- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03274089
Health Outcomes of Patients With Stable Chronic Disease Managed With a Healthcare Kiosk
A Randomized Controlled Trial to Evaluate the Health Outcomes of Patients With Stable Chronic Disease Managed With a Healthcare Kiosk
The chronic disease burden is increasing worldwide leading to a rise in the demand for primary healthcare and a shortage of primary care physicians. Addressing this shortage entails a multi-prong approach with innovations in care delivery, greater use of healthcare technology, and more efficient use of all healthcare providers on the care team.
We previously developed an interactive self-service healthcare kiosk (Self-empowering and enabling kiosk - SEEK® MyHealthKiosk) for the management of patients with stable chronic disease in the primary care setting. A feasibility study using SEEK showed high levels of acceptance and satisfaction from patients and healthcare providers.
The aim of this follow-up study is to evaluate the health outcomes of patients with stable chronic disease who are on kiosk management compared to patients who are on routine management by nurse clinicians. We hypothesize that patients who are managed by the kiosk continue to maintain good disease control that are comparable to patients who are managed by a nurse clinician.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Patients who seek primary healthcare vary in their time and resource requirements. Patients with acute medical conditions or poorly controlled chronic disease typically require more time and attention compared to patients with stable chronic disease.
Patients with chronic disease routinely make follow-up visits to their primary care provider for assessment of their chronic disease status and for changes to their medications as necessary. Patients with well-controlled stable chronic disease may go through several visits to their primary care provider in 3 or 4-monthly intervals with little or no change to their medication regimen. These patients have to wait in line with the rest of the patient crowd for a doctor's consultation before getting their regular supply of medications. We hence saw the potential of replacing some of these physician visits with an automated healthcare kiosk so that if the disease condition of such patients remained stable, they can continue on their current medications without having to see a doctor.
We previously described the feasibility of using an automated healthcare kiosk (SEEK® MyHealthKiosk) for the management of patients with stable chronic disease in the primary care setting. We propose a follow-up study to show equivalence of health outcomes for patients managed with SEEK compared to the current standard of care. The study will be a 2-armed randomized controlled trial of 120 patients with stable chronic disease on 4-monthly follow-up visits over a 12-month period. Patients will be assigned randomly to intervention or control groups to receive kiosk or nurse management respectively. The main primary outcome measure is the overall chronic disease control of the patients. Other primary outcome measures are the blood pressure and low-density lipoprotein cholesterol levels for patients without diabetes; and blood pressure, low-density lipoprotein cholesterol and hemoglobin A1c levels for patients with diabetes. Secondary outcome measures are visit duration, patient satisfaction with the management process, health-related quality of life, and the occurrence of any adverse event.
The potential benefits from the use of SEEK are:
- Appropriate stratification of patient care needs so that more time and resources can be channeled to patients with complex or acute needs;
- Patient empowerment in the management of their chronic health conditions, with flexibility of self-care and monitoring and decreased dependency on healthcare providers;
- Substitution of nurse clinicians for the management of stable chronic disease;
- Reduction in the number of doctor visits per year for patients with stable chronic disease.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Singapore, Singapur
- Reclutamiento
- SingHealth Polyclinics - Punggol
-
Contacto:
- Executive
- Número de teléfono: 6643 6969
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- are between the ages of 21 and 75 years
- have at least one chronic medical condition that includes hypertension, hyperlipidemia, diabetes mellitus
- have blood pressure, low-density lipoprotein cholesterol (LDL-C) and HbA1c levels within the recommended targets according to the Ministry of Health Singapore clinical practice guidelines for their current and last follow-up visits
- are able to provide informed consent.
Exclusion Criteria:
- have serum creatinine more than 140 mmol/L (from tests done within the past year)
- have serum potassium less than 3.5 mmol/L or more than 5 mmol/L (from tests done within the past year)
- have overt proteinuria (urine protein:creatinine ratio more than 0.5)
- were discharged from hospital or specialist follow-up within the last 6 months
- have any pending laboratory or investigation result
- are scheduled for any laboratory investigation within the next 4 months (except HbA1c or panel test)
- have any new complaint related to their chronic medical conditions
- have a known history of white coat hypertension
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Kiosk intervention group
|
SEEK automates the management of patients with stable well-controlled chronic disease. SEEK has the following capabilities:
Otros nombres:
|
|
Sin intervención: Nurse clinician control group
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Presión arterial
Periodo de tiempo: 12 meses
|
12 meses
|
|
Hemoglobina a1c
Periodo de tiempo: 12 meses
|
12 meses
|
|
Disease control
Periodo de tiempo: 12 months
|
12 months
|
|
Low-density lipoprotein cholesterol
Periodo de tiempo: 12 months
|
12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Eventos adversos
Periodo de tiempo: 12 meses
|
12 meses
|
|
|
Visit duration
Periodo de tiempo: 8 months
|
8 months
|
|
|
Patient satisfaction questionnaire
Periodo de tiempo: 12 months
|
The following areas of patient satisfaction will be scored on a Likert scale: convenience of visit schedule, location of kiosk or nurse consultation, appropriateness of management, duration of time spent in kiosk usage or nurse consultation, and the replacement of a doctor's visit by the kiosk or nurse clinician.
Qualitative feedback will be captured via free-text inputs.
|
12 months
|
|
Health-related quality of life questionnaire
Periodo de tiempo: 12 months
|
Health-related quality of life will be assessed using the EQ-5D-5L questionnaire.
|
12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1629027001
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.
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. .
Ensayos clínicos sobre Kiosk intervention group
-
Norther Private Collage of NursingTerminadoIntervenciones de enfermeríaArabia Saudita, Egipto
-
University of California, Los AngelesNational Institute of Mental Health (NIMH); Partners in Hope, Inc.Reclutamiento
-
PeriPharmAún no reclutandoEstudio en el Mundo Real sobre el Impacto de la Dermatitis Atópica desde la Perspectiva del CuidadorEczema | Dermatitis atópica | Cuidador | Carga | Eccema Dermatitis atópica
-
PeriPharmTerminadoLupus | Artritis lúpica | Artritis lúpica, lupus eritematoso sistémico | Calidad de vida (CV)Canadá
-
Cairo UniversityTerminadoObesidad y Sobrepeso del SueñoEgipto
-
Centre Leon BerardNutricia, Inc.Aún no reclutandoTrastorno del olfato | Alteraciones del Gusto | Cambios en el Comportamiento AlimentarioFrancia
-
PeriPharmAún no reclutandoHidradenitis supurativa (HS)
-
Montefiore Medical CenterNational Center for Advancing Translational Sciences (NCATS)Aún no reclutandoEnfermedades inflamatorias del intestino | Enfermedad de Crohn | Colitis ulcerosaEstados Unidos
-
Centre Hospitalier Universitaire de Saint EtienneLyon Neuroscience Research Center (CRNL)Aún no reclutandoEnfermedad de Alzheimer o Trastorno AsociadoFrancia
-
Saglik Bilimleri UniversitesiAún no reclutandoEfecto de la reflexología en los síntomas del síndrome premenstrual