Measuring the Impact of an Innovative Educational Intervention in Inflammatory Arthritis
NCT ID: NCT04606810
Last Updated: 2020-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
112 participants
INTERVENTIONAL
2015-10-01
2019-10-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
Participants in group 2 first received usual care, and after 3 months were offered the intervention.
SUPPORTIVE_CARE
NONE
Study Groups
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Arm1, Participants received the multidisciplinary educational intervention at baseline
Participants in arm1 received the usual care plus the multidisciplinary educational intervention consisting of an educational DVD followed by a teleconference at baseline.
multidisciplinary educational intervention
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.
Arm2, Participants in arm2 received the educational intervention after 3 months
Participants in group 2 first received usual care, and after 3 months were offered the multidisciplinary educational intervention.
multidisciplinary educational intervention
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.
Interventions
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multidisciplinary educational intervention
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.
Eligibility Criteria
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Inclusion Criteria
* 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 answer questionnaires,
* patient unable to view a DVD at home
* patient unable to participate in a teleconference
18 Years
ALL
No
Sponsors
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Canadian Rheumatology Association
OTHER
The Arthritis Society, Canada
OTHER
Laval University
OTHER
CISSS de Chaudière-Appalaches
OTHER_GOV
Clinique Rhumatologie/Physiatrie Centre du Québec, Trois-Rivières
UNKNOWN
Centre de Rhumatologie de l'Est du Québec
OTHER
CHU de Quebec-Universite Laval
OTHER
Responsible Party
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Other Identifiers
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MP-20-2015-2242
Identifier Type: -
Identifier Source: org_study_id