NCT05403255

Quality of Life and Psychosocial Dimension in Children With Hypopituitarism

Quality of Life and Psychosocial Dimensions in Children With Congenital or Acquired Hypopituitarism

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Relatively little is known about the quality of life (QOL) of patients with hypopituitarism, particularly children. Quality of life studies have mostly focused on improvements following the initiation of growth hormone treatment in adults with growth hormone deficiency. Overall QOL data on patients with multiple pituitary hormone deficiency or another isolated deficiency are much scarcer. These studies suggest however that pituitary deficiencies affect the QOL and social integration of adults. In children, the psychosocial repercussions of the disease are very poorly understood, particularly in the case of multiple congenital pituitary hormone deficiency.

Detailed description

Objectives: * Describe the quality of life and psychosocial repercussions of the disease in children 10-17 years of age with multiple pituitary hormone deficiency (either acquired or congenital), or isolated pituitary hormone deficiency (other than idiopathic isolated growth hormone deficiency). * Compare the QOL and psychosocial indicators of these patients with those of the general population * Study the effects of various factors (medical, social, psychological) on patient outcomes and experiences of the disease. Methods * Prospective analytical pilot study involving the four hospitals in the Referral Centre for Rare Pituitary Diseases (Centre de Référence des Maladies Rares de l'Hypophyse, HYPO) * Questionnaire data will be collected among patients and their parents during follow-up consultations. * Children's quality of life will be evaluated using the Kidscreen-10 questionnaire (for children and parents) and PedsQL multidimensional fatigue scale. Psychosocial indicators (standard of living, schooling, recreation activities, social and family relationships, perceived health status and physical appearance) will be gathered using a questionnaire based on the HBSC (Health Behaviour in School-Aged Children) questionnaire (INPES 2010), and compared with data from the general population of elementary-, middle-and high-school children in France.

Conditions

• Congenital or Acquired Hypopituitarism

Interventions

Type	Name	Description
OTHER	evaluation of the quality of life with questionnaires	Questionnaire data will be collected among patients and their parents during follow-up consultations. Children's quality of life will be evaluated using the Kidscreen-10 questionnaire (for children and parents) and PedsQL multidimensional fatigue scale. Psychosocial indicators (standard of living, schooling, recreation activities, social and family relationships, perceived health status and physical appearance) will be gathered using a questionnaire based on the HBSC (Health Behaviour in School-Aged Children) questionnaire (INPES 2010), and compared with data from the general population of elementary-, middle-and high-school children in France.

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-07-01
• Completion: 2024-01-01
• First posted: 2022-06-03
• Last updated: 2022-06-03

Locations

1 site across 1 country: France