Arthritis Health Journal Proof of Concept Study

NCT ID: NCT01941433

Last Updated: 2018-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-02-29

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arthritis Health Journal

Participants in this group will use the Arthritis Health Journal in the first 6 months of study.

Group Type EXPERIMENTAL

Arthritis Health Journal

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Arthritis Health Journal

Intervention Type BEHAVIORAL

Interventions

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Arthritis Health Journal

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Initiative for Outcomes in Rheumatology Care

OTHER

Sponsor Role collaborator

Vancouver Coastal Health

OTHER_GOV

Sponsor Role collaborator

Provincial Health Services Authority

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Diane Lacaille

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diane Lacaille, MD MHSc

Role: PRINCIPAL_INVESTIGATOR

Arthritis Research Centre of Canada

Locations

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Arthritis Research Centre of Canada

Richmond, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H12-00691

Identifier Type: -

Identifier Source: org_study_id

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