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Primary Technology Enhanced Care in Hypertension (PTEC)

10 de octubre de 2018 actualizado por: Valerie Teo, National Healthcare Group Polyclinics

Evaluation of Clinical Pathways for Patients With Hypertension on Follow-up in the Polyclinics

This study evaluates the impact of the use of a technology-enabled home blood pressure monitor amongst hypertensive patients in primary care. Half of the patients will receive the blood pressure monitor for home monitoring, while the other half will receive usual care at the polyclinic. The hypothesis is tele-monitoring along with nurse led tele-support and medical review (i.e. tele-treatment) can enhance primary care management of hypertension by improving patient outcomes and reducing health costs.

Descripción general del estudio

Estado

Desconocido

Condiciones

Descripción detallada

A literature review on telemedicine in primary care indicated that tele-monitoring can enhance primary care management of hypertension (HT) by improving patient outcomes and reducing health costs. In addition, technology-enabled blood pressure (BP) self-monitoring interventions have even better BP control outcomes if (i) nurse led tele-support and (ii) medication review (i.e. tele-treatment) are added.

This study comprises 2 phases:

Phase 1: Intervention phase This will be an open label (unblinded), parallel, non-randomized, quasi-experimental study conducted within 1 study site. Patients who are under the care of 2 clinical teams, called teamlets (comprising 2 family physicians, a care coordinator and a care manager who is a nurse), will be recruited into the study.

Patients under the care of 1 teamlet will be allocated to the intervention group, while those under the care of the other teamlet will be allocated to the usual care group.

One key modality for this study will be the use of a network-based home blood pressure monitor to provide patient-led tele-monitoring for BP levels for patients in the intervention group. The monitor will be loaned to patients in the intervention group, who will be asked to monitor their blood pressure at least once every week using the network based home blood pressure monitor, which automatically uploads measured blood pressure readings to the MyHealthSentinel (MHS) portal for care managers (CM) in the teamlet to review blood pressure readings.

The network-based home blood pressure monitor will be used to enhance nurse-led tele-support in the following ways:

  1. the CM will access the MHS portal to review the patient's blood pressure and provide updates to the patient on blood pressure control.
  2. If a patient's blood pressure is elevated, using the established protocols, the CM can titrate medications over the phone and provide follow up tele-consultation and necessary treatment in 2 to 4 weeks to assess subsequent blood pressure levels and side effects. The titration of medication is part of usual care and is managed by the ordering physician. Patients will be contacted after dose titration to see whether his or her blood pressure has improved. The care manager will also use the same phone call to check whether patients followed the titrated medication dosage.

Patients in the usual care group will continue to be followed up and managed as per usual, there will be no additional clinical intervention provided to patients in this group.

At 6 months after recruitment into the study, the patients' clinical outcomes will be measured. Specific outcome variables are as follows:

(i) blood pressure after 6 months, (ii) Proportion of HT patients with controlled BP at each month and (iii) Time to BP control (only if medications review is done). The above variables will be extracted from Electronic Medical Records database, as well as the MHS portal to derive the above mentioned outcome variables along with additional variables to be extracted.

A questionnaire will be administered to both groups at the first study visit and at the visit after 6 months to survey patients on their sodium intake, quality of life, beliefs about medication, medication adherence, and satisfaction with the care provided.

Patients in both arms will receive reimbursement at the end of study participation.

Phase 2: Qualitative phase A sub-group of patients (control group and intervention group) and teamlet staff, will be invited to participate in one-to-one semi-structured in-depth interviews and/or focus group discussions (FGDs), to find out their experience with the managing blood pressure via telemonitoring or physical clinic visit. All interviews and FGDs will be audio-recorded and later transcribed. Transcripts will not contain any personal data. Field notes will be taken during the interviews and memos written after the completion of interview. Both deductive and inductive approaches will be adopted to analyze the collected data using elements of thematic analysis and constant comparison approaches.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

240

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

      • Singapore, Singapur, 569666
        • Reclutamiento
        • Ang Mo Kio Polyclinic
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Valerie Teo

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

21 años a 99 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Adult patients
  • Patients with hypertension only, or hypertension and hyperlipidemia
  • Patients who are cared for by teamlets
  • Patients who are technology savvy and are able and willing to use telemedicine devices, or have a family member who is willing to assist in using telemedicine for blood pressure control
  • Clinic teams who are directly involved in patient care

Exclusion Criteria:

  • Patients who have cognitive impairment
  • Pregnant patients
  • Patients with hypertension and other chronic illnesses other than hyperlipidemia, such as diabetes.
  • Patients with a history of ischemic heart disease, congestive heart failure, stroke, transient ischemic attack, atrial fibrillation and renal impairment.

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: Investigación de servicios de salud
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Control
Usual care of 3 to 6-monthly clinic visit
Experimental: Intervention
Network-based home blood pressure monitor (Fora P20b Blood Pressure Monitor) and telephone consult with care team
A network-based home blood pressure monitor will be loaned to patients in the intervention group, who will be asked to monitor their blood pressure at least once every week using the network based home blood pressure monitor, which automatically uploads measured blood pressure readings to the portal for care managers (CM) to review blood pressure readings and provide updates to the patient on blood pressure control. If a patient's blood pressure is elevated, the CM can titrate medications over the phone and provide follow up tele-consultation and necessary treatment.
Otros nombres:
  • Fora P20b Blood Pressure Monitor

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Blood pressure control
Periodo de tiempo: 6 months
Change in systolic and diastolic blood pressure (in mmHg) after 6 months. Readings will be obtained monthly from the MHS portal.
6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to blood pressure control
Periodo de tiempo: 6 months
Trend of time taken for blood pressure to be controlled if medication review is done. Readings will be obtained monthly from the MHS portal. This will be measured in hours, days or months.
6 months
Proportion of participants with controlled blood pressure
Periodo de tiempo: 6 months
Change in proportion of participants with controlled blood pressure, measured by systolic & diastolic blood pressure, at each month. This will be measured in percentage.
6 months
Healthcare utilization of participants
Periodo de tiempo: 6 & 12 months
Trend of utilization of healthcare services by participants. These include number of hospitalizations, doctor consultations, nurse consultations, teleconsultations, treatment & procedures, screening, laboratory tests, pharmacy services. These information will be obtained from the electronic medical records.
6 & 12 months
Healthcare costs incurred by participants
Periodo de tiempo: 6 & 12 months
Change in costs of healthcare services utilized by participants. These include administrative costs, costs of doctor consultations, nurse consultations, teleconsultations, treatment & procedures, medications, screening, laboratory tests, pharmacy services. These information will be obtained from institution's Finance system and the electronic medical records. All amounts will be in Singapore dollars.
6 & 12 months
Number of medications prescribed to participants
Periodo de tiempo: 6 months
Change in number of medications prescribed to participants during the course of study participation. This information will be obtained from the electronic medical records.
6 months
Type of medications prescribed to participants
Periodo de tiempo: 6 months
Change in type of medications prescribed to participants during the course of study participation, e.g. antihypertensive drug class. This information will be obtained from the electronic medical records.
6 months
Quality of life of participants
Periodo de tiempo: 6 months
Change in quality of life of participants. This will be measured by the 5-level EuroQol 5-dimension questionnaire (EQ-5D-5L) which will be completed by participants at the baseline visit and 6-month phone call. The scale measures self-reported health outcomes. Each of the 5 domains will be coded from 1 to 5, and the final 5-digit health state will be converted into a single index value to facilitate calculation of quality-adjusted life years (QALY).
6 months
Medication adherence
Periodo de tiempo: 6 months
Change in medication adherence of participants. This will be measured by self-report through a questionnaire with 4-point Likert scale, adapted from the Hill-Bone Compliance to High Blood Pressure Therapy Scale. Total score for each patient will be from 4 to 12, with higher scores reflecting poorer adherence to medication. This will be completed at the baseline visit and 6-month phone call.
6 months
Patient satisfaction
Periodo de tiempo: 6 months
Patient satisfaction with telemonitoring or usual care will be measured by a self-reported questionnaire on a 6-point Likert scale which will be completed at the 6-month phone call. Total score for each patient will be from 6 to 30 with higher scores reflecting better satisfaction.
6 months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Valerie Teo, National Healthcare Group Polyclinics

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)

17 de septiembre de 2018

Finalización primaria (Anticipado)

30 de junio de 2019

Finalización del estudio (Anticipado)

31 de diciembre de 2019

Fechas de registro del estudio

Enviado por primera vez

1 de octubre de 2018

Primero enviado que cumplió con los criterios de control de calidad

4 de octubre de 2018

Publicado por primera vez (Actual)

9 de octubre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de octubre de 2018

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

10 de octubre de 2018

Última verificación

1 de octubre de 2018

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2018/00785

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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