Clinical trial NCT01941433: Arthritis Health Journal Proof of Concept Study
Official title: Proof of Concept Study of the Arthritis Health Journal, a Patient Passport for Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
self-management
online
patient passport
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Initiative for Outcomes in Rheumatology Care
name: Vancouver Coastal Health
name: Provincial Health Services Authority
First posted: 2013-09-13
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Self-Management Behaviours
timeFrame: 6 months
Secondary outcomes:
measure: Self-Efficacy
timeFrame: 6 months
measure: Consumer Effectiveness
timeFrame: 6 months
measure: Patient Satisfaction with Care
timeFrame: 6 months
measure: Self-Management Behaviours
timeFrame: 6 months
Other outcomes:
Locations:
city: Richmond
country: Canada
facility: Arthritis Research Centre of Canada
state: British Columbia
Study officials:
affiliation: Arthritis Research Centre of Canada
name: Diane Lacaille, MD MHSc
role: PRINCIPAL_INVESTIGATOR
References: