- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03928132
Integrating Sex and Gender Into CPD for Depression/Diabetes (INCluDED)
Integrating Sex and Gender Considerations Into a Continuing Professional Development Activity on Diabetes and Depression: Protocol for a Non-Randomized Controlled Trial
People with type 2 diabetes are twice as likely to experience depression as nondiabetic individuals, and depression in turn increases the risk of diabetes. Clinical care for patients for either condition usually fails to consider the impact of sex and gender on tests, diagnosis and treatment, and evidence on these impacts is limited. The investigators aim to assess the impact of a continuing professional education activity (CPD) on diabetes and depression that includes considerations of sex and gender on the clinical behaviours of French-speaking healthcare professionals in Canada.
In a non-randomised controlled trial, the investigators are assessing the impacts of two CPD activities on depression and diabetes, one that includes considerations of sex and gender, and an identical one that omits sex and gender considerations, on French-speaking healthcare professionals' self-reported clinical behaviors regarding sex and gender considerations post-intervention and at 3 months. Data collection will occur in three distinct locations in Canada. Project development, data collection and analysis and dissemination of results will all integrate considerations of sex and gender. The process of creating a CPD activity that integrates considerations of sex and gender could be scaled up to other CPD activities in other clinical subjects and in other minority languages.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Quebec
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Québec, Quebec, Canadá
- CERSSPL
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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:
- French-speaking health professionals (in practice and in training).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: CPD Workshop on Depression and Diabetes
Participants in this arm will take part in a clinical CPD activity on depression and diabetes.
The activity will include considerations of sex and gender, e.g. the different risk factors and impacts of treatment among women and men.
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2 parallel face-to-face onsite workshops on diabetes and depression in primary care given by experts in French (control and experimental) using Powerpoint presentations.
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Comparador falso: CPD Workshop on Depression and Diabetes II
Participants in this arm will take part in a clinical CPD activity on depression and diabetes.
The activity will exclude considerations of sex and gender, e.g. the different risk factors and impacts of treatment among women and men.
|
2 parallel face-to-face onsite workshops on diabetes and depression in primary care given by experts in French (control and experimental) using Powerpoint presentations.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Immediate clinical behavioural intention, as measured by CPD-REACTION questionnaire
Periodo de tiempo: Immediately following the intervention
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Clinical behavioural intention to integrate considerations of sex and gender into the diagnosis and treatment of depression and diabetes, using the validated CPD-REACTION scale.
CPD=continuing professional development, REACTION=a theoRy-basEd instrument to assess the impACT of continuing professional development activities on professional behavIOr chaNge.
A 12-item Likert-type scale (i.e., Strongly disagree = 1, Strongly agree = 7; Never = 1, Always = 7, etc.) evaluates 5 constructs: 1) intention; 2) social influence; 3) beliefs about capabilities; 4) moral norms; and 5) beliefs about consequences.
Sociodemographic questions are asked on sex, age (10 age ranges), province, rural/urban/semi-rural practice, and language of consultation.
Mean, standard deviation, median and frequencies are calculated to summarize participant characteristics and questionnaire item responses.
Construct scores are obtained by calculating the mean score for the items.
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Immediately following the intervention
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Change from immediate clinical behavioural intention at 3 months, as measured by CPD-REACTION questionnaire
Periodo de tiempo: 3 months after the intervention
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Evolution of clinical behavioural intention to integrate considerations of sex and gender into the diagnosis and treatment of depression and diabetes, using the validated CPD-REACTION scale, after a 3-month period.
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3 months after the intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Acceptability Questionnaire
Periodo de tiempo: Immediately following the intervention.
|
1) Participants rate acceptability of workshop with the following 9 items: organization, clarity, mastery of subject by trainer, exercises and discussion, presentation of sex and gender data, group interaction, overall quality, organization and quality of discussions and presentations, quality of documents distributed (Poor, Acceptable, Good, Very Good, or Excellent); 2) Participants rate the workshop length (too short, just right, too long); 3) Participants rate their confidence in incorporating the notions presented in the workshop in their management of Type 2 Diabetes (with or without depression) (scale of 1-10, 1=very little confidence, 10=very confident) both before and after the workshop; 4) Participants describe what changes they will make in their practice following the workshop; 5) Participants describe what they liked most and 6) least about the workshop; 7) Participants are asked if they thought the presentation was biased (yes/no) and if yes, are asked for details.
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Immediately following the intervention.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: France Légaré, MD, PhD, CERSSPUL
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (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
- 384530
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
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