Knowledge, Attitudes, PracticeNCT05284669
Effect of an E-learning Intervention on Knowledge, Attitudes and Beliefs of Healthcare Professionals Managing Low Back Pain.
A study testing Experimental e-learning and Traditional e-learning in people with Knowledge, Attitudes, Practice and Low Back Pain, run by Antoine Fourré at 1 site in Belgium.
Trial summary
The purpose of the current research project is to examine if the healthcare professionals (HCPs) knowledge, attitudes, beliefs and behavior about the management of low back pain (LBP) patients changes following an e-learning intervention (experimental interactive e-learning versus traditional non-interactive… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knowledge, Attitudes, Practice, Low Back Pain, Physical Therapy
- What is being tested?
- Experimental e-learning and Traditional e-learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,720 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Aug 2021to 1 Mar 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be an healthcare practitioner (general practitioner, physiotherapist, specialist physician, student in medicine including specialization, student in physiotherapy)
- Working or studying in Belgium or France
- Being in possession of an internet connected device (e.g. computer, tablet or smartphone) with speaker
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an E-learning Intervention on Knowledge, Attitudes and Beliefs of Healthcare Professionals Managing Low Back Pain: a Randomized Controlled Trial With Nested Process Evaluation.
The purpose of the current research project is to examine if the healthcare professionals (HCPs) knowledge, attitudes, beliefs and behavior about the management of low back pain (LBP) patients changes following an e-learning intervention (experimental interactive e-learning versus traditional non-interactive e-learning)
Read the detailed description
The purpose of the current research project is to use an e-learning educational approach to implement guideline-adherent care in first line HCPs. We aim to enhance the knowledge, attitudes, beliefs and behavior of HCPs towards a biopsychosocial approach in the management of LBP patients. We will compare the effect of an interactive e-learning intervention (i.e. experimental intervention) to an e-learning intervention without interaction (i.e. traditional intervention). Both interventions will be based on the most recent scientific literature regarding the management of LBP, but both the focus and the didactical approach will slightly differ between the interventions. We will use a mixed methods approach to gain an in-depth understanding of HCPs behavior in clinical practice.
- Being tested
- Experimental e-learning, Traditional e-learning
- Keywords
- Distance education, Musculoskeletal pain, Guideline adherence, First-line care
- Medical subject headings
- Behavior, Low Back Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental e-learningOther
Interactive lecture based on the guidelines for the management of LBP with a focus on self-management and patient's reassurance
Traditional e-learningOther
Traditional lecture based on the guidelines for the management of LBP with a focus on diagnostic triage and specific cause of LBP
| Study group | Role | What they receive |
|---|---|---|
| Experimental e-learning | Experimental | The experimental interactive intervention is based on international guidelines for the management of LBP and includes multiple interactions with the participant in a virtual environment. Metaphors and concrete clinical situations are presented to translate the knowledge (i.e. the management of low back pain from a biopsychosocial point of view) to clinical practice. Interactions consists of videos, open and closed questions and audio records. Receives: Other: Experimental e-learning |
| Traditional e-learning | Other | The traditional intervention consists of a traditional online lecture based on international guidelines for the management of LBP without any interaction. The focus is more fundamental (theoretical) without metaphors or clinical cases. Receives: Other: Traditional e-learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Health Care Providers Pain and Impairment Relationship Scale (HC-PAIRS)
The HC-PAIRS assesses attitudes and beliefs about functional expectations for patients with chronic LBP. It consists of 13 statements that must be rated on a seven-point Likert scale, ranging from 'totally disagree' to 'totally agree'. A high score on the HC-PAIRS reflects a belief with a strong relationship between pain and impairment. Psychometric properties of this questionnaire have been established.
Measured: Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)
Vignette of Rainville
The clinical vignette described a patient with non-specific LBP. This vignette was developed by Rainville. Participants were asked to assess the patient's ability to work, from 1 (full-time) to 5 (remain out of work) and gave their opinion on the appropriate level of activity, with choices graded from 1 (no limitations on activity) to 5 (limit all physical activity). If the score of the participant was between 1 and 2 it was considered guideline adherent. If the score was between 3 and 5 it was considered guidelines discordant.
Measured: Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)
Secondary outcomes (5)
The Back Pain and Attitudes Questionnaire (Back-PAQ ; 10-items version)
The Back-PAQ questionnaire (10 items version) assesses attitudes and underlying beliefs about back pain on a 5-point Likert scale. The scoring of the answers ranges from -2 to +2. A negative score reflects beliefs that are unhelpful and vice-versa. All items were written in the second person to personalize the questionnaire. The purpose of this personalization is that HCPs or students present their own beliefs rather than projecting their beliefs onto people with LBP or presenting their beliefs about people with LBP.
Measured: Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)
The Neurophysiology of Pain Questionnaire (NPQ)
The Neurophysiology of pain questionnaire (NPQ) assesses how an individual conceptualizes biological mechanisms underpinning pain. The NPQ includes 19 questions with three answer options (true; undecided; false). The scoring is 1 for a correct answer and 0 if the participant was wrong or undecided. This questionnaire was included to reflect recommendations of the guidelines for the management of LBP that encourages clinicians to explain and reassure the patient about their personal experience of pain.
Measured: Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)
Fictive clinical cases of patients with LBP
4 clinical cases were developed by a multidisciplinary team of experts in the field (general practitioners, orthopedic surgeons, physiotherapists, and academics). Two cases described the symptoms of a patient with specific LBP and the two others described the symptoms of a patient with non-specific LBP. A specific and non-specific clinical case were presented at baseline and post-intervention assessment. Participants answered 3 open questions related to the clinical case: "In your opinion, what are the causes/contributing factors to the pain of this patient?"; "As an healthcare practitioners what would be your first approach to manage this patient?"; "Which advices would you give to this patient concerning physical activity".
Coding of the answers in a matrix using keywords and themes will be used to analyse the orientation of the healthcare practitioners (guideline adherent or guideline discordant).
Measured: Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)
Experiences of HCPs with the e-learning (quantitative)
A Likert scale (1-7) will be used to examine the participants experiences regarding the content and quality of the intervention and the Technology acceptance. The questions of this survey are based on Cheng et al. 2012 and cover global system quality and technology acceptance of the e-learning. Higher score reflects a better experience with the e-learning intervention.
Measured: Post-intervention assessment (between 2 and 4 weeks after baseline)
Experiences of HCPs with the e-learning (qualitative)
A purposive sample of participants agreeing to take part in a phone interview will be invited to an in-depth interview. We foresee to start with 10 HCPs of each group (experimental and traditional e-learning intervention) to provide depth and breadth of experiences and will continue until no new themes emerge (Bowen 2008). The principles of qualitative research will be used to explore how participants experienced the e-learning intervention and which impact had the e-learning on their clinical practice.
Measured: Between 4 and 6 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 posted17 Mar 2022
- Study start27 Aug 2021
- Primary completion31 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knowledge, Attitudes, PracticeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antoine Fourré
- Sponsor type
- University, hospital or other
- Collaborators
- University of Mons, Universiteit Antwerpen, Universite de Picardie Jules Verne
- Responsible party
- Sponsor-investigator, Antoine Fourré, Universiteit Antwerpen
- Investigators
- Nathalie Roussel, PhD, Principal investigator, Universiteit AntwerpenLaurence Ris, PhD, Study director, University of MonsAntoine Fourré, MSc, Principal investigator, University of Mons / University of AntwerpRob Vanderstraeten, MSc, Principal investigator, Universiteit AntwerpenJef Michielsen, MD, PhD, Study director, Universiteit AntwerpenHilde Bastiaens, MD, PhD, Study director, Universiteit AntwerpenSybil Anthierens, PhD, Study director, Universiteit AntwerpenFrédéric Telliez, PhD, Study director, Universite de Picardie Jules Verne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284669
- Sponsor's protocol ID
- 20/51/714
- Status last verified
- May 2023
- First submitted
- 10 Mar 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fourre A, Fierens A, Michielsen J, Ris L, Dierick F, Roussel N. An interactive e-learning module to promote bio-psycho-social management of low back pain in healthcare professionals: a pilot study. J Man Manip Ther. 2022 Apr;30(2):105-115. doi: 10.1080/10669817.2021.1988397. Epub 2021 Oct 22.
PubMed 34678129
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an E-learning Intervention on Knowledge, Attitudes and Beliefs of Healthcare Professionals Managing Low Back Pain: a Randomized Controlled Trial With Nested Process Evaluation.
- ClinicalTrials.gov ID
- NCT05284669
- Acronym / sponsor ID
- 20/51/714
- Keywords
- Distance education, Musculoskeletal pain, Guideline adherence, First-line care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,720 participants (actual)
- Lead sponsor
- Antoine FourréUniversity, hospital or other
- Collaborators
- University of Mons, Universiteit Antwerpen, Universite de Picardie Jules Verne
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 17 Mar 2022 (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.
The purpose of the current research project is to examine if the healthcare professionals (HCPs) knowledge, attitudes, beliefs and behavior about the management of low back pain (LBP) patients changes following an e-learning intervention (experimental interactive e-learning versus traditional non-interactive e-learning)
Detailed description
The purpose of the current research project is to use an e-learning educational approach to implement guideline-adherent care in first line HCPs. We aim to enhance the knowledge, attitudes, beliefs and behavior of HCPs towards a biopsychosocial approach in the management of LBP patients. We will compare the effect of an interactive e-learning intervention (i.e. experimental intervention) to an e-learning intervention without interaction (i.e. traditional intervention). Both interventions will be based on the most recent scientific literature regarding the management of LBP, but both the focus and the didactical approach will slightly differ between the interventions. We will use a mixed methods approach to gain an in-depth understanding of HCPs behavior in clinical practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental e-learning | Experimental | Other: Experimental e-learningThe experimental interactive intervention is based on international guidelines for the management of LBP and includes multiple interactions with the participant in a virtual environment. Metaphors and concrete clinical situations are presented to translate the knowledge (i.e. the management of low back pain from a biopsychosocial point of view) to clinical practice. Interactions consists of videos, open and closed questions and audio records. |
| Traditional e-learning | Other | Other: Traditional e-learningThe traditional intervention consists of a traditional online lecture based on international guidelines for the management of LBP without any interaction. The focus is more fundamental (theoretical) without metaphors or clinical cases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be an healthcare practitioner (general practitioner, physiotherapist, specialist physician, student in medicine including specialization, student in physiotherapy)
- Working or studying in Belgium or France
- Being in possession of an internet connected device (e.g. computer, tablet or smartphone) with speaker
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Experimental e-learningInteractive lecture based on the guidelines for the management of LBP with a focus on self-management and patient's reassurance | Other | Experimental e-learning |
| Traditional e-learningTraditional lecture based on the guidelines for the management of LBP with a focus on diagnostic triage and specific cause of LBP | Other | Traditional e-learning |
Primary outcome
The Health Care Providers Pain and Impairment Relationship Scale (HC-PAIRS)
Time frame: Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)
The HC-PAIRS assesses attitudes and beliefs about functional expectations for patients with chronic LBP. It consists of 13 statements that must be rated on a seven-point Likert scale, ranging from 'totally disagree' to 'totally agree'. A high score on the HC-PAIRS reflects a belief with a strong relationship between pain and impairment. Psychometric properties of this questionnaire have been established.
Vignette of Rainville
Time frame: Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)
The clinical vignette described a patient with non-specific LBP. This vignette was developed by Rainville. Participants were asked to assess the patient's ability to work, from 1 (full-time) to 5 (remain out of work) and gave their opinion on the appropriate level of activity, with choices graded from 1 (no limitations on activity) to 5 (limit all physical activity). If the score of the participant was between 1 and 2 it was considered guideline adherent. If the score was between 3 and 5 it was considered guidelines discordant.
5 secondary outcomes
The Back Pain and Attitudes Questionnaire (Back-PAQ ; 10-items version)
Time frame: Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)
The Neurophysiology of Pain Questionnaire (NPQ)
Time frame: Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)
Fictive clinical cases of patients with LBP
Time frame: Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)
Experiences of HCPs with the e-learning (quantitative)
Time frame: Post-intervention assessment (between 2 and 4 weeks after baseline)
Experiences of HCPs with the e-learning (qualitative)
Time frame: Between 4 and 6 weeks after baseline
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 10 May 2023.
- Results publication: PubMed 34678129Fourre A, Fierens A, Michielsen J, Ris L, Dierick F, Roussel N. An interactive e-learning module to promote bio-psycho-social management of low back pain in healthcare professionals: a pilot study. J Man Manip Ther. 2022 Apr;30(2):105-115. doi: 10.1080/10669817.2021.1988397. Epub 2021 Oct 22.
- Website of the European project (Interreg FWVl NOMADe - N° 4.7.360)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Nathalie Roussel, PhD principal investigator
Universiteit Antwerpen
Laurence Ris, PhD study director
University of Mons
Antoine Fourré, MSc principal investigator
University of Mons / University of Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental e-learning and Traditional e-learning in people with Knowledge, Attitudes, Practice and Low Back Pain, run by Antoine Fourré at 1 site in Belgium.
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 3 inclusion and 0 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 10 May 2023. 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 Belgium. 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?
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?
The Health Care Providers Pain and Impairment Relationship Scale (HC-PAIRS) (time frame: Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)). The study lists 2 primary outcomes in all. 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 NCT05284669, which also lists 1 linked publication.
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 10 May 2023.