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Recruiting NCT02194816

Modifiable Variables in Parkinsonism (MVP)

Observational Parkinson's Disease Parkinsonism MSA - Multiple System Atrophy Progressive Supranuclear Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Parkinson's Disease, Parkinsonism, MSA - Multiple System Atrophy, Progressive Supranuclear Palsy. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • CAM Care for PD survey [Time frame: 5 years]
  • PROMIS: Global Health [Time frame: 5 years]
  • Patient-Reported Outcomes in PD (PRO-PD) [Time frame: 5 years]
Secondary outcome measures (1)
  • Qualitative [Time frame: 5 years]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Bastyr University — Kenmore

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. PMID 21069833
  • 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. PMID 21532567
  • Positive Deviance Initiative. 2010 [cited 2012 30 Dec 2012]; Available from: http://www.positivedeviance.org/about_pd/index.html

Identifiers

NCT: NCT02194816 · BU-13A-1332

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗