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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05284669
Other study ID # 20/51/714
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 27, 2021
Est. completion date March 1, 2023

Study information

Verified date May 2023
Source Universiteit Antwerpen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 e-learning)


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.


Recruitment information / eligibility

Status Completed
Enrollment 2720
Est. completion date March 1, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Experimental e-learning
Interactive lecture based on the guidelines for the management of LBP with a focus on self-management and patient's reassurance
Traditional e-learning
Traditional lecture based on the guidelines for the management of LBP with a focus on diagnostic triage and specific cause of LBP

Locations

Country Name City State
Belgium Online study Brussels

Sponsors (4)

Lead Sponsor Collaborator
Antoine Fourré Universiteit Antwerpen, University of Mons, University of Picardie Jules Verne

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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: 10.1080/10 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)
Primary 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. Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)
Secondary 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. Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)
Secondary 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. Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)
Secondary 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).
Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)
Secondary 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. Post-intervention assessment (between 2 and 4 weeks after baseline)
Secondary 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. Between 4 and 6 weeks after baseline
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