In-Home Care for Patients With Parkinson's Disease

NCT03189459 | Completed

• 2 other identifiers: 170802093994097
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Caregiver Strain using the MCSI

  1 year

• Effectiveness of Peer Mentoring using the HADS

  16 weeks

Study Arms (4)

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.

Behavioral: Home Visit Program

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.

Behavioral: Home Visit Program; Behavioral: Caregiver Mentorship Program

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

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.

Behavioral: Caregiver Mentorship Program

Interventions

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

HVP Caregiver-Subject; HVP Patient-Subject

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

HVP Caregiver-Subject; HVP Peer Mentors

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

• 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.

  PMID: 36446676 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.

  PMID: 35963046 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.

  PMID: 35481819 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.

  PMID: 34238753 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jori Fleisher, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective cohort study (Aims 1 \& 2) stepped wedge trial of caregiver peer mentoring (Aim 3)

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: June 16, 2017
• Study Start: May 7, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

US (1)