Web-based Adherence Information Integrated Nurse-led Monitoring Clinic

NCT04244123 | Completed FDA Drug

• 1 other identifier: B00672
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Non-adherence is a recognized problem with growth hormone treatment in children. In this study, we aim to utilize web-based information derived from easypod growth hormone injection devices and easypod connect devices in a nurse-led telephone clinic to improve adherence and therefore optimize growth. Our primary aim is to test height SDS change over a 12 month period. Our secondary aims are to test adherence, acceptance/satisfaction and qualitative assessment.

Conditions

Short Stature; Growth Hormone Treatment

Keywords

Growth Hormone

Outcome Measures

Primary Outcomes (1)

• change in height SDS

  difference in height SDS

  12 months

Secondary Outcomes (2)

• Adherence to medication

  12 months

• Qualitative assessment

  12 months

Other Outcomes (1)

• Family feedback

  12 months

Study Arms (5)

growth hormone deficiency

growth hormone deficiency, requiring growth hormone treatment

Combination Product: integrated information and nurse led telephone clinic

small for gestational age

small for gestational age and failure of post natal catch up height gain, requiring growth hormone treatment

Combination Product: integrated information and nurse led telephone clinic

Turner syndrome

short stature due to Turner syndrome, on growth hormone treatment

Combination Product: integrated information and nurse led telephone clinic

chronic renal failure

short stature due to chronic renal failure, treated with growth hormone treatment

Combination Product: integrated information and nurse led telephone clinic

Prader Willi syndrome

short stature due to Prader Willi syndrome, treated with growth hormone treatment

Combination Product: integrated information and nurse led telephone clinic

Interventions

integrated information and nurse led telephone clinic COMBINATION_PRODUCT

combining web-based information from easypod connect with nurse led telephone clinic

Prader Willi syndrome; Turner syndrome; chronic renal failure; growth hormone deficiency; small for gestational age

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with short stature, due to various causes and receiving growth hormone treatment as per licensed indications will be eligible for recruitment if they use the easypod growth hormone device.

You may qualify if:

• All patients who receive easypod GH of age 1-14 years will be approached for consent to participate in the study. Patients may have any valid cause for short stature. These may include children with
• isolated growth hormone deficiency
• multiple pituitary hormone deficiencies
• non-growth hormone deficient conditions such as
• Small for gestational age with postnatal failure of height gain
• chronic renal failure and
• Turner syndrome. Patients will be recruited to the study irrespective of diagnosis and will not be stratified by diagnosis at entry to the study. However, in analysis of data, subgroup analysis may be performed on groups such as those with isolated growth hormone deficiency, dependent on the frequency of recruitment.
• All patients will be identified at the start of the study. A one month period will be considered before the study commences to contact families for potential recruitment. Each patient will remain in the study for 12 months. The active study duration will be 18 months whereby all eligible patients will be recruited and followed up for a 12 month period. This period will be followed by a buffer period to gather necessary data for analysis.

You may not qualify if:

• Patients on growth hormone treatment but using other growth hormone devices Patients who are younger or older than the age limits.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Indraneel Banerjee

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Dwarfism

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Indi Banerjee

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 28, 2020
• Study Start: January 24, 2020
• Primary Completion: December 13, 2021
• Study Completion: January 5, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)