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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06346106
Other study ID # 23-0075
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 24, 2023
Est. completion date April 30, 2024

Study information

Verified date March 2024
Source Children's Hospital Colorado
Contact Natalia Klamut
Phone ?(720) 277-9095?
Email malerettstudy@cuanschutz.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Diagnostic Experience of Male Rett Syndrome collects information on the lived experiences of parents or caregivers to boys with Rett Syndrome. Key information examined includes the process of getting a male Rett syndrome diagnosis, your son's systems of care, and your priorities for his health needs. Enrolled participants will complete an online survey with questions about having a son with Rett Syndrome. The Diagnostic Experience of Male Rett Syndrome study is available to parents or caregivers to boys (alive or passed) with Rett Syndrome. Compensation is not provided.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers
Gender Male
Age group 0 Years to 100 Years
Eligibility Inclusion Criteria: - English-speaking parents (over the age of 18) of male children (all ages, alive or deceased) with confirmed genetic diagnosis of male RTT Exclusion Criteria: - parents of male MECP2 duplication syndrome

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
Male Rett
This study does not have an intervention. Participants of this study must be parents or caregivers to boys with Rett syndrome.

Locations

Country Name City State
United States University of Colorado Anschutz Medical Campus Aurora Colorado

Sponsors (7)

Lead Sponsor Collaborator
Children's Hospital Colorado International Rett Syndrome Foundation, Rocky Mountain Rett Association, University of Alabama at Birmingham, University of Colorado, Denver, University of Pennsylvania, Vanderbilt University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic experiences Qualitative interview retrospective from birth
Primary Attainment of developmental milestones and any regressions Remote survey of developmental milestones, reported in months retrospective from birth
Primary QI-disability "QI-Disability" is a published remote survey of symptom ratings that are combined into an aggregate score of quality of life retrospective over prior month
Primary Parent priorities for care and counseling Remote survey the asks parents to prioritize with a rating scale their priorities for patient care retrospective from birth
Primary Parenting experience Remote survey the asks parents to rate with a rating scale their parenting experience retrospective from birth
Primary Information regarding child's death, if applicable Questionnaire that asks parents about the details of their child's death, if applicable retrospective from birth
Secondary Family demographics Questionnaire retrospective, over last 12 months
Secondary Systems of supports Questionnaire retrospective, over last 12 months
Secondary Healthcare preferences Questionnaire retrospective, over last 12 months
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