Health TrialsbyHealthPanel

Improving Outcomes in PICS With Home-Based Program of Rehabilitation and Health Coaching

ConditionPost-Intensive Care Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Home-based Physical Rehabilitation

    Behavioral

    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 Coaching

    Behavioral

    Study-trained nurse whom utilizes participant data to guide interactions in weekly calls.

Treatment groups

220 Participants
are divided into 3 treatment groups
Group A: Piolt (Aim 1) Group: Home-Based Program of Rehabilitation and Health CoachingExperimental treatment 1 intervention
Group B: Home-Based Program of Rehabilitation and Health CoachingExperimental treatment 2 interventions
Group C: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Completion of home-based rehabilitation program

Total number of subjects to complete the home-based rehabilitation program per protocol

Time frame
12 weeks
2

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.

Time frame
Baseline, 3 months

Secondary outcomes

1

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.

Time frame
Baseline, 3 months
2

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.

Time frame
Baseline, 3 months
3

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.

Time frame
Baseline, 3 months
4

Change in Daily Steps

Number of daily steps taken measured by wearable devices

Time frame
Baseline, 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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