Rheumatoid ArthritisI3ANCT04606810
Measuring the Impact of an Innovative Educational Intervention in Inflammatory Arthritis
A study testing multidisciplinary educational intervention in people with Rheumatoid Arthritis, run by CHU de Quebec-Universite Laval.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- multidisciplinary educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 7 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patient unable to consent,
- patient unable to answer questionnaires,
- patient unable to view a DVD at home
- patient unable to participate in a teleconference
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- multidisciplinary educational intervention
- Keywords
- Patient therapeutic education, BioSecure questionnaire, Theory of planned behavior, Beliefs about medicines questionnaire
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidisciplinary educational interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: multidisciplinary educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline knowledge on self-care safety skills at 3 months.
Secondary outcomes (3)
Change of behavioral intention
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.
Measured: Change of baseline behavioral intention at 6 months.
Change of medication beliefs
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.
Measured: Change of baseline medication beliefs at 6 months.
Change of medication adherence
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
Measured: Change of medication adherence from 3 months before the study to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start1 Oct 2015
- Primary completion30 Apr 2019
- Study completion7 Oct 2019
Why it stopped: Difficulties at recruiting enough participants for this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Rheumatology Association, The Arthritis Society, Canada, Laval University, CISSS de Chaudière-Appalaches, Clinique Rhumatologie/Physiatrie Centre du Québec, Trois-Rivières, Centre de Rhumatologie de l'Est du Québec
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606810
- Sponsor's protocol ID
- MP-20-2015-2242
- Acronym
- I3A
- Status last verified
- Oct 2020
- First submitted
- 19 Oct 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04606810
- Acronym / sponsor ID
- I3A / MP-20-2015-2242
- Conditions
- Rheumatoid Arthritis
- Keywords
- Patient therapeutic education, BioSecure questionnaire, Theory of planned behavior, Beliefs about medicines questionnaire
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties at recruiting enough participants for this study
- Enrolment
- 112 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Canadian Rheumatology Association, The Arthritis Society, Canada, Laval University, CISSS de Chaudière-Appalaches, Clinique Rhumatologie/Physiatrie Centre du Québec, Trois-Rivières, Centre de Rhumatologie de l'Est du Québec
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm1, Participants received the multidisciplinary educational intervention at baseline | Active comparator | Other: multidisciplinary educational interventionParticipants in arm1 received the usual care plus the multidisciplinary educational intervention consisting of an educational DVD followed by a teleconference at baseline. |
| Arm2, Participants in arm2 received the educational intervention after 3 months | Other | Other: multidisciplinary educational interventionParticipants in group 2 first received usual care, and after 3 months were offered the multidisciplinary educational intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- patient unable to consent,
- patient unable to answer questionnaires,
- patient unable to view a DVD at home
- patient unable to participate in a teleconference
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multidisciplinary educational interventionAt 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 | Arm1, Participants received the multidisciplinary educational intervention at baseline, Arm2, Participants in arm2 received the educational intervention after 3 months |
Primary outcome
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.
3 secondary outcomes
Change of behavioral intention
Time frame: Change of baseline behavioral intention at 6 months.
Change of medication beliefs
Time frame: 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
Results and safety
The study was stopped early (reason given: Difficulties at recruiting enough participants for this study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing multidisciplinary educational intervention in people with Rheumatoid Arthritis, run by CHU de Quebec-Universite Laval.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties at recruiting enough participants for this study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of knowledge on self-care safety skills (time frame: Change from baseline knowledge on self-care safety skills at 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.