Disease Burden and Living Situation of Patients With Facioscapulohumeral Muscular Dystrophy

NCT ID: NCT06517498

Last Updated: 2024-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-07-31

Brief Summary

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The goal of this observational study is to learn the patient journey, disease burden, living situation, quality of life and etc. in patients with Facioscapulohumeral Muscular Dystrophy in all sex/gender and age groups. The main questions it aims to answer are:

1. What's the patient journey of patients with Facioscapulohumeral Muscular Dystrophy?
2. How does Facioscapulohumeral Muscular Dystrophy burden the patients?
3. How's the quality of life of patients with Facioscapulohumeral Muscular Dystrophy?

Patients with Facioscapulohumeral Muscular Dystrophy will be asked to:

1. fill a questionnaire.
2. be interviewed and answer questions about their illness experience, economic burden, quality of life and etc.

Medical experts on Facioscapulohumeral Muscular Dystrophy will be asked to be interviewed and answer questions about understanding on the disease and the patients.

Detailed Description

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Study Objective This observational study aims to comprehensively understand the patient journey, disease burden, living situation, and quality of life in individuals diagnosed with Facioscapulohumeral Muscular Dystrophy (FSHD). The study encompasses all sex/gender and age groups to provide a holistic view of the disease's impact.

Research Questions

The study focuses on answering the following key questions:

1. What is the patient journey of individuals with Facioscapulohumeral Muscular Dystrophy?
2. How does Facioscapulohumeral Muscular Dystrophy burden the patients?
3. What is the quality of life of patients with Facioscapulohumeral Muscular Dystrophy?

Methodology

To gather comprehensive data, participants will be engaged in two main activities:

1.Questionnaire Completion: Participants will fill out a detailed questionnaire designed to capture quantitative data on their health status, symptoms, treatments received, and the impact of FSHD on their daily lives. The questionnaire will also collect demographic information and other relevant background data.

2.In-Depth Interviews with patients with Facioscapulohumeral Muscular Dystrophy: They will undergo semi-structured interviews conducted by trained researchers. These interviews will delve into the personal experiences of living with FSHD, including:

1. Illness Experience: Participants will describe their journey from initial symptoms to diagnosis and ongoing management of the disease.
2. Economic Burden: Discussions will cover the financial impact of FSHD, including costs related to medical care, treatments, and any income loss due to the inability to work.
3. Quality of Life: Interviews will explore the effects of FSHD on various life domains, such as physical health, mental well-being, social relationships, and overall life satisfaction.

3.In-Depth Interviews with medical experts on Facioscapulohumeral Muscular Dystrophy: They will undergo semi-structured interviews conducted by trained researchers. These interviews will delve into their understanding on the disease and the patients.

Expected Outcomes The study aims to generate a detailed understanding of the multifaceted impact of FSHD on patients' lives. By examining the patient journey, disease burden, and quality of life, the study seeks to identify gaps in current healthcare provisions and areas where additional support may be needed. This information will be valuable for healthcare providers, policymakers, and patient support organizations in improving care and support for individuals with FSHD.

Conditions

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Muscular Dystrophy, Facioscapulohumeral

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients With Facioscapulohumeral Muscular Dystrophy

No intervention will be administered

No Intervention

Intervention Type OTHER

No Intervention will be conducted

Interventions

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No Intervention

No Intervention will be conducted

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Having been diagnosed as Facioscapulohumeral Muscular Dystrophy

Exclusion Criteria

* No
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Organization for Rare Disorders

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role collaborator

Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Wenjing Ji

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wenjing Ji, PhD

Role: PRINCIPAL_INVESTIGATOR

Xi'an Jiaotong University

Locations

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Health Science Center of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenjing Ji, PhD

Role: CONTACT

+86 18221252258

Facility Contacts

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Wenjing Ji, PhD

Role: primary

+86 18221252258

Other Identifiers

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XJTU-CDSP_02

Identifier Type: -

Identifier Source: org_study_id

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