- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04606810
Measuring the Impact of an Innovative Educational Intervention in Inflammatory Arthritis (I3A)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 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.
|
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.
|
OTHER: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from baseline knowledge on self-care safety skills at 3 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of behavioral intention
Time Frame: Change of baseline behavioral intention at 6 months.
|
According to published data on the Theory of Planned Behavior, a questionnaire to evaluate behavioral intention was developed, focussing on the appropriate or inappropriate intention to take an injection of a biologic agent while presenting symptoms of infection.
It comprises 12 questions to be answered by the use of a 7-point Likert scale, from "Completely disagree" to "Completely agree".
High values correspond to good attitude, norm, control or intention.
There were 2 questions on attitude, 6 questions on perceived norms, 2 questions on perceived behavioral control, 1 question on intention, and 1 question on past behavior.
Intention was dichotomized for analysis purpose, with values 1 to 3 considered as health-promoting intentions, while values 4 to 7 were health-damaging intentions.
|
Change of baseline behavioral intention at 6 months.
|
Change of medication beliefs
Time Frame: Change of baseline medication beliefs at 6 months.
|
For medication beliefs, the Belief about Medicines Questionnaire (BMQ) was adapted from the literature to RA medication.
This questionnaire consists of 18 questions to evaluate the four sub-scales of the BMQ, ie specific-necessity (5 questions), specific-concern (5 questions), general-harm (4 questions), and general-overuse (4 questions), to be completed by selecting one item among five choices from "completely agree" to "completely disagree".
The score of each subscale is the sum of its items, and thus has a maximum value of 25 or 20 points depending on its number of items.
A high value corresponds to greater necessity, concern, harm or overuse.
|
Change of baseline medication beliefs at 6 months.
|
Change of medication adherence
Time Frame: Change of medication adherence from 3 months before the study to 6 months
|
Medication adherence was assessed using pharmacy records data.
The proportion of adherence was calculated by dividing the quantity received by the quantity prescribed, separately for biologic agents and nbDMARDs, for each month starting 3 months before enrolment until 6 months after.
For each time period (3 months before the study to baseline, baseline to 3 months, and 3 months to 6 months), the mean proportion of adherence per medication was then calculated taking the mean of all months included in each of the three periods.
For each of these periods, the patient was considered to be adherent if the mean was equal to 100%.
However, sensitivity analyses for adherence were also conducted using a threshold greater or equal to 80%, which is used in most clinical studies
|
Change of medication adherence from 3 months before the study to 6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP-20-2015-2242
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rheumatoid Arthritis
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
National Institute of Arthritis and Musculoskeletal...Children's Hospital Medical Center, CincinnatiCompleted
-
University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedRheumatoid Arthritis | Juvenile Rheumatoid ArthritisUnited States
-
University of Missouri-ColumbiaCompletedJuvenile Rheumatoid ArthritisUnited States
-
Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
-
Amsterdam UMC, location VUmcEuropean CommissionCompletedRheumatoId ArthritisNetherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
Clinical Trials on multidisciplinary educational intervention
-
Instituto Nacional de Cancerologia de MexicoInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; Instituto... and other collaboratorsRecruitingBreast NeoplasmMexico
-
Sykehuset Innlandet HFUniversity of BergenCompletedMusculoskeletal DiseasesNorway
-
Aveiro UniversityFundação para a Ciência e a TecnologiaCompleted
-
Consorci Sanitari del MaresmeCompleted
-
Consorci Sanitari del MaresmeActive, not recruitingFrailty | Sarcopenia | Muscle StrenghSpain
-
University of British ColumbiaInterior Health; Canadian Rheumatology AssociationCompleted
-
University of Sao PauloFederal University of São Paulo; Universidade de Campinas; Universidad Nacional...Unknown
-
Basque Health ServiceUnknownHeart Failure | Pulmonary Disease, Chronic ObstructiveSpain
-
University Hospital, GhentVZW kinderkankerfonds, BelgiumRecruitingRehabilitation | Exercise Therapy | Cancer SurvivorsBelgium
-
Soroka University Medical CenterTerminated