Measuring the Impact of an Innovative Educational Intervention in Inflammatory Arthritis

NCT04606810 | Terminated

• 1 other identifier: MP-20-2015-2242
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Keywords

Patient therapeutic education; BioSecure questionnaire; Theory of planned behavior; Beliefs about medicines questionnaire

Outcome Measures

Primary Outcomes (1)

• Change of knowledge on self-care safety skills

  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.

  Change from baseline knowledge on self-care safety skills at 3 months.

Secondary Outcomes (3)

• 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

Study Arms (2)

Arm1, Participants received the multidisciplinary educational intervention at baseline

ACTIVE COMPARATOR

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

Other: multidisciplinary educational intervention

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

OTHER

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

Other: multidisciplinary educational intervention

Interventions

multidisciplinary educational intervention OTHER

At randomization, participants in arm 1 received the educational DVD with the instruction to review its contents within the next two weeks. Between 2 and 4 weeks after randomization, reinforcement teleconferences were done in small groups of 10 participants maximum per session with every participant who mentioned having watched the DVD. Each participant attended only to one teleconference. Usual care consisted in regular follow-up with the treating rheumatologist and possibility of asking questions of the rheumatology nurse by phone.

Arm1, Participants received the multidisciplinary educational intervention at baseline; Arm2, Participants in arm2 received the educational intervention after 3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Canadian Rheumatology Association: collaborator
• The Arthritis Society, Canada: collaborator
• Laval University: collaborator
• CISSS de Chaudière-Appalaches: collaborator
• Clinique Rhumatologie/Physiatrie Centre du Québec, Trois-Rivières: collaborator
• Centre de Rhumatologie de l'Est du Québec: collaborator

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 28, 2020
• Study Start: October 1, 2015
• Primary Completion: April 30, 2019
• Study Completion: October 7, 2019
• Last Updated: October 28, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share