TakeCharge: Telephone Delivered Self-management Intervention for People With Multiple Sclerosis (MS) (TakeCharge)
Telephone Delivered Self-management Intervention for People With Multiple Sclerosis Addressing Pain, Fatigue, Depression, and Cognitive Difficulties
The proposed project will evaluate the efficacy of a telephone-delivered self-management (T-SM) intervention for reducing the impact of secondary conditions in persons with multiple sclerosis (MS), including chronic pain, fatigue, depression, and cognitive impairment. It is hypothesized that if the effects of these conditions are reduced, study participants will demonstrate improved participation in the community and improved employment outcomes. This project is important because the majority of persons with MS experience one or more of the following secondary conditions: fatigue, pain, depression, and cognitive impairment. These secondary conditions are not always readily apparent and constitute what has been described by our Rehabilitation Research and Training Center as "hidden disabilities." Secondary conditions such as pain, depression, fatigue, and cognitive impairment frequently not only cause distress in their own right but also affect employment, participation, and quality of life. Having more than one often compounds the effect; the effect of all may be greater than the sum of each individually (e.g. depression can worsen fatigue, and cognitive impairment can worsen depression).
It is critical that this constellation of secondary symptoms be addressed using state of the art techniques based on self-management training and that intervention effects be documented with carefully controlled treatment efficacy studies.
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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Washington
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Seattle, Washington, Estados Unidos, 98195
- University of Washington
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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:
- Must be diagnosed with MS by a physician.
- Must be at least 18 years of age.
- Must be able to understand, speak, and read English.
- Must have the presence of at least one of four common secondary conditions (fatigue, pain, depression, cognitive difficulties) that interferes with employment, participation, and functioning.
Exclusion Criteria:
- Unable to understand or read English.
- Severe cognitive impairment, defined as one or more errors on the 6-item screener, that would prevent informed consent and inability to carry on a phone conversation.
- Currently participating in regularly scheduled psychotherapy.
- Psychiatric contraindications such as current psychosis, active suicidal ideation, or current alcohol or drug use.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Self-management Intervention
Telephone based self management intervention targeted at pain, fatigue, depression, and cognitive difficulties.
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Brief counseling technique, self-management,
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Comparador activo: Education
Education about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
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Educational information about pain, fatigue, depression, and cognitive difficulties in multiple sclerosis.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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PHQ 9
Periodo de tiempo: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
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Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
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Brief Pain Inventory
Periodo de tiempo: Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
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Baseline, 5 weeks, 10 weeks, 6 months, and 12 months
|
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Modified Fatigue Impact Scale
Periodo de tiempo: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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PROMIS Depression Short Form
Periodo de tiempo: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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PROMIS Pain Impact Short Form
Periodo de tiempo: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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PROMIS Fatigue Short Form
Periodo de tiempo: Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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Baseline, 5 weeks, 10 weeks, 6 months, 12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dawn Ehde, PhD, University of Washington
- Director de estudio: George Kraft, MD, University of Washington
Publicaciones y enlaces útiles
Publicaciones Generales
- Knowles LM, Arewasikporn A, Kratz AL, Turner AP, Alschuler KN, Ehde DM. Early Treatment Improvements in Depression Are Associated With Overall Improvements in Fatigue Impact and Pain Interference in Adults With Multiple Sclerosis. Ann Behav Med. 2021 Aug 23;55(9):833-843. doi: 10.1093/abm/kaaa102.
- Ehde DM, Arewasikporn A, Alschuler KN, Hughes AJ, Turner AP. Moderators of Treatment Outcomes After Telehealth Self-Management and Education in Adults With Multiple Sclerosis: A Secondary Analysis of a Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Jul;99(7):1265-1272. doi: 10.1016/j.apmr.2017.12.012. Epub 2018 Jan 11.
- Ehde DM, Elzea JL, Verrall AM, Gibbons LE, Smith AE, Amtmann D. Efficacy of a Telephone-Delivered Self-Management Intervention for Persons With Multiple Sclerosis: A Randomized Controlled Trial With a One-Year Follow-Up. Arch Phys Med Rehabil. 2015 Nov;96(11):1945-58.e2. doi: 10.1016/j.apmr.2015.07.015. Epub 2015 Aug 6.
Enlaces Útiles
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
- 36021-C
- H133B080025 (Otro número de subvención/financiamiento: NIDRR)
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