Validation of a Questionnaire That Identifies the Reasons for Non-adherence to Existing Growth Hormone Therapy
NCT ID: NCT03672617
Last Updated: 2019-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
321 participants
OBSERVATIONAL
2018-10-02
2019-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Children and adolescents
Children and adolescents, who administer growth hormone (GH) themselves (self-injections) will be asked to complete the questionnaire.
No treatment given
No treatment is given to study participants. Only evaluation of a questionnaire assessing reasons for non-adherence to growth hormone therapy (GHT) and to determine its validity and reliability.
The preliminary working title of the questionnaire GHCQ used in the outcome measures was renamed for simplicity reasons into BAR-GHT (abbreviation for barriers to growth hormone therapy) after study completion.
Parents/legal guardians
Parents/legal guardians who administer the GH to their child will be asked to complete the questionnaire.
No treatment given
No treatment is given to study participants. Only evaluation of a questionnaire assessing reasons for non-adherence to growth hormone therapy (GHT) and to determine its validity and reliability.
The preliminary working title of the questionnaire GHCQ used in the outcome measures was renamed for simplicity reasons into BAR-GHT (abbreviation for barriers to growth hormone therapy) after study completion.
Interventions
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No treatment given
No treatment is given to study participants. Only evaluation of a questionnaire assessing reasons for non-adherence to growth hormone therapy (GHT) and to determine its validity and reliability.
The preliminary working title of the questionnaire GHCQ used in the outcome measures was renamed for simplicity reasons into BAR-GHT (abbreviation for barriers to growth hormone therapy) after study completion.
Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Reporting Anchor and Disclosure (1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Mainz, , Germany
Countries
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References
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de Zwaan M, Fischer-Jacobs J, Wabitsch M, Reinehr T, Meckes-Ferber S, Crosby RD. Development and Psychometric Evaluation of an Instrument Assessing Barriers to Growth Hormone Treatment (BAR-GHT). Front Endocrinol (Lausanne). 2020 Feb 25;11:84. doi: 10.3389/fendo.2020.00084. eCollection 2020.
Other Identifiers
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U1111-1210-1036
Identifier Type: OTHER
Identifier Source: secondary_id
GH-4415
Identifier Type: -
Identifier Source: org_study_id
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