- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02716064
TAPESTRY for People With Cardiovascular and Metabolic Disease: A Pilot Study (TAPESTRY-CM)
Teams Advancing Patient Experience: Strengthening Quality for People With Cardiovascular and Metabolic Disease (TAPESTRY-CM): A Pilot Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This pilot study is a program evaluation that will employ developmental evaluation techniques to collect qualitative and quantitative data that will be handled, using a sequential explanatory mixed methods approach.Developmental evaluation is particularly useful for pre-formative development of potential scalable interventions. Developmental evaluation tracks and attempts to make sense of what emerges under conditions of complexity, documenting and interpreting the dynamics, interactions, and interdependencies that occur as innovations unfold. It will be helpful to explicitly understand: 1) what important decisions occur during the TAPESTRY-CM intervention development process and; 2) what data have validated those decisions about how the intervention will be structured and delivered. This understanding will provide a basis for describing key decisions and their rationale to our community and to other communities so that they make more informed adaptations to their local context.
TAPESTRY-CM has applied the principles of participatory design by engaging community stakeholders to co-create and refine TAPESTRY-CM interventions in the early phases of the project.
The use of mixed methods was purposefully chosen for this developmental evaluation. Answering a set of related research questions which included the collecting, analyzing and interpreting of qualitative and quantitative data increases the depth of understanding of results, provides stronger evidence for patterns or themes if data converge, can neutralize or cancel out some of the disadvantages of each method alone, and explicitly recognizes that social phenomena are complex such that varied methods are helpful to best understand these complexities.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Hamilton, Ontario, Canadá, L8S 1A4
- McMaster Family Practice
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Hamilton, Ontario, Canadá, L8W3J6
- Stonechurch Family Health Centre (SFHC)
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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:
- Patients over the age of 55 at the start of the study
- Patients with both diabetes and hypertension
- Patients with access to a computer and the internet
Exclusion Criteria:
- Patient is palliative or receiving end-of-life care
- Patient is deceased
- Has explicitly stated that they do not want to be part of a research project
- Patient resides in long-term care
- Patient has indicated that they do not want to receive a home visit from trained community volunteers.
- Patient or family member does not speak English
- Patient will be out of the country for more than 50% of trial duration
- Patients without access to a computer with the internet
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: TAP-CM Intervention
Patients in this arm will be encouraged to complete the Healthy Lifestyle App modules and use McMaster PHR to self manage their chronic disease.
Participants will also be completing the health and life goals using the App.
The TAPESTRY-CM reports generated will then be reviewed by the clinic huddle teams
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The intervention includes: 1) Healthy Lifestyle App Goal Setting and Prioritization and modules, 2) TAP-CM Report triage Huddle with Interprofessional Team 3) The connection of patients to appropriate community resources 4) Volunteer helping with technology use
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The experience of patients, family members, primary health care providers, volunteers and community organizations with the TAPESTRY-CM program
Periodo de tiempo: 12 weeks
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Qualitative measure and chart audit evaluating the experience of all participants in the pilot
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12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Experience of enrollment by patients
Periodo de tiempo: 12 weeks
|
Qualitative measure - focus groups/interviews with patients
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12 weeks
|
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Extent volunteers needed to facilitate PHR set-up
Periodo de tiempo: 12 weeks
|
Quantitaive measures: technology skills self-assessment scale (volunteers) scale, Qualitative measure: usability testing, and documentation of help-line inquiries
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12 weeks
|
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Burden on healthcare providers to respond to PHR queries from patients
Periodo de tiempo: 12 weeks
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Qualitative measure - focus groups and interviews with involved healthcare providers to assess the role of or burden on healthcare providers.
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12 weeks
|
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Patient interest in digital step tracking devise
Periodo de tiempo: 12 weeks
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Measure 1: yes/no data from App; Measure 2: qualitative- focus groups or interviews to test the usability of activity trackers.
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12 weeks
|
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Feasibility of using a structured goal setting process with patients including a formal Goal Attainment Scaling
Periodo de tiempo: 12 weeks
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Qualitative: focus groups or interviews and patient enablement scores; Quantitative: Using Goal Attainment Scales, to assess the usability of Goal Attainment Scaling;
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12 weeks
|
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Developmental decision evaluation - I
Periodo de tiempo: 12 weeks
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mportant decisions during the TAPESTRY-CM intervention development process that affected initial implementation or changes in delivery of the TAP-CM intervention and what data supported the decisions made.
Using a template to record the number and type of decisions, assessed using qualitative and quantitative analysis
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12 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Gina Agarwal, PhD, McMaster University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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 (Estimar)
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
- 14-450
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