NCT03672617

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 321 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Growth Hormone Deficiency in Children

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-10-02
• Primary completion: 2019-04-25
• Completion: 2019-04-25
• First posted: 2018-09-14
• Last updated: 2019-09-23

Locations

1 site across 1 country: Germany