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Effectiveness of Community Health Workers in Hypertension Adherence

17 de febrero de 2022 actualizado por: Cao Nguyen Hoai Thuong, Pham Ngoc Thach University of Medicine

Effectiveness of Community Health Workers in Hypertension Adherence: a Community Intervention in Elderly Patients

A community intervention in elderly hypertension patients by Community Health Workers in order to improve patients adherence to treatment

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

537

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

      • Ho Chi Minh City, Vietnam
        • Pham Ngoc Thach University of Medicine

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

60 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • All patients aged 60 years and older who had been diagnosed with hypertension for more than 3 months at the time of the study were eligible for inclusion.

Exclusion Criteria:

  • People who are not able to answer interviews or have mental illnesses.
  • Those who, after being interviewed, re-confirmed that they did not have a diagnosis of hypertension from a medical facility.

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: Prevención
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: intervention ward

Patients received interventions as follow:

  • The health education syllabus included 4 chapters: (1) introduction to hypertension, (2) complications of high blood pressure, (3) lifestyle management, and (4) SCORE - European High-Risk Chart
  • Home health education by Community Health Workers every month for 6 months

Patients received interventions as follow:

  • The health education syllabus included 4 chapters: (1) introduction to hypertension, (2) complications of high blood pressure, (3) lifestyle management, and (4) SCORE - European High-Risk Chart
  • Home health education by Community Health Workers every month for 6 months
Sin intervención: control ward
Patients received usual care, consisted of existing services in the community

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change Medication adherence
Periodo de tiempo: Patients were assessed Medication adherence at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
Medication adherence was assessed using The 8-item Morisky Medication Adherence Scale (MMAS-8). The scale is based on the patients' self-response and consists of eight questions, seven items with yes or no response, and one item with a 5-point Likert scale response option. The total score ranges from 1 to 8, the patient whose adherence score was six or more is considered adherent.
Patients were assessed Medication adherence at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change Follow-up compliance
Periodo de tiempo: Patients were assessed Follow-up compliance at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
patients are considered Follow-up compliance when they have had a follow-up examination for hypertension in the past 3 months, according to the doctor's appointment, or early/delayed within 3 days
Patients were assessed Follow-up compliance at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
Change Compliance with reducing salt intake
Periodo de tiempo: Patients were assessed Compliance with reducing salt intake at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
patients are said to comply with salt reduction when using < 5g salt/day (corresponding to < 1.9g Na/day). Daily sodium intake was calculated based on the Food Frequency Questionnaire (FFQ) on foods high in salt (preserved meat, salt, fish sauce, soy sauce, ketchup) according to the formula [portion size in grams] x [reported consumption frequency (converted to times per day)] x [nutrient per gram]
Patients were assessed Compliance with reducing salt intake at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
Change Physical activity compliance
Periodo de tiempo: Patients were assessed Physical activity compliance at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
Physical activity compliance assessed by The International Physical Activity Questionnaire - Short Form (IPAQ-SF). The IPAQ-SF includes 4 questions, collects physical activity information for the previous 7 days regarding vigorous and moderate activity, walking and sedentary behaviors, units in MET-minutes/week. Patients were considered compliant with moderate and high levels of physical activity according to the IPAQ-SF assessment guidelines.
Patients were assessed Physical activity compliance at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
Change Smoking compliance
Periodo de tiempo: Patients were assessed Smoking compliance at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
patients are considered Smoking compliance when they currently do not smoke or completely quit smoking (including e-cigarettes)
Patients were assessed Smoking compliance at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
Change Compliance with alcohol consumption
Periodo de tiempo: Patients were assessed Compliance with alcohol consumption at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
patients are considered Compliance with alcohol consumption when minimizing alcohol consumption, if drinking, the amount should be ≤ 2 standard drinks/day (men) or ≤ 1 standard drinks/day (women), and the total must be ≤ 10 standard drinks/week (men) or ≤ 5 standard drinks/week (women)
Patients were assessed Compliance with alcohol consumption at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este 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)

3 de noviembre de 2020

Finalización primaria (Actual)

18 de febrero de 2022

Finalización del estudio (Actual)

18 de febrero de 2022

Fechas de registro del estudio

Enviado por primera vez

23 de diciembre de 2021

Primero enviado que cumplió con los criterios de control de calidad

13 de enero de 2022

Publicado por primera vez (Actual)

26 de enero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de febrero de 2022

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

17 de febrero de 2022

Última verificación

1 de febrero de 2022

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 8286

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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