Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment arthritis health journal
Sponsor University of British Columbia
Collaborator Canadian Initiative for Outcomes in Rheumatology Care (CIORA)
Start date September 2013
End date January 2015
Trial size 50 participants
Trial identifier NCT01941433, H12-00691

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Participants in this group will use the Arthritis Health Journal in the first 6 months of study.
arthritis health journal
(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.
arthritis health journal

Primary Outcomes

Measure
Self-Management Behaviours
time frame: 6 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Proof of Concept Study of the Arthritis Health Journal, a Patient Passport for Rheumatoid Arthritis
Principal investigator Diane Lacaille, MD MHSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by University of British Columbia.