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Improving Psychological Distress Among Critical Illness Survivors and Their Caregivers

9 de enero de 2020 actualizado por: Duke University
Patients who receive life support in intensive care units commonly suffer from persistent depression, anxiety, and post-traumatic stress disorder (PTSD) symptoms after discharge. We are trying to learn which is a better way to manage this distress: a telephone-based adaptive coping skills training program or an educational program.

Descripción general del estudio

Descripción detallada

Public Summary of Research Project Why is this important? Nearly 800,000 Americans receive mechanical ventilation for acute respiratory failure in the ICU each year. Afterward, over half of both patients and their family caregivers suffer from psychological distress (depression, anxiety, and post-traumatic stress ["PTSD"]) for over 1 year after discharge. Patients and families told us that they need help with their distress because it worsens their quality of life. More specifically, patients said that learning how to adapt (that is, how to cope) with the physical and emotional changes of critical illness would be helpful. In fact, most ICU survivors use coping skills infrequently, which worsens psychological distress. But patients also told us that they wanted more information about critical illness, recovery, and what to expect. A lack of information increases PTSD symptoms. However, there are few treatments for this distress that can overcome ICU survivors' physical disability, great distance from expert medical centers, and concerns about how much treatments would cost. Therefore, we developed two treatments to address coping and lack of information.

What is the main goal? We aim to compare which of two treatments are more effective in reducing psychological distress and improving quality of life. One is a coping skills training (CST) program provided by telephone. The other is an education program about critical illness that is accessed primarily online. Also, we will determine if unique groups of people with special characteristics have especially good improvement-and if so, what personal factors explain this response.

How will we know which treatment is better? We will determine which treatment is most helpful by comparing participants' levels of psychological distress and quality of life with surveys taken over 6 months. We'll also record patients' own descriptions of how the treatments impacted their daily lives. The study will take 3 years and would be performed at 5 medical centers across the US that treat patients with diverse backgrounds and illnesses. 200 ICU survivor-family member pairs will be randomly assigned (like a coin flip) to receive either the CST program or the education program. Treatments consist of 6 weekly telephone calls with a trained staff member, web-based modules, and handouts.

How will this help others in the future? This research is important because it aims to improve long-term recovery for entire families by focusing on a devastating, common, yet inadequately addressed problem. These treatments were developed with the direct input of patients and families. These treatments represent a new direction in treating critical illness because they can be delivered inexpensively by phone, easily adapted to future technologies, overcome barriers to care common to ICU survivors, and shared easily by phone or computer with others in need across the world.

Tipo de estudio

Intervencionista

Inscripción (Actual)

417

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

    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • University of North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
        • Duke University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15261
        • University of Pittsburgh
    • Washington
      • Seattle, Washington, Estados Unidos, 98195
        • University of Washington

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

Patient inclusion criteria:

  • age >=18 and
  • mechanical ventilation for more than 48 consecutive hours

Patient exclusions (pre-consent):

  • current significant cognitive impairment (>=3 errors on the Callahan scale) or lacks decisional capacity
  • pre-existing significant cognitive impairment
  • residence at location other than home before hospital admission
  • need for a translator because of poor English fluency [many study instruments are not validated in other languages]
  • expected survival <3 months
  • discharged to hospice (outpatient or inpatient)
  • not liberated from mechanical ventilation at discharge

Additional patient exclusion criteria (present post-consent but pre-randomization):

  • Patients will become ineligible if they become too ill to participate
  • they develop significant cognitive disability, exhibit suicidality, they do not return home within 2 months after hospital discharge, or die.

Informal caregiver inclusion criteria:

  • age >=18 years
  • person most likely to provide the most post-discharge care.

Exclusions for caregivers are:

  • history of significant cognitive impairment
  • English fluency poor enough to require a medical translator

Informal caregiver exclusion criteria present after consent but before randomization:

  • no longer available
  • become too ill to participate
  • exhibit suicidality

A total of 200 patient-caregiver dyads (total cohort = 400) are targeted

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: Coping skills training
6 sessions of weekly telephone-based coping skills training delivered by trained interventionist
6-session coping skills training program delivered by telephone w/ web augmentation
Comparador activo: education program
6 week access to a web-based, critical illness-specific education program
web-based, ICU-specific education program

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Hospital Anxiety and Depression Scale Score
Periodo de tiempo: 3 & 6 months post-randomization
Hospital Anxiety and Depression Scale (HADS) questionnaire: The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale. The 3 month measure is primary outcome timing, though changes at 6 months will be tested as well
3 & 6 months post-randomization

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Impact of Events Scale-revised (IES-R) Score
Periodo de tiempo: 3 & 6 months post-randomization
The IES-R evaluates subjective distress caused by traumatic events and assesses manifestations of post-traumatic stress disorder (PTSD) or acute stress disorder. It is not diagnostic but possesses excellent reliability and validity for manifestations of PTSD. The IES-R has three subscales (eight items on intrusion, eight items on avoidance, and six items on hyperarousal). Each item is scored on a four point scale: 0 = "not at all," 1 = "a little bit," 2 = "moderately often," 3 = "quite a bit," and 4 = "extremely often." The total score of each subscale may be averaged and a cumulative score of 30 is indicative of the presence of PTSD. The maximum score for each subscale is 32 for intrusion, 32 for avoidance, and 24 for hyperarousal. The minimum cumulative score is 0 and the maximum cumulative score possible is 88.3 months post-randomization is main time point while The 3 month IES-R score will be the primary analysis, though 6 month changes will be tested as well.
3 & 6 months post-randomization

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Total Weeks at Home Post-randomization
Periodo de tiempo: over 6 months follow up
here reported as weeks (instead of days) not at home for simplicity
over 6 months follow up

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Christopher E Cox, MD MPH, Duke University

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.

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

1 de octubre de 2013

Finalización primaria (Actual)

1 de febrero de 2016

Finalización del estudio (Actual)

1 de abril de 2016

Fechas de registro del estudio

Enviado por primera vez

1 de noviembre de 2013

Primero enviado que cumplió con los criterios de control de calidad

7 de noviembre de 2013

Publicado por primera vez (Estimar)

13 de noviembre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de enero de 2020

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

9 de enero de 2020

Última verificación

1 de enero de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Pro00043171
  • PCORI PFA 195 (Otro número de subvención/financiamiento: PCORI PFA 195)

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 coping skills training

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