FibromyalgiaFIBROK-PILOTNCT07865767
Feasibility and Preliminary Effects of an Asynchronous Microlearning Intervention on Fibromyalgia Knowledge Among Primary Health Care Workers
A study testing Written Educational Material on Fibromyalgia and Asynchronous Microlearning Intervention on Fibromyalgia in people with Fibromyalgia and Fibromyalgia (FM), run by Instituto Neurociencia Del Dolor at 1 site in Chile.
Trial summary
This randomized controlled pilot trial will evaluate the feasibility and preliminary effects of an asynchronous microlearning intervention on fibromyalgia knowledge among Primary Health Care workers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Fibromyalgia (FM), Fibromyalgia Syndrome
- What is being tested?
- Written Educational Material on Fibromyalgia and Asynchronous Microlearning Intervention on Fibromyalgia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChile
- Study dates
- 1 Jun 2027to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PHC workers belonging to employment categories A, B, C, or D who perform clinical duties at CESFAM San Vicente.
- Currently employed and actively working at the study site during the study period.
- Access to an electronic device that allows completion of the FKQ electronically.
- Availability to participate in the activities corresponding to the assigned study group.
- Voluntary agreement to participate, documented through written informed consent.
Who cannot join
- Workers on prolonged medical leave, vacation, authorized leave, or any other administrative situation that prevents participation during the study period.
- Undergraduate students undertaking professional placements, internships, or other pre-professional training activities at the study site.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site
CESFAM San Vicente
Talcahuano, Bío-Bío, 4261461
Romualdo Ordóñez Vega, 982256426, kine.ordonez@gmail.com
About this study
Official title: "Feasibility and Preliminary Effects of an Asynchronous Microlearning Intervention on Fibromyalgia Knowledge Among Primary Health Care Workers: A Randomized Pilot Trial (FIBROK-PILOT)"
This randomized controlled pilot trial will evaluate the feasibility and preliminary effects of an asynchronous microlearning intervention on fibromyalgia knowledge among Primary Health Care workers. Participants will be randomly assigned in a 1:1 ratio to either a control group receiving evidence-based written educational material on fibromyalgia or an experimental group receiving the same written material plus an approximately 5-minute asynchronous educational microlearning video. Participants will have two weeks to review the assigned educational content. Fibromyalgia knowledge will be assessed using the Fibromyalgia Knowledge Questionnaire (FKQ) at baseline, before randomization, and two weeks later. Trial feasibility will be assessed through recruitment, retention, intervention participation, and assessment completion indicators.
Read the detailed description
Fibromyalgia is a chronic primary pain condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, cognitive difficulties, and functional limitations. Despite advances in its understanding, relevant knowledge gaps regarding its diagnosis, underlying mechanisms, and management persist among healthcare professionals. In Primary Health Care (PHC) settings, strengthening knowledge about fibromyalgia may contribute to more evidence-informed clinical practice.
FIBROK-PILOT is a randomized controlled pilot trial designed to evaluate the feasibility and preliminary effects of a brief asynchronous microlearning intervention on fibromyalgia knowledge among PHC workers at CESFAM San Vicente (San Vicente Family Health Center) in Talcahuano, Chile. The trial will use a two-arm parallel design with a 1:1 allocation ratio. The target is to randomize 68 participants (34 per group), allowing for an anticipated loss of up to 10% and aiming to obtain at least 60 post-intervention assessments.
Participants assigned to the control group will receive an evidence-based written educational document on fibromyalgia. The material will be approximately 2-4 pages in length, with an estimated reading time of 5 minutes, and will address three main areas: conceptualization and diagnosis, pathophysiological mechanisms, and pharmacological and non-pharmacological management.
Participants assigned to the experimental group will receive the same written educational material plus an approximately 5-minute asynchronous microlearning video covering the same core topics. The video will be available asynchronously, allowing participants to access it according to their availability. Both groups will have two weeks to review their assigned educational content.
Fibromyalgia knowledge will be assessed using the FQK at baseline, before randomization, and two weeks after baseline. The FKQ consists of 18 items and provides a total score ranging from 0 to 26, with higher scores indicating greater fibromyalgia knowledge. The preliminary effect of the intervention will be estimated by comparing post-intervention FKQ scores between groups while adjusting for baseline FKQ scores.
As a pilot trial, the primary focus will be on feasibility rather than confirmatory effectiveness. Feasibility will be assessed through recruitment, retention, participation in the assigned educational intervention, and completion of study assessments. The findings will be used to determine whether this educational strategy is feasible in a PHC setting and to provide preliminary estimates that may inform the design of a future definitive trial.
- Conditions
- Fibromyalgia, Fibromyalgia (FM), Fibromyalgia Syndrome
- Being tested
- Written Educational Material on Fibromyalgia, Asynchronous Microlearning Intervention on Fibromyalgia
- Keywords
- Fibromyalgia, Fibromyalgia Knowledge, Asynchronous Learning, Microlearning, Primary Health Care, Educational Intervention
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Educational Material on FibromyalgiaBehavioural
Participants will receive a 2-4 page digital educational document containing evidence-based information on fibromyalgia. The material will cover three core areas: conceptualization and diagnosis, pathophysiological mechanisms, and pharmacological and non-pharmacological management. The estimated reading time is approximately 5 minutes. The material will be available for review during a two-week period.
Asynchronous Microlearning Intervention on FibromyalgiaBehavioural
Participants assigned to the experimental arm will additionally receive an approximately 5-minute asynchronous educational microlearning video on fibromyalgia. The video will address three core areas: conceptualization and diagnosis (approximately 2 minutes), pathophysiological mechanisms (approximately 1.5 minutes), and pharmacological and non-pharmacological management (approximately 1.5 minutes). The video will be available asynchronously during the two-week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Written Educational Material on Fibromyalgia | Active comparator | Participants assigned to the control group will receive evidence-based written educational material on fibromyalgia. The material will consist of a 2-4 page digital document with an estimated reading time of approximately 5 minutes, covering fibromyalgia conceptualization and diagnosis, pathophysiological mechanisms, and pharmacological and non-pharmacological management. Participants will have two weeks to review the material. Receives: Behavioral: Written Educational Material on Fibromyalgia |
| Written Educational Material on Fibromyalgia and Asynchronous Microlearning Intervention on Fibromya | Experimental | Participants assigned to the experimental group will receive the same evidence-based written educational material provided to the control group, plus an approximately 5-minute asynchronous educational microlearning video. The video will cover key aspects of fibromyalgia conceptualization and diagnosis, pathophysiological mechanisms, and pharmacological and non-pharmacological management. Participants will have two weeks to review the assigned educational content. Receives: Behavioral: Written Educational Material on Fibromyalgia; Behavioral: Asynchronous Microlearning Intervention on Fibromyalgia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Proportion of eligible invited PHC workers who provide informed consent and are randomized. Calculated as the number of participants randomized divided by the total number of eligible workers invited, multiplied by 100. Higher percentages indicate greater recruitment feasibility.
Measured: From start of recruitment until completion of recruitment, up to 3 months
Retention rate
Proportion of randomized participants who complete the post-intervention assessment. Calculated as the number of participants completing the post-intervention assessment divided by the total number randomized, multiplied by 100. Higher percentages indicate greater retention feasibility.
Measured: 2 weeks after baseline and randomization
Assessment Completion Rate
Proportion of scheduled FKQ assessments completed by participants. Completion will be assessed for the baseline and post-intervention evaluations. Higher percentages indicate greater assessment feasibility.
Measured: Baseline and 2 weeks after baseline
Intervention participation rate
Participation in the assigned educational intervention. Receipt of the written educational material will be recorded in both groups. In the experimental group, access to and completion of the asynchronous microlearning video will also be recorded using available platform data or participant self-report when platform data are unavailable.
Measured: During the 2-week intervention period
Secondary outcomes (1)
FKQ Total Score
Fibromyalgia knowledge will be assessed using the FKQ, an 18-item questionnaire with a total score ranging from 0 to 26 points. Higher scores indicate greater knowledge about fibromyalgia. The preliminary intervention effect will be estimated by comparing post-intervention FKQ total scores between groups, adjusted for baseline FKQ scores.
Measured: Baseline and 2 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Jun 2027 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group randomized controlled pilot trial with a 1:1 allocation ratio. Participants will be randomly assigned to either a control group receiving evidence-based written educational material on fibromyalgia or an experimental group receiving the same written material plus an approximately 5-minute asynchronous microlearning video. Both groups will have two weeks to review the assigned educational content.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Neurociencia Del Dolor
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alcala, Pontificia Universidad Catolica de Valparaiso
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865767
- Sponsor's protocol ID
- FIBROK-PILOT
- Acronym
- FIBROK-PILOT
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the informed consent and the current study protocol do not include provisions for sharing individual-level data with external researchers. Study results will be disseminated in aggregate form to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Feasibility and Preliminary Effects of an Asynchronous Microlearning Intervention on Fibromyalgia Knowledge Among Primary Health Care Workers: A Randomized Pilot Trial (FIBROK-PILOT)"
- ClinicalTrials.gov ID
- NCT07865767
- Acronym / sponsor ID
- FIBROK-PILOT / FIBROK-PILOT
- Conditions
- Fibromyalgia, Fibromyalgia (FM), Fibromyalgia Syndrome
- Keywords
- Fibromyalgia, Fibromyalgia Knowledge, Asynchronous Learning, Microlearning, Primary Health Care, Educational Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Instituto Neurociencia Del DolorUniversity, hospital or other
- Collaborators
- University of Alcala, Pontificia Universidad Catolica de Valparaiso
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- 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.
This randomized controlled pilot trial will evaluate the feasibility and preliminary effects of an asynchronous microlearning intervention on fibromyalgia knowledge among Primary Health Care workers. Participants will be randomly assigned in a 1:1 ratio to either a control group receiving evidence-based written educational material on fibromyalgia or an experimental group receiving the same written material plus an approximately 5-minute asynchronous educational microlearning video. Participants will have two weeks to review the assigned educational content. Fibromyalgia knowledge will be assessed using the Fibromyalgia Knowledge Questionnaire (FKQ) at baseline, before randomization, and two weeks later. Trial feasibility will be assessed through recruitment, retention, intervention participation, and assessment completion indicators.
Detailed description
Fibromyalgia is a chronic primary pain condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, cognitive difficulties, and functional limitations. Despite advances in its understanding, relevant knowledge gaps regarding its diagnosis, underlying mechanisms, and management persist among healthcare professionals. In Primary Health Care (PHC) settings, strengthening knowledge about fibromyalgia may contribute to more evidence-informed clinical practice.
FIBROK-PILOT is a randomized controlled pilot trial designed to evaluate the feasibility and preliminary effects of a brief asynchronous microlearning intervention on fibromyalgia knowledge among PHC workers at CESFAM San Vicente (San Vicente Family Health Center) in Talcahuano, Chile. The trial will use a two-arm parallel design with a 1:1 allocation ratio. The target is to randomize 68 participants (34 per group), allowing for an anticipated loss of up to 10% and aiming to obtain at least 60 post-intervention assessments.
Participants assigned to the control group will receive an evidence-based written educational document on fibromyalgia. The material will be approximately 2-4 pages in length, with an estimated reading time of 5 minutes, and will address three main areas: conceptualization and diagnosis, pathophysiological mechanisms, and pharmacological and non-pharmacological management.
Participants assigned to the experimental group will receive the same written educational material plus an approximately 5-minute asynchronous microlearning video covering the same core topics. The video will be available asynchronously, allowing participants to access it according to their availability. Both groups will have two weeks to review their assigned educational content.
Fibromyalgia knowledge will be assessed using the FQK at baseline, before randomization, and two weeks after baseline. The FKQ consists of 18 items and provides a total score ranging from 0 to 26, with higher scores indicating greater fibromyalgia knowledge. The preliminary effect of the intervention will be estimated by comparing post-intervention FKQ scores between groups while adjusting for baseline FKQ scores.
As a pilot trial, the primary focus will be on feasibility rather than confirmatory effectiveness. Feasibility will be assessed through recruitment, retention, participation in the assigned educational intervention, and completion of study assessments. The findings will be used to determine whether this educational strategy is feasible in a PHC setting and to provide preliminary estimates that may inform the design of a future definitive trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group randomized controlled pilot trial with a 1:1 allocation ratio. Participants will be randomly assigned to either a control group receiving evidence-based written educational material on fibromyalgia or an experimental group receiving the same written material plus an approximately 5-minute asynchronous microlearning video. Both groups will have two weeks to review the assigned educational content.
| Arm | Type | Receives |
|---|---|---|
| Written Educational Material on Fibromyalgia | Active comparator | Behavioral: Written Educational Material on FibromyalgiaParticipants assigned to the control group will receive evidence-based written educational material on fibromyalgia. The material will consist of a 2-4 page digital document with an estimated reading time of approximately 5 minutes, covering fibromyalgia conceptualization and diagnosis, pathophysiological mechanisms, and pharmacological and non-pharmacological management. Participants will have two weeks to review the material. |
| Written Educational Material on Fibromyalgia and Asynchronous Microlearning Intervention on Fibromya | Experimental | Behavioral: Written Educational Material on Fibromyalgia, Behavioral: Asynchronous Microlearning Intervention on FibromyalgiaParticipants assigned to the experimental group will receive the same evidence-based written educational material provided to the control group, plus an approximately 5-minute asynchronous educational microlearning video. The video will cover key aspects of fibromyalgia conceptualization and diagnosis, pathophysiological mechanisms, and pharmacological and non-pharmacological management. Participants will have two weeks to review the assigned educational content. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- PHC workers belonging to employment categories A, B, C, or D who perform clinical duties at CESFAM San Vicente.
- Currently employed and actively working at the study site during the study period.
- Access to an electronic device that allows completion of the FKQ electronically.
- Availability to participate in the activities corresponding to the assigned study group.
- Voluntary agreement to participate, documented through written informed consent.
Key exclusion criteria (2 listed)
- Workers on prolonged medical leave, vacation, authorized leave, or any other administrative situation that prevents participation during the study period.
- Undergraduate students undertaking professional placements, internships, or other pre-professional training activities at the study site.
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 |
|---|---|---|
| Written Educational Material on FibromyalgiaParticipants will receive a 2-4 page digital educational document containing evidence-based information on fibromyalgia. The material will cover three core areas: conceptualization and diagnosis, pathophysiological mechanisms, and pharmacological and non-pharmacological management. The estimated reading time is approximately 5 minutes. The material will be available for review during a two-week period. | Behavioural | Written Educational Material on Fibromyalgia, Written Educational Material on Fibromyalgia and Asynchronous Microlearning Intervention on Fibromya |
| Asynchronous Microlearning Intervention on FibromyalgiaParticipants assigned to the experimental arm will additionally receive an approximately 5-minute asynchronous educational microlearning video on fibromyalgia. The video will address three core areas: conceptualization and diagnosis (approximately 2 minutes), pathophysiological mechanisms (approximately 1.5 minutes), and pharmacological and non-pharmacological management (approximately 1.5 minutes). The video will be available asynchronously during the two-week intervention period. | Behavioural | Written Educational Material on Fibromyalgia and Asynchronous Microlearning Intervention on Fibromya |
Primary outcome
Recruitment rate
Time frame: From start of recruitment until completion of recruitment, up to 3 months
Proportion of eligible invited PHC workers who provide informed consent and are randomized. Calculated as the number of participants randomized divided by the total number of eligible workers invited, multiplied by 100. Higher percentages indicate greater recruitment feasibility.
Retention rate
Time frame: 2 weeks after baseline and randomization
Proportion of randomized participants who complete the post-intervention assessment. Calculated as the number of participants completing the post-intervention assessment divided by the total number randomized, multiplied by 100. Higher percentages indicate greater retention feasibility.
Assessment Completion Rate
Time frame: Baseline and 2 weeks after baseline
Proportion of scheduled FKQ assessments completed by participants. Completion will be assessed for the baseline and post-intervention evaluations. Higher percentages indicate greater assessment feasibility.
Intervention participation rate
Time frame: During the 2-week intervention period
Participation in the assigned educational intervention. Receipt of the written educational material will be recorded in both groups. In the experimental group, access to and completion of the asynchronous microlearning video will also be recorded using available platform data or participant self-report when platform data are unavailable.
1 secondary outcome
FKQ Total Score
Time frame: Baseline and 2 weeks after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the informed consent and the current study protocol do not include provisions for sharing individual-level data with external researchers. Study results will be disseminated in aggregate form to protect participant confidentiality.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written Educational Material on Fibromyalgia and Asynchronous Microlearning Intervention on Fibromyalgia in people with Fibromyalgia and Fibromyalgia (FM), run by Instituto Neurociencia Del Dolor at 1 site in Chile.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 13 Oct 2026. 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 Chile. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romualdo Luciano Ordóñez Vega, Master, and PhD student (982256426, kine.ordonez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: From start of recruitment until completion of recruitment, up to 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.