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Arthritis Health Journal Proof of Concept Study (AHJ)

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ClinicalTrials.gov Identifier: NCT01941433
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : June 29, 2018
Sponsor:
Collaborators:
Canadian Initiative for Outcomes in Rheumatology Care
Vancouver Coastal Health
Provincial Health Services Authority
Information provided by (Responsible Party):
Diane Lacaille, University of British Columbia

Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Behavioral: Arthritis Health Journal Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Proof of Concept Study of the Arthritis Health Journal, a Patient Passport for Rheumatoid Arthritis
Study Start Date : September 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arthritis Health Journal
Participants in this group will use the Arthritis Health Journal in the first 6 months of study.
Behavioral: Arthritis Health Journal
Control
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.
Behavioral: Arthritis Health Journal



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Self-Efficacy [ Time Frame: 6 months ]
    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.

  2. Consumer Effectiveness [ Time Frame: 6 months ]
    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.

  3. Patient Satisfaction with Care [ Time Frame: 6 months ]
    We will use the Patient Satisfaction Questionnaire to measure satisfaction with care and patient-physician interactions.

  4. Self-Management Behaviours [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941433


Locations
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Canada, British Columbia
Arthritis Research Centre of Canada
Richmond, British Columbia, Canada, V6X 2C7
Sponsors and Collaborators
University of British Columbia
Canadian Initiative for Outcomes in Rheumatology Care
Vancouver Coastal Health
Provincial Health Services Authority
Investigators
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Principal Investigator: Diane Lacaille, MD MHSc Arthritis Research Centre of Canada
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Responsible Party: Diane Lacaille, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01941433    
Other Study ID Numbers: H12-00691
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Keywords provided by Diane Lacaille, University of British Columbia:
rheumatoid arthritis
self-management
online
patient passport
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases