Web-Based Program for Symptom Management in Fibromyalgia

Collinge and Associates

Status and phase: Completed; Phase 2

Conditions: Fibromyalgia

Treatments: Behavioral: The Fibromyalgia Wellness Project

Study type: Interventional

Funder types: Other

Identifiers

NCT02515552

FM Wellness Project

Details and patient eligibility

About

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.

Full 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.

Enrollment: 883 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Self-reported presence of fibromyalgia

Exclusion criteria

• None

Trial design

883 participants in 1 patient group

All applicants

Other group

Description:

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.

Treatment:

Behavioral: The Fibromyalgia Wellness Project