Measuring the impact of an educational intervention in rheumatoid arthritis: An open-label, randomized trial
Laëtitia Michou1,2,3, Anne-Sophie Julien4, Holly O. Witteman5, Jean Légaré6, Lucie Ratelle1, Alexandra Godbout1, Johanne Tardif3, Suzanne Côté3, Geneviève Boily3, Rebecca Lui3, Alena Ikic2,3, Judith Trudeau7, Jean-Luc Tremblay8, Isabelle Fortin9, Louis Bessette1,2,3, Anne-Laure Chetaille1,2,3, Paul R Fortin1,2,3
1CHU de Québec-Université Laval Research Centre, Québec (Québec) Canada
2Department of Medicine, Division of Rheumatology, Université Laval, Québec (Québec) Canada
3CHU de Québec-Université Laval, Québec (Québec) Canada
4Department of Mathematics and statistics, Université Laval, Québec (Québec) Canada
5Department of Family Medicine and Emergency Medicine, Faculty of Medicine, Université Laval, Québec (Québec) Canada
6Arthritis Alliance of Canada, Québec (Québec) Canada
7Department of Rheumatology, Hôtel-Dieu de Lévis, Lévis, (Québec) Canada
8Clinique de Rhumatologie du Centre du Québec, Trois-Rivières, (Québec) Canada
9Centre de Rhumatologie de l’Est du Québec, Rimouski, (Québec) Canada
Keywords: Health behaviors, patient education, rheumatoid arthritis, questionnaire
Objectives: This study aims to determine whether patients with active rheumatoid arthritis (RA), either starting on or changing biological or targeted synthetic disease-modifying antirheumatic drugs (DMARDs), demonstrate better self-management safety skills three months after receiving a multidisciplinary educational intervention compared to patients receiving usual care.
Patients and methods: Between October 2015 and October 2018 , this open-label, randomized-controlled trial included a total of 107 RA patients (27 males, 80 females; mean age: 60.2±10.4 years; range, 54 to 71 years) who were on treatment or in whom treatment was changed with a biological or targeted synthetic DMARD. The patients were randomized into two groups: Group 1 (n=57) received additional intervention with educational DVD and one teleconference session and Group 2 (n=55) received usual care and were offered the intervention at three months. All patients underwent a final visit at six months. At each visit, the patients completed the BioSecure questionnaire measuring the self-care safety skills, a behavioral intention questionnaire, and the Beliefs about Medicines Questionnaire (BMQ).
Results: No significant difference was observed in the Biosecure score at three months between the two groups (p=0.08). After pooling the first three-month data in Group 1 and the last three-month data in Group 2, the mean score of the BioSecure questionnaire increased to 7.10±0.92 in the group receiving educational intervention (p<0.0001). This increase was maintained at six months in Group 2 (p=0.88). The rate of appropriate behavioral intention increased over time (76% at baseline and 85% at six months for both groups). There was no significant change in the BMQ (p=0.44 to 0.84).
Conclusion: The development of an educational DVD followed by a teleconference seem to improve self-care safety skills of the patients in practical situations.
Citation: Michou L, Julien AS, Witteman HO, Légaré J, Ratelle J, Godbout A, et al. Measuring the impact of an educational intervention in rheumatoid arthritis: An open-label, randomized trial. Arch Rheumatol 2022;37(2):169-179.
The study protocol was approved by the CHU de Québec-Université Laval Ethics Committee (MP-20-2015-2242). The study was conducted in accordance with the principles of the Declaration of Helsinki.
A written informed consent was obtained from each patient.
Data Sharing Statement: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Study design: LM, HOW, PRF. Patient recruitment and acquisition of data: LM, LR, AG, JT, SC, GB, RL, AI, JT, JLT, IF, LB, ALC, PRF. Analysis and interpretation of data: ASJ, LM, HOW, JL, JT, SC, GB, RL, AI, JT, JLT, IF, LB, ALC, PRF. Revision of manuscript content: all authors. Approving final version of manuscript: all authors. LM takes responsibility for the integrity of the data analysis.
The authors declared no conflicts of interest with respect to the authorship and/or publication of this article.
Dr. Michou is supported by a career award from the Fonds de recherche du Québec-Santé. HOW is Dr Witteman supported by a Tier 2 Canada Research Chair in Human-Centred Digital Health. Dr. Fortin is supported by a Tier 1 Canada Research Chair on Systemic Autoimmune Rheumatic Diseases. This study was funded by a CIORA grant from the Canadian Rheumatology Association and by The Arthritis Society through Rheumatic Health Unit fundings.
We would like to thank Dr Laure Gossec and Dr Catherine Beauvais from the French Rheumatology Society for helpful discussions on the BioSecure questionnaire and the CHU de QuébecUniversité Laval hospital for allowing the participation of healthcare professionals to our research project. We also would like to thank Mrs Muriel Kelly for the manuscript revision.