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Web-Based Program for Symptom Management in Fibromyalgia

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: NCT02515552
Recruitment Status : Completed
First Posted : August 4, 2015
Last Update Posted : August 4, 2015
Sponsor:
Information provided by (Responsible Party):
William Collinge, PhD, Collinge and Associates, Inc.

Brief Summary:
Fibromyalgia is a complex chronic illness affecting 6-12 million Americans. Self-management strategies play a key role in reducing symptoms and maintaining functioning. The proposed project offers a web-based self management tool that enables FM sufferers to identify significant linkages between their personal symptom levels and their personal self-management efforts over time in order to plan their own optimal approach to disease management.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: The Fibromyalgia Wellness Project Phase 2

Detailed Description:
This Phase II project will complete development of the SMART (Self-Monitoring and Review Tool) Log program for symptom management and health promotion in FM and evaluate its efficacy in a large web-based trial that will closely emulate its planned application in Phase III. The SMARTLog program is an interactive web-based self-monitoring and feedback intervention that employs proprietary statistical analysis procedures to give the user personally optimized guidance on behavioral, lifestyle and coping strategies that yield effective symptom reduction for that individual. The program incorporates longitudinal collection and analysis of the individual's self-monitoring data followed by delivery of personalized feedback derived from those same personal data. The program helps FM sufferers discover and monitor linkages between specific personal health-related behaviors and management strategies and their symptom levels over time. Feasibility was demonstrated in Phase I by very high retention rates, ratings of satisfaction and perceived relevance, evidence of impact of utilization on improved well-being over the use period, and qualitative data indicating strong interest in continuation with the program.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 883 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Web-Based Program for Symptom Management in Fibromyalgia
Study Start Date : September 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
All applicants
Study applicants who consented and completed the application to participate in the Fibromyalgia Wellness Project. From that point forward all subjects used the intervention program to at whatever frequency they chose voluntarily. It was recommended subjects complete a SMARTLog at least three times per week for at least three months.
Behavioral: The Fibromyalgia Wellness Project
Web-based symptom and behavior self-monitoring program with automated feedback derived from the user's personal data. A personal informatics approach is used involving proprietary within-subject statistical analysis procedures to determine user feedback that provides behavioral guidance based on statistically significant change in symptom levels associated with specific user behavior and self-management strategies.




Primary Outcome Measures :
  1. Change in daily symptom Levels [ Time Frame: Baseline to user-defined end date (variable time series design) up to 9 months ]
    Change in Likert-scaled (0-10) daily symptom severity levels on the SMARTLog tracking instrument. Daily reported levels over multiple days are aggregated to calculate trends over the user-defined reporting period.


Secondary Outcome Measures :
  1. Change in Fibromyalgia Impact Questionnaire scores [ Time Frame: Baseline to user-defined end date (variable time series design) up to 9 months ]
  2. Change in Self-Efficacy for Chronic Disease Scale scores [ Time Frame: Baseline to user-defined end date (variable time series design) up to 9 months ]
  3. Change in SF12 scores [ Time Frame: Baseline to user-defined end date (variable time series design) up to 9 months ]
  4. Change in Multi-dimensional Health Locus of Control Scale scores [ Time Frame: Baseline to user-defined end date (variable time series design) up to 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Self-reported presence of fibromyalgia

Exclusion Criteria:

  • None

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): NCT02515552


Locations
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United States, Oregon
Collinge and Associates, Inc.
Eugene, Oregon, United States, 97405
Sponsors and Collaborators
Collinge and Associates, Inc.
Investigators
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Principal Investigator: William B Collinge, PhD, MPH Collinge and Associates, Inc.
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: William Collinge, PhD, President, Collinge and Associates, Inc.
ClinicalTrials.gov Identifier: NCT02515552    
Other Study ID Numbers: FM Wellness Project
First Posted: August 4, 2015    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases