Evaluating tools to communicate scleroderma research results to patients - trial #2
| ISRCTN | ISRCTN17218321 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17218321 |
| Secondary identifying numbers | 2024-4165-2 |
- Submission date
- 21/10/2025
- Registration date
- 27/10/2025
- Last edited
- 27/10/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Engaging people with lived experience (PWLE) in research is an important component of ethical research, and major research funders mandate or encourage engagement of PWLE to improve research relevance and trust in the findings. PWLE can be engaged in research across all stages and have different levels of influence on decision-making, including (1) consulting by providing opinions or perspectives on a topic or problem related to planned or ongoing research; (2) being involved or advising via two-way conversations with researchers on one or more aspects of a research study; and (3) partnering, which involves working as equals with researchers to collaborate and make decisions related to multiple aspects of one or more studies.
The SPIN – Communicating Latest Evidence and Results (SPIN-CLEAR) trial series will test different ways of communicating research results to study participants and others with relevant lived experience. This will be the second SPIN-CLEAR trial. The primary objective of this trial will be to compare among PWLE the perceived relevance and trustworthiness of research described in plain-language research summaries. We will compare plain-language summaries with a description of PWLE engagement versus plain-language summaries with no mention of PWLE engagement. We will also evaluate ratings of information completeness, understandability of the plain-language summaries, whether participants were pleased to have received results, intention to participate in future studies, and for all primary and secondary outcomes, subgroup analyses of effects by participant characteristics (age, gender, race or ethnicity, country, language, education level, health literacy).
Who can participate?
The Scleroderma Patient-centered Intervention Network (SPIN) is a collaboration of researchers, clinicians, and people with systemic sclerosis (SSc; also known as scleroderma). People with SSc in the SPIN Cohort and other people with SSc not in the Cohort can participate. Participants must be aged 18 years and over, confirm that they have been classified as having SSc by a physician, and be fluent in English or French. People not able to access or respond to questionnaires via the internet are excluded.
What does the study involve?
Those who consent will be randomized to receive plain-language summaries with a description of PWLE engagement or plain-language summaries with no mention of PWLE engagement. Items to rate outcomes will be presented to participants following each plain-language summary on a Qualtrics online survey platform. We estimate that participants will require between 5 and 15 minutes to review dissemination tools, and we will record this. There will not be any limits on how many times participants can access the tools prior to responding to the outcome measurements. We will send email and text reminders to participants who have consented but not completed all outcome measures at 7-days and 11-days post-consent, and data collection will end on day 14 by closing the Qualtrics survey. Outcomes will be linked to sociodemographic, medical, and health literacy data collected via the SPIN Cohort, which has been done with 100% linking success in previous trials. Sociodemographic and medical data will be collected directly in each trial survey from non-SPIN participants.
What are the possible benefits and risks of participating?
There are no direct health benefits from participating, but participants may find the research informative. The only possible harm we identified is that being informed of study results may lead to disappointment if the results are not as hoped. The findings will help improve how research is shared with patients in the future. There will be no financial compensation for participants in the trials.
Where is the study run from?
The study is run by the SPIN research team at the Jewish General Hospital (Montréal, Québec, Canada).
When is the study starting and how long is it expected to run for?
January 2026 to February 2026
Who is funding the study?
Canadian Institutes of Health Research (CIHR) (Canada)
Who is the main contact?
Dr Brett D. Thombs, brett. thombs@mcgill.ca.
Contact information
Public, Scientific, Principal investigator
Jewish General Hospital
3755 Côte-Sainte-Catherine Road, H4.83
Montréal
H3T 1E2
Canada
 ORCID ID |
0000-0002-5644-8432 |
|---|---|
| Phone | +1 (0)514 340 8222 |
| brett.thombs@mcgill.ca |
Study information
| Study design | Two-arm parallel-group randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Scientific title | A randomized controlled trial to compare the effectiveness of dissemination tools to share research results with patients - SPIN-CLEAR trial #2 |
| Study acronym | SPIN-CLEAR #2 |
| Study objectives | 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 second trial in the series will compare plain-language research summaries with a description of people with lived experience (PWLE) engagement versus plain-language summaries with no mention of PWLE engagement on the perceived relevance and trustworthiness of the research. 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. |
| Ethics approval(s) |
Approved 27/08/2025, CIUSSS West-Central Montreal Research Ethics Board (3755, Chemin de la Côte Ste-Catherine, bureau A-925, Montréal, H3T 1E2, Canada; +1 (0)514 340 8222 ext 22445; cer@jgh.mcgill.ca), ref: 2024-4165 |
| Health condition(s) or problem(s) studied | Comparison of research dissemination tools to people living with systemic sclerosis (SSc; scleroderma) |
| Intervention | 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 second trial in the series will compare plain-language research summaries with a description of people with lived experience (PWLE) engagement (Engagement arm) against plain-language summaries with no mention of PWLE engagement (No Engagement arm). Plain-language summaries will be co-created by a research team member experienced in knowledge translation in collaboration and a person with SSc who was engaged in the study being disseminated. We will utilize a template developed and tested by the Patient-Centered Outcomes Research Institute (PCORI) to develop the plain-language summaries. In the Engagement arm, plain-language summaries will include a description of PWLE engagement. In the No Engagement arm, plain-language summaries will not mention PWLE engagement. The three plain-language summaries will describe three recently completed but not yet published SPIN studies with high levels of PWLE engagement across all research stages. PIN 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. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Relevance of the research: "The information in this plain-language summary is relevant to me”. Response options = 0-10 numerical rating scales (0 = strongly disagree, 10 = strongly agree). Time frame: immediately post-intervention (intervention and outcomes in one login - outcomes approx.. 30 min after randomization). 2. Trustworthiness of the research: “I trust that the information in this plain-language summary is accurate and unbiased”. Response options = 0-10 numerical rating scales (0 = strongly disagree, 10 = strongly agree). Time frame: immediately post-intervention (intervention and outcomes in one login - outcomes approx.. 30 min after randomization) |
| Secondary outcome measures | 1. Information completeness: “The information presented in the 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). Time frame: immediately post-intervention (intervention and outcomes in one login - outcomes approx. 30 min after randomization). 2. Understandability: “The information presented in the plain-language summary was easy to understand”. Response options = 0-10 numerical rating scales (0 = strongly disagree, 10 = strongly agree). Time frame: immediately post-intervention (intervention and outcomes in one login - outcomes approx. 30 min after randomization). 3. Pleased 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). Time frame: immediately post-intervention (intervention and outcomes in one login - outcomes approx. 30 min after randomization). 4. Intention to participate in future studies: “In the future, I would agree to participate in a similar study to the one presented in the plain-language summary”. Response options = 0-10 numerical rating scales (0 = strongly disagree, 10 = strongly agree). Time frame: immediately post-intervention (intervention and outcomes in one login - outcomes approx. 30 min after randomization). |
| Overall study start date | 15/01/2026 |
| Completion date | 28/02/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target number of participants | 118 |
| Key inclusion criteria | 1. 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. 2. External enrollment with patient-reported physician classification of SSc and aged 18 years or older. |
| Key exclusion criteria | Patients not able to access or respond to questionnaires via the internet |
| Date of first enrolment | 15/01/2026 |
| Date of final enrolment | 28/02/2026 |
Locations
Countries of recruitment
- Canada
Study participating centre
Montréal
H3T 1E2
Canada
Sponsor information
Hospital/treatment centre
3755 Côte-Sainte-Catherine Road
Montréal
H3T 1E2
Canada
| Phone | +1 (0)514 340 8222 |
|---|---|
| info@jghfoundation.org | |
| Website | https://www.jgh.ca/ |
"ROR" |
https://ror.org/056jjra10 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR - Welcome to the Canadian Institutes of Health Research, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | 01/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Our strategy includes multiple dissemination tools: scientific publications, patient organization news articles, patient-oriented tools, toolkits, conferences, and co-presentation workshops. Our patient organization partners intend to work with our Scleroderma Patient-centered Intervention Network (SPIN) to make share the results of these trials to their members. |
| IPD sharing plan | All data and materials will be provided upon reasonable requests to the corresponding author, Dr Brett Thombs (brett.thombs@mcgill.ca). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 08/05/2025 | 27/10/2025 | Yes | No |
Editorial Notes
22/10/2025: Study's existence confirmed by the CIUSSS West-Central Montreal Research Ethics Board.
