- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01129076
Perceptions of Thalassemia Major in Singapore: An Exploratory Study of Stigma
14 de diciembre de 2019 actualizado por: National Human Genome Research Institute (NHGRI)
Background:
- Thalassemia major (TM) is a chronic disorder that affects a person s ability to produce hemoglobin, resulting in anemia. Hemoglobin is a component of red blood cells that carries oxygen and nutrients to cells in the body. As a result, individuals require life-long blood transfusions and extensive medical management. Studies have shown that because of its demanding nature, TM might negatively affect an individual s quality of life, sense of self, and social integration, but little is known about affected individuals overall experiences with and perceptions of TM.
- TM is caused by a genetic change in the thalassemia gene. The disease is passed to children by parents who carry one copy of the altered thalassemia gene. The parents are called carriers of the condition and have a 25 percent chance of having a child with TM. It is possible to screen for carriers of TM and use this information for pregnancy planning and management.
- TM is common among people from South and South East Asia and is an important public health concern in Singapore. More research is needed to explore the lives of people with TM, and the societal perceptions that exist in Singapore about TM.
Objectives:
- To describe the familial, social, and professional experiences of individuals with TM.
- To investigate the social messages being given out about TM in Singapore and the sources of those messages.
- To explore the impact of these experiences, perceptions, and social messages on individuals who have TM.
- To explore how the experiences and perceptions of individuals who have TM affect their life, sense of self, social integration, and compliance with medical treatment.
Eligibility:
- Residents of Singapore who are 14 years of age or older, can speak English, and currently have TM.
- Parents of individuals with TM who are 14 years of age or older. Parents must be 21 years of age or older, be able to speak English, and have had caregiving responsibilities for their child at some point.
Design:
- All participants will have a one-time semi-structured interview, followed by a questionnaire to obtain demographic information.
- Interviews will be conducted in Singapore and are expected to last for 30 to 90 minutes.
- Individuals with TM will be asked about their own perceptions of TM; familial, social, and professional experiences involving TM; and their perceptions of others views and of social messages related to TM.
- Parents of individuals with TM will be asked about their experiences in caring for a child with TM, talking to their child about TM, telling people about their child s TM, and interacting with health care providers.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Thalassemia major (TM) is a chronic, inherited hematological disorder that can require life-long medical care.
As a result of the chronic and demanding nature of the condition, studies have shown that TM might negatively affect an individual s quality of life, sense of self, social integration, and compliance with medical treatment.
Yet, little is known about affected individuals overall experiences with and perceptions of TM.
In this study, the concept of stigma will be used to explore and understand these experiences and perceptions in the population of individuals with TM in Singapore.
This study will involve qualitative interviews with TM patients and parents of TM patients.
Interviews will focus on individuals family, social and professional experiences with TM; the social messages that exist in Singapore about TM and their sources; individuals perceptions of how others view TM; individuals own perceptions of TM; and the impact of these various experiences, messages and perceptions on the individual with TM.
Interviews will be conducted with approximately 20-30 individuals with TM, and 10-20 parents of individuals with TM.
Interviews will be transcribed and subjected to thematic analysis to identify common themes.
The results of this study will further our understanding of the psychosocial burden of TM and the potential role of stigma in this population, which may ultimately inform the care for individuals with TM.
The study s setting will also provide insights into the impact of the Singaporean sociocultural context on the psychosocial elements of living with a genetic condition, which might eventually help to inform the development of appropriate psychosocial support services and genetic counseling services in the region.
Tipo de estudio
De observación
Inscripción (Actual)
30
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Singapore, Singapur
- KK Women's & Children's Hospital
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Singapore, Singapur, 169608
- Singapore General Hospital Outram Rd.
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
14 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
- INCLUSION CRITERIA:
- Individuals who currently have TM and receive at least 8 blood transfusions in a year
- Residents of Singapore
- Must speak English
- Parents of individuals with TM will be eligible for participation if they are age 21 years or older
- Parents must be residents of Singapore
- Parents must speak English
- For a parent to participate in the study, it will not be required that his or her child also participate in the study or vice versa.
EXCLUSION CRITERIA:
- Children under age 14 years
- Non-English speaking individuals
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Major B, O'Brien LT. The social psychology of stigma. Annu Rev Psychol. 2005;56:393-421. doi: 10.1146/annurev.psych.56.091103.070137.
- Ismail A, Campbell MJ, Ibrahim HM, Jones GL. Health Related Quality of Life in Malaysian children with thalassaemia. Health Qual Life Outcomes. 2006 Jul 2;4:39. doi: 10.1186/1477-7525-4-39.
- Hoedemaekers R, ten Have H. Geneticization: the Cyprus paradigm. J Med Philos. 1998 Jun;23(3):274-87. doi: 10.1076/jmep.23.3.274.2585.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
23 de abril de 2010
Finalización del estudio
7 de enero de 2016
Fechas de registro del estudio
Enviado por primera vez
21 de mayo de 2010
Primero enviado que cumplió con los criterios de control de calidad
21 de mayo de 2010
Publicado por primera vez (Estimar)
24 de mayo de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de diciembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
14 de diciembre de 2019
Última verificación
7 de enero de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 999910104
- 10-HG-N104
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .