Supporting Patient Care With Electronic Resource (SuPER)
SuPER
1 other identifier
interventional
148
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 3, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJune 29, 2017
June 1, 2017
2.9 years
September 1, 2015
June 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Decisional Conflict Scale
The Decisional Conflict Scale (short version) measures personal perceptions of uncertainty in choosing options, factors contributing to uncertainty, and effective decision-making. It is one-dimensional and has 10 questions and three response categories (yes/no/unsure) used to compute one score.
Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1)
Secondary Outcomes (3)
MeiQ
Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1, and at month 2)
Partners in Health Scale
Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1, and at month 2)
Health Resource Utilization
Change measure (baseline score compared to after using the ANSWER-2 at month 2)
Other Outcomes (1)
CollaboRATE Scale
Change measure (baseline score compared to after using the ANSWER-2 intervention at month 1)
Study Arms (2)
ANSWER-2 decision aid
EXPERIMENTALThe 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.
Control Group (TAS Consumer Guide)
ACTIVE COMPARATORThe 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 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.
The Arthritis Society Consumer guide pdf.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- University of Albertacollaborator
- Simon Fraser Universitycollaborator
- Arthritis Research Centre of Canadacollaborator
- Vancouver General Hospitalcollaborator
Study Sites (1)
Arthritis Research Canada
Richmond, British Columbia, V6X2C7, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Linda Li, PhD
Professor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 1, 2015
First Posted
September 3, 2015
Study Start
January 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
June 29, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share