Early Inflammatory ArthritisP2P EIA RCTNCT01347359
Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis: An Effectiveness Study (Pilot RCT)- Peer Mentoring Program
A study testing One-on-one peer support in people with Early Inflammatory Arthritis, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
Trial summary
Peer support (including informational, emotional, appraisal support) has been shown to help persons with chronic conditions. The goal of this research is to examine the impact of early peer support on the health and quality of life of individuals with early inflammatory arthritis (EIA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Inflammatory Arthritis
- What is being tested?
- One-on-one peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- May 2011to May 2013
- 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
- EIA disease (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis) duration 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 (Lineker et al., 1999)
- Prescription of a DMARD/biologic by the treating rheumatologist
- Ability to speak, understand, read and write English without the aid of a secondary support person
- Ability to provide informed consent
Who cannot join
- Diagnosis of osteoarthritis, Systemic lupus erythematosus, DM neuropathy or trauma
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, M5T 3L9
About this study
Peer support (including informational, emotional, appraisal support) has been shown to help persons with chronic conditions. The goal of this research is to examine the impact of early peer support on the health and quality of life of individuals with early inflammatory arthritis (EIA). The investigators hypothesize that early peer support will result in improved use of disease modifying anti-rheumatic drug (DMARD) or biologic treatment, self-efficacy, coping efficacy, social support, health-related quality of life, self-management, and disease activity score as well as reduced anxiety for individuals with EIA within two years of their diagnosis. In this study, persons with IA will be trained as peer mentors using a training program developed for a pilot study. Individuals with EIA will be randomized to receive either "peer support program" or "standard care". Peer mentors will be paired with a person with EIA to provide one-on-one support (face-to-face or telephone) once a week for approximately 30 minutes over a 12-week period. All "standard care" participants will receive the peer mentoring intervention at the end of study. Both groups will be evaluated using self-administered questionnaires and clinical assessments, and results of the two groups will be compared. This information will be used to design a larger study.
Read the detailed description
Background: The investigators are proposing to examine the effectiveness of a peer support program, the aim of which is to assist individuals with early inflammatory arthritis (EIA) to receive the education and support they need to make decisions to manage their disease. Peer support (including informational, emotional, appraisal support) has been shown to assist persons with chronic conditions and may address challenges with receiving timely and proper treatment in persons with EIA.
Purpose: The goal of this pilot randomized controlled trial (RCT) is to evaluate the effectiveness of peer support to improve the health and quality of life of individuals with EIA. The investigators hypothesize that early peer support will result in improved use of treatment, self-efficacy, coping efficacy, social support, health-related quality of life, self-management, and disease activity score, as well as reduced anxiety for individuals with EIA within two years of their diagnosis.
Methods: This proposal builds on a pilot study, currently underway, to develop and evaluate the acceptability and feasibility of a peer support intervention for persons with EIA. The proposed effectiveness study will employ a RCT design with a wait list control group. Individuals with IA (diagnosis 2 or more years) will be trained as peer mentors using the revised pilot study training program. Peer mentors will be matched with a person newly diagnosed with IA to provide one-on-one support (face-to-face or telephone) over a 12-week period. Individuals with EIA will be recruited from rheumatology clinics at Sunnybrook Health Sciences Centre and Mount Sinai Hospital. Individuals with EIA will be randomized to either "intervention" or "standard care" (wait list). All "standard care" participants with EIA will receive the peer mentoring program at the end of study period; their outcomes will be also be evaluated. Both "intervention" and "standard care" participants will complete clinical assessments and self-administered questionnaires before and after (immediate post-program and 3-month follow-up) study completion to evaluate use of treatment, self-efficacy, coping efficacy, social support, health-related quality of life, anxiety, self-management, and disease activity count.
Implication: The study aims to improve the education and support for patients with EIA. The data from this study will be used to further refine the intervention and study design to be subsequently submitted for further effectiveness testing in a larger scale RCT.
- Conditions
- Early Inflammatory Arthritis
- Being tested
- One-on-one peer support, Standard of care
- Keywords
- Peer support, Peer mentoring, Peer counselling, Arthritis, Inflammatory arthritis, Early inflammatory arthritis, Rheumatoid arthritis, Chronic disease
- Medical subject headings
- Arthritis, Arthritis, Rheumatoid, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-on-one peer supportBehavioural
The peer support intervention will take the form of a one-on-one peer mentoring program, using a mutually agreed upon method of communication between each pair of peer mentor and EIA participant (either by telephone or face-to-face meeting at a neutral public location). The research team will pair trained peer mentors and individuals with EIA as closely as possible based on such characteristics as sex, age, working status, and specific disease/type of IA. Peer mentors will be responsible to initiate and maintain contact with individuals with EIA. Individuals with EIA and peer mentors will be asked to have contact once a week for 30 minutes during the 12-week study period. Meetings/ interactions will not be prescribed; rather they will be defined by the individual with EIA. Peer mentors will provide support based on the needs of the individual they are mentoring. As such the nature of each interaction is likely to vary among pairs and from one interaction to the next.
Standard of careBehavioural
"Standard of care" is at the discretion of the treating rheumatologist. In addition to information and patient education about the underlying disease process provided at the time of diagnosis, it may include referral to allied health professionals (e.g., physiotherapist, occupational therapist, podiatrist, social worker). This may be via referral to The Arthritis Society or directly to individual practitioners. In addition, it may include referral to voluntary support programs in the community (e.g., Arthritis Self-Management Program).
| Study group | Role | What they receive |
|---|---|---|
| One-on-one peer support | Experimental | The peer support intervention will take the form of a one-on-one peer mentoring program, either face-to-face or by telephone. Receives: Behavioral: One-on-one peer support |
| Control - Standard of care | Active comparator | "Standard of care" is at the discretion of the treating rheumatologist. Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of orally administered DMARD or biologic treatment
Use of orally administered DMARD or biologic treatment in individuals with EIA as determined indirectly through the modified Morisky scale for medication adherence
Measured: 0 months (baseline), immediate post-program, 3 months post-program
Secondary outcomes (7)
Self-efficacy
Self-efficacy using Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES)
Measured: 0 months (baseline), immediate post-program, 3 months post-program
Health-related quality of life
Health-related quality of life as measured by the Arthritis Impact Measurement Scales, 2nd edition (AIMS2
Measured: 0 months (baseline), immediate post-program, 3 months post-program
Anxiety
Anxiety is measured by the Arthritis Impact Measurement Scales, 2nd edition (AIMS2), dimension sub score for anxiety
Measured: 0 months (baseline), immediate post-program, 3 months post-program
Coping-efficacy
Coping-efficacy as assessed using a measure developed by Gignac et al. (2000)
Measured: 0 months (baseline), immediate post-program, 3 months post-program
Social support
Social support as measured by Medical Outcomes Study Social Support Survey (MOSSS)
Measured: 0 months (baseline), immediate post-program, 3 months post-program
Self-management
Self-management as evaluated using Patient Activation Measure (PAM) to measure the knowledge, skills, and confidence aspects of self management
Measured: 0 months (baseline), immediate post-program, 3 months post-program
Disease activity
Disease activity as assessed using the Clinical Disease Activity Index (CDAI): A rheumatologist from the research team will conduct clinical assessments for CDAI score, which is a propensity score for disease activity in rheumatoid arthritis. It accounts for upper extremity tender and swollen joints, and patient and evaluator impressions of disease progression
Measured: 0 months (baseline), immediate post-program, 3 months post-program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Rheumatology Association, Mount Sinai Hospital, Canada, The Arthritis Society, Canada, Unity Health Toronto, University of Toronto
- Responsible party
- Principal investigator, Dr. Mary Bell, Sunnybrook Health Sciences Centre
- Investigators
- Mary J Bell, MD, FRCPC, Principal investigator, Division of Reumatology, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347359
- Sponsor's protocol ID
- 094-2011
- Acronym
- P2P EIA RCT
- Status last verified
- Apr 2018
- First submitted
- 2 May 2011
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer to Peer Mentoring For Individuals With Early Inflammatory Arthritis: An Effectiveness Study (Pilot RCT)- Peer Mentoring Program
- ClinicalTrials.gov ID
- NCT01347359
- Acronym / sponsor ID
- P2P EIA RCT / 094-2011
- Conditions
- Early Inflammatory Arthritis
- Keywords
- Peer support, Peer mentoring, Peer counselling, Arthritis, Inflammatory arthritis, Early inflammatory arthritis, Rheumatoid arthritis, Chronic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Rheumatology Association, Mount Sinai Hospital, Canada, The Arthritis Society, Canada, Unity Health Toronto, University of Toronto
- Study start
- May 2011 (actual)
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 May 2011 (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.
Peer support (including informational, emotional, appraisal support) has been shown to help persons with chronic conditions. The goal of this research is to examine the impact of early peer support on the health and quality of life of individuals with early inflammatory arthritis (EIA). The investigators hypothesize that early peer support will result in improved use of disease modifying anti-rheumatic drug (DMARD) or biologic treatment, self-efficacy, coping efficacy, social support, health-related quality of life, self-management, and disease activity score as well as reduced anxiety for individuals with EIA within two years of their diagnosis. In this study, persons with IA will be trained as peer mentors using a training program developed for a pilot study. Individuals with EIA will be randomized to receive either "peer support program" or "standard care". Peer mentors will be paired with a person with EIA to provide one-on-one support (face-to-face or telephone) once a week for approximately 30 minutes over a 12-week period. All "standard care" participants will receive the peer mentoring intervention at the end of study. Both groups will be evaluated using self-administered questionnaires and clinical assessments, and results of the two groups will be compared. This information will be used to design a larger study.
Detailed description
Background: The investigators are proposing to examine the effectiveness of a peer support program, the aim of which is to assist individuals with early inflammatory arthritis (EIA) to receive the education and support they need to make decisions to manage their disease. Peer support (including informational, emotional, appraisal support) has been shown to assist persons with chronic conditions and may address challenges with receiving timely and proper treatment in persons with EIA.
Purpose: The goal of this pilot randomized controlled trial (RCT) is to evaluate the effectiveness of peer support to improve the health and quality of life of individuals with EIA. The investigators hypothesize that early peer support will result in improved use of treatment, self-efficacy, coping efficacy, social support, health-related quality of life, self-management, and disease activity score, as well as reduced anxiety for individuals with EIA within two years of their diagnosis.
Methods: This proposal builds on a pilot study, currently underway, to develop and evaluate the acceptability and feasibility of a peer support intervention for persons with EIA. The proposed effectiveness study will employ a RCT design with a wait list control group. Individuals with IA (diagnosis 2 or more years) will be trained as peer mentors using the revised pilot study training program. Peer mentors will be matched with a person newly diagnosed with IA to provide one-on-one support (face-to-face or telephone) over a 12-week period. Individuals with EIA will be recruited from rheumatology clinics at Sunnybrook Health Sciences Centre and Mount Sinai Hospital. Individuals with EIA will be randomized to either "intervention" or "standard care" (wait list). All "standard care" participants with EIA will receive the peer mentoring program at the end of study period; their outcomes will be also be evaluated. Both "intervention" and "standard care" participants will complete clinical assessments and self-administered questionnaires before and after (immediate post-program and 3-month follow-up) study completion to evaluate use of treatment, self-efficacy, coping efficacy, social support, health-related quality of life, anxiety, self-management, and disease activity count.
Implication: The study aims to improve the education and support for patients with EIA. The data from this study will be used to further refine the intervention and study design to be subsequently submitted for further effectiveness testing in a larger scale RCT.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-on-one peer support | Experimental | Behavioral: One-on-one peer supportThe peer support intervention will take the form of a one-on-one peer mentoring program, either face-to-face or by telephone. |
| Control - Standard of care | Active comparator | Behavioral: Standard of care"Standard of care" is at the discretion of the treating rheumatologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- EIA disease (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis) duration 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 (Lineker et al., 1999)
- Prescription of a DMARD/biologic by the treating rheumatologist
- Ability to speak, understand, read and write English without the aid of a secondary support person
- Ability to provide informed consent
Key exclusion criteria (1 listed)
- Diagnosis of osteoarthritis, Systemic lupus erythematosus, DM neuropathy or trauma
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 |
|---|---|---|
| One-on-one peer supportThe peer support intervention will take the form of a one-on-one peer mentoring program, using a mutually agreed upon method of communication between each pair of peer mentor and EIA participant (either by telephone or face-to-face meeting at a neutral public location). The research team will pair trained peer mentors and individuals with EIA as closely as possible based on such characteristics as sex, age, working status, and specific disease/type of IA. Peer mentors will be responsible to initiate and maintain contact with individuals with EIA. Individuals with EIA and peer mentors will be asked to have contact once a week for 30 minutes during the 12-week study period. Meetings/ interactions will not be prescribed; rather they will be defined by the individual with EIA. Peer mentors will provide support based on the needs of the individual they are mentoring. As such the nature of each interaction is likely to vary among pairs and from one interaction to the next. | Behavioural | One-on-one peer support |
| Standard of care"Standard of care" is at the discretion of the treating rheumatologist. In addition to information and patient education about the underlying disease process provided at the time of diagnosis, it may include referral to allied health professionals (e.g., physiotherapist, occupational therapist, podiatrist, social worker). This may be via referral to The Arthritis Society or directly to individual practitioners. In addition, it may include referral to voluntary support programs in the community (e.g., Arthritis Self-Management Program). | Behavioural | Control - Standard of care |
Primary outcome
Use of orally administered DMARD or biologic treatment
Time frame: 0 months (baseline), immediate post-program, 3 months post-program
Use of orally administered DMARD or biologic treatment in individuals with EIA as determined indirectly through the modified Morisky scale for medication adherence
7 secondary outcomes
Self-efficacy
Time frame: 0 months (baseline), immediate post-program, 3 months post-program
Health-related quality of life
Time frame: 0 months (baseline), immediate post-program, 3 months post-program
Anxiety
Time frame: 0 months (baseline), immediate post-program, 3 months post-program
Coping-efficacy
Time frame: 0 months (baseline), immediate post-program, 3 months post-program
Social support
Time frame: 0 months (baseline), immediate post-program, 3 months post-program
Self-management
Time frame: 0 months (baseline), immediate post-program, 3 months post-program
Disease activity
Time frame: 0 months (baseline), immediate post-program, 3 months post-program
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 12 Apr 2018.
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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
Division of Reumatology, Sunnybrook Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-on-one peer support in people with Early Inflammatory Arthritis, run by Sunnybrook Health Sciences Centre at 2 sites 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 1 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 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Use of orally administered DMARD or biologic treatment (time frame: 0 months (baseline), immediate post-program, 3 months post-program). 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 12 Apr 2018.