Clinical trial NCT02515552: Web-Based Program for Symptom Management in Fibromyalgia
Official title: Web-Based Program for Symptom Management in Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia
Lead sponsor: Collinge and Associates, Inc.
Sponsor class: OTHER
First posted: 2015-08-04
Enrollment: 883
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: Inclusion Criteria:

* Self-reported presence of fibromyalgia

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in daily symptom Levels
timeFrame: Baseline to user-defined end date (variable time series design) up to 9 months
Secondary outcomes:
measure: Change in Fibromyalgia Impact Questionnaire scores
timeFrame: Baseline to user-defined end date (variable time series design) up to 9 months
measure: Change in Self-Efficacy for Chronic Disease Scale scores
timeFrame: Baseline to user-defined end date (variable time series design) up to 9 months
measure: Change in SF12 scores
timeFrame: Baseline to user-defined end date (variable time series design) up to 9 months
measure: Change in Multi-dimensional Health Locus of Control Scale scores
timeFrame: Baseline to user-defined end date (variable time series design) up to 9 months
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Collinge and Associates, Inc.
state: Oregon
Study officials:
affiliation: Collinge and Associates, Inc.
name: William B Collinge, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.