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临床试验/NCT03005561
NCT03005561Unknown不适用

Multi Center, Interventional, Randomized Study Detection of Difficulties and Improvement Compliance to Growth Hormone Treatment

Prof. Eli Hershkovitz0 个研究点目标入组 200 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
200
主要终点
Change in height

研究概览

简要总结

In the last 50 years the use of growth hormone (rhGH, somatropin) has become commonly to treat problems such as GH deficiency, chronic renal failure and Turner syndrome and Prader-Willi. Giving the hormone in childhood and adolescence is designed to accelerate growth to close the gap in the average population and reach a final height is normal, while minimizing risks and costs.

Noncompliance to treatment with GH is common; Other estimates are that one third to one half of patients do not comply with the provisions as require. This may result in linear growth depreciation, unnecessary diagnostic tests, unnecessary change of dosage and treatment and higher costs.

Many studies have been devoted to locating factors make it difficult to adhere to their chronic diseases in children, including conditions that require treatment with GH.

Pain is the primary cause for difficulties. In recent decades, many resources were devoted to research and development of ways of dealing with pain in all aspects.

In order to implement all of the information collected, appropriate interventions medium should be found; In this study we intend to use the method of playback. Playback define that improvisation as a theater facilitator asks the audience to share moments, feelings and stories of his daily life, and a group of actors improvise their stories in front of the stage as a kind of "play-back". Unlike hobbies such as sports or singing, the method allows not only to unload the tensions but also communication and collaboration. It is very reminiscent of psychodrama, but unlike, is not considered a therapeutic tool.

Assumption:

Intervention of two playback meetings during the year will uncover the difficulties and engage ways of dealing with pain. That will reduce the difficulties caused by GH injections and improve compliance to treatment.

详细描述

In the last 50 years the use of growth hormone (rhGH, somatropin) has become commonly to treat problems such as GH deficiency, chronic renal failure and Turner syndrome and Prader-Willi. Giving the hormone in childhood and adolescence is designed to accelerate growth to close the gap in the average population and reach a final height is normal, while minimizing risks and costs.

Noncompliance to treatment with GH is common; Other estimates are that one third to one half of patients do not comply with the provisions as require. This may result in linear growth depreciation, unnecessary diagnostic tests, unnecessary change of dosage and treatment and higher costs.

GH therapy in all non-yielding satisfactory results, it is recommended first of all to consider noncompliance before turning to look for other causes.

Many studies have been devoted to locating factors make it difficult to adhere to their chronic diseases in children, including conditions that require treatment with GH.

Pain is the primary cause for difficulties. Despite the pain seems fairly simple phenomenon, it is actually very complex. Untreated pain is manifested prominently course and immediate distress to the child and the parent, but it has other deep effects; It seems that pain not receiving treatment at early stages in children's lives adversely affects the central nervous system development. This assumption is supported by various studies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Patients diagnosed with a growth hormone deficiency
  • •Patients treated with growth hormone for at least two years.
  • •The patient and parent signing an inform consent in the mother tongue.
  • •Patients speakers and readers of Hebrew.
  • •Age range: Boys 7 years to 12 years, Girls 7 years to 11 years.

排除标准

  • •Patients receiving growth hormone for other reasons.
  • •Patients with comorbidities (celiac disease, hypothyroidism).
  • •Children who began signs of puberty (Tanner 2 or higher).
  • •Patients who completed growth, closed epiphysis.

研究组 & 干预措施

Intervention

Experimental

100 participants that will be participating in the Play Back meetings.

干预措施: Play Back Sessions (Behavioral)

Control

No Intervention

100 participants that will not be participating in the Play Back meetings.

结局指标

主要结局

Change in height

时间窗: 6 months

change in height between visit no.1 and last visit.

次要结局

  • Change in weight(6 months)

研究者

发起方
Prof. Eli Hershkovitz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Eli Hershkovitz

Prof.

Soroka University Medical Center

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