio interviews.

Status:

Sustainability phase recruitment began May 1, 2010 and ended on Aug 15, 2010. Analyses are continuing.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Estimated Percentage of Participants in Blood Pressure Control at Baseline
timeFrame: Baseline
measure: Estimated Percentage of Participants in Blood Pressure Control at 6 Months
timeFrame: 6month
measure: Estimated Percentage of Participants in Blood Pressure Control at 12 Months
timeFrame: 12 month
measure: Estimated Percentage of Participants in Blood Pressure Control at 18 Months
timeFrame: 18 month
measure: Blood Pressure Averages Systolic & Diastolic
timeFrame: Baseline
measure: Blood Pressure Averages Systolic & Diastolic
timeFrame: 12-month
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Hayden B. Bosworth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.