Rheumatoid ArthritisAHJNCT01941433
Arthritis Health Journal Proof of Concept Study
A study testing Arthritis Health Journal in people with Rheumatoid Arthritis, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether an online patient passport tool called the Arthritis Health Journal can assist people with rheumatoid arthritis in managing their disease. 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?
- Arthritis Health Journal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Feb 2016
- 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
- Be 18 years of age or older
- Have a diagnosis of rheumatoid arthritis
- Be under the ongoing care of a rheumatologist
- Be comfortable using a computer and online applications
- Have access to an Internet connection
- Be able to read and write English without needing a translator
Who cannot join
- Younger than 18 years of age;
- Diagnoses of arthritis other than rheumatoid arthritis
- not under the ongoing care of a rheumatologist
- not comfortable using a computer
- lack of Internet access
- inability to read and write in English without a translator
Trial locations and contacts
1 site in 1 country.
Canada1 site
Arthritis Research Centre of Canada
Richmond, British Columbia, V6X 2C7
About this study
Official title: Proof of Concept Study of the Arthritis Health Journal, a Patient Passport for Rheumatoid Arthritis
The purpose of this study is to determine whether an online patient passport tool called the Arthritis Health Journal can assist people with rheumatoid arthritis in managing their disease.
Read the detailed description
Patient passports have been developed and used in chronic diseases, such as diabetes, to promote active involvement of patients in their care, and have led to better treatment and health outcomes. In rheumatoid arthritis (RA), active involvement of patients in monitoring their symptoms and their disease activity may facilitate treatment according to current recommendations, which emphasize the need for aggressive treatment to suppress inflammation and for using a "Treat to Target" approach where treatment is escalated until a target is reached and is promptly modified when target is no longer met. In this study, the investigators have developed an online tool that aims to help people with RA monitor their symptoms and their disease activity and self-manage their arthritis. The investigators will perform a proof of concept study assessing how the Arthritis Health Journal affects consumer effectiveness, patient self-efficacy, communication with health professionals, shared decision-making, and satisfaction with medical care. The investigators will also evaluate the feasibility and satisfaction with using the Arthritis Health Journal. The investigators will use a stepped wedge study design, in which 50 participants will be randomized to either the intervention group (immediate use of the Arthritis Health Journal) or the control group (waitlisted for 6 months). Due to the nature of the intervention, the study is not blinded.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Arthritis Health Journal
- Keywords
- rheumatoid arthritis, self-management, online, patient passport
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthritis Health JournalBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arthritis Health Journal | Experimental | Participants in this group will use the Arthritis Health Journal in the first 6 months of study. Receives: Behavioral: Arthritis Health Journal |
| Control | Other | Participants in this group will receive a delayed intervention. They will receive usual care for the first 6 months of study, during which time they will contribute control data, and they will use the Arthritis Health Journal in the second 6 months of study, during which time they will contribute intervention data. Receives: Behavioral: Arthritis Health Journal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Management Behaviours
We will use the overall score from the Partners in Health Scale, an 11 item questionnaire based on the principles of self-management, which measures people's ability to engage in behaviours for the self-management of a chronic disease.
Measured: 6 months
Secondary outcomes (4)
Self-Efficacy
We will use the Stanford Self-Efficacy Scale to measure patient's confidence in their ability to perform certain actions to manage their disease and cope with the consequences of their disease. Specifically we will include the "Manage Arthritis Symptoms", "Manage Disease in General", and "Communicate with Physician" subscales.
Measured: 6 months
Consumer Effectiveness
We will use the Effective Consumer (EC-17) scale to measure patient's ability to deal with a chronic condition and make decisions about their health care. We will use the global EC-17 score, as well as results to individual questions (6, 7, 9, and 13) which were selected for their relevance to our intervention.
Measured: 6 months
Patient Satisfaction with Care
We will use the Patient Satisfaction Questionnaire to measure satisfaction with care and patient-physician interactions.
Measured: 6 months
Self-Management Behaviours
We will measure the results of individual questions 7 to 11 from the Partners in Health Scale, which specifically measure involvement in aspects of care relevant to our intervention.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2015
- Study completionFeb 2016
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.
- More trials run by University of British ColumbiaThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Initiative for Outcomes in Rheumatology Care, Vancouver Coastal Health, Provincial Health Services Authority British Columbia
- Responsible party
- Principal investigator, Diane Lacaille, University of British Columbia
- Investigators
- Diane Lacaille, MD MHSc, Principal investigator, Arthritis Research Centre of Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941433
- Sponsor's protocol ID
- H12-00691
- Acronym
- AHJ
- Status last verified
- Jun 2018
- First submitted
- 10 Sep 2013
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Study of the Arthritis Health Journal, a Patient Passport for Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01941433
- Acronym / sponsor ID
- AHJ / H12-00691
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, self-management, online, patient passport
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Initiative for Outcomes in Rheumatology Care, Vancouver Coastal Health, Provincial Health Services Authority British Columbia
- Study start
- Sep 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 13 Sep 2013 (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.
The purpose of this study is to determine whether an online patient passport tool called the Arthritis Health Journal can assist people with rheumatoid arthritis in managing their disease.
Detailed description
Patient passports have been developed and used in chronic diseases, such as diabetes, to promote active involvement of patients in their care, and have led to better treatment and health outcomes. In rheumatoid arthritis (RA), active involvement of patients in monitoring their symptoms and their disease activity may facilitate treatment according to current recommendations, which emphasize the need for aggressive treatment to suppress inflammation and for using a "Treat to Target" approach where treatment is escalated until a target is reached and is promptly modified when target is no longer met. In this study, the investigators have developed an online tool that aims to help people with RA monitor their symptoms and their disease activity and self-manage their arthritis. The investigators will perform a proof of concept study assessing how the Arthritis Health Journal affects consumer effectiveness, patient self-efficacy, communication with health professionals, shared decision-making, and satisfaction with medical care. The investigators will also evaluate the feasibility and satisfaction with using the Arthritis Health Journal. The investigators will use a stepped wedge study design, in which 50 participants will be randomized to either the intervention group (immediate use of the Arthritis Health Journal) or the control group (waitlisted for 6 months). Due to the nature of the intervention, the study is not blinded.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthritis Health Journal | Experimental | Behavioral: Arthritis Health JournalParticipants in this group will use the Arthritis Health Journal in the first 6 months of study. |
| Control | Other | Behavioral: Arthritis Health JournalParticipants in this group will receive a delayed intervention. They will receive usual care for the first 6 months of study, during which time they will contribute control data, and they will use the Arthritis Health Journal in the second 6 months of study, during which time they will contribute intervention data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 18 years of age or older
- Have a diagnosis of rheumatoid arthritis
- Be under the ongoing care of a rheumatologist
- Be comfortable using a computer and online applications
- Have access to an Internet connection
Key exclusion criteria (6 listed)
- Younger than 18 years of age;
- Diagnoses of arthritis other than rheumatoid arthritis
- not under the ongoing care of a rheumatologist
- not comfortable using a computer
- lack of Internet access
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 |
|---|---|---|
| Arthritis Health Journal | Behavioural | Arthritis Health Journal, Control |
Primary outcome
Self-Management Behaviours
Time frame: 6 months
We will use the overall score from the Partners in Health Scale, an 11 item questionnaire based on the principles of self-management, which measures people's ability to engage in behaviours for the self-management of a chronic disease.
4 secondary outcomes
Self-Efficacy
Time frame: 6 months
Consumer Effectiveness
Time frame: 6 months
Patient Satisfaction with Care
Time frame: 6 months
Self-Management Behaviours
Time frame: 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 Jun 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.
Diane Lacaille, MD MHSc principal investigator
Arthritis Research Centre of Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthritis Health Journal in people with Rheumatoid Arthritis, run by University of British Columbia 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 6 inclusion and 6 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 Jun 2018. 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?
Self-Management Behaviours (time frame: 6 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 29 Jun 2018.