Parkinson DiseaseCHAPSNCT01532986
Randomized Trial to Test the "Coordinated Care for Health Promotion and Activities in Parkinson's Disease" Intervention in the VA
A study testing Coordinated care management for Parkinson's disease and Educational handout in people with Parkinson Disease, run by VA Office of Research and Development at 5 sites in United States.
Trial summary
Health care benefits and services are received through the Veterans Health Administration (VHA), a component of the United States Department of Veterans Affairs. Over 40,000 Veterans across the Veterans Health Administration are diagnosed with Parkinson's disease (PD), a chronic condition that affects motor function… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Coordinated care management for Parkinson's disease and Educational handout
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 5 sitesUnited States
- Study dates
- 9 Jul 2012to 30 Apr 2017
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran of the United States of America
- Receiving health care at one of five Veterans Health Administration medical centers in the southwest United States: Greater Los Angeles, Loma Linda, Long Beach, or San Diego, California, or Las Vegas, Nevada.
- Diagnosis of Parkinson's disease (PD)
- At least two ICD-9 diagnostic codes for PD (332.0) in the administrative data from October 1, 2010 - to present date or until recruitment target is met
- At least 18 years of age
- Must demonstrate capacity to provide consent for study participation.
Who cannot join
- Any Veteran who is a study subject in the Deep Brain Stimulation (DBS) VA cooperative study as these subjects are not to enroll in any other study per DBS study protocol.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
VA Southern Nevada Healthcare System, North Las Vegas, NV
Las Vegas, Nevada, 89106
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, 92357
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
Official title: Improving Quality of Care in Parkinson's Disease: A Randomized Controlled Trial
Health care benefits and services are received through the Veterans Health Administration (VHA), a component of the United States Department of Veterans Affairs. Over 40,000 Veterans across the Veterans Health Administration are diagnosed with Parkinson's disease (PD), a chronic condition that affects motor function as well as cognition, mood, sleep, and autonomic function. There are not enough subspecialists to manage every Veteran with Parkinson's disease. However, a care model of nurse care managers as catalysts and advocates using needs assessments, evidence-based protocols, and VHA and community access coordination mechanisms to optimize Parkinson's disease care may improve quality of Parkinson's disease care and patient-centered outcomes. If efficacious, this model may be practical to disseminate via an existing VHA national consortium network for Parkinson's disease.
Objectives are (1) to implement then analyze via a randomized controlled trial whether a nurse-led, coordinated care management intervention, Care Coordination for Health Promotion and Activities in Parkinson's Disease (CHAPS), compared to usual care will improve adherence to evidence-based practice guidelines and improve health outcomes in Veterans with Parkinson's disease in a region of the southwest United States, and (2) to analyze extent of implementation of the CHAPS intervention and its costs to determine how the intervention can be made sustainable and disseminated throughout Veterans Affairs Medical Centers if efficacious.
Read the detailed description
In a 5-year randomized controlled trial, we enrolled 345 Veterans with PD that were then randomized in a 1:1 ratio to receive up to 24 months of a PD care management program, "Care Coordination for Health Promotion and Activities in Parkinson's Disease" (CHAPS), or continue with usual care. Eligible participants across 5 sites of the Southwest Parkinson's Disease Research, Education and Clinical Center (SW PADRECC): Greater Los Angeles, Las Vegas, Loma Linda, Long Beach and San Diego VISN 22 (VA Desert Pacific Healthcare Network) facilities were identified through administrative data and vetted by physicians. The multi-faceted nurse-led intervention, CHAPS, incorporated PD quality improvement (QI) tools to enhance proactive Veteran-centered care delivery. PDQI tools included: (1) a structured telephone assessment administered by a nurse care manager (NCM) to proactively identify medical problems and unmet needs; (2) problem-specific evidence-based interventions organized into treatment plans including follow-up/monitoring protocols with VA and community linkages; (3) the Siebens Domain Management ModelTM, a structural approach to improve collection and organization of health information and enrich communication among providers; (4) Siebens Health Care Notebooks prepared with Veteran self-management materials; (5) a Microsoft Access care management database, containing the CHAPS Assessment and algorithms for problem identification based on Veteran data; and (6) decision-support meetings of NCMs with movement disorder specialists. Research interviewers administer a structured telephone survey at baseline, 6, 12, 18, and 24 months. Participants were provided $25 per survey. Medical records were abstracted.
Ongoing analyses (1) measure PD quality indicator adherence, health outcomes, and health service utilization; (2) evaluate qualitative and quantitative data to summarize the extent of intervention implementation and barriers and facilitators to potential dissemination; and (3) examine costs of CHAPS care and cost offset between randomization arms to provide new knowledge to aid in future dissemination of the CHAPS Program in a "National Rollout" according to the VA Quality Enhancement Research Initiative QUERI process.
- Conditions
- Parkinson Disease
- Being tested
- Coordinated care management for Parkinson's disease, Educational handout
- Keywords
- Quality of Health Care, Nursing Care Management, Care Coordination, Randomized Trials
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coordinated care management for Parkinson's diseaseOther
Nurse care managers will use standardized assessment tools and care coordination protocols to address unmet needs of Veterans with PD, and collaborate with these Veterans and their families, providers, and community partners to manage PD care.
Educational handoutOther
To minimize potential bias from participants' awareness of randomization arm assignment, the investigators will provide to all study participants (intervention arm and usual care arm) on enrollment a brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook (page 273). This information includes a definition of PD, its symptoms, and several suggestions for managing PD such as medications and regular exercise.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (Arm 1) | Other | Veterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook. Receives: Other: Coordinated care management for Parkinson's disease; Other: Educational handout |
| Intervention (Arm 2) | Experimental | A delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners.
Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook. Receives: Other: Coordinated care management for Parkinson's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Measures Adhered To in the PD Guidelines
Adherence to quality measures for Parkinson's disease care during study period. We operationalized 18 quality measures: 12 were determined through chart review, and 6 were measured using patient survey data.
Range and direction of score: 0 (worst) to 1 (best)
Measured: 18 months
Secondary outcomes (9)
Health Utilities Index (HUI3)
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.
Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.
Range and direction of score: -0.36 (worst) to 1 (best)
Measured: 18 months
Activities of Daily Living (ADL), (Speech and Swallowing Only)
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.
Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.
Range and direction of score: 0 (best) to 16 (worst)
Measured: 18 months
Medical Outcomes Study (MOS)
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.
Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.
Range and direction of score: 1 (worst) to 5 (best)
Measured: 18 months
General Self-Efficacy Scale (GSES)
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.
Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.
Range and direction of score: 10 (worst) to 40 (best)
Measured: 18 months
Consumer Assessment of Healthcare Providers and Systems (CAHPS)
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.
Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.
Range and direction of score: 0 (worst) to 100 (best)
Measured: 18 months
Patient Assessement of Care for Chronic Conditions (PACIC)
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.
Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.
Range and direction of score: 1 (worst) to 5 (best)
Measured: 18 months
World Health Organization Well-Being Index (WHO-5)
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.
Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.
Range and direction of score: 1 (worst) to 25 (best)
Measured: 18 months
Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.
PHQ-2 score ranges from 0 to 4. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.
Higher scores indicate detection of depressive symptoms
Measured: 18 months
Patient Healthcare Questionnaire-9 (PHQ-9)
Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.
Range and direction of score: 0 (best) to 27 (worst). Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.
PHQ-9 was only administered to subjects who had a score of 3 or higher on the PHQ-2
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study start9 Jul 2012
- Primary completion31 Jan 2017
- Study completion30 Apr 2017
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 (5)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 VA Office of Research and DevelopmentThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Karen Connor, PhD RN MBA, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532986
- Sponsor's protocol ID
- NRI 11-126
- Acronym
- CHAPS
- Status last verified
- Mar 2019
- First submitted
- 13 Jan 2012
- Last updated
- 8 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Connor K, Cheng E, Siebens HC, Lee ML, Mittman BS, Ganz DA, Vickrey B. Study protocol of "CHAPS": a randomized controlled trial protocol of Care Coordination for Health Promotion and Activities in Parkinson's Disease to improve the quality of care for individuals with Parkinson's disease. BMC Neurol. 2015 Dec 15;15:258. doi: 10.1186/s12883-015-0506-y.
PubMed 26670300Connor KI, Siebens HC, Mittman BS, Ganz DA, Barry F, McNeese-Smith DK, Cheng EM, Vickrey BG. Implementation fidelity of a nurse-led RCT-tested complex intervention, care coordination for health promotion and activities in Parkinson's disease (CHAPS) in meeting challenges in care management. BMC Neurol. 2022 Jan 24;22(1):36. doi: 10.1186/s12883-021-02481-5.
PubMed 35073865Connor KI, Siebens HC, Mittman BS, McNeese-Smith DK, Ganz DA, Barry F, Edwards LK, McGowan MG, Cheng EM, Vickrey BG. Stakeholder perceptions of components of a Parkinson disease care management intervention, care coordination for health promotion and activities in Parkinson's disease (CHAPS). BMC Neurol. 2020 Dec 2;20(1):437. doi: 10.1186/s12883-020-02011-9.
PubMed 33267827Connor KI, Siebens HC, Mittman BS, Ganz DA, Barry F, Ernst EJ, Edwards LK, McGowan MG, McNeese-Smith DK, Cheng EM, Vickrey BG. Quality and extent of implementation of a nurse-led care management intervention: care coordination for health promotion and activities in Parkinson's disease (CHAPS). BMC Health Serv Res. 2020 Aug 10;20(1):732. doi: 10.1186/s12913-020-05594-8.
PubMed 32778083Connor KI, Cheng EM, Barry F, Siebens HC, Lee ML, Ganz DA, Mittman BS, Connor MK, Edwards LK, McGowan MG, Vickrey BG. Randomized trial of care management to improve Parkinson disease care quality. Neurology. 2019 Apr 16;92(16):e1831-e1842. doi: 10.1212/WNL.0000000000007324. Epub 2019 Mar 22.
PubMed 30902908
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Care in Parkinson's Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01532986
- Acronym / sponsor ID
- CHAPS / NRI 11-126
- Conditions
- Parkinson Disease
- Keywords
- Quality of Health Care, Nursing Care Management, Care Coordination, Randomized Trials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 9 Jul 2012 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 15 Feb 2012 (estimated)
- Results
- Posted 8 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Health care benefits and services are received through the Veterans Health Administration (VHA), a component of the United States Department of Veterans Affairs. Over 40,000 Veterans across the Veterans Health Administration are diagnosed with Parkinson's disease (PD), a chronic condition that affects motor function as well as cognition, mood, sleep, and autonomic function. There are not enough subspecialists to manage every Veteran with Parkinson's disease. However, a care model of nurse care managers as catalysts and advocates using needs assessments, evidence-based protocols, and VHA and community access coordination mechanisms to optimize Parkinson's disease care may improve quality of Parkinson's disease care and patient-centered outcomes. If efficacious, this model may be practical to disseminate via an existing VHA national consortium network for Parkinson's disease.
Objectives are (1) to implement then analyze via a randomized controlled trial whether a nurse-led, coordinated care management intervention, Care Coordination for Health Promotion and Activities in Parkinson's Disease (CHAPS), compared to usual care will improve adherence to evidence-based practice guidelines and improve health outcomes in Veterans with Parkinson's disease in a region of the southwest United States, and (2) to analyze extent of implementation of the CHAPS intervention and its costs to determine how the intervention can be made sustainable and disseminated throughout Veterans Affairs Medical Centers if efficacious.
Detailed description
In a 5-year randomized controlled trial, we enrolled 345 Veterans with PD that were then randomized in a 1:1 ratio to receive up to 24 months of a PD care management program, "Care Coordination for Health Promotion and Activities in Parkinson's Disease" (CHAPS), or continue with usual care. Eligible participants across 5 sites of the Southwest Parkinson's Disease Research, Education and Clinical Center (SW PADRECC): Greater Los Angeles, Las Vegas, Loma Linda, Long Beach and San Diego VISN 22 (VA Desert Pacific Healthcare Network) facilities were identified through administrative data and vetted by physicians. The multi-faceted nurse-led intervention, CHAPS, incorporated PD quality improvement (QI) tools to enhance proactive Veteran-centered care delivery. PDQI tools included: (1) a structured telephone assessment administered by a nurse care manager (NCM) to proactively identify medical problems and unmet needs; (2) problem-specific evidence-based interventions organized into treatment plans including follow-up/monitoring protocols with VA and community linkages; (3) the Siebens Domain Management ModelTM, a structural approach to improve collection and organization of health information and enrich communication among providers; (4) Siebens Health Care Notebooks prepared with Veteran self-management materials; (5) a Microsoft Access care management database, containing the CHAPS Assessment and algorithms for problem identification based on Veteran data; and (6) decision-support meetings of NCMs with movement disorder specialists. Research interviewers administer a structured telephone survey at baseline, 6, 12, 18, and 24 months. Participants were provided $25 per survey. Medical records were abstracted.
Ongoing analyses (1) measure PD quality indicator adherence, health outcomes, and health service utilization; (2) evaluate qualitative and quantitative data to summarize the extent of intervention implementation and barriers and facilitators to potential dissemination; and (3) examine costs of CHAPS care and cost offset between randomization arms to provide new knowledge to aid in future dissemination of the CHAPS Program in a "National Rollout" according to the VA Quality Enhancement Research Initiative QUERI process.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care (Arm 1) | Other | Other: Coordinated care management for Parkinson's disease, Other: Educational handoutVeterans randomized to the usual care arm will continue to receive care they would have received if they had not enrolled in the study; no care or resources that are made available in general by VA will be withheld from participants in either arm or to any Veterans who wish to use those resources. Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook. |
| Intervention (Arm 2) | Experimental | Other: Coordinated care management for Parkinson's diseaseA delivery system redesign, with nurse care managers, using standardized assessment tools and care coordination protocols to address unmet needs of Veterans with Parkinson's Disease (PD) by collaborating with these Veterans and their families, providers, and community partners. Educational handout: brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Veteran of the United States of America
- Receiving health care at one of five Veterans Health Administration medical centers in the southwest United States: Greater Los Angeles, Loma Linda, Long Beach, or San Diego, California, or Las Vegas, Nevada.
- Diagnosis of Parkinson's disease (PD)
- At least two ICD-9 diagnostic codes for PD (332.0) in the administrative data from October 1, 2010 - to present date or until recruitment target is met
- At least 18 years of age
Key exclusion criteria (1 listed)
- Any Veteran who is a study subject in the Deep Brain Stimulation (DBS) VA cooperative study as these subjects are not to enroll in any other study per DBS study protocol.
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 |
|---|---|---|
| Coordinated care management for Parkinson's diseaseNurse care managers will use standardized assessment tools and care coordination protocols to address unmet needs of Veterans with PD, and collaborate with these Veterans and their families, providers, and community partners to manage PD care. | Other | Intervention (Arm 2), Usual Care (Arm 1) |
| Educational handoutTo minimize potential bias from participants' awareness of randomization arm assignment, the investigators will provide to all study participants (intervention arm and usual care arm) on enrollment a brief educational handout on Parkinson's disease that is available in the VA's "Healthwise for Life" handbook (page 273). This information includes a definition of PD, its symptoms, and several suggestions for managing PD such as medications and regular exercise. | Other | Usual Care (Arm 1) |
Primary outcome
Proportion of Measures Adhered To in the PD Guidelines
Time frame: 18 months
Adherence to quality measures for Parkinson's disease care during study period. We operationalized 18 quality measures: 12 were determined through chart review, and 6 were measured using patient survey data. Range and direction of score: 0 (worst) to 1 (best)
9 secondary outcomes
Health Utilities Index (HUI3)
Time frame: 18 months
Activities of Daily Living (ADL), (Speech and Swallowing Only)
Time frame: 18 months
Medical Outcomes Study (MOS)
Time frame: 18 months
General Self-Efficacy Scale (GSES)
Time frame: 18 months
Consumer Assessment of Healthcare Providers and Systems (CAHPS)
Time frame: 18 months
Patient Assessement of Care for Chronic Conditions (PACIC)
Time frame: 18 months
World Health Organization Well-Being Index (WHO-5)
Time frame: 18 months
Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3
Time frame: 18 months
Patient Healthcare Questionnaire-9 (PHQ-9)
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26670300Connor K, Cheng E, Siebens HC, Lee ML, Mittman BS, Ganz DA, Vickrey B. Study protocol of "CHAPS": a randomized controlled trial protocol of Care Coordination for Health Promotion and Activities in Parkinson's Disease to improve the quality of care for individuals with Parkinson's disease. BMC Neurol. 2015 Dec 15;15:258. doi: 10.1186/s12883-015-0506-y.
- Derived from this study: PubMed 35073865Connor KI, Siebens HC, Mittman BS, Ganz DA, Barry F, McNeese-Smith DK, Cheng EM, Vickrey BG. Implementation fidelity of a nurse-led RCT-tested complex intervention, care coordination for health promotion and activities in Parkinson's disease (CHAPS) in meeting challenges in care management. BMC Neurol. 2022 Jan 24;22(1):36. doi: 10.1186/s12883-021-02481-5.
- Derived from this study: PubMed 33267827Connor KI, Siebens HC, Mittman BS, McNeese-Smith DK, Ganz DA, Barry F, Edwards LK, McGowan MG, Cheng EM, Vickrey BG. Stakeholder perceptions of components of a Parkinson disease care management intervention, care coordination for health promotion and activities in Parkinson's disease (CHAPS). BMC Neurol. 2020 Dec 2;20(1):437. doi: 10.1186/s12883-020-02011-9.
- Derived from this study: PubMed 32778083Connor KI, Siebens HC, Mittman BS, Ganz DA, Barry F, Ernst EJ, Edwards LK, McGowan MG, McNeese-Smith DK, Cheng EM, Vickrey BG. Quality and extent of implementation of a nurse-led care management intervention: care coordination for health promotion and activities in Parkinson's disease (CHAPS). BMC Health Serv Res. 2020 Aug 10;20(1):732. doi: 10.1186/s12913-020-05594-8.
- Derived from this study: PubMed 30902908Connor KI, Cheng EM, Barry F, Siebens HC, Lee ML, Ganz DA, Mittman BS, Connor MK, Edwards LK, McGowan MG, Vickrey BG. Randomized trial of care management to improve Parkinson disease care quality. Neurology. 2019 Apr 16;92(16):e1831-e1842. doi: 10.1212/WNL.0000000000007324. Epub 2019 Mar 22.
- Individual participant dataSharing planned: No
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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.
Karen Connor, PhD RN MBA principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coordinated care management for Parkinson's disease and Educational handout in people with Parkinson Disease, run by VA Office of Research and Development at 5 sites 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 6 inclusion and 1 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 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 8 Mar 2019). 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?
Proportion of Measures Adhered To in the PD Guidelines (time frame: 18 months). 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 NCT01532986, which also lists 5 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 8 Mar 2019.