Modifiable Variables in Parkinsonism (MVP)

NCT ID: NCT02194816

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2030-12-31

Brief Summary

We are trying to identify factors associated with improved quality of life and fewer PD symptoms. We are attempting to identify practices, beliefs, and therapies used by individuals who report excellent quality of life, few PD symptoms, and reduced rates of progression. After agreeing to participate, we will ask participants to fill our questionnaires about their experience with PD, their health in general, along with their food intake every six months for five years.

Detailed Description

This is a prospective, observational study designed to describe disease progression, symptom change, quality of life, diet and lifestyle habits among patients with Parkinson's disease (PD). This study will identify and describe those individuals with the highest quality of life and least amount of disease activity, in order to describe medication, diet, and lifestyle patterns associated with a lack of PD disease progression and high quality of life.

Participants will be asked to complete online surveys every six months for five years. The time requirement is about an hour to an hour and a half every six months. Participants do not need to answer questions if they do not feel comfortable answering.

At each six month time point we will send participants an email with the link to the CAM Care in PD survey, a questionnaire about health and wellbeing (completed in REDCap). After participants have completed this survey we will send participants a link to the second survey, about dietary intake (completed on ASA24.gov). Because there is a designated window of time during which surveys must be completed, participants may receive a gentle reminder from us if time is running out.

This study is not designed to provide care. Participants are encouraged to consult with any providers you wish. Participants will not directly benefit from the study, but information gathered during the course of this study may help us begin to assess the longer-term effects of complementary and integrative care on health, disease progression and quality of life in PD patients.

Conditions

Parkinson's Disease; Parkinsonism; MSA - Multiple System Atrophy; Progressive Supranuclear Palsy; Shy-Drager Syndrome; Corticobasal Degeneration; Dementia With Lewy Bodies; Pick Disease; Olivopontocerebellar Atrophies

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Parkinson's Disease Patients

Any individuals who has a diagnosis of Parkinson's disease (PD), parkinsonism, or a parkinson's plus syndrome will be allowed to participate.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Parkinson's disease (PD)
• Parkinsonism
• Parkinson-plus syndromes (e.g. Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP), Corticobasal degeneration (CBGD), Dementia with Lewy bodies)
• Must have online access, an email address, basic computer literacy
• Must be willing to complete online surveys every 6 months for 5 years

Exclusion Criteria

• Inability to read/write English
• Inability or unwillingness to complete surveys every six (6) months (~90 min)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bastyr University

OTHER

Sponsor Role: lead

Responsible Party

Laurie Mischley

Assistant Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laurie K Mischley, ND, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Bastyr University

Locations

Bastyr University

Kenmore, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Research Assistant

Role: CONTACT

neuroresearch@bastyr.edu

425-602-3306

Facility Contacts

Laurie K Mischley, ND, PhD, MPH

Role: primary

neuroresearch@bastyr.edu

425-602-3306

References

Tomlinson CL, Stowe R, Patel S, Rick C, Gray R, Clarke CE. Systematic review of levodopa dose equivalency reporting in Parkinson's disease. Mov Disord. 2010 Nov 15;25(15):2649-53. doi: 10.1002/mds.23429.

Reference Type: BACKGROUND

PMID: 21069833 (View on PubMed)

Meissner WG, Frasier M, Gasser T, Goetz CG, Lozano A, Piccini P, Obeso JA, Rascol O, Schapira A, Voon V, Weiner DM, Tison F, Bezard E. Priorities in Parkinson's disease research. Nat Rev Drug Discov. 2011 May;10(5):377-93. doi: 10.1038/nrd3430.

Reference Type: BACKGROUND

PMID: 21532567 (View on PubMed)

Positive Deviance Initiative. 2010 [cited 2012 30 Dec 2012]; Available from: http://www.positivedeviance.org/about_pd/index.html

Reference Type: BACKGROUND

Other Identifiers

BU-13A-1332

Identifier Type: -

Identifier Source: org_study_id