NCT02515552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
883

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
Last Updated

August 4, 2015

Status Verified

July 1, 2015

Enrollment Period

2.9 years

First QC Date

July 29, 2015

Last Update Submit

August 3, 2015

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Change in Fibromyalgia Impact Questionnaire scores

    Baseline to user-defined end date (variable time series design) up to 9 months

  • 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 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

Study Arms (1)

All applicants

OTHER

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.

Behavioral: The Fibromyalgia Wellness Project

Interventions

The Fibromyalgia Wellness ProjectBEHAVIORAL

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.

All applicants

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-reported presence of fibromyalgia

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Collinge and Associates, Inc.

Eugene, Oregon, 97405, United States

Location

Related Publications (2)

  • 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.

    PMID: 24251273RESULT

  • 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.

    PMID: 32131045DERIVED

Related Links

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • William B Collinge, PhD, MPH

    Collinge and Associates, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

July 29, 2015

First Posted

August 4, 2015

Study Start

September 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

August 4, 2015

Record last verified: 2015-07

Locations

US(1)