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NCT Number: NCT02194816

Modifiable Variables in Parkinsonism (MVP)

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.

Recruiting

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Key information

Conditions

Parkinson's Disease Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebellar Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corticobasal Degeneration Cranial Nerve Diseases Dementia Dementia With Lewy Bodies Eye Diseases Frontotemporal Dementia Frontotemporal Lobar Degeneration Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Hypotension Lewy Body Disease MSA - Multiple System Atrophy Mental Disorders Movement Disorders Multiple System Atrophy Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Ocular Motility Disorders Olivopontocerebellar Atrophies Ophthalmoplegia Paralysis Parkinson Disease Parkinsonian Disorders Parkinsonism Pathological Conditions, Signs and Symptoms Pick Disease Pick Disease of the Brain Primary Dysautonomias Progressive Supranuclear Palsy Shy-Drager Syndrome Signs and Symptoms Spinal Cord Diseases Spinocerebellar Degenerations Supranuclear Palsy, Progressive Synucleinopathies Tauopathies Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bastyr University

Kenmore, Washington, 98028, United States

Location status: Recruiting

Location contact

Laurie K Mischley, ND, PhD, MPH

CONTACT

[email protected]

425-602-3306

Laurie K Mischley, ND, PhD, MPH

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. CAM Care for PD survey

    Time frame: 5 years

    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.

  2. PROMIS: Global Health

    Time frame: 5 years

    This outcome measure will be used to assess general health and well-being in the cohort.

  3. Patient-Reported Outcomes in PD (PRO-PD)

    Time frame: 5 years

    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.

Secondary outcomes

  1. Qualitative

    Time frame: 5 years

    Participants will be given 'free space' to provide additional information they consider relevant.

Study contacts

Contact information is provided by the study sponsor or research team.

Research Assistant

CONTACT

[email protected]

425-602-3306

Sponsors and collaborators

Lead sponsor

Bastyr University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2030
Study completion
2030
First posted
Jul 18, 2014
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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