Web-Based Program for Symptom Management in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Web-Based Program for Symptom Management in Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515552
• Other study ID #: FM Wellness Project
• Status: Completed
• Phase: Phase 2
• First received: July 29, 2015
• Last updated: August 3, 2015
• Start date: September 2008
• Est. completion date: August 2011

Study information

• Verified date: July 2015
• Source: Collinge and Associates, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 883
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Self-reported presence of fibromyalgia

Exclusion Criteria:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
United States	Collinge and Associates, Inc.	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Collinge and Associates, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 10.4103/1947-2714.11 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in daily symptom Levels	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.	Baseline to user-defined end date (variable time series design) up to 9 months	No
Secondary	Change in Fibromyalgia Impact Questionnaire scores		Baseline to user-defined end date (variable time series design) up to 9 months	No
Secondary	Change in Self-Efficacy for Chronic Disease Scale scores		Baseline to user-defined end date (variable time series design) up to 9 months	No
Secondary	Change in SF12 scores		Baseline to user-defined end date (variable time series design) up to 9 months	No
Secondary	Change in Multi-dimensional Health Locus of Control Scale scores		Baseline to user-defined end date (variable time series design) up to 9 months	No

External Links

•   Description of the FM Wellness Project
•   Results article online (open access)