Vet-Harts Pilot Intervention for Veterans With Coronary Heart Disease (VHPI)
12 de junio de 2018 actualizado por: VA Office of Research and Development
Representational Telehealth Nursing Intervention for Veterans With CHD
The purpose of this research study is to survey patients to learn about their beliefs and behaviors related to the management of heart disease and to discuss options for making healthy lifestyle changes.
From the information the investigators get from patients, the investigators hope to develop better methods for taking care of patients who have heart disease.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Coronary heart disease (CHD) is a significant health threat among veterans.
Compared to their civilian counterparts, veterans experience greater disability, reinfarction, and mortality following myocardial infarction (MI) and other acute coronary syndromes (ACS).
High rates of hypertension, diabetes, and cardiac risk behaviors (e.g., smoking) and low socioeconomic status (SES) further increase veterans' CHD-related morbidity and mortality.
The proposed pilot project will establish the feasibility of a telehealth nursing intervention for veterans with CHD who are recovering from MI/ACS.
The Veterans Heart Attack Representations Telehealth (Vet-HART) intervention is designed to promote adaptive conceptual change in veterans' beliefs (common sense models or representations) about CHD etiology and self-management and facilitate health behavior changes (e.g., smoking cessation, medication adherence, diet management, and increased physical activity).
The long-term goal of this research program is to improve veterans' quality of life (QoL) and reduce their CHD-related morbidity/mortality.
The proposed project is the requisite next step in attaining that goal.
Tipo de estudio
Intervencionista
Inscripción (Actual)
12
Fase
- Fase 2
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
-
-
Iowa
-
Iowa City, Iowa, Estados Unidos, 52246-2208
- Iowa City VA Health Care System, Iowa City, IA
-
-
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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Admission to an inpatient medicine unit for MI, ACS, and coronary angiography
- Age
Exclusion Criteria:
- Altered mental status
- Language barriers
- Dementia or Cognitive Impairment
- Diagnostic Study
- Resident in long-term care facility prior to the present admission
- Planned discharge to a skilled or intermediate care facility or hospice
- Lack of access to a functioning phone
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Motivational Interview
For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention.
The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.
|
For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention.
The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.
|
|
Sin intervención: Usual Care
For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
SF-36v Physical Function Scale
Periodo de tiempo: Change from baseline to 3-months post hospital discharge
|
Physical Functioning Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
|
Change from baseline to 3-months post hospital discharge
|
|
SF-36v Role Limitations Due to Physical Health Scale
Periodo de tiempo: Change from baseline to 3-months post hospital discharge
|
Role Limitations Due to Physical Health Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
|
Change from baseline to 3-months post hospital discharge
|
|
SF-36v Role Limitations Due to Emotional Problems Scale
Periodo de tiempo: Change from baseline to 3-months post hospital discharge
|
Role Limitations Due to Emotional Problems Scale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
|
Change from baseline to 3-months post hospital discharge
|
|
SF-36v Energy-Fatigue Scale
Periodo de tiempo: Change from baseline to 3-months post hospital discharge
|
Energy-Fatigue Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
|
Change from baseline to 3-months post hospital discharge
|
|
SF-36v Emotional Well-Being Scale
Periodo de tiempo: Change from baseline to 3-months post hospital discharge
|
Emotional Well-Being Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
|
Change from baseline to 3-months post hospital discharge
|
|
SF-36v Social Functioning Scale
Periodo de tiempo: Change from baseline to 3-months post hospital discharge
|
Social Functioning Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
|
Change from baseline to 3-months post hospital discharge
|
|
SF-36v Pain Scale
Periodo de tiempo: Change from baseline to 3-months post hospital discharge
|
Pain Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
|
Change from baseline to 3-months post hospital discharge
|
|
SF-36v General Health Scale
Periodo de tiempo: Change from baseline to 3-months post hospital discharge
|
General Health Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
|
Change from baseline to 3-months post hospital discharge
|
|
Seattle Angina Questionnaire Physical Limitations Scale
Periodo de tiempo: Change from baseline to 3-months post hospital discharge
|
Physical Limitations Subscale from the Seattle Angina Questionnaire.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
|
Change from baseline to 3-months post hospital discharge
|
|
Seattle Angina Questionnaire Angina Stability Scale
Periodo de tiempo: Change from baseline to 3-months post hospital discharge
|
Angina Stability Subscale from the Seattle Angina Questionnaire.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
|
Change from baseline to 3-months post hospital discharge
|
|
Seattle Angina Questionnaire Angina Frequency Scale
Periodo de tiempo: Change from baseline to 3-months post hospital discharge
|
Angina Frequency Subscale from the Seattle Angina Questionnaire.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
|
Change from baseline to 3-months post hospital discharge
|
|
Seattle Angina Questionnaire Treatment Satisfaction Scale
Periodo de tiempo: Change from baseline to 3-months post hospital discharge
|
Treatment Satisfaction Subscale from the Seattle Angina Questionnaire.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
|
Change from baseline to 3-months post hospital discharge
|
|
Seattle Angina Questionnaire Disease Perception Scale
Periodo de tiempo: Change from baseline to 3-months post hospital discharge
|
Disease Perception Subscale from the Seattle Angina Questionnaire.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
|
Change from baseline to 3-months post hospital discharge
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mark W Vander Weg, PhD MS BA, Iowa City VA Health Care System, Iowa City, IA
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)
30 de abril de 2012
Finalización primaria (Actual)
30 de junio de 2012
Finalización del estudio (Actual)
31 de octubre de 2012
Fechas de registro del estudio
Enviado por primera vez
19 de marzo de 2012
Primero enviado que cumplió con los criterios de control de calidad
26 de marzo de 2012
Publicado por primera vez (Estimar)
29 de marzo de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de diciembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
12 de junio de 2018
Última verificación
1 de junio de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PPO 09-283
- 200910778 (Otro identificador: University of Iowa)
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. .