Application of Web-based Adherence Information Integrated Nurse-led Monitoring Clinic for Growth Hormone Treatment in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- change in height SDS
研究概览
简要总结
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.
详细描述
Background:
Recombinant human growth hormone (GH) is used in the treatment of short stature due to growth hormone deficiency, Turner syndrome, Prader Willi syndrome, small for gestational age with failure of catch up growth, chronic renal failure and SHOX deficiency. Growth hormone is administered at home as daily injections and given over several years. Administration of growth hormone involves considerable commitment from parents and families and incurs significant cost to the NHS in the UK. Current treatment regimens using a range of GH formulations are not based on drug efficacy, cost effectiveness or cost of treatment.
It is well recognised that adherence to treatment is directly correlated to height performance in patients receiving GH. Several studies have indicated better height outcomes through use of technology to enhance patient adherence. The standard model of care of GH therapy involves patients returning to review appointments with clinicians for GH monitoring and dose adjustment. This model requires travel to hospitals at regular intervals (3-4 monthly), causing disruption to regular routines, inconveniencing family commitments, education and school. Importantly, this model does not encourage adherence or compliance with GH and relies on individual patient and family initiative to ensure treatment delivery. Alternative and more user-friendly models of care promoting greater adherence to GH are required to improve efficiency of GH treatment outcomes.
We have proposed a novel model of GH treatment monitoring integrating web-based adherence information in paediatric endocrine specialist nurse-led telephone clinics. A specialist nurse-led telephone clinic for management of growth hormone already exists at the Royal Manchester Children's Hospital (RMCH) and generates positive feedback from parents and families whilst releasing capacity in face to face growth clinics. The WAIN-MC model integrates and improves this specialist nurse-led clinic with web-based GH adherence information as a clinical innovation. The proposed model enables remote monitoring without travel to the hospital, review of growth performance in relation to adherence information and improved engagement of parents/families, thereby increasing adherence, satisfaction and height gain.
Rationale:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients on growth hormone treatment but using other growth hormone devices Patients who are younger or older than the age limits.
结局指标
主要结局
change in height SDS
时间窗: 12 months
difference in height SDS
次要结局
- Qualitative assessment(12 months)
- Adherence to medication(12 months)