Promoting Medication Adherence Among Older Adults With Hypertension
15 de octubre de 2020 actualizado por: Marie Krousel-Wood, Tulane University School of Medicine
Overcoming Immunity to Change: A Feasibility Study of a New Method to Promote Medication Adherence Among Older Adults With Hypertension
Over 70% of US adults 65 or older are diagnosed with hypertension, the leading cause of cardiovascular disease and premature deaths in the world. Despite availability of effective drugs to control blood pressure, uncontrolled blood pressure and low adherence to antihypertensive drugs persist as major public health and clinical challenges. On average, 50% of adults adhere to chronic disease medications and lower levels of adherence are associated with worse blood pressure control and adverse outcomes. Many barriers to adherence are well known and have been targeted in interventions to improve medication adherence. As of yet, no single intervention has emerged as superior or even particularly effective in improving adherence. The investigators have recently identified unconscious, self-protective 'hidden motives' that contribute to nonadherence to chronic disease medications. There is a critical need to expand on this insight to test the potential for targeting individuals' 'hidden motives' for low adherence using an innovative learning process called Immunity-to-Change.
As a critical step in testing this intervention to target these 'hidden motives', the investigators will undertake a pilot study to assess the feasibility and acceptability of the Overcoming Immunity-to-Change intervention and determine effect sizes of the intervention on adherence, blood pressure (BP) control, and quality of life (QOL). The investigators will test the Immunity-to-Change intervention in a sample of nonadherent older adults with hypertension (n=18). Another sample of nonadherent older adults with hypertension will be monitored for comparison (n=18).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
36
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
-
-
Louisiana
-
New Orleans, Louisiana, Estados Unidos, 70112
- Tulane University
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-
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
55 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Men and women ages 55 and older, with the goal of a sex- and race-balanced sample
- Diagnosis of essential hypertension
- Uncontrolled hypertension
- Current treatment with antihypertensive medication
- Low antihypertensive pharmacy refill
- English speaking
- Telephone access
- Ability to read print on a computer screen and use the computer keyboard
- Written consent to participate and HIPAA authorization
- Written acceptance of study contract
- Approval of health care provider
Exclusion Criteria:
- Cognitive impairment
- Enrollment in another clinical trial
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 paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Cuidado usual
|
|
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Experimental: Health coaching
Two-hour in-person group counseling session led by health coach, involving development of personalized immunity maps that lay out adherence goal, behaviors that distract from goal, hidden motives that compete with achieving goal, and underlying assumptions Eight 50-minute individual telephone counseling sessions every three weeks with a health coach, focusing on uncovering hidden motives and challenging assumptions with the goal of overturning nonadherence mindsets |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in medication adherence (PDC)
Periodo de tiempo: Baseline to 6 months
|
Change in proportion of days covered (PDC) from baseline to 6 months
|
Baseline to 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in medication adherence (MMAS-8)
Periodo de tiempo: Baseline to 6 months
|
Change in MMAS-8 score from baseline to 6 months
|
Baseline to 6 months
|
|
Change in medication adherence (KWood-4)
Periodo de tiempo: Baseline to 6 months
|
Change in KWood-4 score from baseline to 6 months
|
Baseline to 6 months
|
|
Change in medication adherence (MMAS-8)
Periodo de tiempo: Baseline to 3 months
|
Change in MMAS-8 score from baseline to 3 months
|
Baseline to 3 months
|
|
Change in medication adherence (KWood-4)
Periodo de tiempo: Baseline to 3 months
|
Change in KWood-4 score from baseline to 3 months
|
Baseline to 3 months
|
|
Change in proportion with low adherence (PDC)
Periodo de tiempo: Baseline to 6 months
|
Change in proportion with low adherence (PDC<0.8)
from baseline to 6 months
|
Baseline to 6 months
|
|
Change in proportion with low adherence (MMAS-8)
Periodo de tiempo: Baseline to 6 months
|
Change in proportion with low adherence (MMAS-8<6) from baseline to 6 months
|
Baseline to 6 months
|
|
Change in proportion with low adherence (KWood-4)
Periodo de tiempo: Baseline to 6 months
|
Change in proportion with low adherence (KWood-4>0) from baseline to 6 months
|
Baseline to 6 months
|
|
Change in proportion with low adherence (MMAS-8)
Periodo de tiempo: Baseline to 3 months
|
Change in proportion with low adherence (MMAS-8<6) from baseline to 3 months
|
Baseline to 3 months
|
|
Change in proportion with low adherence (KWood-4)
Periodo de tiempo: Baseline to 3 months
|
Change in proportion with low adherence (KWood-4>0) from baseline to 3 months
|
Baseline to 3 months
|
|
Change in systolic blood pressure
Periodo de tiempo: Baseline to 6 months
|
Change in systolic blood pressure from baseline to 6 months
|
Baseline to 6 months
|
|
Change in diastolic blood pressure
Periodo de tiempo: Baseline to 6 months
|
Change in diastolic blood pressure from baseline to 6 months
|
Baseline to 6 months
|
|
Change in systolic blood pressure
Periodo de tiempo: Baseline to 3 months
|
Change in systolic blood pressure from baseline to 3 months (if available from insurance records)
|
Baseline to 3 months
|
|
Change in diastolic blood pressure
Periodo de tiempo: Baseline to 3 months
|
Change in diastolic blood pressure from baseline to 3 months (if available from insurance records)
|
Baseline to 3 months
|
|
Change in proportion with controlled blood pressure
Periodo de tiempo: Baseline to 6 months
|
Change in proportion with controlled blood pressure (SBP<140 & DBP<90) from baseline to 6 months
|
Baseline to 6 months
|
|
Change in proportion with controlled blood pressure
Periodo de tiempo: Baseline to 3 months
|
Change in proportion with controlled blood pressure (SBP<140 & DBP<90) from baseline to 3 months
|
Baseline to 3 months
|
|
Change in health-related quality of life
Periodo de tiempo: Baseline to 6 months
|
Change in health-related quality of life score (SF-36) from baseline to 6 months
|
Baseline to 6 months
|
|
Change in health-related quality of life
Periodo de tiempo: Baseline to 3 months
|
Change in health-related quality of life score (SF-36) from baseline to 3 months
|
Baseline to 3 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in hidden motives score
Periodo de tiempo: Baseline to 6 months
|
Change in hidden motives score from baseline to 6 months
|
Baseline to 6 months
|
|
Change in hidden motives score
Periodo de tiempo: Baseline to 3 months
|
Change in hidden motives score from baseline to 3 months
|
Baseline to 3 months
|
|
Change in explicit attitudes score
Periodo de tiempo: Baseline to 6 months
|
Change in explicit attitudes score (Beliefs about Medicines Questionnaire) from baseline to 6 months
|
Baseline to 6 months
|
|
Change in explicit attitudes score
Periodo de tiempo: Baseline to 3 months
|
Change in explicit attitudes score (Beliefs about Medicines Questionnaire) from baseline to 3 months
|
Baseline to 3 months
|
|
Change in implicit attitudes score
Periodo de tiempo: Baseline to 6 months
|
Change in implicit attitudes score (d-score from single-category implicit association test) from baseline to 6 months
|
Baseline to 6 months
|
|
Change in explicit ambivalence score
Periodo de tiempo: Baseline to 6 months
|
Change in explicit ambivalence score (absolute value of difference between standardized positive and negative explicit attitudes scores) from baseline to 6 months
|
Baseline to 6 months
|
|
Change in explicit ambivalence score
Periodo de tiempo: Baseline to 3 months
|
Change in explicit ambivalence score (absolute value of difference between standardized positive and negative explicit attitudes scores) from baseline to 3 months
|
Baseline to 3 months
|
|
Change in implicit ambivalence score
Periodo de tiempo: Baseline to 6 months
|
Change in implicit ambivalence score (absolute value of difference between standardized explicit and implicit attitude scores)
|
Baseline to 6 months
|
|
Change in short risk aversion switch point
Periodo de tiempo: Baseline to 6 months
|
Change in short switch point on risk aversion scale from baseline to 6 months
|
Baseline to 6 months
|
|
Change in short risk aversion switch point
Periodo de tiempo: Baseline to 3 months
|
Change in short switch point on risk aversion scale from baseline to 3 months
|
Baseline to 3 months
|
|
Change in long risk aversion switch point
Periodo de tiempo: Baseline to 6 months
|
Change in long switch point on risk aversion scale from baseline to 6 months
|
Baseline to 6 months
|
|
Change in long risk aversion switch point
Periodo de tiempo: Baseline to 3 months
|
Change in long switch point on risk aversion scale from baseline to 3 months
|
Baseline to 3 months
|
|
Change in risk valuation
Periodo de tiempo: Baseline to 6 months
|
Change in value indicated on risk aversion scale from baseline to 6 months
|
Baseline to 6 months
|
|
Change in risk valuation
Periodo de tiempo: Baseline to 3 months
|
Change in value indicated on risk aversion scale from baseline to 3 months
|
Baseline to 3 months
|
|
Change in medication-taking self-efficacy (MUSE)
Periodo de tiempo: Baseline to 6 months
|
Change in score on MUSE medication-taking subscale from baseline to 6 months
|
Baseline to 6 months
|
|
Change in medication-taking self-efficacy (MUSE)
Periodo de tiempo: Baseline to 3 months
|
Change in score on MUSE medication-taking subscale from baseline to 3 months
|
Baseline to 3 months
|
|
Change in learning-about-medications self-efficacy (MUSE)
Periodo de tiempo: Baseline to 6 months
|
Change in score on MUSE learning-about-medications subscale from baseline to 6 months
|
Baseline to 6 months
|
|
Change in learning-about-medications self-efficacy (MUSE)
Periodo de tiempo: Baseline to 3 months
|
Change in score on MUSE learning-about-medications subscale from baseline to 3 months
|
Baseline to 3 months
|
|
Change in self-efficacy (MUSE)
Periodo de tiempo: Baseline to 6 months
|
Change in score on MUSE scale from baseline to 6 months
|
Baseline to 6 months
|
|
Change in self-efficacy (MUSE)
Periodo de tiempo: Baseline to 3 months
|
Change in score on MUSE scale from baseline to 3 months
|
Baseline to 3 months
|
|
Change in self-efficacy (Self-Efficacy for Managing Chronic Disease)
Periodo de tiempo: Baseline to 6 months
|
Change in score on SEMCD scale from baseline to 6 months
|
Baseline to 6 months
|
|
Change in self-efficacy (Self-Efficacy for Managing Chronic Disease)
Periodo de tiempo: Baseline to 3 months
|
Change in score on SEMCD scale from baseline to 3 months
|
Baseline to 3 months
|
|
Change in chronic stress
Periodo de tiempo: Baseline to 6 months
|
Change in chronic stress from baseline to 6 months, as measured by salivary cortisol
|
Baseline to 6 months
|
|
Change in perceived stress
Periodo de tiempo: Baseline to 6 months
|
Change in score on 4-item version of Perceived Stress Scale from baseline to 6 months
|
Baseline to 6 months
|
|
Change in perceived stress
Periodo de tiempo: Baseline to 3 months
|
Change in score on 4-item version of Perceived Stress Scale from baseline to 3 months
|
Baseline to 3 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Marie A Krousel-Wood, MD MSPH, Tulane University
- Director de estudio: Erin M Peacock, PhD MPH, Tulane University
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.
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 (Actual)
1 de octubre de 2016
Finalización primaria (Actual)
30 de diciembre de 2019
Finalización del estudio (Actual)
30 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
24 de mayo de 2016
Primero enviado que cumplió con los criterios de control de calidad
22 de julio de 2016
Publicado por primera vez (Estimar)
27 de julio de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de octubre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
15 de octubre de 2020
Última verificación
1 de octubre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 735133
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
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