SclerodermaSPIN-CLEAR #1NCT06373263
Evaluating Tools to Communicate Scleroderma Research Results to Patients - Trial #1
A study testing Plain-language summary and Dissemination Tool (Infographic) in people with Scleroderma and Systemic Sclerosis, run by Lady Davis Institute at 1 site in Canada.
Trial summary
Sharing research results with patients is required by ethical regulations. Yet, most researchers do not share results from their studies with patients. The investigators plan to conduct a series of randomized controlled trials among people with scleroderma, a rare autoimmune disease, in a large international cohort… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Systemic Sclerosis
- What is being tested?
- Plain-language summary and Dissemination Tool (Infographic)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 511 participants
- Where
- 1 siteCanada
- Study dates
- 5 Dec 2025to 2 Jan 2026
- 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
- Enrollment in SPIN Cohort, which requires a systemic sclerosis (SSc) classification by a site physician based on 2013 American College of Rheumatology/European League Against Rheumatism criteria, ≥18 years old, being fluent in English or French, and have completed one SPIN Cohort assessment in the last year.
- External enrollment with patient-reported physician classification of SSc and age 18 or older.
Who cannot join
- Patients not able to access or respond to questionnaires via the internet are excluded.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Lady Davis Institute for Medical Research
Montreal, Quebec, H3T 1E4
About this study
Official title: A Randomized Controlled Trial to Compare the Effectiveness of Dissemination Tools to Share Research Results With Patients - SPIN-CLEAR Trial #1
Sharing research results with patients is required by ethical regulations. Yet, most researchers do not share results from their studies with patients. The investigators plan to conduct a series of randomized controlled trials among people with scleroderma, a rare autoimmune disease, in a large international cohort, to identify the most effective methods for communicating study results with patients.
The first trial in the series will compare a research dissemination tool (infographic) against a plain-language summary comparator. Participants will be randomly assigned to receive the dissemination tool or comparator. Study participants will rate communication tools for (1) information completeness; (2) understandability; and (3) ease of use of format. Our results can be used by researchers and patient organizations who disseminate research results so that they can tailor the way they disseminate results to patient needs.
Read the detailed description
Background: Research ethics guidance mandates that study results be shared with participants, and CIHR's Knowledge Translation Strategy emphasizes dissemination to others with relevant lived experiences. Yet, most researchers do not share results with patients, and do not know which dissemination tools (e.g., lay summaries, infographics, podcasts) or tool features best facilitate effective communication. Only 3 randomized controlled trials (RCTs) have compared tool effectiveness, and none assessed which approaches work best for which patients. Comparative effectiveness trials are needed to build an evidence base to help us understand what tools are most effective for communicating different types of research to different patients. The investigators will use the multinational Scleroderma Patient-centered Intervention Network (SPIN) Cohort to conduct a series of RCTs to compare tools among people with systemic sclerosis, or scleroderma. The first trial in the series will compare a research dissemination tool (infographic) against a plain-language summary comparator.
Objectives: An effective tool must communicate information patients want to know, understandably, in an easy-to-use format. The trial will compare the effectiveness of an infographic and lay summary, overall and for patients with different sociodemographic or educational characteristics.
Primary Objectives: The first trial will compare tools based on (1) information completeness; (2) understandability; and (3) ease of use, as prioritized by our Patient Advisory Team.
Secondary Objectives: The investigators will evaluate comprehension of key aspects of disseminated research; likelihood that participants would enroll in a similar future study; and, for all primary and secondary outcomes, analyze effects by participant characteristics (e.g., age, country, language, education level, eHealth literacy).
Methods: Parallel-group RCT that will compare 2 tools (infographic and plain-language summary comparator. For this trial, SPIN patients and researchers will select systemic sclerosis research to disseminate. Tools will be developed by experienced tool developers, patients, and researchers. SPIN Cohort participants (N = 1,250 and growing) will be invited to enrol, and those enrolled will be randomized to a dissemination tool and complete outcomes. Response options will be 0 to 10 numerical rating scales (0 = strongly disagree, 10 = strongly agree). The primary analysis will be intention-to-treat, using a linear mixed effects model with multiple observations per participant (using the lmer function from the lme4 package in R).
- Conditions
- Scleroderma, Systemic Sclerosis
- Being tested
- Plain-language summary, Dissemination Tool (Infographic)
- Keywords
- Scleroderma, Knowledge Translation, Dissemination Tools, E-Health, Intervention, Systemic Sclerosis
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plain-language summaryOther
Participants will receive information about a research study via a plain-language summary. The comparator will be a plain-language summary, since plain-language summaries are commonly used and more easily developed than other tools. The summary will be designed based on Canadian government and other key recommendations, including from the Cochrane Collaboration. It will include Background and Objectives, Methods, Results, Limitations, and Key Message for Patients sections and include information on how evidence informs knowledge or health care options. Abstract will be < 500 words long and use short, positive, active-voice sentence structures and everyday words. Reading level will be between 8th and 9th grade based on Flesch-Kincaid Grade Level and readability score between 60 and 70 based on Flesch Reading Ease.
Dissemination Tool (Infographic)Other
The infographic will be developed based on key principles including clearly defining the audience and purpose; sharing a story, rather than just facts, with brief, clear messaging; highlighting main ideas; using an attractive title and images; and following principles of good graphic design.
| Study group | Role | What they receive |
|---|---|---|
| Dissemination tool (infographic) | Experimental | Infographic Receives: Other: Dissemination Tool (Infographic) |
| Plain-language summary | Active comparator | Plain-language summary Receives: Other: Plain-language summary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completeness
"The information presented in the [tool - e.g., "infographic", "plain-language summary"] told me everything I wanted to know about the study".
Response options = 0-10 numerical rating scales (0 = strongly disagree, 10 = strongly agree)
Measured: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)
Understandability
"The information presented in the [tool] was easy to understand". Response options = 0-10 numerical rating scales (0 = strongly disagree, 10 = strongly agree)
Measured: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)
Ease of use
"The [tool] was designed in a way that made it easy to use". Response options = 0-10 numerical rating scales (0 = strongly disagree, 10 = strongly agree)
Measured: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)
Secondary outcomes (3)
Please to have received results
"I am glad that I received the study results"); Response options = 0-10 numerical rating scales (0 = strongly disagree, 10 = strongly agree)
Measured: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)
Intention to participate in future studies
"In the future, I would agree to participate in a similar study to the one presented in the [tool]". Response options = 0-10 numerical rating scales (0 = strongly disagree, 10 = strongly agree)
Measured: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)
Open-ended items
"What did you like about the way the information was communicated?"; "What did you dislike about the way the information was communicated?"; "Do you have suggestions for improving how the information is communicated?"
Measured: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start5 Dec 2025
- Primary completion19 Dec 2025
- Study completion2 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett D Thombs, Lady Davis Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373263
- Sponsor's protocol ID
- 2024-4165
- Acronym
- SPIN-CLEAR #1
- Status last verified
- Dec 2025
- First submitted
- 15 Apr 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data and materials will be provided upon reasonable requests to the corresponding author.
Publications
Thombs BD, Adams C, Nassar EL, Carrier ME, Golberg M, Bharthi K, Wurz A, South A, Kwakkenbos L, Hoa S, Rice DB, Guillot G, Lawrie-Jones A, Sauve M, Bartlett SJ, Fortune C, Gietzen A, Gottesman K, Hudson M, Hummers LK, Malcarne VL, Mayes MD, Richard M, Stempel J, Wojeck RK, Blagrave K, Boruff JT, Cook V, Culos-Reed N, Frobert O, Gillies K, Granikov V, Hemkens LG, Jimenez EY, Kocher A, Leite C, Lim MAWT, Maltez N, Michalski J, Mieszczak T, Ndosi M, Pope J, Rannou F, Rozee K, Straus SE, Sydes MR, Thabane L, Varga J, Yap T, Zwarenstein M, Mouthon L, Benedetti A; SPIN Investigators. Master protocol for a series of cohort-based randomized controlled trials to test tools to communicate research results to study participants and others with relevant lived experience: the SPIN-CLEAR Trials. Trials. 2025 May 8;26(1):149. doi: 10.1186/s13063-025-08846-2.
PubMed 40340935
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Compare the Effectiveness of Dissemination Tools to Share Research Results With Patients - SPIN-CLEAR Trial #1
- ClinicalTrials.gov ID
- NCT06373263
- Acronym / sponsor ID
- SPIN-CLEAR #1 / 2024-4165
- Conditions
- Scleroderma, Systemic Sclerosis
- Keywords
- Scleroderma, Knowledge Translation, Dissemination Tools, E-Health, Intervention, Systemic Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 2 Jan 2026 (actual)
- First posted
- 18 Apr 2024 (actual)
- 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.
Sharing research results with patients is required by ethical regulations. Yet, most researchers do not share results from their studies with patients. The investigators plan to conduct a series of randomized controlled trials among people with scleroderma, a rare autoimmune disease, in a large international cohort, to identify the most effective methods for communicating study results with patients.
The first trial in the series will compare a research dissemination tool (infographic) against a plain-language summary comparator. Participants will be randomly assigned to receive the dissemination tool or comparator. Study participants will rate communication tools for (1) information completeness; (2) understandability; and (3) ease of use of format. Our results can be used by researchers and patient organizations who disseminate research results so that they can tailor the way they disseminate results to patient needs.
Detailed description
Background: Research ethics guidance mandates that study results be shared with participants, and CIHR's Knowledge Translation Strategy emphasizes dissemination to others with relevant lived experiences. Yet, most researchers do not share results with patients, and do not know which dissemination tools (e.g., lay summaries, infographics, podcasts) or tool features best facilitate effective communication. Only 3 randomized controlled trials (RCTs) have compared tool effectiveness, and none assessed which approaches work best for which patients. Comparative effectiveness trials are needed to build an evidence base to help us understand what tools are most effective for communicating different types of research to different patients. The investigators will use the multinational Scleroderma Patient-centered Intervention Network (SPIN) Cohort to conduct a series of RCTs to compare tools among people with systemic sclerosis, or scleroderma. The first trial in the series will compare a research dissemination tool (infographic) against a plain-language summary comparator.
Objectives: An effective tool must communicate information patients want to know, understandably, in an easy-to-use format. The trial will compare the effectiveness of an infographic and lay summary, overall and for patients with different sociodemographic or educational characteristics.
Primary Objectives: The first trial will compare tools based on (1) information completeness; (2) understandability; and (3) ease of use, as prioritized by our Patient Advisory Team.
Secondary Objectives: The investigators will evaluate comprehension of key aspects of disseminated research; likelihood that participants would enroll in a similar future study; and, for all primary and secondary outcomes, analyze effects by participant characteristics (e.g., age, country, language, education level, eHealth literacy).
Methods: Parallel-group RCT that will compare 2 tools (infographic and plain-language summary comparator. For this trial, SPIN patients and researchers will select systemic sclerosis research to disseminate. Tools will be developed by experienced tool developers, patients, and researchers. SPIN Cohort participants (N = 1,250 and growing) will be invited to enrol, and those enrolled will be randomized to a dissemination tool and complete outcomes. Response options will be 0 to 10 numerical rating scales (0 = strongly disagree, 10 = strongly agree). The primary analysis will be intention-to-treat, using a linear mixed effects model with multiple observations per participant (using the lmer function from the lme4 package in R).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Dissemination tool (infographic) | Experimental | Other: Dissemination Tool (Infographic)Infographic |
| Plain-language summary | Active comparator | Other: Plain-language summaryPlain-language summary |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Enrollment in SPIN Cohort, which requires a systemic sclerosis (SSc) classification by a site physician based on 2013 American College of Rheumatology/European League Against Rheumatism criteria, ≥18 years old, being fluent in English or French, and have completed one SPIN Cohort assessment in the last year.
- External enrollment with patient-reported physician classification of SSc and age 18 or older.
Key exclusion criteria (1 listed)
- Patients not able to access or respond to questionnaires via the internet are excluded.
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 |
|---|---|---|
| Plain-language summaryParticipants will receive information about a research study via a plain-language summary. The comparator will be a plain-language summary, since plain-language summaries are commonly used and more easily developed than other tools. The summary will be designed based on Canadian government and other key recommendations, including from the Cochrane Collaboration. It will include Background and Objectives, Methods, Results, Limitations, and Key Message for Patients sections and include information on how evidence informs knowledge or health care options. Abstract will be < 500 words long and use short, positive, active-voice sentence structures and everyday words. Reading level will be between 8th and 9th grade based on Flesch-Kincaid Grade Level and readability score between 60 and 70 based on Flesch Reading Ease. | Other | Plain-language summary |
| Dissemination Tool (Infographic)The infographic will be developed based on key principles including clearly defining the audience and purpose; sharing a story, rather than just facts, with brief, clear messaging; highlighting main ideas; using an attractive title and images; and following principles of good graphic design. | Other | Dissemination tool (infographic) |
Primary outcome
Completeness
Time frame: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)
"The information presented in the [tool - e.g., "infographic", "plain-language summary"] told me everything I wanted to know about the study". Response options = 0-10 numerical rating scales (0 = strongly disagree, 10 = strongly agree)
Understandability
Time frame: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)
"The information presented in the [tool] was easy to understand". Response options = 0-10 numerical rating scales (0 = strongly disagree, 10 = strongly agree)
Ease of use
Time frame: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)
"The [tool] was designed in a way that made it easy to use". Response options = 0-10 numerical rating scales (0 = strongly disagree, 10 = strongly agree)
3 secondary outcomes
Please to have received results
Time frame: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)
Intention to participate in future studies
Time frame: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)
Open-ended items
Time frame: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)
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 10 Sep 2026.
- Background: PubMed 40340935Thombs BD, Adams C, Nassar EL, Carrier ME, Golberg M, Bharthi K, Wurz A, South A, Kwakkenbos L, Hoa S, Rice DB, Guillot G, Lawrie-Jones A, Sauve M, Bartlett SJ, Fortune C, Gietzen A, Gottesman K, Hudson M, Hummers LK, Malcarne VL, Mayes MD, Richard M, Stempel J, Wojeck RK, Blagrave K, Boruff JT, Cook V, Culos-Reed N, Frobert O, Gillies K, Granikov V, Hemkens LG, Jimenez EY, Kocher A, Leite C, Lim MAWT, Maltez N, Michalski J, Mieszczak T, Ndosi M, Pope J, Rannou F, Rozee K, Straus SE, Sydes MR, Thabane L, Varga J, Yap T, Zwarenstein M, Mouthon L, Benedetti A; SPIN Investigators. Master protocol for a series of cohort-based randomized controlled trials to test tools to communicate research results to study participants and others with relevant lived experience: the SPIN-CLEAR Trials. Trials. 2025 May 8;26(1):149. doi: 10.1186/s13063-025-08846-2.
- Individual participant dataSharing planned: Yes. All data and materials will be provided upon reasonable requests to the corresponding author.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plain-language summary and Dissemination Tool (Infographic) in people with Scleroderma and Systemic Sclerosis, run by Lady Davis Institute at 1 site in Canada.
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 2 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 10 Sep 2026. 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 Canada. 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?
Completeness (time frame: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06373263, which also lists 1 linked publication.
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 10 Sep 2026.