Clinical trial NCT05679076: A Qualitative Study on the Pain and Quality of Life of Patients With Fabry Disease
Official title: A Qualitative Study on the Pain and Quality of Life of Patients With Fabry Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fabry Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fabry patients

Brief summary: Background It is necessary to find out the difficulties experienced by patients with Fabry disease and their families, and to seek solutions for them. For this purpose, qualitative research with a patient-centered approach is useful.

Objectives The Objective of this study is to understand the various difficulties of patients with Fabry disease and to help them establish a comprehensive support system, medical, health, and welfare service system, and develop the direction and components of social and educational programs.

Methods The subjects of this study are patients who have been diagnosed with Fabry disease, and among them, are selected considering the selection and exclusion criteria, confirm consent for participation in the study after sufficient explanation, and then enroll. The target number of subjects is 10 people. Subjects who consented to the study had an in-depth interview centered on the in-depth interview questionnaire through the HA Research Institute, a specialized institution.

* The principle of saturation is observed by conducting 3 interviews per research subject.
* The duration of each interview per research subject is 50 to 60 minutes.
* All dictations of the research subjects were recorded with prior consent and then transcribed into a written copy.
* For 3 interviews, the number of interviews can be reduced to 1 or 2 by extending the interview time according to the research subject's request.
* As for the place of interview, the research counseling room at Severance Cardiovascular Hospital or the in-depth interview room in the HA Research Institute can be used, and the interview can be conducted at other places desired by the research subject at the request of the research subject.


Eligibility criteria: Inclusion Criteria:

1. Subjects who have delayed diagnosis of Fabry disease or have experienced treatment refusal.
2. Subjects who have been diagnosed with Fabry name for more than 3 years or who have been treated for more than 1 year
3. Adults between the ages of 19 and 70 who have the ability to consent to participate in the research (excluding those subject to adult guardianship) and have the cognitive ability to dictate their experiences
4. Subjects who have experienced disadvantages and support in health-related quality of life, academic, job, family, social, and heterosexual relationships due to Fabry disease
5. Subjects who voluntarily gave written consent after hearing the explanation of the purpose and method of this clinical study

Exclusion Criteria:

1. Subjects who, in the opinion of the researcher, are unlikely to complete the study

Primary outcomes:
measure: Identify negative problems experienced by patients with Fabry disease
timeFrame: up to 5 months
measure: Check the quality of life of patients with Fabry disease
timeFrame: up to 5 months
measure: Identifying the structural causes of policies for patients with Fabry disease
timeFrame: up to 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital
name: Geu-Ru Hong
role: PRINCIPAL_INVESTIGATOR
References: