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

Growth Hormone Deficiency in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03672617
• Other study ID #: GH-4415
• Secondary ID: U1111-1210-1036
• Status: Completed
• Start date: October 2, 2018
• Est. completion date: April 25, 2019

Study information

• Verified date: September 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: April 25, 2019
• Est. primary completion date: April 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Growth Hormone Deficiency in Children

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of the Growth Hormone Compliance Questionnaire child/adolescent version (GHCQ-CA)	The GHCQ-CA is a patient-reported outcome measure designed to assess reasons for non-adherence to growth hormone therapy in children/adolescents from the child's/adolescent's perspective. The GHCQ-CA currently has 34 items. All GHCQ-CA questions are answered on a 5-point Likert scale from 'Never' to 'Always'.	Day 1
Primary	Validity of the GHCQ-CA	The GHCQ-CA is a patient-reported outcome measure designed to assess reasons for non-adherence to growth hormone therapy in children/adolescents from the child's/adolescent's perspective. The GHCQ-CA currently has 34 items. All GHCQ-CA questions are answered on a 5-point Likert scale from 'Never' to 'Always'.	Day 14
Primary	Reliability of the GHCQ-CA	The GHCQ-CA is a patient-reported outcome measure designed to assess reasons for non-adherence to growth hormone therapy in children/adolescents from the child's/adolescent's perspective. The GHCQ-CA currently has 34 items. All GHCQ-CA questions are answered on a 5-point Likert scale from 'Never' to 'Always'.	Day 1
Primary	Reliability of the GHCQ-CA	The GHCQ-CA is a patient-reported outcome measure designed to assess reasons for non-adherence to growth hormone therapy in children/adolescents from the child's/adolescent's perspective. The GHCQ-CA currently has 34 items. All GHCQ-CA questions are answered on a 5-point Likert scale from 'Never' to 'Always'.	Day 14
Primary	Validity of the Growth Hormone Compliance Questionnaire parent version (GHCQ-P)	The GHCQ-P is a patient-reported outcome measure designed to assess reasons for non-adherence to growth hormone therapy in children/adolescents from the parents'/legal guardian's perspective. The GHCQ-P currently has 50 items. All GHCQ-P questions are answered on a 5-point Likert scale from 'Never' to 'Always'.	Day 1
Primary	Validity of the GHCQ-P	The GHCQ-P is a patient-reported outcome measure designed to assess reasons for non-adherence to growth hormone therapy in children/adolescents from the parents'/legal guardian's perspective. The GHCQ-P currently has 50 items. All GHCQ-P questions are answered on a 5-point Likert scale from 'Never' to 'Always'.	Day 14
Primary	Reliability of the GHCQ-P	The GHCQ-P is a patient-reported outcome measure designed to assess reasons for non-adherence to growth hormone therapy in children/adolescents from the parents'/legal guardian's perspective. The GHCQ-P currently has 50 items. All GHCQ-P questions are answered on a 5-point Likert scale from 'Never' to 'Always'.	Day 1
Primary	Reliability of the GHCQ-P	The GHCQ-P is a patient-reported outcome measure designed to assess reasons for non-adherence to growth hormone therapy in children/adolescents from the parents'/legal guardian's perspective. The GHCQ-P currently has 50 items. All GHCQ-P questions are answered on a 5-point Likert scale from 'Never' to 'Always'.	Day 14