TElemedicine to Replace Face-to-face Physician Consultation in Patients With HyperTension : a Pilot Randomized-controlled Trial (SATE-HT)
7 de marzo de 2022 actualizado por: Lee Kam Pui, Chinese University of Hong Kong
Safety, Feasibility and Acceptability of Using TElemedicine to Replace Face-to-face Physician Consultation in Patients With HyperTension in Hong Kong: a Pilot Randomized-controlled Trial
The investigators has developed a blood pressure telemonitoring system. It is hypothesized that, when optimal control of BP is confirmed on the telemonitoring system, the index physician's consultation can be safely deferred, and medications can still be prescribed without such face-to-face consultation. Despite potentially resource-saving for doctors and time-saving for patients, the feasibility and patients' acceptability of the use of the telemonitoring system to replace face-to-face physician consultation remains unclear.
For primary outcome, the investigators hypothesize that this telemonitoring system will be feasible and acceptable to patients and can replace physicians' face-to-face consultations. For secondary outcomes, the investigators hypothesize that patients receiving care through telemonitoring have non-inferior BP control when compared with patients receiving usual care. Furthermore, the patients receiving telemonitoring may also have enhanced self-efficacy and compliance to drugs and lifestyle interventions
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
50
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
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Hong Kong, Hong Kong
- Lek Yuen Clinic and Fanling clinic
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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
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- have a diagnosis of essential hypertension (HT) and are currently taking antihypertensive agents
- have good control of clinic BP as confirmed on ambulatory blood pressure monitoring (ABPM) (daytime BP ≤135/85mmHg)
- can read basic Chinese (as the content of the app in Chinese)
- have a home BP monitor (HBPM)
- used any mobile app (not HT-related) in the previous 1 year
Exclusion Criteria:
- an inability to give informed consent
- unwillingness to conduct HBPM or repeated ABPM
- current use of any other HT app for BP monitoring
- relative contraindications to ABPM (diagnosed atrial fibrillation, occupational drivers or patients with bleeding tendencies)
- severe mental illness, including those diagnosed with schizophrenia, dementia or as being actively suicidal, because these patients may have diminished ability to use the HT app;
- a diagnosis of other chronic disease(s) that need regular physical assessments and doctors' consultations (e.g. diabetes and asthma that are being treated, but patients with hypertension and hyperlipidaemia will remain eligible)
- diagnosed active cancer,
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: telemedicine group
The HT app (HealthCap) allows patients to record their home BP measurements (HBPM) and can automatically provide mean BP values from the previous 7 or 30 days.
1-2 week prior to a scheduled physician, HealthCap and a research assistant will remind patients to take dual BP readings both in the morning and evening for 1 week for doctors' management.
The mean values of the 7-day home BP will be checked before the index consultation.
If the home BP control was optimal (i.e.
≤135/85 mmHg), other important parameters will be checked automatically by a questionnaire in the app: (i) if they have good drug compliance and if they experienced any side effects,(ii) if they have symptoms suggestive of target organ damages such as chest pain or hemiplegia, and (iii) if they have any problem(s) that need to consult a physician.
If no complaints are identified, the patient can collect medications directly from the clinic and the physician appointment will be deferred for 3 months
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a mobile app and telemedicine platform to confirm good blood pressure control and may save doctor face-to-face consultation
These patients have unrestricted access to healthcare resources such as general outpatient clinics and emergency departments
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Comparador de placebos: usual care
Patients in the usual care group will be asked to refrain from downloading or using any health care apps related to HT
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These patients have unrestricted access to healthcare resources such as general outpatient clinics and emergency departments
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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rate of recruitment
Periodo de tiempo: baseline
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number of patients recruited per month during the recruitment period
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baseline
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rate of retention
Periodo de tiempo: baseline, 6-month
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number of dropouts during the 6-month study period
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baseline, 6-month
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acceptability
Periodo de tiempo: at 6-month
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interview of around 20 patients in the intervention group
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at 6-month
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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blood pressure levels on 24-hour ambulatory blood pressure
Periodo de tiempo: baseline, 6-month
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daytime, nighttime, and 24-hour systolic and diastolic blood pressure
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baseline, 6-month
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healthcare utilization
Periodo de tiempo: 6-month
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number of visits to general outpatient clinic, specialist clinic(s) and hospitalization during study period
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6-month
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self-efficacy scale
Periodo de tiempo: baseline, 6-month
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5-item self-efficacy scale specific to hypertension; a mean score from the items of a 9 or above were classified as having good self-efficacy
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baseline, 6-month
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medication and diet adherence
Periodo de tiempo: baseline, 6-month
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Treatment Adherence Questionnaire for Patients with Hypertension (TAQPH); Score was summed to give a total range, higher score represented better adherence
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baseline, 6-month
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exercise level
Periodo de tiempo: baseline, 6-month
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Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ); higher scores represented higher exercise level
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baseline, 6-month
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eHealth literacy
Periodo de tiempo: baseline, 6-month
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Chinese 8-item eHealth literacy scale; higher scores represented higher eHealth literacy
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baseline, 6-month
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health literacy
Periodo de tiempo: baseline, 6-month
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3-item Brief Health Literacy; higher scores represented higher health literacy
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baseline, 6-month
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
7 de octubre de 2020
Finalización primaria (Actual)
31 de diciembre de 2021
Finalización del estudio (Actual)
31 de diciembre de 2021
Fechas de registro del estudio
Enviado por primera vez
2 de septiembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
2 de septiembre de 2020
Publicado por primera vez (Actual)
9 de septiembre de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de marzo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
7 de marzo de 2022
Última verificación
1 de marzo de 2022
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SATE-HT
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
May be available when inquired by other researchers
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
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