An observational study in Congenital or Acquired Hypopituitarism, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-06-03.
Sponsored by Assistance Publique Hopitaux De Marseille · Observational
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.
Objectives:
Methods
47 studies on the registry are indexed under Hypopituitarism; 8 are open to participants now.
This study's planned enrollment of 120 is below the median of 137 across 17 observational studies indexed under Hypopituitarism.
Browse Hypopituitarism studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.
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The research involves the inclusion of special populations. Indeed, the research plans to include 120 patients aged 10 to 17 years.
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Exclusion Criteria:
Patient with multiple pituitary deficiency or isolated pituitary deficiency diagnosed for at least 6 months.
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.
Quality of life measurement
The KIDSCREEN-10 score consists of 10 items and provides a Rasch-scaled single score of HRQoL. Both self-report and proxy versions will be used.
Time frame: 1 day
Psychosocial parameters
HBSC questionnaires (Aged Behaviour in School-agedd Children, INPES 2014). This international standard questionnaire enables the collection of common data across participating countries and thus enables the quantification of patterns of key health behaviours, health indicators and contextual variables.
Time frame: 1 day
Socioeconomic status
ENVU questionaire ( Social and health vulnerability identification questionnaire in pediatrics )
Time frame: 1 day
Fatigue
PedsQL multidimensional fatigue scale
Time frame: 1 day
Start is estimated for Jul 2022; primary completion for Jul 2023, 12 months later.
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This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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