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Evaluating Tools to Communicate Scleroderma Research Results to Patients - Trial #1

Study acronym: SPIN-CLEAR #1
StatusCompleted
PhaseNot applicable
Started2025-12-05
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
Study Status, Study Design, Contacts/Locations v15
Completed without a posted recruiting period
Final enrollment: 511 participants (planned 128)
Enrollment targetestimated 128→confirmed 511
Study sites0→1
2025-12-01
Study Status, Oversight, Study Description, IPDSharing, References v14
Primary completion date2025-12→2025-12-19
Completion date2025-12→2026-01-02
Start date2025-12→2025-12-05
Study description+206 characters
[...] e randomized to a dissemination tool and complete outcomes. AnalysesResponse options will be intent0 to 10 numerical rating scales (0 = strongly disagree, 10 = strongly agree). The primary analysis will be intention-to-treat, andusing usea proportionallinear oddsmixed regressioneffects modelsmodel with multiple observations per participant (using the lmer function from the lme4 package in R).
Publicationsdetails revised at 1 of 1 entry
2025-09-22
Study Identification, Study Status v13
Study title+11 characters
Evaluating Tools to Communicate Scleroderma Research Results to Patients - Trial #1
2025-08-29
Study Status, Oversight v12
Primary completion date2025-09→2025-12
Completion date2025-09→2025-12
Start date2025-09→2025-12
2025-07-08
Study Status v11
Primary completion date2025-07→2025-09
Completion date2025-07→2025-09
Start date2025-07→2025-09
Show 10 earlier versions
2025-05-12
Study Identification, Study Status, Oversight v10
Primary completion date2025-05→2025-07
Completion date2025-05→2025-07
Start date2025-05→2025-07
2025-03-25
Study Status v9
Primary completion date2025-03→2025-05
Completion date2025-03→2025-05
Start date2025-03→2025-05
2025-02-19
Study Status, Study Design v8
Enrollment target488→128
2025-02-03
Study Status, Outcome Measures v7
Primary completion date2025-02→2025-03
Completion date2025-02→2025-03
Start date2025-02→2025-03
Secondary endpointsdetails revised at 2 of 3 entries
2025-01-17
Study Status v6
Primary completion date2025-01→2025-02
Completion date2025-01→2025-02
Start date2025-01→2025-02
2024-12-17
Study Status, Arms and Interventions v5
Re-verified, no change to tracked fields
2024-11-27
Study Status v4
Primary completion date2024-12→2025-01
Completion date2024-12→2025-01
Start date2024-12→2025-01
2024-11-05
Study Status v3
Primary completion date2024-11→2024-12
Completion date2024-11→2024-12
Start date2024-11→2024-12
2024-10-07
Study Identification, Study Status, Oversight, Contacts/Locations v2
Primary completion date2024-10→2024-11
Completion date2024-10→2024-11
Start date2024-10→2024-11
2024-08-20
Study Status, Eligibility v1
Primary completion date2024-06→2024-10
Completion date2024-06→2024-10
Start date2024-06→2024-10
Eligibility criteria+44 characters
Inclusion Criteria: 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 confirmed by a SPIN site physician and, ≥18 years old, plus being fluent in English or French, and have completed one SPIN Cohort assessment in the last year. External enrollment with confirmation ofpatient-reported physician classification of SSc and age 18 or older. Exclus [...]
2024-04-17
Original filing
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.
Trial Details
NCT Number NCT06373263
Lead Sponsor Lady Davis Institute
Conditions Scleroderma, Systemic Sclerosis
Enrollment 511 participants
Start Date 2025-12-05
Primary Completion 2025-12-19 (estimated)
Study Completion 2026-01-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-10