FibromyalgiaPhase 2NCT02515552
Web-Based Program for Symptom Management in Fibromyalgia
A Phase 2 study testing The Fibromyalgia Wellness Project in people with Fibromyalgia, run by Collinge and Associates, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- The Fibromyalgia Wellness Project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 883 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported presence of fibromyalgia
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- The Fibromyalgia Wellness Project
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Fibromyalgia Wellness ProjectBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: The Fibromyalgia Wellness Project |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to user-defined end date (variable time series design) up to 9 months
Secondary outcomes (4)
Change in Fibromyalgia Impact Questionnaire scores
Measured: Baseline to user-defined end date (variable time series design) up to 9 months
Change in Self-Efficacy for Chronic Disease Scale scores
Measured: Baseline to user-defined end date (variable time series design) up to 9 months
Change in SF12 scores
Measured: Baseline to user-defined end date (variable time series design) up to 9 months
Change in Multi-dimensional Health Locus of Control Scale scores
Measured: Baseline to user-defined end date (variable time series design) up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startSep 2008
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 883 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collinge and Associates, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Collinge, PhD, Collinge and Associates, Inc.
- Investigators
- William B Collinge, PhD, MPH, Principal investigator, Collinge and Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515552
- Sponsor's protocol ID
- FM Wellness Project
- Status last verified
- Jul 2015
- First submitted
- 29 Jul 2015
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24251273Collinge 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.
PubMed 32131045
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-Based Program for Symptom Management in Fibromyalgia
- ClinicalTrials.gov ID
- NCT02515552
- Acronym / sponsor ID
- FM Wellness Project
- Conditions
- Fibromyalgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 883 participants (actual)
- Lead sponsor
- Collinge and Associates, Inc.University, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All applicants | Other | Behavioral: The Fibromyalgia Wellness ProjectStudy 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Self-reported presence of fibromyalgia
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Fibromyalgia Wellness ProjectWeb-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. | Behavioural | All applicants |
Primary outcome
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.
4 secondary outcomes
Change in Fibromyalgia Impact Questionnaire scores
Time frame: Baseline to user-defined end date (variable time series design) up to 9 months
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
Change in SF12 scores
Time frame: Baseline to user-defined end date (variable time series design) up to 9 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
- Results publication: PubMed 24251273Collinge 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.
- Derived from this study: PubMed 32131045Collinge 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.
- Results article online (open access)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William B Collinge, PhD, MPH principal investigator
Collinge and Associates, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing The Fibromyalgia Wellness Project in people with Fibromyalgia, run by Collinge and Associates, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily symptom Levels (time frame: Baseline to user-defined end date (variable time series design) up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02515552, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2015.