- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03698890
Primary Technology Enhanced Care in Hypertension (PTEC)
Evaluation of Clinical Pathways for Patients With Hypertension on Follow-up in the Polyclinics
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
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:
- the CM will access the MHS portal to review the patient's blood pressure and provide updates to the patient on blood pressure control.
- 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
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Valerie Teo
- Número de teléfono: +653553000
- Correo electrónico: Valerie_Hy_TEO@nhgp.com.sg
Copia de seguridad de contactos de estudio
- Nombre: Sok Huang Teo
- Número de teléfono: +6564966106
- Correo electrónico: Sok_Huang_TEO@nhgp.com.sg
Ubicaciones de estudio
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Singapore, Singapur, 569666
- Reclutamiento
- Ang Mo Kio Polyclinic
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Contacto:
- Sok Huang Teo
- Número de teléfono: +6564966106
- Correo electrónico: Sok_Huang_TEO@nhgp.com.sg
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Contacto:
- Valerie Teo
- Número de teléfono: +6563553000 +6563553000
- Correo electrónico: Valerie_Hy_TEO@nhgp.com.sg
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Investigador principal:
- Valerie Teo
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿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
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Experimental: Intervention
Network-based home blood pressure monitor (Fora P20b Blood Pressure Monitor) and telephone consult with care team
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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:
|
¿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
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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.
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6 months
|
Healthcare utilization of participants
Periodo de tiempo: 6 & 12 months
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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
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Healthcare costs incurred by participants
Periodo de tiempo: 6 & 12 months
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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.
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6 & 12 months
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Number of medications prescribed to participants
Periodo de tiempo: 6 months
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Change in number of medications prescribed to participants during the course of study participation.
This information will be obtained from the electronic medical records.
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6 months
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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).
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6 months
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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.
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6 months
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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.
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6 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Valerie Teo, National Healthcare Group Polyclinics
Publicaciones y enlaces útiles
Publicaciones Generales
- Purcell R, McInnes S, Halcomb EJ. Telemonitoring can assist in managing cardiovascular disease in primary care: a systematic review of systematic reviews. BMC Fam Pract. 2014 Mar 7;15:43. doi: 10.1186/1471-2296-15-43.
- Duan Y, Xie Z, Dong F, Wu Z, Lin Z, Sun N, Xu J. Effectiveness of home blood pressure telemonitoring: a systematic review and meta-analysis of randomised controlled studies. J Hum Hypertens. 2017 Jul;31(7):427-437. doi: 10.1038/jhh.2016.99. Epub 2017 Mar 23.
- Chandak A, Joshi A. Self-management of hypertension using technology enabled interventions in primary care settings. Technol Health Care. 2015;23(2):119-28. doi: 10.3233/THC-140886.
- Bosworth HB, Olsen MK, Grubber JM, Neary AM, Orr MM, Powers BJ, Adams MB, Svetkey LP, Reed SD, Li Y, Dolor RJ, Oddone EZ. Two self-management interventions to improve hypertension control: a randomized trial. Ann Intern Med. 2009 Nov 17;151(10):687-95. doi: 10.7326/0003-4819-151-10-200911170-00148.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
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.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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