Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373263
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-15
Brief Title:
Evaluating Tools to Communicate Scleroderma Research Results to Patients
Sponsor:
Lady Davis Institute
Organization:
Lady Davis Institute
Study Overview
Official Title:
A Randomized Controlled Trial to Compare the Effectiveness of Dissemination Tools to Share Research Results with Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPIN-KT
Brief 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 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
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 CIHRs 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 eg 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 eg 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 1250 and growing will be invited to enrol and those enrolled will be randomized to a dissemination tool and complete outcomes Analyses will be intent-to-treat and use proportional odds regression models
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 eg 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 1250 and growing will be invited to enrol and those enrolled will be randomized to a dissemination tool and complete outcomes Analyses will be intent-to-treat and use proportional odds regression models
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None