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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- CHU de Quebec-Universite Laval
- Enrollment
- 112
- Primary Endpoint
- Change of knowledge on self-care safety skills
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change of knowledge on self-care safety skills
Time Frame: Change from baseline knowledge on self-care safety skills at 3 months.
To measure the knowledge on self-care safety skills, the BioSecure questionnaire was used. This 55-item questionnaire measures the self-care safety skills of patients treated by biologic agent by the use of both knowledge and coping items. This questionnaire mainly contains true or false questions to assess patient's knowledge. Each good answer is given one point. The sum of points is then transformed into a percentage. A value of 100% represents a patient with perfect knowledge.
Secondary Outcomes
- Change of behavioral intention(Change of baseline behavioral intention at 6 months.)
- Change of medication beliefs(Change of baseline medication beliefs at 6 months.)
- Change of medication adherence(Change of medication adherence from 3 months before the study to 6 months)