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Completed

NCT Number: NCT01941433

Arthritis Health Journal Proof of Concept Study

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arthritis Research Centre of Canada

Richmond, British Columbia, V6X 2C7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthritis Health Journal

Behavioral

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Initiative for Outcomes in Rheumatology Care
  • Provincial Health Services Authority British Columbia
  • Vancouver Coastal Health

Registry information

Official study title

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

Acronym: AHJ

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Sep 13, 2013
Registry last updated
Jun 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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