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"SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia (SMART-FM)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05005351
Recruitment Status : Completed
First Posted : August 13, 2021
Results First Posted : August 1, 2023
Last Update Posted : August 1, 2023
Sponsor:
Information provided by (Responsible Party):
Swing Therapeutics, Inc.

Study Description
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Brief Summary:
This is a non-significant risk, multi-center, randomized, active-controlled study to compare the effectiveness of two digital therapies in the management of fibromyalgia over 12 weeks. The primary endpoint is mean change from baseline to Week 12 in the weekly revised Fibromyalgia Impact Questionnaire (FIQ-R) total score.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: Digital ACT Device: Digital Symptom Tracker Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
Actual Study Start Date : October 28, 2020
Actual Primary Completion Date : July 9, 2021
Actual Study Completion Date : July 9, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Digital Acceptance and Commitment Therapy (ACT) Device: Digital ACT
Participants in Digital ACT arm complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.
Active Comparator: Digital Symptom Tracker Device: Digital Symptom Tracker
Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual.


Outcome Measures
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Primary Outcome Measures :
  1. Revised Fibromyalgia Impact Questionnaire (FIQ-R) Total Score [ Time Frame: Baseline to Week 12 ]
    FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity.


Secondary Outcome Measures :
  1. Key Secondary Endpoint of This Clinical Trial - Rate of Patient's Global Impression of Change (PGIC) Responders at Week 12 - Any Improvement [ Time Frame: Week 12 ]
    PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Subject is 22 to 75 years of age, inclusive

  2. Subject has a diagnosis of primary FM as defined by the 2016 American College of Rheumatology Preliminary Diagnostic Criteria for FM, which requires satisfaction of the following criteria:

    1. Widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5, OR WPI 4-6 and SS scale score ≥9;
    2. Symptoms have been present at a similar level for at least 3 months;
    3. Pain must be present in at least 4 out of 5 body regions
  3. Subject with ongoing treatments should be on stable therapy for 30 days prior to screening appointment.
  4. Subject is capable of reading and understanding English and has provided written informed consent to participate.

Key Exclusion Criteria:

  1. Lifetime history of bipolar disorder as assessed by the MINI.
  2. Current, untreated, major depressive episode and/or anxiety disorders as assessed by the MINI.
  3. Subject has a BDI-II total score > 25 at either the Screening appointment or Baseline appointment.
  4. The subject is at increased risk of suicide on the basis of the investigator's judgment, a response > 1 to BDI item #9, or the results of the Columbia-Suicide Severity Rating Scale ("C-SSRS") conducted at Screening or Baseline (i.e., any suicidal behavior during the preceding year or C-SSRS Type 3, 4, or 5 suicidal ideation during the preceding year).
  5. Subject has any other disease or medical condition that, in the opinion of the Investigator or Sponsor, could endanger the subject, interfere with the evaluation of the study device's efficacy or safety, or compromise the subject's ability to comply with/complete the study.
Contacts and Locations
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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): NCT05005351


Locations
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United States, California
Excell Research, Inc.
Oceanside, California, United States, 92056
Superior Research LLC
Sacramento, California, United States, 95831
United States, Florida
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32801
United States, New York
Upstate Clinical Research Associates LLC
Williamsville, New York, United States, 14221
United States, Ohio
University of Cincinnati Physicians Company, LLC
Cincinnati, Ohio, United States, 45219
Neuro-Behavioral Clinical Research, Inc.
North Canton, Ohio, United States, 44720
United States, Pennsylvania
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States, 18104
Sponsors and Collaborators
Swing Therapeutics, Inc.
Investigators
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Study Director: Michael Gendreau, MD Consulting Chief Medical Officer
  Study Documents (Full-Text)

Documents provided by Swing Therapeutics, Inc.:
Study Protocol  [PDF] January 10, 2021
No Statistical Analysis Plan (SAP) exists for this study.

More Information
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Additional Information:

Publications of Results:

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Responsible Party: Swing Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05005351    
Other Study ID Numbers: Swing-004
First Posted: August 13, 2021    Key Record Dates
Results First Posted: August 1, 2023
Last Update Posted: August 1, 2023
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases