Patient and Caregiver Psychological Functioning Following Neuro-ICU Admission: A Prospective Investigation

NCT ID: NCT02435641

Last Updated: 2018-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-08-31

Brief Summary

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The current study has the following objectives:

1. To determine predictors of time 2 and 3 (3 and 6 months post-ICU admission) depression, PTSD, satisfaction with life and quality of life in both patients and caregivers, after controlling for injury severity and impairment.
2. To determine factors associated with patient and caregiver satisfaction with medical care at time 2 and time 3.

The investigators would thus be able to identify the best time point for intervention delivery, intervention targets, and risk factors for chronic psychological distress.

Detailed Description

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Conditions

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Intensive Care Neurological Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ICU Questionnaires

After enrollment, all subjects (patients and their primary caregiver) will be given baseline measures assessing: sociodemographics, depression, anxiety, distress, stress, PTSD, coping, mindfulness, quality of life, satisfaction with life, resiliency/self efficacy (patient only), patient caregiver interaction, caregiver preparedness (caregiver only), caregiver self efficacy (caregiver only), quality of adherence measure, and health care satisfaction.

Subjects will complete the same measures again at time 2 (3 months) and time 3 (6 months). The study endpoint is time 3 follow up (6 months).

Questionnaires

Intervention Type OTHER

All subjects (patients and caregivers) will complete a battery of psychological questionnaires at baseline (ICU admission), 3 months post-baseline, and 6 months post-baseline.

Interventions

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Questionnaires

All subjects (patients and caregivers) will complete a battery of psychological questionnaires at baseline (ICU admission), 3 months post-baseline, and 6 months post-baseline.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 18 years of age and older
2. English fluency and literacy
3. Admitted to the Neuro-ICU


1. 18 years of age and older
2. English fluency and literacy
3. Family member of patient who is identified by patient as the primary caregiver

Exclusion Criteria

1. Patients who cannot complete questionnaires due to their medical condition, and are anticipated to not be able to complete questionnaires at any of the future time points, due to permanent impairment.
2. Patients who lack decision-making capacity as determined by their clinical team
3. Patients who are comfort measures only (CMO)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ana-Maria Vranceanu, PhD

Clinical Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana-Maria Vranceanu, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2014P002793

Identifier Type: -

Identifier Source: org_study_id

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