Development and Usability Testing of a Progressive WebApp for Women With Heart Disease (at heart)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Phase 3 (Study 3): Pilot Randomized Controlled Trial of the at heart (formerly called HEARTPA♀N) Intervention.
The at heart intervention is the first of its kind; there are no previous trials of the efficacy of such an intervention to decrease pain and improve HRQoL in women with heart disease. The investigators will undertake a process and preliminary effect evaluation of the intervention for women with heart disease, as guided by the MRC framework. The primary objective is to determine the feasibility of implementing an RCT of the intervention. A process evaluation will be conducted to examine: 1) the feasibility of randomization, recruitment and retention, 2) acceptability and barriers to implementing the intervention (including the symptom triage algorithms), and 3) the extent of engagement with the intervention. The investigators will also undertake a preliminary efficacy evaluation of the primary outcomes. Based on the investigator's theorized mechanism of change, they hypothesize that the intervention will reduce pain and improve HRQoL (primary outcomes). The investigators will assess the variability and sensitivity to change for both outcomes. Prior to conducting a full scale RCT of a complex intervention, such as at heart, the MRC recommends that a pilot trial be performed. Results from this pilot trial will inform the success of a future RCT in three ways: 1) help determine sample size calculation for the full-scale trial, 2) test procedures (recruitment, randomization, follow-up), which will make up the design of the full-scale trial, and 3) test feasibility of implementing the intervention, particularly by estimating rates of recruitment and retention. Triage algorithms and self-management interventions will be developed using a strong theoretical framework, informed by needs assessments and a comprehensive integrated mixed methods systematic review, with preliminary acceptability and usability testing by end-users. The investigators anticipate minimal risk to safety but will track adverse events using the Adverse Event Form. Moreover, latest WebApp technologies have been integrated through the use of a Chatbot named 'Holly'.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Monica Parry, PhD
- Número de teléfono: 416.946-3561
- Correo electrónico: monica.parry@utoronto.ca
Copia de seguridad de contactos de estudio
- Nombre: Myra Leyden, MA
- Número de teléfono: 416.978.1327
- Correo electrónico: myra.leyden@utoronto.ca
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M5T 1P8
- Reclutamiento
- Monica Parry
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Contacto:
- Monica Parry, PhD
- Número de teléfono: 416.946.3561
- Correo electrónico: monica.parry@utoronto.ca
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Contacto:
- Arland O'Hara, BA
- Correo electrónico: arland.ohara@utoronto.ca
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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:
- women greater than 18 years of age with obstructive and non-obstructive CAD pain, post PCI/cardiac surgery pain lasting greater than 3 months
- women will be required to speak and read English
Exclusion Criteria:
- severe cognitive impairment assessed using the Six-Item Screener
- major co-morbid medical or psychiatric illness that could preclude their ability to participate
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Control
Participants allocated to the control group will receive the usual care and supports provided to women with cardiac pain, including usual clinic appointments and follow-up.
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Experimental: Treatment
Participants allocated to the treatment group will also learn how to use the progressive WebApp intervention.
The intervention will be delivered on restricted password-protected applications that will permit tracking of adherence (number of logins to app and website using Google Analytics).
Participants will be encouraged to log-in regularly to the progressive WebApp (via automated alerts) over the 3-month period to complete a Heart and/or Wellness Check.
A Chatbot named 'Holly' will assist women with log-in and maintaining health and wellness.
Participants will be directed to the PC for technical problems.
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An integrated smartphone and web-based intervention (at heart) to provide evidence-informed symptom triage and self-management support to reduce pain and increase health-related quality of life (HRQoL) in women with heart disease.
The intervention for participants randomized to the treatment group will consist of regular use of a progressive WebApp that is managed by a Chatbot named 'Holly', in addition to usual care, for a period of 3 months.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility (recruitment, retention, engagement)
Periodo de tiempo: 3 months
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A process evaluation will be used to assess the feasibility of the implementation of the intervention.
The PC will track any issues or difficulties encountered during trial implementation, such as problems using the app.
Engagement will be assessed using Google Analytics, which will track patterns of app and website usage.
Engagement with the app diary will be defined as 100% with daily entries for 3 months.
Engagement with goal setting will be defined as 100% when 12 goals are identified over the 3-month period.
Criteria for implementation success: recruitment rates > 70%, retention > 85%, minimal technical difficulties reported by < 10%, engagement > 80%, and minimal missed responses.
Prevalence of refusal, retention, engagement and technical difficulties reported will be calculated with their 95% confidence intervals.
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3 months
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Feasibility (acceptability, satisfaction)
Periodo de tiempo: 3 months
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The investigators will also assess acceptability and satisfaction in all participants in the intervention group using a modified Acceptability e-Scale (AES).
The modified AES includes 9 items, each with a 5-point Likert response.
Higher scores represent better acceptability/satisfaction.
Responses are summed and averaged.
Criteria for implementation success: AES mean summary score > 4.
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3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Pain (Brief Pain Inventory)
Periodo de tiempo: 3 months
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A preliminary efficacy evaluation will also be undertaken focusing on the outcomes of pain.
Pain will be measured using the Brief Pain Inventory-Short Form (BPI-SF), which rates pain severity and the degree to which pain interferes with mood, sleep, and other physical activities such as work, social activity and relations with others.
We will investigate the variability and sensitivity to change for pain (T2-T1).
We will calculate the number of participants who report clinically meaningful decreases in pain, which has been defined for the BPI-SF as a two-point difference in worst pain.
Variability will be estimated using the mean/median scores and standard deviation, in each group separately, at pre and post-test.
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3 months
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Health-related quality of life (HRQOL)
Periodo de tiempo: 3 months
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A preliminary efficacy evaluation will also be undertaken focusing on the outcomes of HRQOL.
HRQOL will be measured using the SF-36v2TM, which contains 36 items and yields a score for each of the 8 domains of health: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role emotional), and mental health.
We will investigate the variability and sensitivity to change for HRQOL (T2-T1).
Sensitivity to change will be assessed by determining the number of participants who had a clinically meaningful increase in HRQOL: ≥ 15 points in physical functioning, general health and mental health; ≥ 16.7 in role emotional functioning; ≥ 18.5 points in role physical functioning and vitality; ≥ 20 points in bodily pain; and ≥ 25 points in social functioning.
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3 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Monica Parry, PhD, University of Toronto
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
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
- 389044
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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