Quality of Life in Adults With Untreated Fabry Disease in Sweden (QoLUF)

ConditionFabry Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVastra Gotaland Region

About this trial

Fabry disease is a rare, inherited condition that can affect multiple organs, including the heart, kidneys, and nervous system. Many people with Fabry disease live for a period of time without receiving disease-specific treatment, for example because treatment criteria have not yet been met. There is limited knowledge about how patients experience this period without treatment.

The purpose of this study is to improve understanding of how adults with Fabry disease who are not yet receiving disease-specific treatment experience their quality of life, their daily lives, and their contacts with health care services.

This is a national interview study in which participants will take part in one individual digital interview lasting approximately 45-60 minutes. During the interview, participants will be invited to describe their experiences in their own words, including symptoms, how the disease affects everyday life, psychological and emotional well-being, and experiences of follow-up and support from health care providers. Participants will also complete a short questionnaire with basic background information, such as age, education, and living situation.

By collecting and analyzing patients' own narratives, the study aims to identify needs, challenges, and support resources during the period without treatment. The results are expected to contribute to increased knowledge and to the development of more person-centered care for individuals living with Fabry disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Confirmed diagnosis of Fabry disease

Followed at a National Highly Specialized Care (NHV) center for Fabry disease in Sweden (Sahlgrenska University Hospital or Karolinska University Hospital)

Not currently receiving disease-specific treatment for Fabry disease (such as enzyme replacement therapy or chaperone therapy)

Disqualifiers

Current or planned disease-specific treatment for Fabry disease

Disease-specific treatment deemed permanently not indicated due to other medical conditions

Actively declined an offered disease-specific treatment

Inability to participate in a qualitative interview

Trial population

The study population consists of adult patients diagnosed with Fabry disease who are not currently receiving disease-specific treatment. Participants are followed at national highly specialized care centers in Sweden and represent individuals living with Fabry disease during a period without active treatment.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • Qualitative Interview

    Other intervention

    Non-interventional

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Adults with Fabry Disease Not Receiving Disease-Specific Treatment1 intervention

Trial outcomes

Primary outcomes

1

Patient-reported experiences of quality of life while living with untreated Fabry disease

Quality of life is explored through participant narratives obtained in a single semi-structured qualitative interview. Participants describe how Fabry disease and the absence of disease-specific treatment affect their daily life, physical well-being, psychological and emotional experiences, social activities, and overall life situation.

Time frame
Single assessment during one qualitative interview (approximately 45-60 minutes)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vastra Gotaland Region

Lead sponsor

Karolinska University Hospital

Collaborator

Sahlgrenska University Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: