Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-03-05 @ 10:31 PM
Study NCT ID:
NCT03329833
Status:
UNKNOWN
Last Update Posted:
2020-10-14
First Post:
2017-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motivational Interviewing and Physical Activity Change in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will be aware which group they are assigned to. Study team members who will be providing assessments will be blinded to the condition the participant is in.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': "This study examines how a web-based application and/or motivational interviewing impact a participant's exercise routine compared to an educational control group."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-09', 'studyFirstSubmitDate': '2017-10-16', 'studyFirstSubmitQcDate': '2017-10-30', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Test the efficacy of the Motivational Interviewing (MI) Intervention and the Web-Based Self-Monitoring Application Intervention by monitoring the change in physical activity using data collected from an Actigraph activity monitor.', 'timeFrame': 'Assessment will occur at baseline, 3 months, 6 months and 9 months.', 'description': 'Participants will wear an Actigraph activity monitor for one week every quarter to collect data about physical activity throughout the duration of the study. Time spent doing physical activity will be compared at each assessment for this outcome.'}, {'measure': 'Test the efficacy of the MI Intervention and the Web-Based Self-Monitoring Application Intervention by monitoring the change in physical activity using the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD).', 'timeFrame': 'Assessment will occur at baseline, 3 months, 6 months and 9 months.', 'description': 'PASIPD is a 13-item 7-day physical activity recall questionnaire designed to evaluate physical activity levels in people with physical disabilities by soliciting information about leisure time activities, household activities, and work- related activities.'}], 'secondaryOutcomes': [{'measure': 'Test the efficacy of the Motivational Interviewing (MI) intervention and the Web-Based Self-Monitoring Application Intervention for improving balance using the Berg Balance Scale (BBS).', 'timeFrame': 'Assessment will occur at baseline, 3 months, 6 months and 9 months.', 'description': 'The Berg Balance Scale is a 14-item performance measure to assess static balance and fall risk.'}, {'measure': 'Test the efficacy of the Motivational Interviewing (MI) intervention and the Web-Based Self-Monitoring Application Intervention for improving balance using the Activities-Specific Balance Confidence Scale (ABC).', 'timeFrame': 'Assessment will occur at baseline, 3 months, 6 months and 9 months.', 'description': 'Activities-Specific Balance Confidence Scale is a 16-item self-report measure of confidence in performing various activities of daily living without falling.'}, {'measure': "Test the efficacy of the Motivational Interviewing (MI) intervention and the Web-Based Self-Monitoring Application Intervention for improving balance using the Unified Parkinson's Disease Rating Scale (UPDRS).", 'timeFrame': 'Assessment will occur at baseline, 3 months, 6 months and 9 months.', 'description': 'The UPDRS is an assessment that monitors the progression of Parkinson\'s Disease. For this outcome, the "postural stability" portion of the assessment will be used to determine balance improvements.'}, {'measure': 'Test the efficacy of the Motivational Interviewing (MI) intervention and the Web-Based Self-Monitoring Application Intervention for improving quality of life using the assessment measure Neuro-QOL.', 'timeFrame': 'Assessment will occur at baseline, 3 months, 6 months and 9 months.', 'description': 'The Neuro-QOL is a set of self-report measures that assess the health-related quality of life of adults and children with neurological disorders.'}, {'measure': 'Test the efficacy of the Motivational Interviewing (MI) intervention and the Web-Based Self-Monitoring Application Intervention for improving quality of life using the assessment measure Patient-Reported Outcomes Measurement Information System (PROMIS).', 'timeFrame': 'Assessment will occur at baseline, 3 months, 6 months and 9 months.', 'description': 'PROMIS Global Health is a 10-item scale rating physical and mental health and overall quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's Disease", "Parkinson's", 'Motivational Interviewing', 'Exercise', 'Motivation'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '20057213', 'type': 'BACKGROUND', 'citation': 'Stuart M, Chard S, Benvenuti F, Steinwachs S. Community exercise: a vital component to healthy aging. Healthc Pap. 2009;10(1):23-8; discussion 79-83. doi: 10.12927/hcpap.2009.21219.'}, {'pmid': '15809561', 'type': 'BACKGROUND', 'citation': 'Brown DR, Yore MM, Ham SA, Macera CA. Physical activity among adults >or=50 yr with and without disabilities, BRFSS 2001. Med Sci Sports Exerc. 2005 Apr;37(4):620-9. doi: 10.1249/01.mss.0000158189.17546.ed.'}, {'pmid': '21768599', 'type': 'BACKGROUND', 'citation': 'Ahlskog JE. Does vigorous exercise have a neuroprotective effect in Parkinson disease? Neurology. 2011 Jul 19;77(3):288-94. doi: 10.1212/WNL.0b013e318225ab66.'}, {'pmid': '21799425', 'type': 'BACKGROUND', 'citation': "Alberts JL, Linder SM, Penko AL, Lowe MJ, Phillips M. It is not about the bike, it is about the pedaling: forced exercise and Parkinson's disease. Exerc Sport Sci Rev. 2011 Oct;39(4):177-86. doi: 10.1097/JES.0b013e31822cc71a."}, {'pmid': '18646126', 'type': 'BACKGROUND', 'citation': 'Angevaren M, Aufdemkampe G, Verhaar HJ, Aleman A, Vanhees L. Physical activity and enhanced fitness to improve cognitive function in older people without known cognitive impairment. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD005381. doi: 10.1002/14651858.CD005381.pub3.'}, {'pmid': '22753348', 'type': 'BACKGROUND', 'citation': "Bezard E, Yue Z, Kirik D, Spillantini MG. Animal models of Parkinson's disease: limits and relevance to neuroprotection studies. Mov Disord. 2013 Jan;28(1):61-70. doi: 10.1002/mds.25108. Epub 2012 Jul 2."}, {'pmid': '15728289', 'type': 'BACKGROUND', 'citation': 'Chen H, Zhang SM, Schwarzschild MA, Hernan MA, Ascherio A. Physical activity and the risk of Parkinson disease. Neurology. 2005 Feb 22;64(4):664-9. doi: 10.1212/01.WNL.0000151960.28687.93.'}, {'pmid': '20199518', 'type': 'BACKGROUND', 'citation': "Cruise KE, Bucks RS, Loftus AM, Newton RU, Pegoraro R, Thomas MG. Exercise and Parkinson's: benefits for cognition and quality of life. Acta Neurol Scand. 2011 Jan;123(1):13-9. doi: 10.1111/j.1600-0404.2010.01338.x."}, {'pmid': '21614433', 'type': 'BACKGROUND', 'citation': "van Nimwegen M, Speelman AD, Hofman-van Rossum EJ, Overeem S, Deeg DJ, Borm GF, van der Horst MH, Bloem BR, Munneke M. Physical inactivity in Parkinson's disease. J Neurol. 2011 Dec;258(12):2214-21. doi: 10.1007/s00415-011-6097-7. Epub 2011 May 26."}, {'pmid': '23288910', 'type': 'BACKGROUND', 'citation': 'Ellis T, Boudreau JK, DeAngelis TR, Brown LE, Cavanaugh JT, Earhart GM, Ford MP, Foreman KB, Dibble LE. Barriers to exercise in people with Parkinson disease. Phys Ther. 2013 May;93(5):628-36. doi: 10.2522/ptj.20120279. Epub 2013 Jan 3.'}, {'pmid': '18319446', 'type': 'BACKGROUND', 'citation': 'Ravesloot C. Changing stage of readiness for physical activity in Medicaid beneficiaries with physical impairments. Health Promot Pract. 2009 Jan;10(1):49-57. doi: 10.1177/1524839906292182. Epub 2008 Mar 4.'}, {'pmid': '10496829', 'type': 'BACKGROUND', 'citation': 'Harland J, White M, Drinkwater C, Chinn D, Farr L, Howel D. The Newcastle exercise project: a randomised controlled trial of methods to promote physical activity in primary care. BMJ. 1999 Sep 25;319(7213):828-32. doi: 10.1136/bmj.319.7213.828.'}, {'pmid': '20696695', 'type': 'BACKGROUND', 'citation': 'Ehrlich-Jones L, Mallinson T, Fischer H, Bateman J, Semanik PA, Spring B, Ruderman E, Chang RW. Increasing physical activity in patients with arthritis: a tailored health promotion program. Chronic Illn. 2010 Dec;6(4):272-81. doi: 10.1177/1742395309351243. Epub 2010 Aug 9.'}, {'pmid': '17258218', 'type': 'BACKGROUND', 'citation': 'Brodie DA, Inoue A, Shaw DG. Motivational interviewing to change quality of life for people with chronic heart failure: a randomised controlled trial. Int J Nurs Stud. 2008 Apr;45(4):489-500. doi: 10.1016/j.ijnurstu.2006.11.009. Epub 2007 Jan 26.'}, {'pmid': '23279630', 'type': 'BACKGROUND', 'citation': 'Tse MM, Vong SK, Tang SK. Motivational interviewing and exercise programme for community-dwelling older persons with chronic pain: a randomised controlled study. J Clin Nurs. 2013 Jul;22(13-14):1843-56. doi: 10.1111/j.1365-2702.2012.04317.x. Epub 2013 Jan 2.'}, {'pmid': '19323865', 'type': 'BACKGROUND', 'citation': 'Haapala I, Barengo NC, Biggs S, Surakka L, Manninen P. Weight loss by mobile phone: a 1-year effectiveness study. Public Health Nutr. 2009 Dec;12(12):2382-91. doi: 10.1017/S1368980009005230. 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Arch Phys Med Rehabil. 2011 Jun;92(6):923-8. doi: 10.1016/j.apmr.2010.12.006. Epub 2011 Apr 19."}, {'pmid': '15838853', 'type': 'BACKGROUND', 'citation': "Lun V, Pullan N, Labelle N, Adams C, Suchowersky O. Comparison of the effects of a self-supervised home exercise program with a physiotherapist-supervised exercise program on the motor symptoms of Parkinson's disease. Mov Disord. 2005 Aug;20(8):971-5. doi: 10.1002/mds.20475."}, {'pmid': '15827933', 'type': 'BACKGROUND', 'citation': "Qutubuddin AA, Pegg PO, Cifu DX, Brown R, McNamee S, Carne W. Validating the Berg Balance Scale for patients with Parkinson's disease: a key to rehabilitation evaluation. Arch Phys Med Rehabil. 2005 Apr;86(4):789-92. doi: 10.1016/j.apmr.2004.11.005."}, {'pmid': '23017069', 'type': 'BACKGROUND', 'citation': "Conradsson D, Lofgren N, Stahle A, Hagstromer M, Franzen E. A novel conceptual framework for balance training in Parkinson's disease-study protocol for a randomised controlled trial. BMC Neurol. 2012 Sep 27;12:111. doi: 10.1186/1471-2377-12-111."}, {'pmid': '23770422', 'type': 'BACKGROUND', 'citation': 'Mhatre PV, Vilares I, Stibb SM, Albert MV, Pickering L, Marciniak CM, Kording K, Toledo S. Wii Fit balance board playing improves balance and gait in Parkinson disease. PM R. 2013 Sep;5(9):769-77. doi: 10.1016/j.pmrj.2013.05.019. Epub 2013 Jun 11.'}, {'pmid': '15619458', 'type': 'BACKGROUND', 'citation': "Lim LI, van Wegen EE, de Goede CJ, Jones D, Rochester L, Hetherington V, Nieuwboer A, Willems AM, Kwakkel G. Measuring gait and gait-related activities in Parkinson's patients own home environment: a reliability, responsiveness and feasibility study. Parkinsonism Relat Disord. 2005 Jan;11(1):19-24. doi: 10.1016/j.parkreldis.2004.06.003."}, {'pmid': '20386056', 'type': 'BACKGROUND', 'citation': 'Hesse BW, Hanna C, Massett HA, Hesse NK. Outside the box: will information technology be a viable intervention to improve the quality of cancer care? J Natl Cancer Inst Monogr. 2010;2010(40):81-9. doi: 10.1093/jncimonographs/lgq004.'}, {'type': 'BACKGROUND', 'citation': 'Abras C, Maloney-Krichmar D, Preece J. User-centered design. In: Bainbridge W, ed. Berkshire Encyclopedia of Human-Computer Interaction. Great Barrington, MA: Berkshire Publishing Group; 2004:463-468'}, {'type': 'BACKGROUND', 'citation': 'Brinck T, Gergle D, Wood S. Usability for the Web: Designing Web Sites that Work. San Francisco, CA: Morgan Kaufmann Publishers; 2002.'}, {'type': 'BACKGROUND', 'citation': 'Nielsen J, Loranger H. Prioritizing web usability. Berkley, CA: New Riders Press; 2006.'}, {'pmid': '14966706', 'type': 'BACKGROUND', 'citation': 'Badke MB, Shea TA, Miedaner JA, Grove CR. Outcomes after rehabilitation for adults with balance dysfunction. Arch Phys Med Rehabil. 2004 Feb;85(2):227-33. doi: 10.1016/j.apmr.2003.06.006.'}, {'pmid': '19479495', 'type': 'BACKGROUND', 'citation': 'Hebert JS, Wolfe DL, Miller WC, Deathe AB, Devlin M, Pallaveshi L. Outcome measures in amputation rehabilitation: ICF body functions. Disabil Rehabil. 2009;31(19):1541-54. doi: 10.1080/09638280802639467.'}, {'pmid': '19025984', 'type': 'BACKGROUND', 'citation': "Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to test the efficacy of a 6-month telephone-based motivational interviewing intervention and a web-based application intervention to improve physical activity in participants with Parkinson's Disease.", 'detailedDescription': "Participants will be randomized into one of four groups to examine two separate interventions. The groups are: motivational interviewing (a counseling/coaching style), a web-based application for participants to keep track of their physical activity, a combination of the motivational interviewing and the web-based application, and an educational program on various issues related to Parkinson's Disease. The intervention will last 6 months with a follow-up appointment at 9 months. Participants will be asked to come to Galter Pavilion at Northwestern Memorial Hospital or Shirley Ryan AbilityLab a total of five times over the course of the nine months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Community dwelling\n* Age 18 or older\n* Physician confirmed diagnosis of PD with Hoehn and Yahr stage ≤3\n* Ability to ambulate independently (walker is allowed) for distance of 50 feet or 10 minutes at a time\n* Does not meet current CDC physical activity guidelines of 150 minutes of moderate to vigorous physical activity per week\n* Currently and plans to have a smartphone, tablet, or computer and access to the internet for the next 9 months\n* Willing to monitor activity on their smartphone, tablet, or computer via a web-based application during the 9-month program\n* Currently uses the internet in a basic capacity\n\nExclusion Criteria:\n\n* Inability to speak and understand English\n* Has a cardiovascular disorder or other health condition that would make exercise unsafe according to their physician\n* Patients who are currently receiving physical therapy or received physical therapy one month prior to study enrollment\n* Cognitive impairment as defined by inability to provide informed consent and to self-report feelings and behaviors\n* Montreal Cognition Scale (MOCA): rating of less than 24, indicative of cognitive dysfunction\n* Patients who indicate it is not recommended they participate in increased physical activity as indicated by the Physical Activity Restriction Questionnaire (PAR-Q)\n* Patients who are in other studies that monitor fitness or physical activity'}, 'identificationModule': {'nctId': 'NCT03329833', 'briefTitle': "Motivational Interviewing and Physical Activity Change in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Shirley Ryan AbilityLab'}, 'officialTitle': "Motivational Interviewing and Physical Activity Change in Parkinson's Disease", 'orgStudyIdInfo': {'id': '90IF0093'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motivational Interviewing', 'description': 'Participants will talk to a coach on the phone who will employ Motivational Interviewing as a coaching style.', 'interventionNames': ['Behavioral: Motivational Interviewing']}, {'type': 'EXPERIMENTAL', 'label': 'Web-Based Application', 'description': 'Participants will use a Web-Based Application to track their daily physical activity.', 'interventionNames': ['Behavioral: Web-based application']}, {'type': 'EXPERIMENTAL', 'label': 'Combination MI and App', 'description': 'Participants will have both a coach by phone who will employ Motivational Interviewing as a coaching style and use a Web-Based Application to track their daily physical activity.', 'interventionNames': ['Behavioral: Motivational Interviewing', 'Behavioral: Web-based application']}, {'type': 'NO_INTERVENTION', 'label': 'Educational Program', 'description': "Participants will get to use a website that contains information relevant to patients with Parkinson's Disease."}], 'interventions': [{'name': 'Motivational Interviewing', 'type': 'BEHAVIORAL', 'description': 'Motivational interviewing will consist of weekly phone calls for two months, bi-weekly phone calls for two months, and monthly phone calls for two months.', 'armGroupLabels': ['Combination MI and App', 'Motivational Interviewing']}, {'name': 'Web-based application', 'type': 'BEHAVIORAL', 'description': 'Web-based application participants will be asked to log activity at least on a daily basis.', 'armGroupLabels': ['Combination MI and App', 'Web-Based Application']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Shirley Ryan Abilitylab', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Linda Ehrlich-Jones, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shirley Ryan AbilityLab'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shirley Ryan AbilityLab', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Disability, Independent Living, and Rehabilitation Research', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Director of Center for Rehabilitation Outcomes Research', 'investigatorFullName': 'Linda Ehrlich-Jones', 'investigatorAffiliation': 'Shirley Ryan AbilityLab'}}}}