- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03189459
In-Home Care for Patients With Parkinson's Disease
Reaching the Most Vulnerable: A Novel Model of Care in Advanced Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: HVP Patient-Subject
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. |
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
|
Active Comparator: HVP Caregiver-Subject
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. |
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
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 |
No Intervention: De-identified Control Subjects
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.
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Active Comparator: HVP Peer Mentors
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. |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Quality of Life using the PDQ-39
Time Frame: 1 year
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Assesses Parkinson's disease-specific health related quality before and after participation in the home visit program
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caregiver Strain using the MCSI
Time Frame: 1 year
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Assesses caregiver strain over the course of the home visit program
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1 year
|
Effectiveness of Peer Mentoring using the HADS
Time Frame: 16 weeks
|
Assesses the anxiety and depression of mentees and mentors before and after participation in the mentorship program
|
16 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17080209
- 3994097 (Other Grant/Funding Number: NIH-NINDS)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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