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Hypertension Intervention Nurse Telemedicine Study (HINTS)

6 de abril de 2015 actualizado por: US Department of Veterans Affairs

Behavioral/Pharmacological Telemedicine Interventions for BP Control

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

591

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27705
        • Durham VA Medical Center, Durham, NC

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Arm 1
Control group - a group of hypertensive patient who receive usual care
Experimental: Arm 2
Nurse Behavioral intervention with Home BP Telemonitoring Nurse-administered tailored behavior intervention
Nurse-administered behavior intervention
Experimental: Arm 3
Nurse Medication Management with Home BP Telemonitoring -- Nurse administer medication management according to hypertension decision support system
Nurse administer medication management according to hypertension decision support
Experimental: Arm 4
Nurse Combined intervention with Home BP Telemonitoring - Combination of the nurse administered tailored behavioral & medication management interventions
Combination of the nurse administered tailored behavioral & medication management

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Estimated Percentage of Participants in Blood Pressure Control at Baseline
Periodo de tiempo: 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
Periodo de tiempo: 6month
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
Periodo de tiempo: 12 month
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
Periodo de tiempo: 18 month
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
Periodo de tiempo: Baseline

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
Periodo de tiempo: 12-month

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Hayden B. Bosworth, PhD, Durham VA Medical Center, Durham, NC

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de mayo de 2006

Finalización primaria (Actual)

1 de agosto de 2010

Finalización del estudio (Actual)

1 de agosto de 2010

Fechas de registro del estudio

Enviado por primera vez

7 de octubre de 2005

Primero enviado que cumplió con los criterios de control de calidad

7 de octubre de 2005

Publicado por primera vez (Estimar)

12 de octubre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

24 de abril de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

6 de abril de 2015

Última verificación

1 de agosto de 2014

Más información

Términos relacionados con este estudio

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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