Parkinson DiseaseNCT03189459
In-Home Care for Patients With Parkinson's Disease
A study testing Home Visit Program and Caregiver Mentorship Program in people with Parkinson Disease, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Home Visit Program and Caregiver Mentorship Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Reaching the Most Vulnerable: A Novel Model of Care in Advanced Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Home Visit Program, Caregiver Mentorship Program
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Visit ProgramBehavioural
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
Caregiver Mentorship ProgramBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Caregiver Mentorship Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
Caregiver Strain using the MCSI
Assesses caregiver strain over the course of the home visit program
Measured: 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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start7 May 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective cohort study (Aims 1 \& 2) stepped wedge trial of caregiver peer mentoring (Aim 3)
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jori Fleisher, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189459
- Sponsor's protocol ID
- 17080209
- Other IDs
- 3994097
- Status last verified
- May 2022
- First submitted
- 25 May 2017
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36446676Fleisher 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.
PubMed 35963046Fleisher 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.
PubMed 35481819Fleisher 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.
PubMed 34238753
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching the Most Vulnerable: A Novel Model of Care in Advanced Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03189459
- Acronym / sponsor ID
- 17080209
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- prospective cohort study (Aims 1 \& 2) stepped wedge trial of caregiver peer mentoring (Aim 3)
| Arm | Type | Receives |
|---|---|---|
| HVP Patient-Subject | Active comparator | Behavioral: Home Visit ProgramPatients 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. |
| HVP Caregiver-Subject | Active comparator | Behavioral: Home Visit Program, Behavioral: Caregiver Mentorship ProgramCaregivers 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. |
| 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 | Behavioral: Caregiver Mentorship ProgramPeer 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Visit ProgramRC: 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 | Behavioural | HVP Caregiver-Subject, HVP Patient-Subject |
| Caregiver Mentorship ProgramBoth 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 | Behavioural | HVP Caregiver-Subject, HVP Peer Mentors |
Primary outcome
Patient Quality of Life using the PDQ-39
Time frame: 1 year
Assesses Parkinson's disease-specific health related quality before and after participation in the home visit program
2 secondary outcomes
Caregiver Strain using the MCSI
Time frame: 1 year
Effectiveness of Peer Mentoring using the HADS
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Derived from this study: PubMed 36446676Fleisher 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.
- Derived from this study: PubMed 35963046Fleisher 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.
- Derived from this study: PubMed 35481819Fleisher 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.
- Derived from this study: PubMed 34238753Fleisher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jori Fleisher, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Visit Program and Caregiver Mentorship Program in people with Parkinson Disease, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Quality of Life using the PDQ-39 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03189459, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.