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

Intensive Care Neurological Disorder Clinical Trial

Official title:

A Prospective Study to Investigate Relationships Between Patient and Family Caregiver Distress Following Neuroscience ICU Admission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435641
• Other study ID #: 2014P002793
• Status: Completed
• Start date: March 2015
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Intensive Care Neurological Disorder
• Nervous System Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age, Gender, Race, Ethnicity, Marital Status, Education Status, and Employment Status of Patients/Caregivers in the ICU	This questionnaire asks ICU patients/caregivers to report their age, gender, race, ethnicity, marital status, highest level of education, and primary employment status over the last 12 months.	Baseline (week 0)
Primary	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)
Primary	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)
Primary	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)
Primary	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	General Self-Efficacy Scale	Measures optimistic self-beliefs to cope with a variety of difficult demands in life. (Completed by the patient only).	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Secondary	Caregiver Self-Efficacy Scale	Measures 3 domains of caregiving self-efficacy: Obtaining Respite, Responding to Disruptive Patient Behaviors, and Controlling Upsetting Thoughts. (Completed by the caregiver only).	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Secondary	Distress Thermometer Scale	Measures one's distress, anxiety, depression, anger, and need for help over the past week on a scale from 0 to 10.	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Secondary	Visual Analog Stress Scale	Measures one's distress, stress, and ability to cope with that stress over the past week on a scale from 0 to 10.	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Secondary	Healthcare satisfaction (CSQ-8)	Measures one's satisfaction with health, human service, governmental, and public benefit programs and services.	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Secondary	Cognitive and Affective Mindfulness Scale (CAMS)	Measures the degree to which individuals experience their thoughts and feelings.	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Secondary	Patient-caregiver interaction (Intimate Bond Measure)	Measures the dimensions of care and control between partners in an intimate relationship.	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Secondary	Measure of Current Status (MOCS-A)	Measures participants' current self-perceived status on several skills that are targeted by the intervention: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed.	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Secondary	Qualitative Adherence Measure	Measures medication and instruction adherence amongst patients and caregivers.	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Secondary	Caregiving Preparedness (Preparedness for Caregiving Scale)	A caregiver self-rated instrument that consists of eight items that asks caregivers how well prepared they believe they are for multiple domains of caregiving. Preparedness is defined as perceived readiness for multiple domains of the caregiving role such as providing physical care, providing emotional support, setting up in-home support services, and dealing with the stress of caregiving. (Completed by the caregiver only).	Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)