Hypertension Intervention Nurse Telemedicine Study (HINTS) - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00237692

Purpose

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.

Condition	Intervention
Hypertension	Behavioral: Nurse Behavioral intervention with Home BP Telemonitoring Behavioral: Nurse Medication Management with Home BP Telemonitoring Behavioral: Nurse Combined intervention with Home BP Telemonitoring

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:	Behavioral/Pharmacological Telemedicine Interventions for BP Control

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Blood pressure control and medication adherence [ Time Frame: Blood pressure measured at 6 mo intervals, baseline, 6 mo, 12 mo, & 18 mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Knowledge & perceived risks associated w/hypertension as determined by questionnaire; confidence w/hypertension regimen using a composite of 4 items; medication adherence (pill refill using calculated Med-out index for interventional period) [ Time Frame: Surveys administered at 6 mo intervals, baseline, 6 mo, 12 mo, & 18 mo ] [ Designated as safety issue: No ]

Enrollment:	609
Study Start Date:	May 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Control group - a group of hypertensive patient who receive usual care
2: Experimental Nurse-administered behavior intervention	Behavioral: Nurse Behavioral intervention with Home BP Telemonitoring Nurse-administered behavior intervention
3: Experimental Nurse administer medication management according to hypertension decision support system	Behavioral: Nurse Medication Management with Home BP Telemonitoring Nurse administer medication management according to hypertension decision support
4: Experimental Combination of the nurse administered tailored behavioral & medication management interventions	Behavioral: Nurse Combined intervention with Home BP Telemonitoring Combination of the nurse administered tailored behavioral & medication management

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237692

Locations

United States, North Carolina
Durham VA Medical Center HSR&D COE
Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Hayden B. Bosworth, PhD

Department of Veterans Affairs

More Information

Publications of Results:

Trivedi RB, Ayotte B, Edelman D, Bosworth HB. The association of emotional well-being and marital status with treatment adherence among patients with hypertension. J Behav Med. 2008 Sep 9; [Epub ahead of print]

Other Publications:

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.

Responsible Party:	Department of Veterans Affairs ( Bosworth, Hayden - Principal Investigator )
Study ID Numbers:	IIR 04-426
Study First Received:	October 7, 2005
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00237692
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Telemedicine
Adherence
Tailored Nurse Intervention
Home Blood Pressure Monitoring
cardiovascular disease

Study placed in the following topic categories:

Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009