- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05284669
Effect of an E-learning Intervention on Knowledge, Attitudes and Beliefs of Healthcare Professionals Managing Low Back Pain.
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium
- Online Study
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental e-learning
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.
|
Interactive lecture based on the guidelines for the management of LBP with a focus on self-management and patient's reassurance
|
|
Other: Traditional e-learning
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.
|
Traditional lecture based on the guidelines for the management of LBP with a focus on diagnostic triage and specific cause of LBP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)
|
|
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.
|
Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 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.
|
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)
|
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.
|
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)
|
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). |
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)
|
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.
|
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
|
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.
|
Between 4 and 6 weeks after baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nathalie Roussel, PhD, Universiteit Antwerpen
- Study Director: Laurence Ris, PhD, University of Mons
- Principal Investigator: Antoine Fourré, MSc, University of Mons / University of Antwerp
- Principal Investigator: Rob Vanderstraeten, MSc, Universiteit Antwerpen
- Study Director: Jef Michielsen, MD, PhD, Universiteit Antwerpen
- Study Director: Hilde Bastiaens, MD, PhD, Universiteit Antwerpen
- Study Director: Sybil Anthierens, PhD, Universiteit Antwerpen
- Study Director: Frédéric Telliez, PhD, Université de Picardie Jules Verne
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20/51/714
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
-
University of Kansas Medical CenterCompletedLower Back Pain | Low Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, Postural | Postural Low Back Pain | Mechanical Low Back Pain | Low Back Ache | Recurrent Low Back Pain | Lower Back Pain Chronic | Low Back Pain, Posterior Compartment | Low BackacheUnited States
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
Istanbul UniversityIstinye UniversityCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, PosturalTurkey
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
General Incorporated Foundation Ryukyuseimeisaiseikai...CompletedChronic Low Back Pain | Non-specific Low Back Pain | Low Back Pain (LBP)Japan
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
MMJ Labs LLCNational Institute on Drug Abuse (NIDA); Sport and Spine Rehab Clinical Research...CompletedChronic Low-back Pain | Pain, Intractable | Acute Low-back PainUnited States
-
Bern University of Applied SciencesUniversity of Zurich; University of Southern Denmark; University of Applied Sciences...Not yet recruitingAcute Low Back Pain | Chronic Low Back Pain (CLBP)
Clinical Trials on Experimental e-learning
-
University of Sao Paulo General HospitalLuiz Aparecido Bortolotto; Chao Lung Wen; Margarida Vieira; Miriam Harume Tsunemi; Isabela Ribeiro Braga Fistarol and other collaboratorsCompletedHypertension, Resistant to Conventional Therapy | Medication Nonadherence
-
McMaster UniversityCompleted
-
Sultan Qaboos Comprehensive Cancer CenterNot yet recruiting
-
University GhentCompletedVascular DiseaseBelgium
-
Universitätsklinikum Hamburg-EppendorfGerman Cancer Research CenterRecruiting
-
University GhentRecruitingSuicide PreventionBelgium
-
University of Lausanne HospitalsCompletedAcute Myocardial InfarctionSwitzerland
-
National Taipei University of Nursing and Health...Ministry of Science and Technology, TaiwanEnrolling by invitationPregnancy | Gestational Age and Weight Conditions | Literacy | Eating Behaviors | E-learningTaiwan
-
Vilnius UniversityEnrolling by invitationFood Allergy in Children | Food Allergy in InfantsLithuania
-
Centre Hospitalier Universitaire VaudoisRecruitingAutism Spectrum DisorderSwitzerland