Skip to main content
OpenTrials
Completed

NCT Number: NCT02515552

Web-Based Program for Symptom Management in Fibromyalgia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Collinge and Associates, Inc.

Eugene, Oregon, 97405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-reported presence of fibromyalgia

Exclusion criteria

  • None

Treatment and study plan

The Fibromyalgia Wellness Project

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Collinge and Associates, Inc.

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 4, 2015
Registry last updated
Aug 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.