Complementary & Alternative Medicine in Parkinson's Disease (CAM Care in PD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02194816|
Recruitment Status : Recruiting
First Posted : July 18, 2014
Last Update Posted : July 27, 2017
|Condition or disease|
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|
|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|
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.
- 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.
- PROMIS: Global Health [ Time Frame: 5 years ]This outcome measure will be used to assess general health and well-being in the cohort.
- 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.
- Qualitative [ Time Frame: 5 years ]Participants will be given 'free space' to provide additional information they consider relevant.
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
|Contact: Research Assistantfirstname.lastname@example.org|
|United States, Washington|
|Kenmore, Washington, United States, 98028|
|Contact: Laurie K Mischley, NDMPHPhD(c) 425-602-3306 email@example.com|
|Principal Investigator: Laurie K Mischley, NDMPHPhD(c)|
|Principal Investigator:||Laurie K Mischley, NDMPHPhD(c)||Bastyr University|