Clinical trial NCT02194816: Modifiable Variables in Parkinsonism (MVP)
Official title: Modifiable Variables in Parkinsonism (MVP) [Formerly CAM Care in PD]
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Keywords: Parkinson's Disease
PD
Complementary and Alternative
CAM
Lead sponsor: Bastyr University
Sponsor class: OTHER
First posted: 2014-07-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any individual with PD is invited to participate.

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.

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)

Primary outcomes:
measure: CAM Care for PD survey
timeFrame: 5 years
measure: PROMIS: Global Health
timeFrame: 5 years
measure: Patient-Reported Outcomes in PD (PRO-PD)
timeFrame: 5 years
Secondary outcomes:
measure: Qualitative
timeFrame: 5 years
Other outcomes:
Locations:
city: Kenmore
country: United States
facility: Bastyr University
state: Washington
Study officials:
affiliation: Bastyr University
name: Laurie K Mischley, ND, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Positive Deviance Initiative. 2010 [cited 2012 30 Dec 2012]; Available from: http://www.positivedeviance.org/about_pd/index.html