COMA-Family Study

Overview

About this study

Study summary:

The overall plan for this study is to conduct qualitative interviews among 40 family members of patients who have been hospitalized in a coma. Subjects for this study will be recruited by local site P.I.s from intensive care units at the following 18 U.S. centers:

All interviews will be conducted virtually via video conferencing by study staff at the Yale School of Medicine and Massachusetts General Hospital. All study activities following the interviews, including data analysis and manuscript writing, will take place at the Yale School of Medicine and Massachusetts General Hospital. We expect this study to be completed by December 31, 2021.

Hypothesis, Aims, purpose, or objectives and Background:

(Include relevant experience, gaps in current knowledge, preliminary data, etc.):

The purpose of this study is to conduct semi-structured qualitative interviews with caregivers of severely acute brain-injured, incapacitated patients in order to understand specific aspects of their caregiving experience (i.e., emotional coping styles, expectations and understanding of illness, challenges, perceptions of caregiving) and gather information about their preferences for a future psychosocial support intervention (e.g., content, delivery mode [in person vs. secure live video mode], timing). Data from these qualitative interviews will be used to help develop a resiliency-based psychosocial support intervention for caregivers in the future.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Age 18 or older.
English-speaking.
Confirmed by the primary clinical team as the primary caregiver for a patient who:
- Has been admitted to the ICU with a severe acute brain injury:
  - Ischemic stroke;
  - Intracerebral hemorrhage;
  - Subarachnoid hemorrhage;
  - Traumatic brain injury;
  - Hypoxic-ischemic encephalopathy.
- Either will be undergoing tracheostomy and/or percutaneous endoscopic/surgical gastrostomy tube placement for certain, or has already received one/both.
- In the judgment of the medical team, has had a Glasgow Coma Scale score below 9 while not intubated OR an inability to following meaningful commands while intubated at any point during his or her hospitalization course for greater than 24 consecutive hours, felt to be due to the brain injury itself and not a confounding factor (i.e., sedation, seizures, etc.).
- Is still alive in the ICU at the time that the clinical team approaches the primary caregiver about possible recruitment.
- Has a prognosis for survival of greater than 3 months and does not have a concurrent diagnosis of a terminal illness or injury, as judged by the clinical team.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Jacksonville, Fla. Mayo Clinic principal investigator William Freeman, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Jacksonville, Fla.

Mayo Clinic principal investigator

William Freeman, M.D.

Closed for enrollment

More information

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