Web-Based Program for Symptom Management in Fibromyalgia

Phase 2

Completed

• Conditions: Fibromyalgia
• Interventions: Behavioral: The Fibromyalgia Wellness Project

• Registration Number: NCT02515552
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2015-07
• Study First Submitted: 2015-07-29
• Study First Submitted QC: 2015-08-03
• Last Update Submitted: 2015-08-03
• Study First Posted: 2015-08-04
• Last Update Posted: 2015-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 883

Inclusion Criteria

• Self-reported presence of fibromyalgia

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All applicants	The Fibromyalgia Wellness Project	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.

Primary Outcome Measures

Name	Time	Method
Change in daily symptom Levels	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

Name	Time	Method
Change in Self-Efficacy for Chronic Disease Scale scores	Baseline to user-defined end date (variable time series design) up to 9 months
Change in Fibromyalgia Impact Questionnaire scores	Baseline to user-defined end date (variable time series design) up to 9 months
Change in SF12 scores	Baseline to user-defined end date (variable time series design) up to 9 months
Change in Multi-dimensional Health Locus of Control Scale scores	Baseline to user-defined end date (variable time series design) up to 9 months

Trial Locations

Locations (1)

Collinge and Associates, Inc.; 🇺🇸 Eugene, Oregon, United States