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

August 15, 2018 updated by: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the Neuro-ICU and their family caregivers

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
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
Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
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
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)
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.
Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
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).
Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
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.
Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
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.
Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
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.
Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
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.
Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
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.
Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
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.
Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
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.
Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
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).
Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (week 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014P002793

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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