Parkinson DiseaseNCT03329833
Motivational Interviewing and Physical Activity Change in Parkinson's Disease
A study testing Motivational Interviewing and Web-based application in people with Parkinson Disease, run by Shirley Ryan AbilityLab at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Motivational Interviewing and Web-based application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Nov 2017to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Community dwelling
- Age 18 or older
- Physician confirmed diagnosis of PD with Hoehn and Yahr stage ≤3
- Ability to ambulate independently (walker is allowed) for distance of 50 feet or 10 minutes at a time
- Does not meet current CDC physical activity guidelines of 150 minutes of moderate to vigorous physical activity per week
- Currently and plans to have a smartphone, tablet, or computer and access to the internet for the next 9 months
- Willing to monitor activity on their smartphone, tablet, or computer via a web-based application during the 9-month program
- Currently uses the internet in a basic capacity
Who cannot join
- Inability to speak and understand English
- Has a cardiovascular disorder or other health condition that would make exercise unsafe according to their physician
- Patients who are currently receiving physical therapy or received physical therapy one month prior to study enrollment
- Cognitive impairment as defined by inability to provide informed consent and to self-report feelings and behaviors
- Montreal Cognition Scale (MOCA): rating of less than 24, indicative of cognitive dysfunction
- Patients who indicate it is not recommended they participate in increased physical activity as indicated by the Physical Activity Restriction Questionnaire (PAR-Q)
- Patients who are in other studies that monitor fitness or physical activity
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Medicine
Chicago, Illinois, 60611
Shirley Ryan Abilitylab
Chicago, Illinois, 60611
About this study
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.
Read the detailed description
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.
- Conditions
- Parkinson Disease
- Being tested
- Motivational Interviewing, Web-based application
- Keywords
- Parkinson's Disease, Parkinson's, Motivational Interviewing, Exercise, Motivation
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
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.
Web-based applicationBehavioural
Web-based application participants will be asked to log activity at least on a daily basis.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | Participants will talk to a coach on the phone who will employ Motivational Interviewing as a coaching style. Receives: Behavioral: Motivational Interviewing |
| Web-Based Application | Experimental | Participants will use a Web-Based Application to track their daily physical activity. Receives: Behavioral: Web-based application |
| Combination MI and App | Experimental | 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. Receives: Behavioral: Motivational Interviewing; Behavioral: Web-based application |
| Educational Program | No intervention | Participants will get to use a website that contains information relevant to patients with Parkinson's Disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Assessment will occur at baseline, 3 months, 6 months and 9 months.
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).
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.
Measured: Assessment will occur at baseline, 3 months, 6 months and 9 months.
Secondary outcomes (5)
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).
The Berg Balance Scale is a 14-item performance measure to assess static balance and fall risk.
Measured: Assessment will occur at baseline, 3 months, 6 months and 9 months.
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).
Activities-Specific Balance Confidence Scale is a 16-item self-report measure of confidence in performing various activities of daily living without falling.
Measured: Assessment will occur at baseline, 3 months, 6 months and 9 months.
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).
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.
Measured: Assessment will occur at baseline, 3 months, 6 months and 9 months.
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.
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.
Measured: Assessment will occur at baseline, 3 months, 6 months and 9 months.
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).
PROMIS Global Health is a 10-item scale rating physical and mental health and overall quality of life.
Measured: Assessment will occur at baseline, 3 months, 6 months and 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start20 Nov 2017
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study examines how a web-based application and/or motivational interviewing impact a participant's exercise routine compared to an educational control group.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Linda Ehrlich-Jones, Shirley Ryan AbilityLab
- Investigators
- Linda Ehrlich-Jones, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329833
- Sponsor's protocol ID
- 90IF0093
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2017
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20057213Brown 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.
PubMed 15809561Ahlskog JE. Does vigorous exercise have a neuroprotective effect in Parkinson disease? Neurology. 2011 Jul 19;77(3):288-94. doi: 10.1212/WNL.0b013e318225ab66.
PubMed 21768599Alberts 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.
PubMed 21799425Angevaren 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.
PubMed 18646126Bezard 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.
PubMed 22753348Chen 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.
PubMed 15728289Cruise 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.
PubMed 20199518van 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.
PubMed 21614433Ellis 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.
PubMed 23288910Ravesloot 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.
PubMed 18319446Harland 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.
PubMed 10496829Ehrlich-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.
PubMed 20696695Brodie 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.
PubMed 17258218Tse 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.
PubMed 23279630
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing and Physical Activity Change in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03329833
- Acronym / sponsor ID
- 90IF0093
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Parkinson's, Motivational Interviewing, Exercise, Motivation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- This study examines how a web-based application and/or motivational interviewing impact a participant's exercise routine compared to an educational control group.
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational InterviewingParticipants will talk to a coach on the phone who will employ Motivational Interviewing as a coaching style. |
| Web-Based Application | Experimental | Behavioral: Web-based applicationParticipants will use a Web-Based Application to track their daily physical activity. |
| Combination MI and App | Experimental | Behavioral: Motivational Interviewing, Behavioral: Web-based applicationParticipants 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. |
| Educational Program | No intervention | –Participants will get to use a website that contains information relevant to patients with Parkinson's Disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Community dwelling
- Age 18 or older
- Physician confirmed diagnosis of PD with Hoehn and Yahr stage ≤3
- Ability to ambulate independently (walker is allowed) for distance of 50 feet or 10 minutes at a time
- Does not meet current CDC physical activity guidelines of 150 minutes of moderate to vigorous physical activity per week
Key exclusion criteria (7 listed)
- Inability to speak and understand English
- Has a cardiovascular disorder or other health condition that would make exercise unsafe according to their physician
- Patients who are currently receiving physical therapy or received physical therapy one month prior to study enrollment
- Cognitive impairment as defined by inability to provide informed consent and to self-report feelings and behaviors
- Montreal Cognition Scale (MOCA): rating of less than 24, indicative of cognitive dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingMotivational interviewing will consist of weekly phone calls for two months, bi-weekly phone calls for two months, and monthly phone calls for two months. | Behavioural | Combination MI and App, Motivational Interviewing |
| Web-based applicationWeb-based application participants will be asked to log activity at least on a daily basis. | Behavioural | Combination MI and App, Web-Based Application |
Primary outcome
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.
Time frame: Assessment will occur at baseline, 3 months, 6 months and 9 months.
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.
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).
Time frame: Assessment will occur at baseline, 3 months, 6 months and 9 months.
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.
5 secondary outcomes
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).
Time frame: Assessment will occur at baseline, 3 months, 6 months and 9 months.
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).
Time frame: Assessment will occur at baseline, 3 months, 6 months and 9 months.
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).
Time frame: Assessment will occur at baseline, 3 months, 6 months and 9 months.
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.
Time frame: Assessment will occur at baseline, 3 months, 6 months and 9 months.
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).
Time frame: Assessment will occur at baseline, 3 months, 6 months and 9 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 20057213Stuart 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.
- Background: PubMed 15809561Brown 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.
- Background: PubMed 21768599Ahlskog JE. Does vigorous exercise have a neuroprotective effect in Parkinson disease? Neurology. 2011 Jul 19;77(3):288-94. doi: 10.1212/WNL.0b013e318225ab66.
- Background: PubMed 21799425Alberts 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.
- Background: PubMed 18646126Angevaren 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.
- Background: PubMed 22753348Bezard 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.
- Background: PubMed 15728289Chen 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.
- Background: PubMed 20199518Cruise 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.
- Background: PubMed 21614433van 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.
- Background: PubMed 23288910Ellis 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.
- Background: PubMed 18319446Ravesloot 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.
- Background: PubMed 10496829Harland 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Ehrlich-Jones, PhD principal investigator
Shirley Ryan AbilityLab
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Web-based application in people with Parkinson Disease, run by Shirley Ryan AbilityLab at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Assessment will occur at baseline, 3 months, 6 months and 9 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03329833, which also lists 48 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.