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

NCT02435641 | Completed

• 1 other identifier: 2014P002793
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The current study has the following objectives:

1. 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. 2.To determine factors associated with patient and caregiver satisfaction with medical care at time 2 and time 3.

Conditions

Intensive Care Neurological Disorder

Outcome Measures

Primary Outcomes (4)

• Hospital Anxiety and Depression Scale (HADS)

  Measures symptoms of anxiety and depression.

  Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)

• Posttraumatic Stress (PCL-S)

  Measures symptoms of posttraumatic stress disorder

  Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)

• Satisfaction with Life Questionnaire (SWL)

  Measures global cognitive judgements of satisfaction with one's life

  Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)

• World Health Organization QOL Questionnaire (WHOQOL-BREF)

  Measures one's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns.

  Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)

Secondary Outcomes (10)

• General Self-Efficacy Scale

  Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)

• Caregiver Self-Efficacy Scale

  Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)

• Distress Thermometer Scale

  Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)

• Visual Analog Stress Scale

  Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)

• Healthcare satisfaction (CSQ-8)

  Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)

Other Outcomes (1)

• Age, Gender, Race, Ethnicity, Marital Status, Education Status, and Employment Status of Patients/Caregivers in the ICU

  Baseline (week 0)

Study Arms (1)

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).

Other: Questionnaires

Interventions

Questionnaires 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.

ICU Questionnaires

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the Neuro-ICU and their family caregivers

You may qualify if:

• years of age and older
• English fluency and literacy
• Admitted to the Neuro-ICU
• years of age and older
• English fluency and literacy
• Family member of patient who is identified by patient as the primary caregiver

You may not qualify if:

• 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.
• Patients who lack decision-making capacity as determined by their clinical team
• Patients who are comfort measures only (CMO)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ana-Maria Vranceanu, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 6, 2015
• Study Start: March 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

US (1)