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Our Whole Lives: Online Chronic Pain Management (OWL)

9 de febrero de 2018 actualizado por: Paula Gardiner, Boston Medical Center

Reducing Disparities in the Treatment of Chronic Pain Using an Innovative mHealth Tool

This project will work to increase knowledge about the utility of a website for management of chronic pain, Our Whole Lives (OWL). It will do so by examining barriers and facilitators to patient use. In order to gather this information, the investigators will conduct a Science Cafe with 30 individuals (including participants with chronic pain, who have family members with chronic pain or are a stakeholder in the chronic pain community) to gather feedback about how to tailor the OWL website to their needs and preferences and how to improve ease of use for this tool. The investigators will also pilot two cohorts with 40 patients with chronic pain (2 groups of 20 patients) with OWL, the patient-centered, mobile health chronic pain management resource, measuring pain impact (pain severity, pain interference, physical function) and pain associated outcomes (e.g., depression, anxiety, fatigue, sleep disturbance, ability to participate in social roles and activities, pain self-efficacy, health education impact and internalized stigma related to chronic pain).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

During the first 4 months, conduct a science café targeting 30 individuals/families who live with chronic pain and reside in Boston's low-income, ethnically diverse neighborhoods, in order to: a) gather feedback about how to tailor the OWL curriculum based on their needs and preferences, and b) identify potential enhancements to the mobile technology to improve ease of use. For the science cafe, the investigators will use social media (facebook, twitter, listservs, etc.) to invite the community to meet for a two-hour dialog. . Each participant will be paid for attending, refreshments will be served, and a small thank you gift will be provided. Dr. Gardiner will begin the science café by giving an overview of chronic pain in the US. The moderator will ask the participants questions about how chronic pain impacts their communities and how technology might help address it.

A trained qualitative research assistant will be transcribe the science cafe and the transcripts will be analyzed using qualitative methods.

Pilot Cohort Study During the first ten months, the investigators will pilot, using pre-post measures, with 40 patients (2 groups of 20 patients) with OWL. The main outcome is pain impact (pain severity, pain interference, physical function) and pain associated outcomes (e.g., depression, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain self-efficacy).

The target population includes low-income adults >18 years old who self-report: chronic musculoskeletal (extremity, joint, back, neck) pain for at least 3 months, with an average pain intensity for the previous week >4 on a 0 to 10 numerical rating scale. The investigators also require English fluency sufficient to follow instructions. Exclusion criteria include: active or planned worker's compensation, active substance abuse, psychosis, disability or personal injury claims, and known pregnancy. Participants who do not currently have access to the internet are also excluded.

The investigators will recruit patients from 14 Boston area Community Health Centers and the community of Boston Medical Center by reaching out to primary care providers for referrals. Based upon previous pilot experiences, the investigators do not anticipate any difficulty in recruiting for the pilot groups. The investigators will recruit from BMC's primary care practices and several of its 14 affiliated Community Health Centers located in Boston. Participants will receive $50 for their involvement. Based upon this initial referral, if an individual appears to be eligible for participation, he/she will be invited to meet in person with the research assistant. At this visit, eligibility is verified; the study is discussed at length with all questions answered to the participant's satisfaction; and if the patient desires, the patient enrolls by signing the informed consent. For the study, all recruitment materials will be IRB-approved prior to dissemination.

At the beginning of the study, the investigators will hold a group orientation for all 20 participants in the class on how to navigate OWL. A clinician (assisted by a RA) will demonstrate how to use the OWL system, log on, navigate through the nine sessions, complete self-assessment, set goals, and interact on the community page. Participants will have access to OWL for 9 weeks. Each week they will have access to a new content. The clinician will monitor and post questions to facilitate conversation on the community page. At the end of the 9 weeks participants will be invited back to participate in a focus group and complete 9 week follow up surveys.

Tipo de estudio

Intervencionista

Inscripción (Actual)

43

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

    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02118
        • Boston Medical Center

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • For Pilot Cohort Study- Chronic pain greater than or equal to 4 on a 0-10 scale for a least 12 weeks
  • For Pilot Cohort Study- English comprehension sufficient to provide informed consent and understand website information.

Exclusion Criteria:

  • For Pilot Cohort Study: Pregnant or planning to become pregnant in the next 3 months.
  • For Pilot Cohort Study- Does not currently have access to the internet
  • For Pilot Cohort Study- Begun a new pain treatment in the past month or plans to begin new pain treatments in the next 3 months.
  • For Pilot Cohort Study- Does not have an internet enabled device he/she could use to access the website

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: Investigación de servicios de salud
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Science Cafe
One time event, Group discussion for 30 participants who are chronic pain stakeholders on pain in their community.
Experimental: Cohort 1- Pilot OWL Study
Participants will pilot test a website- Our Whole Lives website for nine weeks in order to determine if it will help with their chronic pain management.
OWL is a nine-session, web accessible, self-paced curriculum that has interactive components of self-monitoring and social support (online community).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain Impact
Periodo de tiempo: 9 weeks
a combined score of questions measuring pain severity, pain interference, and physical function. This outcome will be assessed using the PROMIS 29 scale. This information will be gathered both at baseline and in the nine week follow up survey for the two cohorts of participants pilot testing of the OWL website.
9 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Depression
Periodo de tiempo: 9 weeks
These outcomes will also be assessed using the PROMIS 29 measure for the two cohorts of participants pilot testing the website at both baseline and nine weeks.
9 weeks
Anxiety
Periodo de tiempo: 9 weeks
These outcomes will also be assessed using the PROMIS 29 measure for the two cohorts of participants pilot testing the website at both baseline and nine weeks.
9 weeks
Fatigue
Periodo de tiempo: 9 weeks
These outcomes will also be assessed using the PROMIS 29 measure for the two cohorts of participants pilot testing the website at both baseline and nine weeks.
9 weeks
Sleep Disturbance
Periodo de tiempo: 9 weeks
These outcomes will also be assessed using the PROMIS 29 measure for the two cohorts of participants pilot testing the website at both baseline and nine weeks.
9 weeks
Ability to participate in social roles and activities
Periodo de tiempo: 9 weeks
These outcomes will also be assessed using the PROMIS 29 measure for the two cohorts of participants pilot testing the website at both baseline and nine weeks.
9 weeks

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain Self-Efficacy
Periodo de tiempo: 9 weeks
Self-efficacy refers to capacity to persevere in the face of obstacles and adverse experiences, in this instance in the face of pain.
9 weeks
Perceived Stress
Periodo de tiempo: 9 weeks
Perception of Stress
9 weeks
Internalized Stigma from Chronic Pain
Periodo de tiempo: 9 weeks
Perception of stigma from chronic pain
9 weeks
Health Education Impact
Periodo de tiempo: 9 weeks
instrument for the comprehensive evaluation of patient education programs, which can be applied across a broad range of chronic conditions
9 weeks

Colaboradores e Investigadores

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

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Paula Gardiner, MD,MPH, Boston Medical Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

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)

1 de junio de 2016

Finalización primaria (Actual)

1 de enero de 2018

Finalización del estudio (Actual)

1 de enero de 2018

Fechas de registro del estudio

Enviado por primera vez

27 de mayo de 2016

Primero enviado que cumplió con los criterios de control de calidad

1 de junio de 2016

Publicado por primera vez (Estimar)

2 de junio de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de febrero de 2018

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

9 de febrero de 2018

Última verificación

1 de febrero de 2018

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • H-35182

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

producto fabricado y exportado desde los 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. .

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