Modifiable Variables in Parkinsonism (MVP)

Modifiable Variables in Parkinsonism (MVP) [Formerly CAM Care in PD]

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Research Assistant; Phone Number: 425-602-3306; Email: neuroresearch@bastyr.edu

Study Locations

• United States
  • Washington
    • Kenmore, Washington, United States, 98028
      • Recruiting
      • Bastyr University
      • Contact: Laurie K Mischley, ND, PhD, MPH; Phone Number: 425-602-3306; Email: neuroresearch@bastyr.edu
      • Principal Investigator: Laurie K Mischley, ND, PhD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any individual with PD is invited to participate.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAM Care for PD survey	This survey has been developed to identify the complementary and alternative therapies most commonly used by individuals with PD. Results will be reported with descriptive statistics.	5 years
PROMIS: Global Health	This outcome measure will be used to assess general health and well-being in the cohort.	5 years
Patient-Reported Outcomes in PD (PRO-PD)	This outcome measure is a series of 33 slider bars, developed for this study, to evaluate the individual's perception of symptom severity. The cumulative score for all 33 listed symptoms will be reported as the PRO-PD score.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative	Participants will be given 'free space' to provide additional information they consider relevant.	5 years

Collaborators and Investigators

• Sponsor: Bastyr University
• Investigators: Principal Investigator: Laurie K Mischley, ND, PhD, MPH, Bastyr University

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): December 1, 2030
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: July 17, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 18, 2014

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Parkinson's Disease; CAM; PD; Complementary and Alternative
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Neurocognitive Disorders; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathological Conditions, Anatomical; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Dementia; Tauopathies; Cranial Nerve Diseases; Autonomic Nervous System Diseases; Ocular Motility Disorders; Paralysis; Primary Dysautonomias; Hypotension; Frontotemporal Lobar Degeneration; Ophthalmoplegia; Cerebellar Diseases; Spinocerebellar Degenerations; Frontotemporal Dementia; Parkinson Disease; Atrophy; Lewy Body Disease; Multiple System Atrophy; Shy-Drager Syndrome; Pick Disease of the Brain; Parkinsonian Disorders; Supranuclear Palsy, Progressive; Olivopontocerebellar Atrophies
• Other Study ID Numbers: BU-13A-1332