Growth Hormone Deficiency in ChildrenNCT03672617
Validation of a Questionnaire That Identifies the Reasons for Non-adherence to Existing Growth Hormone Therapy
An observational study of Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Growth Hormone Deficiency in Children
- What is being tested?
- No treatment given
- Type of treatment
- Injection or infusion
- How many people
- 321 participants
- Where
- 1 siteGermany
- Study dates
- 2 Oct 2018to 25 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Three hundred (300) participants at about 30 sites for paediatric endocrinology in Germany will be included in this validation study.
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 locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Patient-reported Outcome (PRO) Measure That Assesses Reasons for Non-adherence to Growth Hormone Therapy (GHT)
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
- Being tested
- No treatment given
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Children and adolescents | Children and adolescents, who administer growth hormone (GH) themselves (self-injections) will be asked to complete the questionnaire. Receives: Other: No treatment given | |
| Parents/legal guardians | Parents/legal guardians who administer the GH to their child will be asked to complete the questionnaire. Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start2 Oct 2018
- Primary completion25 Apr 2019
- Study completion25 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone Deficiency in ChildrenStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672617
- Sponsor's protocol ID
- GH-4415
- Other IDs
- U1111-1210-1036
- Status last verified
- Sep 2019
- First submitted
- 7 Sep 2018
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
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.
PubMed 32158432
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Patient-reported Outcome (PRO) Measure That Assesses Reasons for Non-adherence to Growth Hormone Therapy (GHT)
- ClinicalTrials.gov ID
- NCT03672617
- Acronym / sponsor ID
- GH-4415
- Conditions
- Growth Hormone Deficiency in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children and adolescents | – | Other: No treatment givenChildren and adolescents, who administer growth hormone (GH) themselves (self-injections) will be asked to complete the questionnaire. |
| Parents/legal guardians | – | Other: No treatment givenParents/legal guardians who administer the GH to their child will be asked to complete the questionnaire. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Three hundred (300) participants at about 30 sites for paediatric endocrinology in Germany will be included in this validation study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment givenNo 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. | Other | Children and adolescents, Parents/legal guardians |
Primary outcome
Validity of the Growth Hormone Compliance Questionnaire child/adolescent version (GHCQ-CA)
Time frame: Day 1
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'.
Validity of the GHCQ-CA
Time frame: Day 14
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'.
Reliability of the GHCQ-CA
Time frame: Day 1
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'.
Reliability of the GHCQ-CA
Time frame: Day 14
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'.
Validity of the Growth Hormone Compliance Questionnaire parent version (GHCQ-P)
Time frame: Day 1
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'.
Validity of the GHCQ-P
Time frame: Day 14
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'.
Reliability of the GHCQ-P
Time frame: Day 1
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'.
Reliability of the GHCQ-P
Time frame: Day 14
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'.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Derived from this study: PubMed 32158432de 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.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of the Growth Hormone Compliance Questionnaire child/adolescent version (GHCQ-CA) (time frame: Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03672617, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.