Rheumatoid ArthritisSuPER-USNCT02787538
Supporting Patient Care With Electronic Resources in the United States
A study testing US-ANSWER-2 decision aid in people with Rheumatoid Arthritis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This proof-of-concept randomized trial evaluates the effectiveness of using an online decision aid (US-ANSWER-2) in the decision-making to start or switch biologic therapy in US patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- US-ANSWER-2 decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria are as follows:
- with a diagnosis of RA from a rheumatologist
- whose rheumatologists have recommended initiating a biologic or switching to another biologic
- who have internet access and email.
Who cannot join
- Patients who do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Supporting Patient Care With Electronic Resources in the United States (SuPER-US): Effectiveness of an Online Decision Aid for Patients Considering Biologic Therapy for Rheumatoid Arthritis
This proof-of-concept randomized trial evaluates the effectiveness of using an online decision aid (US-ANSWER-2) in the decision-making to start or switch biologic therapy in US patients with rheumatoid arthritis.
Read the detailed description
The proposed project aims to improve the process of making evidence-informed treatment decisions by patients with rheumatoid arthritis (RA) and ultimately empower patient self-management. Current RA treatment emphasizes: 1) the need for early and aggressive treatment, and 2) the use of a treat-to-target approach. However, patients often struggle with treatment decisions, especially when the options have both benefits and risks. To address this challenge, investigators based at Arthritis Research Canada have previously developed an online decision aid called ANSWER-2 (ANimated, Self-serve, WEb-based, Research Tool: Version 2) for RA patients who are considering a biologic, and this tool has been recently adapted for the US healthcare setting (called US-ANSWER-2).
Objectives: 1) To evaluate the effectiveness of US-ANSWER-2 in reducing patients' decisional conflict. 2) To assess the extent to which US-ANSWER-2 improves patients' knowledge about RA medications and confidence in managing their health. 3) To examine the experiences of patients and rheumatologists in using US-ANSWER-2.
The investigators will conduct a proof-of-concept randomized controlled trial with 80 patients with RA. Eligible individuals are those: 1) with a diagnosis of RA from a rheumatologist, 2) whose rheumatologists have recommended initiating a biologic or switching to another biologic, and 3) who have internet access and email. The Intervention Group will receive simple instructions to access the US-ANSWER-2 decision aid and complete the program on their own within two days. At the end of the session, a one-page summary will be produced to help them discuss their questions, concerns, and preferred choices with their health care providers. The Control Group will receive a standard online medication guide, reflective of usual practice. Participants will complete the Decisional Conflict Scale (primary outcome) before and after the intervention (US-ANSWER-2 or standard online medication guide). The following secondary outcome measures will be collected at baseline, Month 1, and Month 2: 1) Medication Education Impact Questionnaire, and 2) Partners in Health Scale. In addition, the use of healthcare resources will be collected at baseline and Month 2, and the use of biologics will be collected at Month 6. All participants and their rheumatologists will be invited to participate in a qualitative interview about their experience with the patient decision aid.
- Conditions
- Rheumatoid Arthritis
- Being tested
- US-ANSWER-2 decision aid, Control group (Online medication guide)
- Keywords
- Rheumatoid Arthritis, Decision Aids, Biologics
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-ANSWER-2 decision aidBehavioural
US-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 (Online medication guide)Behavioural
Standard online medication guide.
| Study group | Role | What they receive |
|---|---|---|
| US-ANSWER-2 decision aid | Experimental | The intervention group will receive simple instructions to access the US-ANSWER-2 decision aid and complete the program on their own computers within two days. At the end of the session, US-ANSWER-2 will produce a one-page summary with the participant's questions, concerns, and preferred medication option. Receives: Behavioral: US-ANSWER-2 decision aid |
| Control group (Online medication guide) | Active comparator | The control group will receive the online medication guide, reflective of usual practice. The online medication guide contains standard information about biologics, including an introduction about biologic options, dosages, and effects. Receives: Behavioral: Control group (Online medication guide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scale (DCS)
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.
Measured: Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1)
Secondary outcomes (3)
Medication Education Impact Questionnaire (MeiQ)
The MeiQ consists of 6 subscales and a total of 29 items. MeiQ was developed and tested in three different samples of patients with rheumatic conditions on their knowledge of medications.
Measured: Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1 and at Month 2
Partners in Health Scale (PHS)
The Partners in Health Scale is an 11-item measure designed to assess self-efficacy, knowledge of RA and treatment, and self-management behaviours such as taking medication appropriately and adopting a healthy lifestyle.
Measured: Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1 and at Month 2
Health Resource Utilization (HRU) Questionnaire
The HRU questionnaire was developed for both self and interviewer administration in people with arthritis and other chronic conditions. It consists of a series of open-ended questions about individuals' visits to health professionals, use of investigative tests, hospital visits, use of medications, purchases of adaptive aids, and estimable productivity loss incurred by the individual and their caregivers due to his/her health.
Measured: Change measure (baseline score compared to after using the US-ANSWER-2 at Month 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startJan 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Research Centre of Canada, Brigham and Women's Hospital
- Responsible party
- Principal investigator, Hyon Choi, Massachusetts General Hospital
- Investigators
- Hyon K Choi, MD, DrPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787538
- Sponsor's protocol ID
- 2015P002116
- Acronym
- SuPER-US
- Status last verified
- Nov 2024
- First submitted
- 26 May 2016
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Patient Care With Electronic Resources in the United States (SuPER-US): Effectiveness of an Online Decision Aid for Patients Considering Biologic Therapy for Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02787538
- Acronym / sponsor ID
- SuPER-US / 2015P002116
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Decision Aids, Biologics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Arthritis Research Centre of Canada, Brigham and Women's Hospital
- Study start
- Jan 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proof-of-concept randomized trial evaluates the effectiveness of using an online decision aid (US-ANSWER-2) in the decision-making to start or switch biologic therapy in US patients with rheumatoid arthritis.
Detailed description
The proposed project aims to improve the process of making evidence-informed treatment decisions by patients with rheumatoid arthritis (RA) and ultimately empower patient self-management. Current RA treatment emphasizes: 1) the need for early and aggressive treatment, and 2) the use of a treat-to-target approach. However, patients often struggle with treatment decisions, especially when the options have both benefits and risks. To address this challenge, investigators based at Arthritis Research Canada have previously developed an online decision aid called ANSWER-2 (ANimated, Self-serve, WEb-based, Research Tool: Version 2) for RA patients who are considering a biologic, and this tool has been recently adapted for the US healthcare setting (called US-ANSWER-2).
Objectives: 1) To evaluate the effectiveness of US-ANSWER-2 in reducing patients' decisional conflict. 2) To assess the extent to which US-ANSWER-2 improves patients' knowledge about RA medications and confidence in managing their health. 3) To examine the experiences of patients and rheumatologists in using US-ANSWER-2.
The investigators will conduct a proof-of-concept randomized controlled trial with 80 patients with RA. Eligible individuals are those: 1) with a diagnosis of RA from a rheumatologist, 2) whose rheumatologists have recommended initiating a biologic or switching to another biologic, and 3) who have internet access and email. The Intervention Group will receive simple instructions to access the US-ANSWER-2 decision aid and complete the program on their own within two days. At the end of the session, a one-page summary will be produced to help them discuss their questions, concerns, and preferred choices with their health care providers. The Control Group will receive a standard online medication guide, reflective of usual practice. Participants will complete the Decisional Conflict Scale (primary outcome) before and after the intervention (US-ANSWER-2 or standard online medication guide). The following secondary outcome measures will be collected at baseline, Month 1, and Month 2: 1) Medication Education Impact Questionnaire, and 2) Partners in Health Scale. In addition, the use of healthcare resources will be collected at baseline and Month 2, and the use of biologics will be collected at Month 6. All participants and their rheumatologists will be invited to participate in a qualitative interview about their experience with the patient decision aid.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US-ANSWER-2 decision aid | Experimental | Behavioral: US-ANSWER-2 decision aidThe intervention group will receive simple instructions to access the US-ANSWER-2 decision aid and complete the program on their own computers within two days. At the end of the session, US-ANSWER-2 will produce a one-page summary with the participant's questions, concerns, and preferred medication option. |
| Control group (Online medication guide) | Active comparator | Behavioral: Control group (Online medication guide)The control group will receive the online medication guide, reflective of usual practice. The online medication guide contains standard information about biologics, including an introduction about biologic options, dosages, and effects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The inclusion criteria are as follows:
Key exclusion criteria (1 listed)
- Patients who do not meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| US-ANSWER-2 decision aidUS-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. | Behavioural | US-ANSWER-2 decision aid |
| Control group (Online medication guide)Standard online medication guide. | Behavioural | Control group (Online medication guide) |
Primary outcome
Decisional Conflict Scale (DCS)
Time frame: Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1)
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.
3 secondary outcomes
Medication Education Impact Questionnaire (MeiQ)
Time frame: Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1 and at Month 2
Partners in Health Scale (PHS)
Time frame: Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1 and at Month 2
Health Resource Utilization (HRU) Questionnaire
Time frame: Change measure (baseline score compared to after using the US-ANSWER-2 at Month 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyon K Choi, MD, DrPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US-ANSWER-2 decision aid in people with Rheumatoid Arthritis, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict Scale (DCS) (time frame: Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.