Parkinson's DiseaseNCT01167608
Barriers to Mental Healthcare Utilization in Parkinson's Disease
An observational study of Parkinson's Disease and Depression, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Parkinson's disease (PD) is the second most common neurodegenerative disorder in the elderly. In most people, the illness is complicated by co-occurring psychiatric problems such as depression and anxiety. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Depression, Anxiety
- How many people
- 883 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Mar 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with Parkinson's disease.
Who may be able to join
- Diagnosis of Parkinson's disease
- At least 18 years of age
Who cannot join
- Less than 18 years of age
- We are looking for responses from those who have, as well as those who have not, had mental health treatment in the past.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers-Robert Wood Johnson Medical School
Piscataway, New Jersey, 08854
About this study
Parkinson's disease (PD) is the second most common neurodegenerative disorder in the elderly. In most people, the illness is complicated by co-occurring psychiatric problems such as depression and anxiety. These non-motor concerns negatively affect the course and management of the disease, often leading to poor outcomes for both patients and their families. Despite these deleterious consequences, psychiatric symptoms in PD are both underreported by patients as well as under-recognized and under-treated by health care providers.
The primary purpose of this study is to identify and describe barriers to mental healthcare utilization for people with Parkinson's disease. Secondary objectives include the assessment of attitudes and preferences regarding the need for mental health services in the PD community and the acceptability of telehealth interventions as a method for improving access and quality of care. In order to accomplish these aims, participants will be asked to fill out an anonymous survey which will take about 15-30 minutes to complete. To best accommodate PD patients with varying levels of disability, participants will have the option to complete the survey online, on paper, or over the phone. The information obtained from this study will be used to support future treatment development efforts (i.e., phone and internet based interventions, community based trainings with local providers) intended to improve access and quality of mental health care for people with PD. To the best of the investigators knowledge, this is the first study to systematically examine barriers to mental healthcare utilization in PD in a national sample.
Read the detailed description
The survey may be completed online at https://www.surveymonkey.com/s/improvecare4pd. Potential participants may also call Dr. Dobkin at 732-235-4051 to complete the survey over the phone or to request a paper copy to mailed out.
- Conditions
- Parkinson's Disease, Depression, Anxiety
- Being tested
- No Intervention. This is a cross-sectional survey study.
- Keywords
- Parkinson's disease, Depression, Anxiety, Treatment
- Medical subject headings
- Parkinson Disease, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention. This is a cross-sectional survey study.Other
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| People with Parkinson's disease | Individuals diagnosed with Parkinson's disease Receives: Other: No Intervention. This is a cross-sectional survey study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Most Commonly Reported Past Barrier to Mental Health Services: "Anyone in my Situation Would be Struggling"
The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the most common past barrier to mental health services reported by survey respondents. The outcome reported is the percentage of all respondents surveyed who endorsed this particular past barrier. This barrier can best be described as low mental health literacy.
Measured: Baseline
2nd Most Commonly Reported Past Barrier to Mental Health Services: "Doctors Are Not Sensitive Enough to PD-related Issues"
The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 2nd most common past barrier to mental health services reported by survey respondents. The outcome reported is the percentage of all respondents surveyed who endorsed this particular past barrier. This barrier can best be described as limited knowledge of PD amongst treatment providers.
Measured: Baseline
3rd Most Commonly Reported Past Barrier to Mental Health Services: "Out of Pocket Cost Was Too High"
The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 3rd most common past barrier to mental health services reported by survey respondents. The outcome reported is the percentage of all respondents surveyed who endorsed this particular past barrier. This barrier can best be described as limited access.
Measured: Baseline
Most Commonly Reported Future Barrier to Mental Health Services: "Out of Pocket Cost Was Too High"
The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the most common future barrier to mental health service reported by respondents to the survey described in the Methods section. Outcome is reported as the percentage of all respondents surveyed who endorsed this particular future barrier. This barrier can best be described as limited access.
Measured: Baseline
2nd Most Commonly Reported Future Barrier to Mental Health Services: "Doctors Are Not Sensitive Enough to PD-related Issues"
The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 2nd most commonly reported future barrier to mental health services reported by those who responded to the survey described in the Methods section. Outcome is reported as the percentage of all respondents surveyed who endorsed this particular future barrier. This barrier can best be described as limited knowledge of PD amongst treatment providers.
Measured: Baseline
3rd Most Commonly Reported Future Barrier to Mental Health Services: "Services Are Not Available in my Community"
The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 3rd most common future barrier to mental health service reported by respondents to the survey described in the Methods section. Outcome is reported as the percentage of all respondents surveyed who endorsed this particular future barrier. This barrier can best be described as limited access.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 883 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roseanne D Dobkin, PhD, Rutgers, The State University of New Jersey
- Investigators
- Roseanne D Dobkin, PhD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167608
- Sponsor's protocol ID
- 0220100120
- Other IDs
- 1K23NS052155-01A2
- Status last verified
- Jun 2019
- First submitted
- 20 Jul 2010
- Last updated
- 16 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dobkin RD, Rubino JT, Friedman J, Allen LA, Gara MA, Menza M. Barriers to mental health care utilization in Parkinson's disease. J Geriatr Psychiatry Neurol. 2013 Jun;26(2):105-16. doi: 10.1177/0891988713481269. Epub 2013 Apr 15.
PubMed 23589410
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers to Mental Healthcare Utilization in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01167608
- Acronym / sponsor ID
- 0220100120
- Conditions
- Parkinson's Disease, Depression, Anxiety
- Keywords
- Parkinson's disease, Depression, Anxiety, Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 883 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jun 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Posted 4 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parkinson's disease (PD) is the second most common neurodegenerative disorder in the elderly. In most people, the illness is complicated by co-occurring psychiatric problems such as depression and anxiety. These non-motor concerns negatively affect the course and management of the disease, often leading to poor outcomes for both patients and their families. Despite these deleterious consequences, psychiatric symptoms in PD are both underreported by patients as well as under-recognized and under-treated by health care providers.
The primary purpose of this study is to identify and describe barriers to mental healthcare utilization for people with Parkinson's disease. Secondary objectives include the assessment of attitudes and preferences regarding the need for mental health services in the PD community and the acceptability of telehealth interventions as a method for improving access and quality of care. In order to accomplish these aims, participants will be asked to fill out an anonymous survey which will take about 15-30 minutes to complete. To best accommodate PD patients with varying levels of disability, participants will have the option to complete the survey online, on paper, or over the phone. The information obtained from this study will be used to support future treatment development efforts (i.e., phone and internet based interventions, community based trainings with local providers) intended to improve access and quality of mental health care for people with PD. To the best of the investigators knowledge, this is the first study to systematically examine barriers to mental healthcare utilization in PD in a national sample.
Detailed description
The survey may be completed online at https://www.surveymonkey.com/s/improvecare4pd. Potential participants may also call Dr. Dobkin at 732-235-4051 to complete the survey over the phone or to request a paper copy to mailed out.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with Parkinson's disease | – | Other: No Intervention. This is a cross-sectional survey study.Individuals diagnosed with Parkinson's disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with Parkinson's disease.
Key inclusion criteria (2 listed)
- Diagnosis of Parkinson's disease
- At least 18 years of age
Key exclusion criteria (2 listed)
- Less than 18 years of age
- We are looking for responses from those who have, as well as those who have not, had mental health treatment in the past.
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 |
|---|---|---|
| No Intervention. This is a cross-sectional survey study.No intervention. | Other | People with Parkinson's disease |
Primary outcome
Most Commonly Reported Past Barrier to Mental Health Services: "Anyone in my Situation Would be Struggling"
Time frame: Baseline
The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the most common past barrier to mental health services reported by survey respondents. The outcome reported is the percentage of all respondents surveyed who endorsed this particular past barrier. This barrier can best be described as low mental health literacy.
2nd Most Commonly Reported Past Barrier to Mental Health Services: "Doctors Are Not Sensitive Enough to PD-related Issues"
Time frame: Baseline
The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 2nd most common past barrier to mental health services reported by survey respondents. The outcome reported is the percentage of all respondents surveyed who endorsed this particular past barrier. This barrier can best be described as limited knowledge of PD amongst treatment providers.
3rd Most Commonly Reported Past Barrier to Mental Health Services: "Out of Pocket Cost Was Too High"
Time frame: Baseline
The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 3rd most common past barrier to mental health services reported by survey respondents. The outcome reported is the percentage of all respondents surveyed who endorsed this particular past barrier. This barrier can best be described as limited access.
Most Commonly Reported Future Barrier to Mental Health Services: "Out of Pocket Cost Was Too High"
Time frame: Baseline
The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the most common future barrier to mental health service reported by respondents to the survey described in the Methods section. Outcome is reported as the percentage of all respondents surveyed who endorsed this particular future barrier. This barrier can best be described as limited access.
2nd Most Commonly Reported Future Barrier to Mental Health Services: "Doctors Are Not Sensitive Enough to PD-related Issues"
Time frame: Baseline
The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 2nd most commonly reported future barrier to mental health services reported by those who responded to the survey described in the Methods section. Outcome is reported as the percentage of all respondents surveyed who endorsed this particular future barrier. This barrier can best be described as limited knowledge of PD amongst treatment providers.
3rd Most Commonly Reported Future Barrier to Mental Health Services: "Services Are Not Available in my Community"
Time frame: Baseline
The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 3rd most common future barrier to mental health service reported by respondents to the survey described in the Methods section. Outcome is reported as the percentage of all respondents surveyed who endorsed this particular future barrier. This barrier can best be described as limited access.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23589410Dobkin RD, Rubino JT, Friedman J, Allen LA, Gara MA, Menza M. Barriers to mental health care utilization in Parkinson's disease. J Geriatr Psychiatry Neurol. 2013 Jun;26(2):105-16. doi: 10.1177/0891988713481269. Epub 2013 Apr 15.
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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.
Roseanne D Dobkin, PhD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Depression, run by Rutgers, The State University of New Jersey 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 2 inclusion and 2 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 16 Jul 2019. 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?
Yes. Results are posted in the registry (first posted 4 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Most Commonly Reported Past Barrier to Mental Health Services: "Anyone in my Situation Would be Struggling" (time frame: Baseline). The study lists 6 primary outcomes in all. 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 NCT01167608, which also lists 1 linked publication.
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 16 Jul 2019.