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Recruiting NCT07374107

MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS)

— Observational IBM IIM Myositis Inflammatory Myopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention - qualitative and mixed methods investigations.
Who it may be relevant to
Registry conditions: IBM, IIM, Myositis, Inflammatory Myopathy. Basic parameters: from 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS) - A Qualitative Study of Patient-voiced Research Priorities Across Rare Myositis Diseases

Overview

Myositis diseases are each rare diseases. As in other rare diseases, people living with myositis diseases face physical and psychosocial challenges that may not be recognized in current research priorities. The PRISMS study is a global investigation that collects patient perspectives through (mostly online) methods of open-ended questions, community forums and survey to identify the most pressing research concerns as identified by patients. Findings will be analyzed to create a patient-voiced set of research priorities that can guide the direction of research and help inform funding decisions across myositis diseases. Potential participants can express interest via https://mihrafoundation.org/mihra-programs/mihra-patient-contact-registry/

Detailed description

This is a patient-initiated observational qualitative (largely online) study engaging people living with myositis diseases (and optionally their care partners) in mixed methods applications to elicit patient-voiced research priorities. Participants will be purposively sampled to ensure representation across myositis subtypes and key demographic/clinical characteristics.

Methods include open-ended narratives, interactive focus groups and forums, rating and ranking to establish degree of importance and priorities.

Results will include a structured set of patient-voiced priority topics/questions and a draft framework for downstream consensus processes and research agenda setting.

Interventions

  • Other No intervention - qualitative and mixed methods investigations
    No Intervention

Primary outcome measures

  • Patient-voiced research priority topics [Time frame: At completion of narrative, focus group forum or survey, up to 90 minute]

Eligibility criteria

Inclusion criteria

  • Ability to provide informed consent
  • Have a clinician diagnosis of an idiopathic inflammatory myopathy or be a care partner or parent of a person living with an idiopathic inflammatory myopathy.
  • Participants who may have signed up through the MIHRA Patient Contact Registry https://mihrafoundation.org/mihra-programs/mihra-patient-contact-registry/

Exclusion criteria

  • Under the age of 7 years old
  • Do not have a diagnosis of an inflammatory myopathy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • MIHRA Foundation - This is a GLOBAL STUDY — New Orleans

Publications

  • Saketkoo LA, Paik JJ, Alexanderson H, Dimachkie MM, Ernste FC, Naddaf E, Shafranski B, Gupta L, Mecoli CA, Saygin D, Albayda J, Basharat P, Day JA, Valenzuela A, Bromley R, de Groot I, Edison SE, Lanis A, Lood C, Regardt M, Yi BY, Benitez AC, Chinoy H, Christopher-Stine L, Isenberg DA, Lang B, Oddis CV, van Royen A, Vencovsky J, Werth VP, Machado PM. Collaborative research in myositis-related diso PMID 38436382
  • Lanis A, Alexanderson H, Ardalan K, Edison S, Graham CD, de Groot I, Gupta L, Kim S, Knight AM, Kobert L, Livermore P, Lood C, Pilkington C, Regardt M, Rubinstein TB, Shenoi S, Turnier L, Voet NBM, Wahezi DM, Saketkoo LA. Mental health in paediatric and adult myositis-related diseases: current state of research, interventions, and future steps from the MIHRA Psychological Impact Scientific Working PMID 38488093
  • Saketkoo LA, Valenzuela A, Kim S, McCann LJ, Lood C, Wahezi DM, Werth VP, Yi B, Alexanderson H, Maillard S, Pilkington C, Fligelstone K, Limbach B, Orandi AB, Regardt M, Russell AM, Davuluri S, deGroot I, Ernste F, Paik JJ, von Muhlen CA, Dimachkie MM, Machado PM, Naddaf E, Shafranski BM, Gupta L, Zulian F, Chung L; International Myositis Assessment and Clinical Studies Group and The Myositis Inte PMID 37449887

Identifiers

NCT: NCT07374107 · MIHRA - 001 · PRISMS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗