Intensive Care Neurological DisorderNCT02435641
Patient and Caregiver Psychological Functioning Following Neuro-ICU Admission: A Prospective Investigation
An observational study of Intensive Care Neurological Disorder, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intensive Care Neurological Disorder
- What is being tested?
- Questionnaires
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients admitted to the Neuro-ICU and their family caregivers
Who may be able to join
- 18 years of age and older
- English fluency and literacy
- Admitted to the Neuro-ICU
- 18 years of age and older
- English fluency and literacy
- Family member of patient who is identified by patient as the primary caregiver
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Prospective Study to Investigate Relationships Between Patient and Family Caregiver Distress Following Neuroscience ICU Admission
The current study has the following objectives:
- 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.
- 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.
- Conditions
- Intensive Care Neurological Disorder
- Being tested
- Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HADS)
Measures symptoms of anxiety and depression.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measures optimistic self-beliefs to cope with a variety of difficult demands in life. (Completed by the patient only).
Measured: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
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).
Measured: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
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.
Measured: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
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.
Measured: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Healthcare satisfaction (CSQ-8)
Measures one's satisfaction with health, human service, governmental, and public benefit programs and services.
Measured: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Cognitive and Affective Mindfulness Scale (CAMS)
Measures the degree to which individuals experience their thoughts and feelings.
Measured: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Patient-caregiver interaction (Intimate Bond Measure)
Measures the dimensions of care and control between partners in an intimate relationship.
Measured: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
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.
Measured: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Qualitative Adherence Measure
Measures medication and instruction adherence amongst patients and caregivers.
Measured: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
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).
Measured: Change between Baseline (week 0), 3-month Follow Up (week 13) and 6-month Follow Up (week 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Neurological DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
- Investigators
- Ana-Maria Vranceanu, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435641
- Sponsor's protocol ID
- 2014P002793
- Status last verified
- Aug 2018
- First submitted
- 29 Apr 2015
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Investigate Relationships Between Patient and Family Caregiver Distress Following Neuroscience ICU Admission
- ClinicalTrials.gov ID
- NCT02435641
- Acronym / sponsor ID
- 2014P002793
- Conditions
- Intensive Care Neurological Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study has the following objectives:
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU Questionnaires | – | Other: QuestionnairesAfter 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Neuro-ICU and their family caregivers
Key inclusion criteria (6 listed)
- 18 years of age and older
- English fluency and literacy
- Admitted to the Neuro-ICU
- 18 years of age and older
- English fluency and literacy
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAll subjects (patients and caregivers) will complete a battery of psychological questionnaires at baseline (ICU admission), 3 months post-baseline, and 6 months post-baseline. | Other | ICU Questionnaires |
Primary outcome
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.
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
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
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.
10 secondary outcomes
General Self-Efficacy Scale
Time frame: 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)
Distress Thermometer Scale
Time frame: 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)
Healthcare satisfaction (CSQ-8)
Time frame: 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)
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)
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)
Qualitative Adherence Measure
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana-Maria Vranceanu, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Neurological Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.