- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02540044
Supporting Patient Care With Electronic Resource (SuPER) (SuPER)
Supporting Patient Care With Electronic Resource (SuPER): Efficacy of an Online Decision Aid for Patients Considering Biologic Therapy for Rheumatoid Arthritis
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The proposed project aims to improve the process of making evidence-informed treatment decisions by patients with rheumatoid arthritis (RA) and ultimately, empower patient self-management. Current RA treatment emphasizes: 1) the need for early and aggressive treatment, and 2) the use of a Treat-to-Target approach. Patients often struggle with treatment decisions, however, especially when the options have both benefits and risks. To address this challenge, the investigators have developed a new online decision aid called ANSWER-2 (ANimated, Self-serve, WEb-based, Research Tool: Version 2) for RA patients who are considering a biologic or other new therapy. A unique feature of ANSWER-2 is its ability to individualize how treatment options are presented based on the patient's preferences.
Objective: 1) To evaluate the effectiveness of ANSWER-2 in reducing patients' decisional conflict. 2) To assess the extent to which ANSWER-2 improves patients' knowledge about RA medications and confidence in managing their health. 3) To examine the experiences of patients and rheumatologists in using the ANSWER-2.
The investigators will conduct a proof-of-concept randomized controlled trial with 148 patients with RA. Eligible individuals are those: 1) with a diagnosis of RA from a rheumatologist, 2) whose rheumatologists have recommended initiating a biologic or other new therapy or switching to another agent, and 3) who have internet access. The Intervention Group will receive simple instructions to access ANSWER-2 and complete the program on their own within two days. At the end of the session, a one-page summary will be produced to help them discuss their questions, concerns, and preferred choices with their health care providers. The Control Group will receive The Arthritis Society's online education booklet "Arthritis Medications: A Consumer's Guide". Participants will complete the Decisional Conflict Scale (primary outcome) before and after the intervention (ANSWER-2 or booklet). The following secondary outcome measures will be collected at baseline, 1 month and 2 months: 1) Medication Education Impact Questionnaire (MeIQ), and 2) Partners in Health Scale (PHS). In addition, use of healthcare resources will be collected at 2 months. Participants will also be asked about their medication preferences at Month 1, as well as the shared decision making process in their last appointment, (using the 3-item CollaboRATE scale), at Month 1. Participants who received the ANSWER-2 decision aid and their rheumatologists will be invited to participate in an interview about their experience with the patient decision aid. The investigators will use analysis of variance (ANOVA) to compare between the Intervention Group and Control Group, using the baseline measure as a covariate. An iterative content analysis will be conducted for the qualitative interviews.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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British Columbia
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Richmond, British Columbia, Canadá, V6X2C7
- Reclutamiento
- Arthritis Research Canada
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Contacto:
- Jasmina Geldman, MS
- Número de teléfono: 604-207-4007
- Correo electrónico: jgeldman@arthritisresearch.ca
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Contacto:
- Navi Grewal, MS
- Número de teléfono: 604-207-4053
- Correo electrónico: ngrewal@arthritisresearch.ca
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Investigador principal:
- Linda Li, PT,PhD
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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:
- The inclusion criteria are as follows: 1) with a diagnosis of RA from a rheumatologist, 2) whose rheumatologists have recommended initiating a biologic/subsequent entry biologic or switching to another biologic agent, and 3) who have internet access and email.
Exclusion Criteria:
- Patients who do not meet the inclusion criteria.
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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Experimental: ANSWER-2 decision aid
The Intervention Group will receive simple instructions to access ANSWER-2 and complete the program on their own computers within two days.
At the end of the session, ANSWER-2 will produce a one-page summary summarizing the participant's questions, concerns, and preferred medication option.
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ANSWER-2 will consist of: 1) an Information Module that presents effectiveness and side effects of each treatment option, and 2) an interactive Value Clarification Module that guides patients to consider what matter to them the most, and the pros and cons of each treatment option.
Within the Information Module, the decision support information (i.e., the benefits and harms of treatment options) will be presented in narrated text, graphics, and a series of animated patient stories demonstrating attributes required for effective communication with doctors and significant others.
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Comparador activo: Control Group (TAS Consumer Guide)
The Control Group will receive the online Arthritis Medications: A Consumer's Guide, published by The Arthritis Society.
It contains standard information about biologics, including an introduction of the different biologic options, dosages and side effects.
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The Arthritis Society Consumer guide pdf.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Decisional Conflict Scale
Periodo de tiempo: Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1)
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The Decisional Conflict Scale (short version) measures personal perceptions of uncertainty in choosing options, factors contributing to uncertainty, and effective decision-making.
It is one-dimensional and has 10 questions and three response categories (yes/no/unsure) used to compute one score.
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Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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MeiQ
Periodo de tiempo: Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1, and at month 2)
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The MeiQ consists of 6 subscales and a total of 29 items.
MeiQ was developed and tested in three different samples of patients with rheumatic conditions on their knowledge of medications.
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Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1, and at month 2)
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Partners in Health Scale
Periodo de tiempo: Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1, and at month 2)
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The Partners in Health Scale is an 11-item measure, designed to assess self-efficacy, knowledge of RA and treatment, and self-management behaviours such as taking medication appropriately and adopting a healthy lifestyle.
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Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1, and at month 2)
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Health Resource Utilization
Periodo de tiempo: Change measure (baseline score compared to after using the ANSWER-2 at month 2)
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The HRU questionnaire was developed for both self and interviewer administration in people with arthritis and other chronic conditions.
It consists of a series of open-ended questions about individuals' visits to health professionals, use of investigative tests, hospital visits, use of medications, purchases of adaptive aids, and estimable productivity loss incurred by the individual and their caregivers due to the his/her health.
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Change measure (baseline score compared to after using the ANSWER-2 at month 2)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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CollaboRATE Scale
Periodo de tiempo: Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1)
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a 3-item measure of the shared decision making process
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Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Linda Li, PhD, Professor
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
- H15-02046
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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