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Completed

NCT Number: NCT02435641

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

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.

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Key information

Conditions

Intensive Care Neurological Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for patients:

  • 18 years of age and older
  • English fluency and literacy
  • Admitted to the Neuro-ICU

Inclusion criteria

for family caregivers:

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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

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

    Measures symptoms of anxiety and depression.

  2. Posttraumatic Stress (PCL-S)

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

    Measures symptoms of posttraumatic stress disorder

  3. Satisfaction with Life Questionnaire (SWL)

    Time frame: 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

  4. World Health Organization QOL Questionnaire (WHOQOL-BREF)

    Time frame: 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.

Secondary outcomes

  1. General Self-Efficacy Scale

    Time frame: 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).

  2. Caregiver Self-Efficacy Scale

    Time frame: 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).

  3. Distress Thermometer Scale

    Time frame: 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.

  4. Visual Analog Stress Scale

    Time frame: 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.

  5. Healthcare satisfaction (CSQ-8)

    Time frame: 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.

  6. Cognitive and Affective Mindfulness Scale (CAMS)

    Time frame: 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.

  7. Patient-caregiver interaction (Intimate Bond Measure)

    Time frame: 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.

  8. Measure of Current Status (MOCS-A)

    Time frame: 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.

  9. Qualitative Adherence Measure

    Time frame: 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.

  10. Caregiving Preparedness (Preparedness for Caregiving Scale)

    Time frame: 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).

Other outcomes

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

    Time frame: Baseline (week 0)

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 6, 2015
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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