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Arthritis Health Journal Proof of Concept Study (AHJ)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Arthritis Health Journal
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, self-management, online, patient passport

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arthritis Research Centre of Canada

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arthritis Health Journal

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Patient Satisfaction with Care
We will use the Patient Satisfaction Questionnaire to measure satisfaction with care and patient-physician interactions.
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.

Full Information

First Posted
September 10, 2013
Last Updated
June 27, 2018
Sponsor
University of British Columbia
Collaborators
Canadian Initiative for Outcomes in Rheumatology Care, Vancouver Coastal Health, Provincial Health Services Authority
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1. Study Identification

Unique Protocol Identification Number
NCT01941433
Brief Title
Arthritis Health Journal Proof of Concept Study
Acronym
AHJ
Official Title
Proof of Concept Study of the Arthritis Health Journal, a Patient Passport for Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Initiative for Outcomes in Rheumatology Care, Vancouver Coastal Health, Provincial Health Services Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis, self-management, online, patient passport

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arthritis Health Journal
Arm Type
Experimental
Arm Description
Participants in this group will use the Arthritis Health Journal in the first 6 months of study.
Arm Title
Control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Arthritis Health Journal
Primary Outcome Measure Information:
Title
Self-Management Behaviours
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Self-Efficacy
Description
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.
Time Frame
6 months
Title
Consumer Effectiveness
Description
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.
Time Frame
6 months
Title
Patient Satisfaction with Care
Description
We will use the Patient Satisfaction Questionnaire to measure satisfaction with care and patient-physician interactions.
Time Frame
6 months
Title
Self-Management Behaviours
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane Lacaille, MD MHSc
Organizational Affiliation
Arthritis Research Centre of Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthritis Research Centre of Canada
City
Richmond
State/Province
British Columbia
ZIP/Postal Code
V6X 2C7
Country
Canada

12. IPD Sharing Statement

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Arthritis Health Journal Proof of Concept Study

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