Post-Intensive Care SyndromeNCT06184308
Improving Outcomes in PICS With Home-Based Program of Rehabilitation and Health Coaching
A study testing Home-based Physical Rehabilitation and Health Coaching in people with Post-Intensive Care Syndrome, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this study is to gather information on the effectiveness of a home-based rehabilitation program that also includes health coaching in patients who may suffer from post-intensive care syndrome (PICS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Intensive Care Syndrome
- What is being tested?
- Home-based Physical Rehabilitation and Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 May 2024to 5 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age ≥ 18) with PICS defined as admitted to the ICU for more than 48 hours with any of the following conditions: respiratory failure of any cause requiring mechanical ventilation ≥ three days, any shock requiring vasopressors and/or inotropes, development of delirium during the ICU stay, , and cardiac arrest during the index hospital admission.
- A HABC-M-SR score > 12 points.
Who cannot join
- Any mechanical ventilation in the last two months before the index ICU admission
- ≥ 5 days in the ICU over the previous month before the index ICU admission
- Receiving hospice or palliative care
- Severe uncontrolled psychological or psychiatric disorders, e.g., schizophrenia, bipolar disorder, struggling to cope as a result of their personality disorder, uncontrolled substance abuse (alcoholism, illegal drugs) homelessness would make them unsuitable for the intervention
- A co-morbidity so severe it would prevent the patient from engaging fully in the intervention/ control, e.g., progressive cancer, anoxic brain injury, severe rheumatoid arthritis or osteoarthritis, multiple sclerosis, chronic widespread pain syndrome, previous cerebral vascular event that the patient would not be able to participate in PR
- Patients with moderate/severe cognitive impairment per medical records screening
- Inability to obtain informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Pilot Clinical Trial of a Home-based Program of Rehabilitation With Health Coaching to Improve Outcomes in Post-intensive Care Syndrome Patients
The purpose of this study is to gather information on the effectiveness of a home-based rehabilitation program that also includes health coaching in patients who may suffer from post-intensive care syndrome (PICS). Many patients who are admitted to a hospital ICU suffer from new or worsening symptoms related to their medical condition and ICU care. These new or worsening symptoms may persist for some time and are collectively called post-intensive care syndrome (PICS).
- Conditions
- Post-Intensive Care Syndrome
- Being tested
- Home-based Physical Rehabilitation, Health Coaching
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Physical RehabilitationBehavioural
Six out of seven days a week, gentle flexibility practice (upper arm and shoulder movements) that can be done seated or standing and two slow walking sessions focused on balance. In addition, complete a breathing practice focused on breathing in through the nose and exhaling through the mouth.
Health CoachingBehavioural
Study-trained nurse whom utilizes participant data to guide interactions in weekly calls.
| Study group | Role | What they receive |
|---|---|---|
| Piolt (Aim 1) Group: Home-Based Program of Rehabilitation and Health Coaching | Experimental | 5-10 subjects will be assigned to complete 20 minutes of Home-based Physical Rehabilitation and Health Coaching for approximately 12 weeks to test feasibility of the home-based rehabilitation program. This will be the initial phase of the study prior to RCT phase. Receives: Behavioral: Health Coaching |
| Home-Based Program of Rehabilitation and Health Coaching | Experimental | Subjects will complete 20 minutes of Home-based Physical Rehabilitation and Health Coaching for approximately 12 weeks. Receives: Behavioral: Home-based Physical Rehabilitation; Behavioral: Health Coaching |
| Usual Care | No intervention | Subjects will receive clinical standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of home-based rehabilitation program
Total number of subjects to complete the home-based rehabilitation program per protocol
Measured: 12 weeks
Change in health related quality of life
Measured by the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) score. Questionnaire assess 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) on a 5 level severity scale of no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems.
Measured: Baseline, 3 months
Secondary outcomes (8)
Change in Anxiety and Depression
Measured using the Hospital Anxiety and Depression Scale (HADS) assessing subjects feelings in the past week. Total score 0-21 with 0-7 = normal, 8-10 borderline abnormal; and 11-21 abnormal.
Measured: Baseline, 3 months
Change in Post-Traumatic Stress Disorder (PTSD) Symptoms
Measured using the Impact of Events Scale-Revised (IES-R) to assess subjective distressing difficulties experienced in the past seven days after a specific stressful event. 22 questions with total scoring range of 0 to 88 with 24 or more indicating PTSD is a clinical concern; 33 and above represents probable diagnosis of PTSD; and 37 or more high enough to suppress immune system's functioning.
Measured: Baseline, 3 months
Change in cognition
Measured by the Healthy Aging Brain Care (HABC)-Monitor self-reported version questionnaire to assess brain health using a scale of not all (0-1 day); several days (2-6 days); more than half the days (7-11 days); and almost daily (12-14 days). Total score range of 0 to 81 with higher scores indicating poor cognitive, functional and behavioral brain health.
Measured: Baseline, 3 months
Change in Daily Steps
Number of daily steps taken measured by wearable devices
Measured: Baseline, 3 months
Change in Sedentary Time
Total sedentary time in hours measured by wearable devices
Measured: Baseline, 3 months
Change in Physical activity
Total time recorded in in light, moderate, and strenuous physical activity in hours measured by wearable devices
Measured: Baseline, 3 months
Change in Sleep time
Total sleep time in hours measured by wearable devices
Measured: Baseline, 3 months
Healthcare Utilization
Number of hospitalizations, outpatient, and ER visits
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start8 May 2024
- Primary completion5 Dec 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Intensive Care SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Cartin-Ceba, Mayo Clinic
- Investigators
- Rodrigo Cartin-Ceba, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184308
- Sponsor's protocol ID
- 23-006637
- Status last verified
- Jul 2026
- First submitted
- 14 Dec 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial of a Home-based Program of Rehabilitation With Health Coaching to Improve Outcomes in Post-intensive Care Syndrome Patients
- ClinicalTrials.gov ID
- NCT06184308
- Acronym / sponsor ID
- 23-006637
- Conditions
- Post-Intensive Care Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 28 Dec 2023 (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.
The purpose of this study is to gather information on the effectiveness of a home-based rehabilitation program that also includes health coaching in patients who may suffer from post-intensive care syndrome (PICS). Many patients who are admitted to a hospital ICU suffer from new or worsening symptoms related to their medical condition and ICU care. These new or worsening symptoms may persist for some time and are collectively called post-intensive care syndrome (PICS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Piolt (Aim 1) Group: Home-Based Program of Rehabilitation and Health Coaching | Experimental | Behavioral: Health Coaching5-10 subjects will be assigned to complete 20 minutes of Home-based Physical Rehabilitation and Health Coaching for approximately 12 weeks to test feasibility of the home-based rehabilitation program. This will be the initial phase of the study prior to RCT phase. |
| Home-Based Program of Rehabilitation and Health Coaching | Experimental | Behavioral: Home-based Physical Rehabilitation, Behavioral: Health CoachingSubjects will complete 20 minutes of Home-based Physical Rehabilitation and Health Coaching for approximately 12 weeks. |
| Usual Care | No intervention | –Subjects will receive clinical standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (age ≥ 18) with PICS defined as admitted to the ICU for more than 48 hours with any of the following conditions: respiratory failure of any cause requiring mechanical ventilation ≥ three days, any shock requiring vasopressors and/or inotropes, development of delirium during the ICU stay, , and cardiac arrest during the index hospital admission.
- A HABC-M-SR score > 12 points.
Key exclusion criteria (7 listed)
- Any mechanical ventilation in the last two months before the index ICU admission
- ≥ 5 days in the ICU over the previous month before the index ICU admission
- Receiving hospice or palliative care
- Severe uncontrolled psychological or psychiatric disorders, e.g., schizophrenia, bipolar disorder, struggling to cope as a result of their personality disorder, uncontrolled substance abuse (alcoholism, illegal drugs) homelessness would make them unsuitable for the intervention
- A co-morbidity so severe it would prevent the patient from engaging fully in the intervention/ control, e.g., progressive cancer, anoxic brain injury, severe rheumatoid arthritis or osteoarthritis, multiple sclerosis, chronic widespread pain syndrome, previous cerebral vascular event that the patient would not be able to participate in PR
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 |
|---|---|---|
| Home-based Physical RehabilitationSix out of seven days a week, gentle flexibility practice (upper arm and shoulder movements) that can be done seated or standing and two slow walking sessions focused on balance. In addition, complete a breathing practice focused on breathing in through the nose and exhaling through the mouth. | Behavioural | Home-Based Program of Rehabilitation and Health Coaching |
| Health CoachingStudy-trained nurse whom utilizes participant data to guide interactions in weekly calls. | Behavioural | Home-Based Program of Rehabilitation and Health Coaching, Piolt (Aim 1) Group: Home-Based Program of Rehabilitation and Health Coaching |
Primary outcome
Completion of home-based rehabilitation program
Time frame: 12 weeks
Total number of subjects to complete the home-based rehabilitation program per protocol
Change in health related quality of life
Time frame: Baseline, 3 months
Measured by the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) score. Questionnaire assess 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) on a 5 level severity scale of no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems.
8 secondary outcomes
Change in Anxiety and Depression
Time frame: Baseline, 3 months
Change in Post-Traumatic Stress Disorder (PTSD) Symptoms
Time frame: Baseline, 3 months
Change in cognition
Time frame: Baseline, 3 months
Change in Daily Steps
Time frame: Baseline, 3 months
Change in Sedentary Time
Time frame: Baseline, 3 months
Change in Physical activity
Time frame: Baseline, 3 months
Change in Sleep time
Time frame: Baseline, 3 months
Healthcare Utilization
Time frame: 3 months
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 22 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Rodrigo Cartin-Ceba, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Physical Rehabilitation and Health Coaching in people with Post-Intensive Care Syndrome, run by Mayo Clinic at 2 sites 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 2 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 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Completion of home-based rehabilitation program (time frame: 12 weeks). The study lists 2 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 22 Jul 2026.