Validation of a Questionnaire That Identifies the Reasons for Non-adherence to Existing Growth Hormone Therapy

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Brief Title

Validation of a Questionnaire That Identifies the Reasons for Non-adherence to Existing Growth Hormone Therapy

Official Title

Validation of a Patient-reported Outcome (PRO) Measure That Assesses Reasons for Non-adherence to Growth Hormone Therapy (GHT)

Brief Summary

      The aim of the study is to examine the suitability, the so-called validation, of a
      questionnaire, with which one can grasp the reasons why injections of growth hormones are
      omitted by patients ("non-adherence"). Participants are treated with growth hormone and are
      therefore eligible to take part in the study. Study doctor will ask participants to answer
      questionnaires. two times within 14 days. The first time participants answer during the
      routine visit to the practice / clinic and the second time at home. There are no risks
      associated with participating in the study as it does not affect participant's medical
      treatment.
    



Study Type

Observational


Primary Outcome

Validity of the Growth Hormone Compliance Questionnaire child/adolescent version (GHCQ-CA)


Condition

Growth Hormone Deficiency in Children

Intervention

No treatment given

Study Arms / Comparison Groups

 Children and adolescents
Description:  Children and adolescents, who administer growth hormone (GH) themselves (self-injections) will be asked to complete the questionnaire.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

321

Start Date

October 2, 2018

Completion Date

April 25, 2019

Primary Completion Date

April 25, 2019

Eligibility Criteria

        Inclusion Criteria: - Children/adolescents, male or female, aged 8 to 18 years who
        self-inject GH as well as their parents/legal guardians or Parents/Legal guardians who
        administer GH to a child/adolescent, male or female, from birth to 18 years - The
        child/adolescent is on prescribed daily GHT due to idiopathic growth hormone deficiency
        (GHD), multiple pituitary hormone deficiency (MPHD/organic GHD), small for gestational age
        (SGA) or Turner syndrome (TS) for at least 6 months before screening visit - Signed
        informed consent obtained by parent/legal guardian and child/adolescent before any
        study-related activities (study-related activities are any procedure related to recording
        of data according to the protocol) Exclusion Criteria: - Mental incapacity, unwillingness
        or language barrier of participant precluding adequate understanding or cooperation -
        Previous participation of participant in this study. Participation is defined as having
        given informed consent in this study - Treatment of child/adolescent with any
        investigational drug within 30 days prior to enrolment into the study
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Clinical Reporting Anchor and Disclosure (1452), , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT03672617

Organization ID

GH-4415

Secondary IDs

U1111-1210-1036

Responsible Party

Sponsor

Study Sponsor

Novo Nordisk A/S


Study Sponsor

Clinical Reporting Anchor and Disclosure (1452), Study Director, Novo Nordisk A/S


Verification Date

September 2019