Critical IllnessASSISTNCT03065829
Self-Management Behaviors of Caregivers of the Chronically Critically Ill
A study testing ASSIST in people with Critical Illness, run by Case Western Reserve University at 1 site in United States.
Trial summary
For family members of chronically critically ill (CCI) patients, an ICU admission marks a significant milestone in the patient's illness trajectory that highlights the onset of end of-life issues and an abrupt need for family members to assume the caregiver role for the first time. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness
- What is being tested?
- ASSIST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 31 Jul 2017
- Phase
- Interventional
- 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
Who may be able to join
- aged 18 years or older
- recognized as the family member who will assume the caregiver role for a critically ill adult requiring at least 72 hours of mechanical ventilation and scheduled for a discharge to an extended care facility
- speak and comprehend English
Who cannot join
- currently practicing mindfulness-based interventions
- require psychotherapy or required psychotherapy within the last three months
- have a history of dementia or major neurological illness
- pregnant
- history of medical conditions or procedures that is contraindicated for fMRI scanning
- claustrophobia requiring anxiolytics or sedation
- expected to relocate from Northeast Ohio within two months
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: The Mediating Effects of Decentering on Self-Management Behaviors in Caregivers of Critically Chronically Ill Patients
For family members of chronically critically ill (CCI) patients, an ICU admission marks a significant milestone in the patient's illness trajectory that highlights the onset of end of-life issues and an abrupt need for family members to assume the caregiver role for the first time. Assuming the caregiver role can have devastating and longstanding health consequences for family members, which can impair their ability to sustain caregiving behaviors for a CCI patient. The unrelenting psychological distress perceived by caregivers of CCI patients is linked to significant reductions in their self-management and health outcomes.
The purpose of this study is to evaluate a theoretically-derived Adaptive SenSor-Based Intervention for Caregiver Self-ManagemenT (ASSIST) intervention compared to an attention control condition for first time caregivers of CCI patients discharged to an extended care facility. One group will be exposed to the ASSIST intervention and will wear the sensor-based technology for 30 days and receive a daily dose of MMT. Biophysical sensor data (blood pressure, heart-rate variability, pedometry, and actigraphy) will be continuously acquired and analyzed using anomaly detection and machine learning techniques to vary the dose intensity (number of doses per day) of the two components of ASSIST adding a real-time, adaptive feature to promote caregiver self-management. The other group will wear the sensor-based technology for 30 days but will not receive the daily dose of MMT. The investigators will randomly assign participants to each group.
Read the detailed description
The investigators will conduct a randomized controlled trial to examine the ASSIST intervention compared to an attention control condition among 20 first time caregivers of CCI patients discharged to an extended care facility. The investigators will collect mixed methods data at baseline (T1) on Day 15 (T2) and Day 30 (T3) after subject enrollment to describe changes in proximal and distal outcomes. We have chosen our time points to capture neural and behavioral changes associated with the intervention.
The investigators aim to:
- Determine whether there are differences in the distal outcomes [psychological burden (anxiety, depression, caregiver burden, HRQoL), cardiovascular health (BP and HRV) and economic costs] between subjects who were exposed to ASSIST compared to those exposed to the attention control condition.
- Examine whether decentering, self-efficacy, decision-making, motivation, caregiver activation, and perceived stress mediate the relationship between exposure to a self-management condition (ASSIST vs. attention control) and the proximal (self-management) outcomes (stress reduction behaviors, sleep hygiene behaviors, and physical activity).
- Determine if social support and demographics (gender and age) moderate the proximal outcomes [emotional distress, sleep quality, and physical activity] or distal outcomes [psychological burden (anxiety, depression, caregiver burden, HRQoL), cardiovascular health (BP and HRV) and economic costs].
- Explore the differences in brain activation (structural and fMRI scans) and HPA function and stress response (hair cortisol, inflammation panel) between subjects exposed to ASSIST compared to those exposed to the attention control condition.
- Conditions
- Critical Illness
- Being tested
- ASSIST, Attention-Control
- Keywords
- caregiver, chronically critically ill
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASSISTBehavioural
Wearable sensor technology delivering mindfulness meditation training (MMT) and health promotion (sleep hygiene and physical activity) .
Attention-ControlBehavioural
Wearable sensor technology only viewing biophysical sensor data.
| Study group | Role | What they receive |
|---|---|---|
| ASSIST | Experimental | The ASSIST intervention will deliver daily doses of MMT and vary dose intensity of all components each day based on the subject's biophysical data. Across a 30-day period, the ASSIST intervention will capture and analyze data to deliver on-demand MMT, guided practices to promote sleep hygiene and physical activity. Each day, subjects will receive at least one prompt to practice MMT (about 5 minutes at a time). However, based on the subject's biophysical sensor data, subjects could receive a maximum of 5 alerts or prompts per day from the device to enhance stress reduction, sleep hygiene, or physical activity. Receives: Behavioral: ASSIST |
| Attention-Control | Experimental | This intervention exposes subjects to the wearable technology without the self-management components to minimize novelty effects. Subjects assigned to this condition will wear the device for 30 days, which offers them an opportunity to experientially learn to self-monitor and employ self-regulatory skills by viewing the display biophysical data. Subjects in this condition will not receive any prompts from the device. Receives: Behavioral: Attention-Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeated Measures
ANCOVA Model (F-Statistic)
Measured: Baseline to 30 days
Secondary outcomes (7)
Change in Active Living Protocol (captured on wearable device)
Measure of Caregiver Sleep Activity
Measured: From Baseline to up to 30 days
Change in Daily Diary of Physical Activity (captured on wearable device)
Measure of Caregiver Physical Activity
Measured: From Baseline to up to 30 days
Change in Perceived Stress Scale
Measure of Caregiver Stress
Measured: From Baseline to up to 30 days
Change in PROMIS-29 Scale
Measure of Caregiver Anxiety and Depression
Measured: From Baseline to up to 30 days
Change in Zarits Burden Interview
Measure of Caregiver Burden
Measured: From Baseline to up to 30 days
Change in Health Behaviors Questionnaire
Measure of Caregiver Health Related Quality of Life
Measured: From Baseline to up to 30 days
Change in Heart Rate Variability (captured on wearable device)
Measure of Caregiver Heart Rate Variablity
Measured: From Baseline to up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study startFeb 2016
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Our model posits that effective caregiver self-management depends on analytic and emotional processing. The investigators hypothesize the ASSIST intervention will improve analytic processing by improving self-monitoring. ASSIST will expose subjects to mindfulness meditation training and promote self-awareness, which will aid the regulation of their emotional processing and improve proximal outcomes. The investigators expect proximal self-management outcomes to influence the distal outcomes of caregiver health. Our model will also test the mediating effects of decentering, processing, the hypothalamic-pituitary axis (HPA), inflammatory stress response, and cognitive mediators. The influence of potential moderators will be assessed for their effect on the relationship between the self-management intervention and the proximal and distal outcomes.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Ronald Hickman, Case Western Reserve University
- Investigators
- Ronald L. Hickman, PhD, RN, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065829
- Sponsor's protocol ID
- 11-15-11
- Other IDs
- P30NR015326
- Acronym
- ASSIST
- Status last verified
- Jul 2018
- First submitted
- 6 Feb 2017
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Moore SM, Musil CM, Alder ML, Pignatiello G, Higgins P, Webel A, Wright KD. Building a Research Data Repository for Chronic Condition Self-Management Using Harmonized Data. Nurs Res. 2020 Jul/Aug;69(4):254-263. doi: 10.1097/NNR.0000000000000435.
PubMed 32205788
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mediating Effects of Decentering on Self-Management Behaviors in Caregivers of Critically Chronically Ill Patients
- ClinicalTrials.gov ID
- NCT03065829
- Acronym / sponsor ID
- ASSIST / 11-15-11
- Conditions
- Critical Illness
- Keywords
- caregiver, chronically critically ill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Study start
- Feb 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 28 Feb 2017 (actual)
- 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.
For family members of chronically critically ill (CCI) patients, an ICU admission marks a significant milestone in the patient's illness trajectory that highlights the onset of end of-life issues and an abrupt need for family members to assume the caregiver role for the first time. Assuming the caregiver role can have devastating and longstanding health consequences for family members, which can impair their ability to sustain caregiving behaviors for a CCI patient. The unrelenting psychological distress perceived by caregivers of CCI patients is linked to significant reductions in their self-management and health outcomes.
The purpose of this study is to evaluate a theoretically-derived Adaptive SenSor-Based Intervention for Caregiver Self-ManagemenT (ASSIST) intervention compared to an attention control condition for first time caregivers of CCI patients discharged to an extended care facility. One group will be exposed to the ASSIST intervention and will wear the sensor-based technology for 30 days and receive a daily dose of MMT. Biophysical sensor data (blood pressure, heart-rate variability, pedometry, and actigraphy) will be continuously acquired and analyzed using anomaly detection and machine learning techniques to vary the dose intensity (number of doses per day) of the two components of ASSIST adding a real-time, adaptive feature to promote caregiver self-management. The other group will wear the sensor-based technology for 30 days but will not receive the daily dose of MMT. The investigators will randomly assign participants to each group.
Detailed description
The investigators will conduct a randomized controlled trial to examine the ASSIST intervention compared to an attention control condition among 20 first time caregivers of CCI patients discharged to an extended care facility. The investigators will collect mixed methods data at baseline (T1) on Day 15 (T2) and Day 30 (T3) after subject enrollment to describe changes in proximal and distal outcomes. We have chosen our time points to capture neural and behavioral changes associated with the intervention.
The investigators aim to:
- Determine whether there are differences in the distal outcomes [psychological burden (anxiety, depression, caregiver burden, HRQoL), cardiovascular health (BP and HRV) and economic costs] between subjects who were exposed to ASSIST compared to those exposed to the attention control condition.
- Examine whether decentering, self-efficacy, decision-making, motivation, caregiver activation, and perceived stress mediate the relationship between exposure to a self-management condition (ASSIST vs. attention control) and the proximal (self-management) outcomes (stress reduction behaviors, sleep hygiene behaviors, and physical activity).
- Determine if social support and demographics (gender and age) moderate the proximal outcomes [emotional distress, sleep quality, and physical activity] or distal outcomes [psychological burden (anxiety, depression, caregiver burden, HRQoL), cardiovascular health (BP and HRV) and economic costs].
- Explore the differences in brain activation (structural and fMRI scans) and HPA function and stress response (hair cortisol, inflammation panel) between subjects exposed to ASSIST compared to those exposed to the attention control condition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Our model posits that effective caregiver self-management depends on analytic and emotional processing. The investigators hypothesize the ASSIST intervention will improve analytic processing by improving self-monitoring. ASSIST will expose subjects to mindfulness meditation training and promote self-awareness, which will aid the regulation of their emotional processing and improve proximal outcomes. The investigators expect proximal self-management outcomes to influence the distal outcomes of caregiver health. Our model will also test the mediating effects of decentering, processing, the hypothalamic-pituitary axis (HPA), inflammatory stress response, and cognitive mediators. The influence of potential moderators will be assessed for their effect on the relationship between the self-management intervention and the proximal and distal outcomes.
| Arm | Type | Receives |
|---|---|---|
| ASSIST | Experimental | Behavioral: ASSISTThe ASSIST intervention will deliver daily doses of MMT and vary dose intensity of all components each day based on the subject's biophysical data. Across a 30-day period, the ASSIST intervention will capture and analyze data to deliver on-demand MMT, guided practices to promote sleep hygiene and physical activity. Each day, subjects will receive at least one prompt to practice MMT (about 5 minutes at a time). However, based on the subject's biophysical sensor data, subjects could receive a maximum of 5 alerts or prompts per day from the device to enhance stress reduction, sleep hygiene, or physical activity. |
| Attention-Control | Experimental | Behavioral: Attention-ControlThis intervention exposes subjects to the wearable technology without the self-management components to minimize novelty effects. Subjects assigned to this condition will wear the device for 30 days, which offers them an opportunity to experientially learn to self-monitor and employ self-regulatory skills by viewing the display biophysical data. Subjects in this condition will not receive any prompts from the device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 years or older
- recognized as the family member who will assume the caregiver role for a critically ill adult requiring at least 72 hours of mechanical ventilation and scheduled for a discharge to an extended care facility
- speak and comprehend English
Key exclusion criteria (7 listed)
- currently practicing mindfulness-based interventions
- require psychotherapy or required psychotherapy within the last three months
- have a history of dementia or major neurological illness
- pregnant
- history of medical conditions or procedures that is contraindicated for fMRI scanning
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 |
|---|---|---|
| ASSISTWearable sensor technology delivering mindfulness meditation training (MMT) and health promotion (sleep hygiene and physical activity) . | Behavioural | ASSIST |
| Attention-ControlWearable sensor technology only viewing biophysical sensor data. | Behavioural | Attention-Control |
Primary outcome
Repeated Measures
Time frame: Baseline to 30 days
ANCOVA Model (F-Statistic)
7 secondary outcomes
Change in Active Living Protocol (captured on wearable device)
Time frame: From Baseline to up to 30 days
Change in Daily Diary of Physical Activity (captured on wearable device)
Time frame: From Baseline to up to 30 days
Change in Perceived Stress Scale
Time frame: From Baseline to up to 30 days
Change in PROMIS-29 Scale
Time frame: From Baseline to up to 30 days
Change in Zarits Burden Interview
Time frame: From Baseline to up to 30 days
Change in Health Behaviors Questionnaire
Time frame: From Baseline to up to 30 days
Change in Heart Rate Variability (captured on wearable device)
Time frame: From Baseline to up to 30 days
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 10 Jul 2018.
- Derived from this study: PubMed 32205788Moore SM, Musil CM, Alder ML, Pignatiello G, Higgins P, Webel A, Wright KD. Building a Research Data Repository for Chronic Condition Self-Management Using Harmonized Data. Nurs Res. 2020 Jul/Aug;69(4):254-263. doi: 10.1097/NNR.0000000000000435.
- Individual participant dataSharing planned: Undecided
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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.
Ronald L. Hickman, PhD, RN principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASSIST in people with Critical Illness, run by Case Western Reserve University 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 3 inclusion and 7 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 10 Jul 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?
Repeated Measures (time frame: Baseline to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03065829, which also lists 1 linked publication.
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 10 Jul 2018.