Congenital or Acquired HypopituitarismQALHYPONCT05403255
Quality of Life and Psychosocial Dimension in Children With Hypopituitarism
An observational study of Congenital or Acquired Hypopituitarism, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Congenital or Acquired Hypopituitarism
- What is being tested?
- evaluation of the quality of life with questionnaires
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2022to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: The research involves the inclusion of special populations. Indeed, the research plans to include 120 patients aged 10 to 17 years.
Who may be able to join
- Age 10-17 years
- Multiple or isolated pituitary hormone deficiency
- Deficiency diagnosed for a least 6 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hopitaux Marseille
Marseille, Bouches-du-Rhône, 13354
Amandine ROLLAND, amandine.rolland@ap-hm.fr
About this study
Official title: Quality of Life and Psychosocial Dimensions in Children With Congenital or Acquired Hypopituitarism
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.
- Conditions
- Congenital or Acquired Hypopituitarism
- Being tested
- evaluation of the quality of life with questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of the quality of life with questionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Multiple or isolated pituitary hormone deficiency group | Patient with multiple pituitary deficiency or isolated pituitary deficiency diagnosed for at least 6 months. Receives: Other: evaluation of the quality of life with questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (3)
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.
Measured: 1 day
Socioeconomic status
ENVU questionaire ( Social and health vulnerability identification questionnaire in pediatrics )
Measured: 1 day
Fatigue
PedsQL multidimensional fatigue scale
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital or Acquired HypopituitarismStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, ASSISTANCE PUBLIQUE HOPITAUX MARSEILLESarah CASTETS, PH, Principal investigator, ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403255
- Sponsor's protocol ID
- 2022-A00504-39
- Acronym
- QALHYPO
- Status last verified
- May 2022
- First submitted
- 17 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Psychosocial Dimensions in Children With Congenital or Acquired Hypopituitarism
- ClinicalTrials.gov ID
- NCT05403255
- Acronym / sponsor ID
- QALHYPO / 2022-A00504-39
- Conditions
- Congenital or Acquired Hypopituitarism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple or isolated pituitary hormone deficiency group | – | Other: evaluation of the quality of life with questionnairesPatient with multiple pituitary deficiency or isolated pituitary deficiency diagnosed for at least 6 months. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The research involves the inclusion of special populations. Indeed, the research plans to include 120 patients aged 10 to 17 years.
Key inclusion criteria (3 listed)
- Age 10-17 years
- Multiple or isolated pituitary hormone deficiency
- Deficiency diagnosed for a least 6 months
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluation of the quality of life with questionnairesQuestionnaire 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. | Other | Multiple or isolated pituitary hormone deficiency group |
Primary outcome
Quality of life measurement
Time frame: 1 day
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.
3 secondary outcomes
Psychosocial parameters
Time frame: 1 day
Socioeconomic status
Time frame: 1 day
Fatigue
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François CREMIEUX study director
ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
Sarah CASTETS, PH principal investigator
ASSISTANCE PUBLIQUE HOPITAUX MARSEILLE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital or Acquired Hypopituitarism, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah CASTETS, PH (04 91 38 67 30, sarah.castets@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life measurement (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.