Arthritis Health Journal Proof of Concept Study (AHJ)

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Behavioral: Arthritis Health Journal

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 Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Richmond, British Columbia, Canada, V6X 2C7
      • Arthritis Research Centre of Canada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months
Patient Satisfaction with Care	We will use the Patient Satisfaction Questionnaire to measure satisfaction with care and patient-physician interactions.	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.	6 months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Provincial Health Services Authority; Vancouver Coastal Health; Canadian Initiative for Outcomes in Rheumatology Care
• Investigators: Principal Investigator: Diane Lacaille, MD MHSc, Arthritis Research Centre of Canada

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: September 10, 2013
• First Submitted That Met QC Criteria: September 12, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Actual): June 29, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: rheumatoid arthritis; self-management; online; patient passport
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: H12-00691