Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT02540044

Conditions

Arthritis, Rheumatoid

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

ANSWER-2 decision aid

Control Group (TAS Consumer Guide)

Study Details

Brief summary:

This proof-of-concept randomized trial evaluates the effectiveness of using an on-line decision aid (ANSWER-2) in the decision making to start or switch biologic therapy in Canadian patients with rheumatoid arthritis.

Conditions

Arthritis, Rheumatoid

Study ID

NCT02540044

Start date

Jan, 2016

Status verified date

Jun, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • The inclusion criteria are as follows: 1) with a diagnosis of RA from a rheumatologist, 2) whose rheumatologists have recommended initiating a biologic/subsequent entry biologic or switching to another biologic agent, and 3) who have internet access and email.

Exclusion Criteria:

  • Patients who do not meet the inclusion criteria.

Study Design

Enrollment

148 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: ANSWER-2 decision aid

The Intervention Group will receive simple instructions to access ANSWER-2 and complete the program on their own computers within two days. At the end of the session, ANSWER-2 will produce a one-page summary summarizing the participant's questions, concerns, and preferred medication option.

active comparator: Control Group (TAS Consumer Guide)

The Control Group will receive the online Arthritis Medications: A Consumer's Guide, published by The Arthritis Society. It contains standard information about biologics, including an introduction of the different biologic options, dosages and side effects.

Interventions

ANSWER-2 decision aid

ANSWER-2 will consist of: 1) an Information Module that presents effectiveness and side effects of each treatment option, and 2) an interactive Value Clarification Module that guides patients to consider what matter to them the most, and the pros and cons of each treatment option. Within the Information Module, the decision support information (i.e., the benefits and harms of treatment options) will be presented in narrated text, graphics, and a series of animated patient stories demonstrating attributes required for effective communication with doctors and significant others.

Control Group (TAS Consumer Guide)

The Arthritis Society Consumer guide pdf.

Primary outcome measure

  • Decisional Conflict Scale [ Time Frame: Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1) ]

Central Contacts and Locations

Central contacts

Jasmina Geldman, MS

604-207-4007jgeldman@arthritisresearch.ca

Navi Grewal, MS

604-207-4053ngrewal@arthritisresearch.ca

Locations

Arthritis Research Canada

Recruiting

Richmond, British Columbia, Canada, V6X2C7

Contacts

Jasmina Geldman, MS

604-207-4007jgeldman@arthritisresearch.ca

Navi Grewal, MS

604-207-4053ngrewal@arthritisresearch.ca

Principal Investigator:

Linda Li, PT,PhD

More Information

Sponsor

University of British Columbia

Last update posted

Jun 29, 2017

Last verified

Jun, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2017-06-29.