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:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT03189459
Eligibility Criteria:
Inclusion Criteria:
HVP Patient-Subject
* Each subject must be 40 years of age or older. A subject may be of either gender, any race, and any ethnicity.
* Subjects must have a diagnosis of idiopathic Parkinson's Disease (inclusive of Parkinson's Disease Dementia) by a neurologist.
* Subjects will have been seen at least once in the past two years in the outpatient movement disorders clinic at Rush University Medical Center
* Subjects must be rated as HY stage 3-5 at the time of screening via chart review of the most recent clinical visit.
* Subjects must reside within a 60-minute public transit or driving distance of Rush University.
* Subjects must live at home (as defined by an independent dwelling such as an apartment, condominium, or house owned or rented by, or provided to/shared with the subject).
* Subjects must be home-bound according to the Medicare definition: "Leaving your home isn't recommended because of your condition; your condition keeps you from leaving home without help (such as using a wheelchair or walker, needing special transportation, or getting help from another person); leaving home takes a considerable and taxing effort." (http://www.medicare.gov/pubs/pdf/10969.pdf)
* Subjects have one or more of the following criteria, as determined by the referring neurologist: motor or cognitive fluctuations, multi-morbidity, medication mismanagement, cognitive impairment, symptoms of depression and/or anxiety, high risk for hospitalization or hospital readmission, high risk for nursing facility admission, suspected elder abuse, recent history of increased falls in home, caregiver burnout suspected, \>2 cancelled or no-show appointments with the movement disorders providers in the preceding 12 months
* Subjects must have a caregiver willing to participate in the study, as defined by an unpaid individual cohabiting with or spending an average of \>20 hours weekly engaged in care-related tasks related to the subject
* Subjects must either: 1) demonstrate capacity to consent, or 2) pending caregiver capacity assessment and caregiver consent, give assent or not dissent. Excluding individuals with cognitive impairment, dementia, depression, or psychosis would limit the generalizability of this study given the prevalence of each in advanced PD.
HVP Caregiver-Subject
* Each subject must be 30 years of age or older. A subject may be of either gender, any race, and any ethnicity.
* Each subject must be an unpaid individual cohabiting with or spending an average of \>20 hours weekly engaged in care-related tasks related to the patient-subject. The caregiver-subject does not need to be the patient-subject's health care proxy or guardian.
* Each subject must demonstrate capacity to consent.
* Each subject must agree to participation in the nested trial of caregiver peer mentoring as a caregiver mentee
* Each subject must have a working telephone number at which he or she can be reached for check-in calls by the study team throughout the study.
Caregiver Peer Mentor
* Each subject must be 30 years of age or older. A subject may be of either gender, any race, and any ethnicity.
* Each subject must have \>2 years of informal caregiving experience for an individual with PD or a related disorder.
* Each subject must have previously participated in a caregiver support group for PD, participated in a PD educational or outreach event, or given permission to be contacted for research.
* Each subject must be primarily English-speaking.
* Each subject must be willing and able to attend a one-time, five-hour mentor training session at Rush University
* Each subject must commit to two, 16-week blocks of peer mentoring either in person, by telephone, or by video conference on a study-provided iPad, for a minimum of 30 minutes weekly.
* Each subject must have a working telephone number at which he or she can be reached for check-in calls by the study team throughout the study.
* Each subject must be willing and able to attend a monthly, 45-minute supervision group during the two 16-week blocks of peer mentoring, held at Rush University.
De-identified Control Subjects
* Each subject must be 40 years of age or older. A subject may be of either gender, any race, and any ethnicity.
* Each subject must be a community-dwelling individual with idiopathic PD as diagnosed by a neurologist
* Each subject must be enrolled in the NPF POP at a US site.
* Each subject must have \>2 consecutive, annual visits documented within the POP at which the subject is staged as HY 3-5.
* Each subject must have a caregiver participating in the POP at the above visits, as defined by completion of the MCSI.
Exclusion Criteria:
* Subjects exhibiting symptoms of a severe psychiatric disorder interfering with their ability to participate in the study, as determined by the referring neurologist, study team member, or PI.
* Subjects who are primarily non-English-speaking.
Exclusion Criteria for Subjects, by type:
HVP Patient-Subject
* Subjects with diagnoses of atypical parkinsonism or possible/probable PSP, MSA, CBS,or DLB will be excluded.
* Subjects without an informal caregiver will be excluded.
HVP Caregiver-Subject
* Active psychosis or other severe psychiatric disease
* Terminal illness (life expectancy \<12 months)
Caregiver Peer Mentor
* Active psychosis or other severe psychiatric disease
* Terminal illness (life expectancy \<12 months)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT03189459
Study Brief:
Protocol Section:
NCT03189459