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| ID | Type | Description | Link |
|---|---|---|---|
| 3994097 | Other Grant/Funding Number | NIH-NINDS |
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Advanced Parkinson's Disease is a debilitating, costly, and understudied condition. Improving access to comprehensive, specialized, in-home patient care and caregiver support offers the potential to minimize the downward spiral of morbidity and preventable healthcare utilization. The aim of this study is to test whether and to what degree an interdisciplinary home visit program, with and without peer mentoring for caregivers, will improve patient- and caregiver-reported outcomes and reduce healthcare costs when compared with usual care in advanced Parkinson's Disease.
This interdisciplinary home visit program consists of 4 visits to patients' homes over the course of one year from a team of a movement disorders doctor, a nurse, a research coordinator, and a social worker. The team will come to a patient's home and assess the needs of both the patient and caregiver, and connect the patient with any needed services. These visits can replace or be in addition to seeing another movement disorders doctor.
As part of this study, not only would the patient receive home visits, but his/her caregiver would be paired with another caregiver from the community with lots of experience caring for someone with PD whose loved one may have passed away, but who volunteers to serve as a mentor. Current caregivers who enroll in the study will be asked to speak to their mentor once a week over a course of 4 months. These meetings can take place in person, by phone, or through video chat on an iPad that will be provided by our study team.
The information collected from the study participants will be compared to data available in the National Parkinson's Foundation's Parkinson's Outcome Project. The data will be matched according to age, gender, and disease severity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HVP Patient-Subject | Active Comparator | Patients will be asked to participate in four study visits, which will involve in-home clinical assessments, a needs assessment, and completion of some questionnaires. Additional information will be obtained from patients' routine medical records: their medical and medication history, family history, neurological examination findings, and office visit records. Completion of Home Visit Program intervention. |
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| HVP Caregiver-Subject | Active Comparator | Caregivers enrolling in the study will be asked to participate in the four home visits, which will involve in-home clinical assessments and completion of some questionnaires. After the first home visit, caregivers will be matched with a peer mentor, an individual who was a prior caregiver to someone with PD who is interested in sharing their knowledge, experience, and time to help improve the lives of current caregivers. Once a week, for a period of 4 months between home visits 2 and 3, caregivers will be asked to meet with their peer mentor, who will be trained to serve as a resource and listening ear, in addition to the medical team. Completion of Home Visit Program and Caregiver Mentorship Program interventions. |
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| De-identified Control Subjects | No Intervention | Control subjects will be drawn from the National Parkinson Foundation Parkinson Outcomes Project (POP). Patient-caregiver dyads will be matched on patient gender, age, and HY stage. | |
| HVP Peer Mentors | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Visit Program | Behavioral | RC: Informed consent discussion, documentation RN: UPDRS I-II, vitals, medication reconciliation, patient medical history and comorbidities RN and SW: Home safety assessment SW: Psychosocial assessment of dyad, HADS, assessment of mobility and homebound status, needs assessment of dyad, caregiver medical history and comorbidities RC: patient and caregiver short MoCA, PD-Rx, health literacy assessment, satisfaction surveys; patient PDQ-39/PDQ-8 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Quality of Life using the PDQ-39 | Assesses Parkinson's disease-specific health related quality before and after participation in the home visit program | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Strain using the MCSI | Assesses caregiver strain over the course of the home visit program | 1 year |
| Effectiveness of Peer Mentoring using the HADS | Assesses the anxiety and depression of mentees and mentors before and after participation in the mentorship program |
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Inclusion Criteria:
HVP Patient-Subject
HVP Caregiver-Subject
Caregiver Peer Mentor
De-identified Control Subjects
Exclusion Criteria:
Exclusion Criteria for Subjects, by type:
HVP Patient-Subject
HVP Caregiver-Subject
Caregiver Peer Mentor
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| Name | Affiliation | Role |
|---|---|---|
| Jori Fleisher, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36446676 | Derived | Fleisher JE, Suresh M, Klostermann EC, Lee J, Hess SP, Myrick E, Mitchem D, Woo K, Sennott BJ, Witek NP, Chen SM, Beck JC, Ouyang B, Wilkinson JR, Hall DA, Chodosh J. IN-HOME-PDCaregivers: The effects of a combined home visit and peer mentoring intervention for caregivers of homebound individuals with advanced Parkinson's disease. Parkinsonism Relat Disord. 2023 Jan;106:105222. doi: 10.1016/j.parkreldis.2022.11.014. Epub 2022 Nov 17. | |
| 35963046 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: _CaregiverPeerMentor | Jul 1, 2019 | Jul 24, 2019 | ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: _Caregiver | Jul 1, 2019 | Jul 24, 2019 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: _Patient | Jul 1, 2019 | Jul 24, 2019 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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prospective cohort study (Aims 1 & 2) stepped wedge trial of caregiver peer mentoring (Aim 3)
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Peer mentors enrolled in this study would be asked to complete a five-hour mentor training program. During this training, caregivers will be asked to complete some questionnaires about their background and caregiving experience. After completion of the mentorship training, peer mentors will be paired with a mentee who is a current caregiver enrolled in the home visit study along with their loved one with Parkinson's. Peer mentors will be asked to speak with their mentee once a week for 16 weeks. After a 16 week break, peer mentors will be paired with a second mentee and will repeat the process for another 16-week-long mentoring session.
Completion of Caregiver Mentorship Program intervention.
|
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| Caregiver Mentorship Program | Behavioral | Both mentors and mentees will be completing this program: Mentors will be asked to complete: 1) a Mentor Training - One 5-hour session at Rush University Medical Center; and 2) two 16-week periods of mentoring someone who is currently a caregiver for a patient with Parkinson's Disease Caregivers mentees will be asked to complete a 16 week mentorship program with their assigned mentor |
|
| 16 weeks |
| Derived |
| Fleisher JE, Hess SP, Klostermann EC, Lee J, Myrick E, Mitchem D, Niemet C, Woo K, Sennott BJ, Sanghvi M, Witek N, Beck JC, Wilkinson JR, Ouyang B, Hall DA, Chodosh J. IN-HOME-PD: The effects of longitudinal telehealth-enhanced interdisciplinary home visits on care and quality of life for homebound individuals with Parkinson's disease. Parkinsonism Relat Disord. 2022 Sep;102:68-76. doi: 10.1016/j.parkreldis.2022.07.017. Epub 2022 Aug 7. |
| 35481819 | Derived | Fleisher JE, Akram F, Lee J, Klostermann EC, Hess SP, Myrick E, Levin M, Ouyang B, Wilkinson J, Hall DA, Chodosh J. Peer Mentoring Program for Informal Caregivers of Homebound Individuals With Advanced Parkinson Disease (Share the Care): Protocol for a Single-Center, Crossover Pilot Study. JMIR Res Protoc. 2022 May 26;11(5):e34750. doi: 10.2196/34750. |
| 34238753 | Derived | Fleisher JE, Hess S, Sennott BJ, Myrick E, Wallace EK, Lee J, Sanghvi M, Woo K, Ouyang B, Wilkinson JR, Beck J, Johnson TJ, Hall DA, Chodosh J. Longitudinal, Interdisciplinary Home Visits Versus Usual Care for Homebound People With Advanced Parkinson Disease: Protocol for a Controlled Trial. JMIR Res Protoc. 2021 Sep 14;10(9):e31690. doi: 10.2196/31690. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |