Early Inflammatory ArthritisNCT01054131
Peer to Peer Mentoring: Facilitating Individuals With Early Inflammatory Arthritis to Manage Their Arthritis: Peer Mentoring Program
A study testing peer support in people with Early Inflammatory Arthritis and Chronic Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Inflammatory arthritis (IA) is a major cause of long-term disability. Peer support may be a solution to the common problem of delayed treatment. Early peer support may result in improved use of therapy, higher self-efficacy, reduced anxiety, and improved coping in the first two years post-diagnosis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Early Inflammatory Arthritis, Chronic Disease
- What is being tested?
- peer support
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Dec 2011
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Have EIA disease duration within 6-52 weeks
- At least 3 swollen joints, assessed by the treating rheumatologist, OR positive compression test for the metacarpophalangeal joints OR positive compression test for the metatarsophalangeal joints OR at least 30 minutes of morning stiffness
- Prescription of a DMARD/biologic by the treating rheumatologist
- Ability to speak and understand English without the aid of a secondary support person; AND
- Capability to provide informed consent.
Who cannot join
- IA disease duration less than 6 weeks or greater than 1 year
- Previous or ongoing DMARD or biologic treatment
- Inability to speak or read grade 6 English; AND
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Inflammatory arthritis (IA) is a major cause of long-term disability. Peer support may be a solution to the common problem of delayed treatment. Early peer support may result in improved use of therapy, higher self-efficacy, reduced anxiety, and improved coping in the first two years post-diagnosis. The whole intervention study comprises of two parts: The first part involves the development and testing of a peer mentor training initiative, which is called "Peer to Peer Mentoring: Facilitating Individuals with Early Inflammatory Arthritis to Manage their Arthritis - Peer Mentor Training". The second part, which is the focus of this study, involves the delivery of a one-on-one peer support intervention from a trained peer mentor to an individual newly diagnosed with EIA. The feasibility and acceptability of the program will be determined, as well as the health outcomes following the participation of the program.
- Conditions
- Early Inflammatory Arthritis, Chronic Disease
- Being tested
- peer support
- Keywords
- peer support, peer mentor, self-management, early inflammatory arthritis, chronic disease
- Medical subject headings
- Arthritis, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peer supportBehavioural
A quasi-experimental, before and after study design will obtain data for planning and implementing a larger-scale study. Exposures and outcomes will be measured at baseline, 3 months (immediate post 12-week program) and 6 months (3 months post-program). Ten individuals with EIA will be recruited by brief screening interviews to ensure they meet inclusion criteria. Each pair of peer mentor and EIA participant will meet at SHSC for an initial contact. EIA participants will receive informational, emotional and appraisal support from trained peer mentors by telephone or neutral private location at a time convenient for both parties, at least once a week for 12 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
DMARD adherence
Measured: 0, 3, 6 months
Secondary outcomes (5)
coping efficacy
Measured: 0, 3 6 months
self-management
Measured: 0, 3, 6 months
anxiety
Measured: 0, 3, 6 months
self efficacy
Measured: 0, 3, 6 months
social support
Measured: 0, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Inflammatory ArthritisStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Arthritis Network
- Responsible party
- Principal investigator, Dr. Mary Bell, Sunnybrook Health Sciences Centre
- Investigators
- Mary J Bell, MD, FRCPC, Principal investigator, Rheumatologist, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054131
- Sponsor's protocol ID
- 420-2009
- Status last verified
- Dec 2011
- First submitted
- 21 Jan 2010
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Sandhu S, Veinot P, Embuldeniya G, Brooks S, Sale J, Huang S, Zhao A, Richards D, Bell MJ. Peer-to-peer mentoring for individuals with early inflammatory arthritis: feasibility pilot. BMJ Open. 2013 Mar 1;3(3):e002267. doi: 10.1136/bmjopen-2012-002267.
PubMed 23457326
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer to Peer Mentoring: Facilitating Individuals With Early Inflammatory Arthritis to Manage Their Arthritis: Peer Mentoring Program
- ClinicalTrials.gov ID
- NCT01054131
- Acronym / sponsor ID
- 420-2009
- Conditions
- Early Inflammatory Arthritis, Chronic Disease
- Keywords
- peer support, peer mentor, self-management, early inflammatory arthritis, chronic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Arthritis Network
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Jan 2010 (estimated)
- 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.
Inflammatory arthritis (IA) is a major cause of long-term disability. Peer support may be a solution to the common problem of delayed treatment. Early peer support may result in improved use of therapy, higher self-efficacy, reduced anxiety, and improved coping in the first two years post-diagnosis. The whole intervention study comprises of two parts: The first part involves the development and testing of a peer mentor training initiative, which is called "Peer to Peer Mentoring: Facilitating Individuals with Early Inflammatory Arthritis to Manage their Arthritis - Peer Mentor Training". The second part, which is the focus of this study, involves the delivery of a one-on-one peer support intervention from a trained peer mentor to an individual newly diagnosed with EIA. The feasibility and acceptability of the program will be determined, as well as the health outcomes following the participation of the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Have EIA disease duration within 6-52 weeks
- At least 3 swollen joints, assessed by the treating rheumatologist, OR positive compression test for the metacarpophalangeal joints OR positive compression test for the metatarsophalangeal joints OR at least 30 minutes of morning stiffness
- Prescription of a DMARD/biologic by the treating rheumatologist
- Ability to speak and understand English without the aid of a secondary support person; AND
- Capability to provide informed consent.
Key exclusion criteria (4 listed)
- IA disease duration less than 6 weeks or greater than 1 year
- Previous or ongoing DMARD or biologic treatment
- Inability to speak or read grade 6 English; AND
- Inability to provide informed consent
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 |
|---|---|---|
| peer supportA quasi-experimental, before and after study design will obtain data for planning and implementing a larger-scale study. Exposures and outcomes will be measured at baseline, 3 months (immediate post 12-week program) and 6 months (3 months post-program). Ten individuals with EIA will be recruited by brief screening interviews to ensure they meet inclusion criteria. Each pair of peer mentor and EIA participant will meet at SHSC for an initial contact. EIA participants will receive informational, emotional and appraisal support from trained peer mentors by telephone or neutral private location at a time convenient for both parties, at least once a week for 12 weeks. | Behavioural | – |
Primary outcome
DMARD adherence
Time frame: 0, 3, 6 months
5 secondary outcomes
coping efficacy
Time frame: 0, 3 6 months
self-management
Time frame: 0, 3, 6 months
anxiety
Time frame: 0, 3, 6 months
self efficacy
Time frame: 0, 3, 6 months
social support
Time frame: 0, 3, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2011.
- Derived from this study: PubMed 23457326Sandhu S, Veinot P, Embuldeniya G, Brooks S, Sale J, Huang S, Zhao A, Richards D, Bell MJ. Peer-to-peer mentoring for individuals with early inflammatory arthritis: feasibility pilot. BMJ Open. 2013 Mar 1;3(3):e002267. doi: 10.1136/bmjopen-2012-002267.
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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.
Mary J Bell, MD, FRCPC principal investigator
Rheumatologist, Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peer support in people with Early Inflammatory Arthritis and Chronic Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 5 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: finished, as of the sponsor's last update on 29 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
DMARD adherence (time frame: 0, 3, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01054131, which also lists 1 linked publication.
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 29 Dec 2011.