Home-Based Rehabilitation + Health Coaching for Post-Intensive Care Syndrome

Recruiting at 1 trial location

Overseen By Johanna Hoult

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Psychiatric disorders, Substance abuse, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a home-based rehabilitation program, combined with health coaching, benefits individuals dealing with post-intensive care syndrome (PICS). PICS can develop after an ICU stay and includes new or worsening symptoms such as breathing issues or mental confusion. Participants will either follow this program or continue with their usual care. Suitable candidates have spent more than two days in the ICU with complications like requiring mechanical ventilation. As an unphased trial, this study provides a unique opportunity to enhance understanding and improve recovery options for PICS patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this home-based rehabilitation and health coaching program is safe for post-intensive care syndrome patients?

Research has shown that home-based rehab programs for people with post-intensive care syndrome (PICS) are generally safe and well-liked. Patients in studies found these programs easy to follow and helpful, with no major reports of negative effects.

Regarding health coaching, studies have shown it is safe and beneficial for people who have been in the ICU. Participants typically handle health coaching well, with no major negative effects reported. This method has even helped improve self-care and reduce stress in other health issues, such as heart failure.

Overall, both treatments offer safe options for people who have been in intensive care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to managing Post-Intensive Care Syndrome (PICS) through home-based rehabilitation combined with health coaching. Unlike traditional care, which often involves hospital-based rehabilitation or self-managed recovery, this method offers a convenient, structured program that patients can do at home. The integration of health coaching is particularly noteworthy, as it provides personalized support and motivation, potentially leading to better adherence and outcomes. This approach could make rehabilitation more accessible and effective for patients recovering from intensive care.

What evidence suggests that this trial's home-based rehabilitation and health coaching program could be effective for post-intensive care syndrome?

This trial will evaluate a Home-Based Program of Rehabilitation and Health Coaching for individuals with post-intensive care syndrome (PICS). Research has shown that physical rehabilitation exercises at home can greatly benefit people with PICS. One study found that this type of rehab improves physical abilities, making home recovery easier for patients. Another review found that additional rehab after hospital discharge enhances the quality of life for those who have been in critical care.

Regarding health coaching, studies have shown it helps people take better care of themselves and reduces stress. While results can vary, health coaching via phone or online often aids in better health management. Together, these methods aim to help people with PICS feel better and manage their symptoms more effectively. Participants in this trial will either receive this combined home-based program or usual care. ^{2 5 6 7 8}

Who Is on the Research Team?

Rodrigo Cartin-Ceba, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've been in the ICU for more than 48 hours due to severe conditions like respiratory failure, shock, delirium, or cardiac arrest. They should have a certain score indicating they might have PICS but can't join if they've had recent mechanical ventilation, extensive ICU stays, are on palliative care, have uncontrolled mental health issues or substance abuse problems.

Inclusion Criteria

I am an adult who was in the ICU for over 48 hours due to severe illness.

A HABC-M-SR score > 12 points.

Exclusion Criteria

I have not been on a breathing machine in the last two months before my recent ICU stay.

I am currently receiving care focused on relieving symptoms and improving quality of life.

I do not have a severe health condition that would stop me from fully participating in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Phase

5-10 subjects will complete 20 minutes of Home-based Physical Rehabilitation and Health Coaching to test feasibility

12 weeks

Treatment

Participants receive 20 minutes of Home-based Physical Rehabilitation and Health Coaching

12 weeks

Follow-up

Participants are monitored for changes in sedentary time, physical activity, sleep time, cognition, healthcare utilization, quality of life, anxiety, depression, PTSD symptoms, and daily steps

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Health Coaching
• Home-based Physical Rehabilitation

Trial Overview

The study tests how effective a home-based rehabilitation program with health coaching is for patients suffering from post-intensive care syndrome (PICS), which includes persistent symptoms following an intensive hospital stay.

How Is the Trial Designed?

Group I: Piolt (Aim 1) Group: Home-Based Program of Rehabilitation and Health Coaching Experimental Treatment 1 Intervention

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.

Group II: Home-Based Program of Rehabilitation and Health Coaching Experimental Treatment 2 Interventions

Subjects will complete 20 minutes of Home-based Physical Rehabilitation and Health Coaching for approximately 12 weeks.

Group III: Usual Care Active Control 1 Intervention

Subjects will receive clinical standard of care.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

The REACH program, an interdisciplinary home-based rehabilitation intervention for patients with Post-Intensive Care Syndrome (PICS), was found to be feasible and well-received, with 79.1% of participants completing the 6-month follow-up without any adverse events.

Patients in the REACH group reported higher satisfaction and a larger number of visits to allied health professionals compared to those receiving usual care, although both groups showed similar recovery in functional outcomes and health-related quality of life at 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a home-based interdisciplinary rehabilitation program for patients with Post-Intensive Care Syndrome: the REACH study. Major, ME., Dettling-Ihnenfeldt, D., Ramaekers, SPJ., et al.[2023]

An eight-week home-based physical rehabilitation program for critically ill survivors did not significantly enhance recovery compared to a control group, as both groups showed similar improvements in physical function over 26 weeks.

Despite the lack of significant differences between the intervention and control groups, both experienced clinically important gains in physical function and endurance, suggesting that some level of recovery occurs naturally after critical illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related quality of life and physical recovery after a critical illness: a multi-centre randomised controlled trial of a home-based physical rehabilitation program. Elliott, D., McKinley, S., Alison, J., et al.[2023]

This randomized controlled trial will assess the effectiveness of an 8-week home-based rehabilitation program for survivors of critical illness, focusing on improving physical and psychological recovery after hospital discharge.

With a target sample size of 200 participants, the study aims to demonstrate a clinically significant 10% improvement in physical functioning, potentially providing a scalable model for enhancing recovery in aging populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol: home-based physical rehabilitation for survivors of a critical illness [ACTRN12605000166673]. Elliott, D., McKinley, S., Alison, JA., et al.[2018]

The study involving 20 ICU survivors showed that an exercise intervention using rhythmic music was both feasible and acceptable, indicating that patients could effectively self-manage their exercise routines with personalized playlists.

Participants reported general, physical, and psychosocial benefits from the music intervention, suggesting it could be a valuable tool for rehabilitation in ICU survivors, warranting further investigation in larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a self-managed exercise to rhythmic music intervention for ICU survivors. Liang, Z., Munro, CL., Ferreira, TBD., et al.[2021]

Survivors of critical illness often experience post-intensive care syndrome (PICS), which includes a range of physical, cognitive, psychological, and existential health issues, highlighting the need for targeted interventions.

Early physical rehabilitation and case management interventions show promise in improving long-term outcomes for ICU survivors, while late interventions have had mixed results, indicating the importance of timely and tailored care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approaches to Addressing Post-Intensive Care Syndrome among Intensive Care Unit Survivors. A Narrative Review. Brown, SM., Bose, S., Banner-Goodspeed, V., et al.[2020]

A novel home-based physiotherapy program for survivors of critical illness was tested, but it showed no significant difference in outcome measures at the 26-week follow-up, indicating that this specific intervention may not be effective for improving post-ICU morbidity.

The study highlights the importance of tailoring post-ICU rehabilitation programs to individual patient and family needs, suggesting that a broader range of outcome measures could provide better insights into the effectiveness of such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The challenge of designing a post-critical illness rehabilitation intervention. Herridge, MS.[2022]

Early rehabilitation practices, including tailored physical therapy and exercise, are effective and safe for improving functional outcomes and quality of life in adult ICU survivors, as supported by a systematic review of current research.

Despite the benefits, critically ill patients often do not receive standard physical therapy, highlighting the need for critical care nurses to advocate for and implement early rehabilitation practices in ICU settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early rehabilitation in the intensive care unit: an integrative literature review. Sosnowski, K., Lin, F., Mitchell, ML., et al.[2022]

The PRACTICE study aims to create a core outcome set (COS) for physical rehabilitation interventions in critically ill patients, addressing the variability in outcomes that complicates research synthesis and clinical application.

Using a mixed methods approach, including systematic reviews and stakeholder consensus, the study seeks to identify key outcomes that will improve the design and effectiveness of future rehabilitation trials for patients transitioning from intensive care to community reintegration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Rehabilitation Core Outcomes In Critical illness (PRACTICE): protocol for development of a core outcome set. Connolly, B., Denehy, L., Hart, N., et al.[2021]

The PIX study found that a supervised exercise program significantly improved fitness and suggested benefits for physical and mental health in patients recovering from critical illness, based on both objective measurements and qualitative feedback.

Participants in the exercise group reported increased motivation, energy levels, and social interaction, highlighting the positive impact of structured exercise on their overall well-being and quality of life after hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Project Post Intensive Care eXercise (PIX): A qualitative exploration of intensive care unit survivors' perceptions of quality of life post-discharge and experience of exercise rehabilitation. Walker, W., Wright, J., Danjoux, G., et al.[2021]

Citations

1.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK487705/

RESULTS - The Effectiveness of Health Coaching - NCBI

The number of health coaching sessions ranged from 3 to 156 with a median of 12. Primary mode of coaching delivery was by phone in 52% of trials, followed by ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8138945/

Peer Support for Post Intensive Care Syndrome Self

This study is the first use of embedding peer-led motivational interviewing training into a peer support intervention for ICU survivors.

3.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2805604

Effect of a Peer Health Coaching Intervention on Clinical ...

In this randomized clinical trial of 264 US veterans, there was no significant improvement in SBP in participants who received the peer health coaching ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0197457225003520

Effectiveness of a digital health coaching self-management ...

This study evaluated the effectiveness of a digital health coaching self-management program for older adults living alone with multiple chronic ...

5.

ahajournals.org

ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.123.011475

Health Coaching Improves Outcomes of Informal ...

CONCLUSIONS: This virtual health coaching intervention was effective in improving self-care and stress in heart failure caregivers.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10202754/

Post-intensive care syndrome (PICS): recent updates - PMC

Another COVID-19 study evaluating outcomes at 1-year follow-up of ICU survivors reported that cognitive and mental impairments always occurred ...

7.

withpower.com

withpower.com/trial/phase-syndrome-1-2024-d45dd

Home-Based Rehabilitation + Health Coaching for Post ...

The studies reviewed suggest that home-based rehabilitation programs, including exercise and health coaching, are generally safe for ICU survivors. Participants ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S2949788423000035

A Narrative Review of Post-Intensive Care Syndrome

This syndrome consists of a collection of new or worsening impairments in the physical, psychological, or cognitive domains that develop after critical illness.