Patient and Caregiver Psychological Functioning Following Neuro-ICU Admission: A Prospective Investigation
- Conditions
- Intensive Care Neurological Disorder
- Interventions
- Other: Questionnaires
- Registration Number
- NCT02435641
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ICU Questionnaires 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).
- Primary Outcome Measures
Name Time Method Posttraumatic Stress (PCL-S) Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) Measures symptoms of posttraumatic stress disorder
Hospital Anxiety and Depression Scale (HADS) Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) Measures symptoms of anxiety and depression.
World Health Organization QOL Questionnaire (WHOQOL-BREF) Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) Measures one's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns.
Satisfaction with Life Questionnaire (SWL) Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) Measures global cognitive judgements of satisfaction with one's life
- Secondary Outcome Measures
Name Time Method Caregiver Self-Efficacy Scale Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) Measures 3 domains of caregiving self-efficacy: Obtaining Respite, Responding to Disruptive Patient Behaviors, and Controlling Upsetting Thoughts. (Completed by the caregiver only).
Cognitive and Affective Mindfulness Scale (CAMS) Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) Measures the degree to which individuals experience their thoughts and feelings.
Qualitative Adherence Measure Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) Measures medication and instruction adherence amongst patients and caregivers.
General Self-Efficacy Scale Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) Measures optimistic self-beliefs to cope with a variety of difficult demands in life. (Completed by the patient only).
Distress Thermometer Scale Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) Measures one's distress, anxiety, depression, anger, and need for help over the past week on a scale from 0 to 10.
Visual Analog Stress Scale Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) Measures one's distress, stress, and ability to cope with that stress over the past week on a scale from 0 to 10.
Healthcare satisfaction (CSQ-8) Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) Measures one's satisfaction with health, human service, governmental, and public benefit programs and services.
Patient-caregiver interaction (Intimate Bond Measure) Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) Measures the dimensions of care and control between partners in an intimate relationship.
Measure of Current Status (MOCS-A) Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) 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.
Caregiving Preparedness (Preparedness for Caregiving Scale) Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26) 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).
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States