Parkinson's DiseaseGROUP-PDNCT00528086
A Pilot, Randomized Controlled Trial of Group Visits for Persons With Parkinson's Disease
An observational study of Parkinson's Disease and Parkinson's Disease Patient Caregivers, run by University of Rochester at 1 site in United States.
Trial summary
To determine patient satisfaction with group visits versus standard of care delivery for patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease, Parkinson's Disease Patient Caregivers
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Aug 2009
- Phase
- Observational
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be recruited from Drs. Dorsey, Biglan, and Marshall's patient populations from the Parkinson disease clinic at the University of Rochester Neurology group.
Who may be able to join
- Clinical diagnosis of idiopathic Parkinson's disease as determined by having two of the four cardinal features of PD (rest tremor, bradykinesia, cogwheel rigidity, and gait instability) and no alternative explanation for the etiology of the symptoms
- Willing and able to provide informed consent and to participate actively in group visits and complete study activities
Who cannot join
- Cognitive impairment, psychiatric disorder, or history of or current clinically significant substance abuse that in the investigator's judgment could interfere in the conduct of group visits or with study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized Controlled, Pilot Study Comparing Group Visits Versus Routine Clinical Care for Participants With Parkinson's Disease (PD).
To determine patient satisfaction with group visits versus standard of care delivery for patients with Parkinson's disease.
Read the detailed description
To establish the feasibility and to estimate the benefit of group visits for individuals with PD and their caregivers. The feasibility will be assessed by the ability to enroll and retain (measured by number of individuals who complete the 12-month study and at least half the study visits) ~40 individuals in the pilot trial. The responsiveness of the following different outcomes to group visits will be assessed during the pilot trial: quality of life, patient satisfaction, depression, caregiver burden, resource utilization, and disease progression. The primary outcome measure for efficacy will be a comparison of the change in the Parkinson's Disease Questionnaire-39 from baseline to 12 months in the control (routine care) and intervention (group visit) groups.
- Keywords
- Group visits
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Parkinson disease patients and their family members or caregivers randomly assigned to receive their PD care in group visit format. | |
| 2 | Parkinson disease patients and their family members or caregivers randomly assigned to receive their PD care in standard of care format (one-on-one physician-patient visits). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility (based on the ability to enroll and retain 40 individuals) and benefit (based on the 12-month change in PDQ-39) of group visits for individuals with Parkinson disease and their caregivers.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)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 University of RochesterThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Parkinson Foundation
- Investigators
- E. Ray Dorsey, MD, MBA, Principal investigator, University of RochesterKevin Biglan, MD, MPH, Principal investigator, University of RochesterFred Marshall, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528086
- Sponsor's protocol ID
- RSRB00019885
- Acronym
- GROUP-PD
- Status last verified
- May 2010
- First submitted
- 7 Sep 2007
- Last updated
- 25 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beck A, Scott J, Williams P, Robertson B, Jackson D, Gade G, Cowan P. A randomized trial of group outpatient visits for chronically ill older HMO members: the Cooperative Health Care Clinic. J Am Geriatr Soc. 1997 May;45(5):543-9. doi: 10.1111/j.1532-5415.1997.tb03085.x.
PubMed 9158573Scott JC, Conner DA, Venohr I, Gade G, McKenzie M, Kramer AM, Bryant L, Beck A. Effectiveness of a group outpatient visit model for chronically ill older health maintenance organization members: a 2-year randomized trial of the cooperative health care clinic. J Am Geriatr Soc. 2004 Sep;52(9):1463-70. doi: 10.1111/j.1532-5415.2004.52408.x.
PubMed 15341547Masley S, Phillips S, Copeland JR. Group office visits change dietary habits of patients with coronary artery disease-the dietary intervention and evaluation trial (D.I.E.T.). J Fam Pract. 2001 Mar;50(3):235-9.
PubMed 11252212Coleman EA, Grothaus LC, Sandhu N, Wagner EH. Chronic care clinics: a randomized controlled trial of a new model of primary care for frail older adults. J Am Geriatr Soc. 1999 Jul;47(7):775-83. doi: 10.1111/j.1532-5415.1999.tb03832.x.
PubMed 10404919Trento M, Passera P, Tomalino M, Bajardi M, Pomero F, Allione A, Vaccari P, Molinatti GM, Porta M. Group visits improve metabolic control in type 2 diabetes: a 2-year follow-up. Diabetes Care. 2001 Jun;24(6):995-1000. doi: 10.2337/diacare.24.6.995.
PubMed 11375359Wagner EH, Grothaus LC, Sandhu N, Galvin MS, McGregor M, Artz K, Coleman EA. Chronic care clinics for diabetes in primary care: a system-wide randomized trial. Diabetes Care. 2001 Apr;24(4):695-700. doi: 10.2337/diacare.24.4.695.
PubMed 11315833Ickovics JR, Kershaw TS, Westdahl C, Rising SS, Klima C, Reynolds H, Magriples U. Group prenatal care and preterm birth weight: results from a matched cohort study at public clinics. Obstet Gynecol. 2003 Nov;102(5 Pt 1):1051-7. doi: 10.1016/s0029-7844(03)00765-8.
PubMed 14672486Grosset KA, Grosset DG. Patient-perceived involvement and satisfaction in Parkinson's disease: effect on therapy decisions and quality of life. Mov Disord. 2005 May;20(5):616-9. doi: 10.1002/mds.20393.
PubMed 15719417Shimbo T, Goto M, Morimoto T, Hira K, Takemura M, Matsui K, Yoshida A, Fukui T. Association between patient education and health-related quality of life in patients with Parkinson's disease. Qual Life Res. 2004 Feb;13(1):81-9. doi: 10.1023/B:QURE.0000015306.59840.95.
PubMed 15058790Global Parkinson's Disease Survey (GPDS) Steering Committee.. Factors impacting on quality of life in Parkinson's disease: results from an international survey. Mov Disord. 2002 Jan;17(1):60-7. doi: 10.1002/mds.10010.
PubMed 11835440Christakis NA, Allison PD. Mortality after the hospitalization of a spouse. N Engl J Med. 2006 Feb 16;354(7):719-30. doi: 10.1056/NEJMsa050196.
PubMed 16481639Aarsland D, Larsen JP, Karlsen K, Lim NG, Tandberg E. Mental symptoms in Parkinson's disease are important contributors to caregiver distress. Int J Geriatr Psychiatry. 1999 Oct;14(10):866-74.
PubMed 10521886Schrag A, Hovris A, Morley D, Quinn N, Jahanshahi M. Caregiver-burden in parkinson's disease is closely associated with psychiatric symptoms, falls, and disability. Parkinsonism Relat Disord. 2006 Jan;12(1):35-41. doi: 10.1016/j.parkreldis.2005.06.011. Epub 2005 Nov 3.
PubMed 16271496Schrag A, Jahanshahi M, Quinn N. What contributes to quality of life in patients with Parkinson's disease? J Neurol Neurosurg Psychiatry. 2000 Sep;69(3):308-12. doi: 10.1136/jnnp.69.3.308.
PubMed 10945804Slawek J, Derejko M, Lass P. Factors affecting the quality of life of patients with idiopathic Parkinson's disease--a cross-sectional study in an outpatient clinic attendees. Parkinsonism Relat Disord. 2005 Nov;11(7):465-8. doi: 10.1016/j.parkreldis.2005.04.006. Epub 2005 Sep 9.
PubMed 16154794
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized Controlled, Pilot Study Comparing Group Visits Versus Routine Clinical Care for Participants With Parkinson's Disease (PD).
- ClinicalTrials.gov ID
- NCT00528086
- Acronym / sponsor ID
- GROUP-PD / RSRB00019885
- Keywords
- Group visits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Parkinson Foundation
- Study start
- Sep 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 11 Sep 2007 (estimated)
- 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.
To determine patient satisfaction with group visits versus standard of care delivery for patients with Parkinson's disease.
Detailed description
To establish the feasibility and to estimate the benefit of group visits for individuals with PD and their caregivers. The feasibility will be assessed by the ability to enroll and retain (measured by number of individuals who complete the 12-month study and at least half the study visits) ~40 individuals in the pilot trial. The responsiveness of the following different outcomes to group visits will be assessed during the pilot trial: quality of life, patient satisfaction, depression, caregiver burden, resource utilization, and disease progression. The primary outcome measure for efficacy will be a comparison of the change in the Parkinson's Disease Questionnaire-39 from baseline to 12 months in the control (routine care) and intervention (group visit) groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Parkinson disease patients and their family members or caregivers randomly assigned to receive their PD care in group visit format. |
| 2 | – | –Parkinson disease patients and their family members or caregivers randomly assigned to receive their PD care in standard of care format (one-on-one physician-patient visits). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited from Drs. Dorsey, Biglan, and Marshall's patient populations from the Parkinson disease clinic at the University of Rochester Neurology group.
Key inclusion criteria (2 listed)
- Clinical diagnosis of idiopathic Parkinson's disease as determined by having two of the four cardinal features of PD (rest tremor, bradykinesia, cogwheel rigidity, and gait instability) and no alternative explanation for the etiology of the symptoms
- Willing and able to provide informed consent and to participate actively in group visits and complete study activities
Key exclusion criteria (1 listed)
- Cognitive impairment, psychiatric disorder, or history of or current clinically significant substance abuse that in the investigator's judgment could interfere in the conduct of group visits or with study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The feasibility (based on the ability to enroll and retain 40 individuals) and benefit (based on the 12-month change in PDQ-39) of group visits for individuals with Parkinson disease and their caregivers.
Time frame: 12 months
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 25 May 2010.
- Background: PubMed 9158573Beck A, Scott J, Williams P, Robertson B, Jackson D, Gade G, Cowan P. A randomized trial of group outpatient visits for chronically ill older HMO members: the Cooperative Health Care Clinic. J Am Geriatr Soc. 1997 May;45(5):543-9. doi: 10.1111/j.1532-5415.1997.tb03085.x.
- Background: PubMed 15341547Scott JC, Conner DA, Venohr I, Gade G, McKenzie M, Kramer AM, Bryant L, Beck A. Effectiveness of a group outpatient visit model for chronically ill older health maintenance organization members: a 2-year randomized trial of the cooperative health care clinic. J Am Geriatr Soc. 2004 Sep;52(9):1463-70. doi: 10.1111/j.1532-5415.2004.52408.x.
- Background: PubMed 11252212Masley S, Phillips S, Copeland JR. Group office visits change dietary habits of patients with coronary artery disease-the dietary intervention and evaluation trial (D.I.E.T.). J Fam Pract. 2001 Mar;50(3):235-9.
- Background: PubMed 10404919Coleman EA, Grothaus LC, Sandhu N, Wagner EH. Chronic care clinics: a randomized controlled trial of a new model of primary care for frail older adults. J Am Geriatr Soc. 1999 Jul;47(7):775-83. doi: 10.1111/j.1532-5415.1999.tb03832.x.
- Background: PubMed 11375359Trento M, Passera P, Tomalino M, Bajardi M, Pomero F, Allione A, Vaccari P, Molinatti GM, Porta M. Group visits improve metabolic control in type 2 diabetes: a 2-year follow-up. Diabetes Care. 2001 Jun;24(6):995-1000. doi: 10.2337/diacare.24.6.995.
- Background: PubMed 11315833Wagner EH, Grothaus LC, Sandhu N, Galvin MS, McGregor M, Artz K, Coleman EA. Chronic care clinics for diabetes in primary care: a system-wide randomized trial. Diabetes Care. 2001 Apr;24(4):695-700. doi: 10.2337/diacare.24.4.695.
- Background: PubMed 14672486Ickovics JR, Kershaw TS, Westdahl C, Rising SS, Klima C, Reynolds H, Magriples U. Group prenatal care and preterm birth weight: results from a matched cohort study at public clinics. Obstet Gynecol. 2003 Nov;102(5 Pt 1):1051-7. doi: 10.1016/s0029-7844(03)00765-8.
- Background: PubMed 15719417Grosset KA, Grosset DG. Patient-perceived involvement and satisfaction in Parkinson's disease: effect on therapy decisions and quality of life. Mov Disord. 2005 May;20(5):616-9. doi: 10.1002/mds.20393.
- Background: PubMed 15058790Shimbo T, Goto M, Morimoto T, Hira K, Takemura M, Matsui K, Yoshida A, Fukui T. Association between patient education and health-related quality of life in patients with Parkinson's disease. Qual Life Res. 2004 Feb;13(1):81-9. doi: 10.1023/B:QURE.0000015306.59840.95.
- Background: PubMed 11835440Global Parkinson's Disease Survey (GPDS) Steering Committee.. Factors impacting on quality of life in Parkinson's disease: results from an international survey. Mov Disord. 2002 Jan;17(1):60-7. doi: 10.1002/mds.10010.
- Background: PubMed 16481639Christakis NA, Allison PD. Mortality after the hospitalization of a spouse. N Engl J Med. 2006 Feb 16;354(7):719-30. doi: 10.1056/NEJMsa050196.
- Background: PubMed 10521886Aarsland D, Larsen JP, Karlsen K, Lim NG, Tandberg E. Mental symptoms in Parkinson's disease are important contributors to caregiver distress. Int J Geriatr Psychiatry. 1999 Oct;14(10):866-74.
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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.
E. Ray Dorsey, MD, MBA principal investigator
University of Rochester
Kevin Biglan, MD, MPH principal investigator
University of Rochester
Fred Marshall, MD principal investigator
University of Rochester
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 Parkinson's Disease Patient Caregivers, run by University of Rochester 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 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 25 May 2010. 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?
The feasibility (based on the ability to enroll and retain 40 individuals) and benefit (based on the 12-month change in PDQ-39) of group visits for individuals with Parkinson disease and their caregivers. (time frame: 12 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 NCT00528086, which also lists 34 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 25 May 2010.