Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Pain Self-management Program for Older Adults

19 de noviembre de 2019 actualizado por: University of Regina

A Pain Self-management Program for Older Adults: Online vs. Workbook Delivery

It is well documented that severe pain is more common in older adults than it is younger persons. Of concern, older adults may not have access to traditional face-to-face self-management programs, which are recognized to be valuable in chronic pain management. Access to effective self-management approaches is particularly important for older adults who may have mobility limitations or live in remote areas, or have difficulty accessing health care services. The development of effective pain self-management programs for older adults who cannot access traditional psychological interventions is of significant importance. Internet self-management programs have the potential to address pain undermanagement. As technology advances, the digital divide between the older and younger demographic continues to progress. Given the known difficulties with treatment access, the purpose of this study is to explore the efficacy and acceptability of a remotely-delivered chronic pain self-management program tailored to older adults, the Pain Course, when delivered in online and workbook formats. The program was previously shown to be effective among younger persons but has not been tested with older adults.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The program is delivered through a secure platform administered by the Online Therapy Unit for Service Education and Research at the University of Regina. Using a patient preference randomized control trial (RCT) design, participants (n = 120) will be enrolled in either the online group or workbook group, or to a wait list control group. The content of both programs will be identical and contain 5 core lessons, which participants will be encouraged to work through over an 8-week period. By exploring the efficacy of an online vs. workbook group, the results from this study may serve as a stepping-stone for improved self-management of chronic pain in older adults.

A patient preference randomized controlled trial (RCT) was chosen for this study. The goal is to have most participants accept randomization by emphasizing they are equally acceptable, so only those with a very strong preference or no access to Internet aren't randomized. According to the preliminary power analysis, a total of 120 participants will be randomly assigned to be enrolled in the online group or workbook group, or be placed on a twelve-week wait list control, which will serve as a control group to control for the influence of time on symptom change between groups.

Tipo de estudio

Intervencionista

Inscripción (Actual)

121

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Canadá
    • Saskatchewan
      • Regina, Saskatchewan, Canadá, S4S 0A2
        • University of Regina

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

65 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • are residents of Canada
  • are 65 years of age or older
  • report experiencing pain for more than three months
  • are not experiencing very severe symptoms of depression or anxiety
  • have regular access to a computer and the internet
  • are proficient in writing and speaking the English language

Exclusion Criteria:

  • high suicide risk
  • concerns about online therapy
  • not present in the country during treatment
  • are younger than 65 years of age

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Online Group
An 8-week remotely-delivered pain self-management program tailored to older adults that have been experiencing pain for at least three months. Participants randomized to the Online Group will receive access to the course on the computer (online). A researcher will act as a guide who provides general support and encouragement, as opposed to a clinician who would offer comprehensive therapy. The guide will aim to contact participants weekly via telephone for approximately 5 to 10 minutes.
Conductual: Online Group
An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in an online format.
Experimental: Workbook Group
An 8-week remotely-delivered pain self-management program tailored to older adults that have been experiencing pain for at least three months. Participants randomized to the Workbook Group will receive access to the course in a printed (workbook) format. A researcher will act as a guide who provides general support and encouragement, as opposed to a clinician who would offer comprehensive therapy. The guide will aim to contact participants weekly via telephone for approximately 5 to 10 minutes.
Conductual: Workbook Group
An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in a printed (workbook) format.
Sin intervención: Wait List Control Group
Participants who are randomly allocated to the wait list control group will be provided access to the course after the twelve-week period has passed.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in the impact of pain in several areas of life
Periodo de tiempo: baseline, 8 weeks, 3 months
Measured by Pain Disability Index (PDI)
baseline, 8 weeks, 3 months
Change in depression
Periodo de tiempo: baseline, 8 weeks, 3 months
Measured by Geriatric Depression Scale-30 (GDS-30)
baseline, 8 weeks, 3 months
Change in anxiety
Periodo de tiempo: baseline, 8 weeks, 3 months
Measured by Generalized Anxiety Disorder Scale 7-Item (GAD-7)
baseline, 8 weeks, 3 months
Change in chronic pain severity
Periodo de tiempo: baseline, 8 weeks, 3 months
Measured by Brief Pain Inventory (BPI)
baseline, 8 weeks, 3 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in beliefs about one's ability to perform every day tasks regardless of chronic pain
Periodo de tiempo: baseline, 8 weeks, 3 months
Measured by Pain Self-Efficacy Questionnaire (PSEQ)
baseline, 8 weeks, 3 months
Change in fear of movement or re-injury
Periodo de tiempo: baseline, 8 weeks, 3 months
Measured by TAMPA Scale of Kinesiophobia (TSK)
baseline, 8 weeks, 3 months
Change in acceptance of chronic pain
Periodo de tiempo: baseline, 8 weeks, 3 months
Measured by Chronic Pain Acceptance Questionnaire (CPAQ-8)
baseline, 8 weeks, 3 months
Change in tendency to amplify the threat value of constant pain
Periodo de tiempo: baseline, 8 weeks, 3 months
Measured by Pain Catastrophizing Scale (PCS)
baseline, 8 weeks, 3 months
Treatment satisfaction
Periodo de tiempo: 8 weeks
Measured by Treatment Satisfaction Questions (TSQ) used in Pain Course
8 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Regina

Colaboradores

Canadian Institutes of Health Research (CIHR)

Investigadores

  • Investigador principal: Thomas Hadjistavropoulos, University of Regina
  • Investigador principal: Heather Hadjistavropoulos, University of Regina

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

23 de febrero de 2018

Finalización primaria (Actual)

20 de abril de 2019

Finalización del estudio (Actual)

20 de abril de 2019

Fechas de registro del estudio

Enviado por primera vez

18 de abril de 2018

Primero enviado que cumplió con los criterios de control de calidad

18 de abril de 2018

Publicado por primera vez (Actual)

30 de abril de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de noviembre de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

19 de noviembre de 2019

Última verificación

1 de noviembre de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2018-004

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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 Online Group

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Canada

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

3
Suscribir