Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT06867367
Eligibility Criteria:
Patient Inclusion/Exclusion Criteria
Inclusion Criteria:
1. Provide signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.
2. Elderly ICU survivors aged over 60 years who have experienced long ICU stays of more than five days.
3. Caregivers who either live in the same household as the survivor or visit more than three times a week.
Exclusion Criteria:
Co-enrollment in other interventional studies will not be allowed.
1. Age \>=85 years (Justification: Assessment instruments not validated in this age group and patients in extremes of age may have limited proficiency to engage in proposed meditative practices)
2. Non-English speaking/Low-English proficiency (Justification: assessment instruments are not validated in a sufficient range of languages, and the research team lacks polylingual capabilities or the financial resources to hire interpreters for the duration of all proposed assessments.)
3. Non-US resident
4. Recent or current meditation, yoga, breathwork or associated MBI intervention practice (\> 2 times per week). (Justification: as the primary outcome is to evaluate the feasibility and adherence of patients to a multicomponent MBI, recent or current practice of the individual or combined components would directly influence the endpoint).
5. Individuals discharged to a non-home location, such as a rehabilitation center, nursing home, or long-term acute care facility.
6. Individuals with limited internet access, which would prevent access to online guided meditation
7. Prisoners.
8. Individuals who refuse to participate in the study.
9. Not on vasopressor or inotropic support at the time of enrollment.
10. Not on non-invasive ventilation, high-flow nasal cannula (HFNC), or mechanically ventilated.
11. Not on continuous renal replacement therapy (CRRT).
12. Failure to pass Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) screening (\>3.6; Justification: Cognitive decline would limit the ability to engage with and complete the study interventions and assessments).
13. Scores ≥ 5 on either the anxiety or depression subscales suggesting severe symptom levels.
14. Known diagnosis of moderate or severe dementia.
15. Neurological injury.
16. Residing in a medical institution before admission.
17. Patient on hospice at or before the time of enrollment.
18. Mechanical ventilation at baseline or solely for airway protection.
19. Patient not expected to go home (e.g., transfer to a facility).
20. Patient not expected to survive two months or expected to transition to hospice.
21. Patient died in hospital before enrollment.
22. Attending physician declined enrollment.
23. Patient discharged before being approached for consent.
24. Either the patient or caregiver in the dyad declined participation (based on IQCODE or consent).
Caregiver Inclusion/Exclusion Criteria
Inclusion Criteria:
1. Provide signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.
2. Caregivers who either live in the same household as the survivor or visit more than three times a week.
3. Age ≥18 years old.
Exclusion Criteria:
1. Non-English speaking/Low-English proficiency (Justification: assessment instruments are not validated in a sufficient range of languages, and the research team lacks polylingual capabilities or the financial resources to hire interpreters for the duration of all proposed assessments.)
2. Non-US resident
3. Recent or current meditation, yoga, breathwork or associated MBI intervention practice (\> 2 times per week). (Justification: as the primary outcome is to evaluate the feasibility and adherence of patients to a multicomponent MBI, recent or current practice of the individual or combined components would directly influence the endpoint).
4. Individuals with limited internet access, which would prevent access to online guided meditation
5. Prisoners.
6. Individuals who refuse to participate in the study.
7. Diagnosed with severe psychiatric disorders, such as schizophrenia, bipolar disorder, or ongoing substance abuse, that could interfere with participation.
8. Individuals actively receiving treatment for recent trauma
9. Scores ≥ 5 on either the anxiety or depression subscales suggesting severe symptom levels.
10. severe or acute medical illness
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06867367
Study Brief:
Protocol Section:
NCT06867367