Measuring the Impact of an Innovative Educational Intervention in Inflammatory Arthritis (I3A)

Laval University

Status: Terminated

Conditions: Rheumatoid Arthritis

Treatments: Other: multidisciplinary educational intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04606810

MP-20-2015-2242

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Arm1, Participants received the multidisciplinary educational intervention at baseline

Active Comparator group

Description:

Participants in arm1 received the usual care plus the multidisciplinary educational intervention consisting of an educational DVD followed by a teleconference at baseline.

Treatment:

Other: multidisciplinary educational intervention

Arm2, Participants in arm2 received the educational intervention after 3 months

Other group

Description:

Participants in group 2 first received usual care, and after 3 months were offered the multidisciplinary educational intervention.

Treatment:

Other: multidisciplinary educational intervention