Arthritis Health Journal Proof of Concept Study

Rheumatoid Arthritis Clinical Trial

— AHJ  

Official title:

Proof of Concept Study of the Arthritis Health Journal, a Patient Passport for Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941433
• Other study ID #: H12-00691
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: February 2016

Study information

• Verified date: June 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: February 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• Arthritis Health Journal

Locations

Country	Name	City	State
Canada	Arthritis Research Centre of Canada	Richmond	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Initiative for Outcomes in Rheumatology Care (CIORA), Provincial Health Services Authority, Vancouver Coastal Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Patient Satisfaction with Care	We will use the Patient Satisfaction Questionnaire to measure satisfaction with care and patient-physician interactions.	6 months
Secondary	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