NCT03672617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

October 2, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2019

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

September 7, 2018

Last Update Submit

September 19, 2019

Conditions

Growth Hormone Deficiency in Children

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Children and adolescents

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

Other: No treatment given

Parents/legal guardians

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

Other: No treatment given

Interventions

No treatment givenOTHER

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.

Children and adolescentsParents/legal guardians

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Three hundred (300) participants at about 30 sites for paediatric endocrinology in Germany will be included in this validation study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Mainz, Germany

Location

Related Publications (1)

  • 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.

    PMID: 32158432DERIVED

Study Officials

  • Clinical Reporting Anchor and Disclosure (1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 14, 2018

Study Start

October 2, 2018

Primary Completion

April 25, 2019

Study Completion

April 25, 2019

Last Updated

September 23, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

More information

Locations

DE(1)