Clinical trial NCT02435641: Patient and Caregiver Psychological Functioning Following Neuro-ICU Admission: A Prospective Investigation
Official title: A Prospective Study to Investigate Relationships Between Patient and Family Caregiver Distress Following Neuroscience ICU Admission
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Neurological Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the Neuro-ICU and their family caregivers

Brief summary: 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.


Eligibility criteria: Inclusion criteria for patients:

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

Inclusion criteria for family caregivers:

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)

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
measure: Posttraumatic Stress (PCL-S)
timeFrame: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
measure: Satisfaction with Life Questionnaire (SWL)
timeFrame: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
measure: World Health Organization QOL Questionnaire (WHOQOL-BREF)
timeFrame: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Secondary outcomes:
measure: General Self-Efficacy Scale
timeFrame: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
measure: Caregiver Self-Efficacy Scale
timeFrame: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
measure: Distress Thermometer Scale
timeFrame: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
measure: Visual Analog Stress Scale
timeFrame: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
measure: Healthcare satisfaction (CSQ-8)
timeFrame: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
measure: Cognitive and Affective Mindfulness Scale (CAMS)
timeFrame: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
measure: Patient-caregiver interaction (Intimate Bond Measure)
timeFrame: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
measure: Measure of Current Status (MOCS-A)
timeFrame: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
measure: Qualitative Adherence Measure
timeFrame: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
measure: Caregiving Preparedness (Preparedness for Caregiving Scale)
timeFrame: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Other outcomes:
measure: Age, Gender, Race, Ethnicity, Marital Status, Education Status, and Employment Status of Patients/Caregivers in the ICU
timeFrame: Baseline (week 0)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References: