An Observational Study on Treatment Compliance by Children Treated With Growth Hormone (IMPACT)

June 25, 2014 updated by: Novo Nordisk A/S

IMprove PAtient Compliance sTudy: An Observational, Cross-sectional Study on Children Treated With Growth Hormone in France

This study is conducted in Europe. This observational study aims at evaluating compliance with growth hormone treatment in children and identifying factors influencing compliance.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children treated for at least one year with growth hormone with any growth hormone product whatever the reason for prescription

Description

Inclusion Criteria:

  • Child treated for at least one year with growth hormone any growth hormone product
  • Followed by the participating paediatrician for at least 1 year.

Exclusion Criteria:

  • Refusal to participate
  • Child and/or parent unable to give consent or fill out the questionnaires
  • Child participating in a therapeutic trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Behavioral: No treatment given
No treatment given to study participants, only behaviorial patterns with respect to treatment compliance is observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average number of injections omitted during the previous month
Time Frame: measured over the past 2 months (retrospective data collection)
measured over the past 2 months (retrospective data collection)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Anticipated)

April 1, 2010

Study Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

February 12, 2010

First Submitted That Met QC Criteria

February 12, 2010

First Posted (Estimate)

February 15, 2010

Study Record Updates

Last Update Posted (Estimate)

June 26, 2014

Last Update Submitted That Met QC Criteria

June 25, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • GH-3787
  • U1111-1113-2490 (Other Identifier: WHO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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