Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
550 participants
INTERVENTIONAL
2023-08-18
2027-02-28
Brief Summary
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The study hypothesizes that tailored digital interventions (plus using PainGuide) will demonstrate greater improvement in pain interference.
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Detailed Description
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increased enrollment numbers, updated recruitment procedures including the Non-Pharma Program (NPP) Sub-Study, as well as changes in time frames.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Structured and tailored PainGuide
Structured and tailored PainGuide
Participants will receive specific instruction to complete one module a week over the first 4 weeks. Participants will then receive tailored messaging using scores from the assessments completed during T1(baseline visit) from the PROMIS 29+2.
The initial group of participants (prior to AME00158411) will complete surveys for 24 weeks.
The NPP Participants will be asked to complete surveys for 52 weeks.
All participants will also be registered with a Fitbit device that is linked to the PainGuide to capture movement data (daily step counts).
Standard PainGuide
Standard PainGuide
Participants in the control group will not receive any messaging once enrolled. The initial group of participants (prior to AME00158411) will complete surveys for 24 weeks.
The NPP Participants will be asked to complete surveys for 52 weeks.
All participants will also be registered with a Fitbit device that is linked to the PainGuide to capture movement data (daily step counts).
Interventions
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Structured and tailored PainGuide
Participants will receive specific instruction to complete one module a week over the first 4 weeks. Participants will then receive tailored messaging using scores from the assessments completed during T1(baseline visit) from the PROMIS 29+2.
The initial group of participants (prior to AME00158411) will complete surveys for 24 weeks.
The NPP Participants will be asked to complete surveys for 52 weeks.
All participants will also be registered with a Fitbit device that is linked to the PainGuide to capture movement data (daily step counts).
Standard PainGuide
Participants in the control group will not receive any messaging once enrolled. The initial group of participants (prior to AME00158411) will complete surveys for 24 weeks.
The NPP Participants will be asked to complete surveys for 52 weeks.
All participants will also be registered with a Fitbit device that is linked to the PainGuide to capture movement data (daily step counts).
Eligibility Criteria
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Inclusion Criteria
* Individuals must have a score of greater or equal to (≥) 60 on PROMIS Pain Interference.
* Non-Pharma Sub-study:
1. Must be referred and currently on the waitlist for the NPP at the Back \& Pain Center (BPC)
Exclusion Criteria
* Diagnosis of autoimmune disease
* Unable to speak, write or read English
* Visual or hearing difficulties
* Pregnancy or breastfeeding
* Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Daniel Clauw, MD
Professor of Anesthesiology
Principal Investigators
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Daniel Clauw, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00214375
Identifier Type: -
Identifier Source: org_study_id
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