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Status unknownNCT05403255QALHYPOUpdated Jun 3, 2022

Quality of Life and Psychosocial Dimension in Children With Hypopituitarism

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

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
10 Years to 17 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Congenital or Acquired Hypopituitarism

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03

Who can participate

Ages eligible
10 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The research involves the inclusion of special populations. Indeed, the research plans to include 120 patients aged 10 to 17 years.

Inclusion criteria

  • Age 10-17 years
  • Multiple or isolated pituitary hormone deficiency
  • Deficiency diagnosed for a least 6 months

Exclusion criteria

Exclusion Criteria:

  • Isolated growth hormone deficiency with normal MRI findings and/or no previous irradiation of the hypothalamo-pituitary region and/or no known genetic cause.
  • Secondary pituitary deficiency due to a secreting adenoma
  • Inability to complete the questionnaire (intellectual disability, low French language proficiency)
  • No health coverage
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • Multiple or isolated pituitary hormone deficiency group

    Patient with multiple pituitary deficiency or isolated pituitary deficiency diagnosed for at least 6 months.

    Other: evaluation of the quality of life with questionnaires

Interventions

  • Otherevaluation 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.

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Socioeconomic status

    ENVU questionaire ( Social and health vulnerability identification questionnaire in pediatrics )

    Time frame: 1 day

  3. Fatigue

    PedsQL multidimensional fatigue scale

    Time frame: 1 day

06

Study locations

1 site
  • Assistance Publique Hopitaux Marseille
    Marseille, Bouches-du-Rhône 13354, France
07

Registry details

Key details

Study ID
NCT05403255
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Jun 3, 2022
Start date
Jul 1, 2022 (estimated)
Primary completion
Jul 1, 2023 (estimated)
Completion
Jan 1, 2024 (estimated)
Last update
Jun 3, 2022

Study contacts

Sarah CASTETS, PH
Contact
sarah.castets@ap-hm.fr
04 91 38 67 30
François CREMIEUX
study director · ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
Sarah CASTETS, PH
principal investigator · ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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