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

Novo Nordisk

Status: Completed

Conditions: Growth Hormone Deficiency in Children

Treatments: Other: No treatment given

Study type: Observational

Funder types: Industry

Identifiers

NCT03672617

GH-4415

U1111-1210-1036 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 321 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

321 participants in 2 patient groups

Children and adolescents

Description:

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

Treatment:

Other: No treatment given

Parents/legal guardians

Description:

Parents/legal guardians who administer the GH to their child will be asked to complete the questionnaire.

Treatment:

Other: No treatment given