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Complementary & Alternative Medicine in Parkinson's Disease (CAM Care in PD)

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ClinicalTrials.gov Identifier: NCT02194816
Recruitment Status : Recruiting
First Posted : July 18, 2014
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Laurie Mischley, Bastyr University

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.

Condition or disease
Parkinson's 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
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Complementary & Alternative Medicine in Parkinson's Disease
Study Start Date : September 2012
Estimated Primary Completion Date : December 2040
Estimated Study Completion Date : December 2040

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 Outcome Measures :
  1. Qualitative [ Time Frame: 5 years ]
    Participants will be given 'free space' to provide additional information they consider relevant.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any individual with PD is invited to participate.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194816


Contacts
Contact: Research Assistant 425-602-3306 neuroresearch@bastyr.edu

Locations
United States, Washington
Bastyr University Recruiting
Kenmore, Washington, United States, 98028
Contact: Laurie K Mischley, NDMPHPhD(c)    425-602-3306    neuroresearch@bastyr.edu   
Principal Investigator: Laurie K Mischley, NDMPHPhD(c)         
Sponsors and Collaborators
Bastyr University
Investigators
Principal Investigator: Laurie K Mischley, NDMPHPhD(c) Bastyr University

Additional Information:
Publications:
Responsible Party: Laurie Mischley, Assistant Research Scientist, Bastyr University
ClinicalTrials.gov Identifier: NCT02194816     History of Changes
Other Study ID Numbers: BU-13A-1332
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017

Keywords provided by Laurie Mischley, Bastyr University:
Parkinson's Disease
PD
Complementary and Alternative
CAM

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases