Clinical trial NCT04606810: Measuring the Impact of an Innovative Educational Intervention in Inflammatory Arthritis
Official title: Measuring the Impact of an Innovative Educational Intervention in Inflammatory Arthritis: a Natural Evolution of the Centre Hospitalier Universitaire (CHU) de Québec's Multidisciplinary Information Session
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Patient therapeutic education
BioSecure questionnaire
Theory of planned behavior
Beliefs about medicines questionnaire
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Canadian Rheumatology Association
name: The Arthritis Society, Canada
name: Laval University
name: CISSS de Chaudière-Appalaches
name: Clinique Rhumatologie/Physiatrie Centre du Québec, Trois-Rivières
name: Centre de Rhumatologie de l'Est du Québec
First posted: 2020-10-28
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Participants in group 1 received the usual care plus the multidisciplinary educational intervention at baseline.

Participants in group 2 first received usual care, and after 3 months were offered the intervention.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Self-management is critical for patients with chronic conditions such as rheumatoid arthritis. Such management requires that patients understand what to do to best manage their condition. This study will use a randomized controlled study design to evaluate the impact of a new educational intervention consisting of an educational digital video disc (DVD) and a self-management support session/teleconference with a multidisciplinary team of health care providers for patients (n=150) with active rheumatoid arthritis (RA) starting on or changing biologic agents. This study aims to test whether this intervention improves behavioural intentions, knowledge, and medication adherence three months post-intervention and whether acquired knowledge is retained six months after the intervention. This project will allow to quantify the impact of the educational intervention on patients' behavioural intentions in practical situations using an existing validated questionnaire called BioSecure. The impact of the educational intervention on disease-specific knowledge and on medication adherence will be evaluated using validated questionnaires.

Detailed description: The primary objective of this study was to determine whether patients with active RA starting or changing biological agents demonstrate better self-care safety skills in practical situations using the BioSecure questionnaire three months after receiving a multidisciplinary educational intervention, as compared to patients who received usual care. The secondary objectives were to assess the impact of the educational intervention on behavioral intentions and beliefs and adherence to RA medications in patients receiving the intervention compared to usual care.

Trial design This was a pilot, unblinded, randomized study. Participants in group 1 received the usual care plus the multidisciplinary educational intervention at baseline. Participants in group 2 first received usual care, and after 3 months were offered the intervention. The patients' self-care safety skills was measured using the BioSecure questionnaire, and the behavioral intentions and beliefs with respect to medications was assessed using structured questionnaires at baseline, 3 and 6 months. With the participant authorization, data on RA medication adherence, i.e. biological agents and other non-biologic Disease-modifying anti-rheumatic drugs (nbDMARDs) was obtained for the 3 months preceding enrollment and up to 6 months afterwards using their pharmacy records.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years and had a diagnosis of RA,
* with active disease as per rheumatologist evaluation,
* having received a trial of two traditional nbDMARDs therapy, and
* who requires the addition or change of a biological agent

Exclusion Criteria:

* patient unable to consent,
* patient unable to answer questionnaires,
* patient unable to view a DVD at home
* patient unable to participate in a teleconference

Primary outcomes:
measure: Change of knowledge on self-care safety skills
timeFrame: Change from baseline knowledge on self-care safety skills at 3 months.
Secondary outcomes:
measure: Change of behavioral intention
timeFrame: Change of baseline behavioral intention at 6 months.
measure: Change of medication beliefs
timeFrame: Change of baseline medication beliefs at 6 months.
measure: Change of medication adherence
timeFrame: Change of medication adherence from 3 months before the study to 6 months
Other outcomes:
Locations:
Study officials:
References: