Web-Based Program for Symptom Management in Fibromyalgia

NCT ID: NCT02515552

Last Updated: 2015-08-04

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

883 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

The Fibromyalgia Wellness Project

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Self-reported presence of fibromyalgia

Exclusion Criteria

* None
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Collinge and Associates, Inc.

OTHER

Sponsor Role lead

Responsible Party

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William Collinge, PhD

President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William B Collinge, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Collinge and Associates, Inc.

Locations

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Collinge and Associates, Inc.

Eugene, Oregon, United States

Site Status

Countries

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United States

References

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Collinge W, Yarnold P, Soltysik R. Fibromyalgia Symptom Reduction by Online Behavioral Self-monitoring, Longitudinal Single Subject Analysis and Automated Delivery of Individualized Guidance. N Am J Med Sci. 2013 Sep;5(9):546-53. doi: 10.4103/1947-2714.118920.

Reference Type RESULT
PMID: 24251273 (View on PubMed)

Collinge W, Soltysik R, Yarnold P. Fibromyalgia Impact Reduction Using Online Personal Health Informatics: Longitudinal Observational Study. J Med Internet Res. 2020 Apr 7;22(4):e15819. doi: 10.2196/15819.

Reference Type DERIVED
PMID: 32131045 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3818828/

Results article online (open access)

Other Identifiers

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FM Wellness Project

Identifier Type: -

Identifier Source: org_study_id

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