Detection of Difficulties and Improvement Compliance to Growth Hormone Treatment

NCT03005561 | Unknown

• 1 other identifier: 0223-16sor
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Growth Hormone Treatment

Outcome Measures

Primary Outcomes (1)

• Change in height

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

  6 months

Secondary Outcomes (1)

• Change in weight

  6 months

Other Outcomes (1)

• Change in IGF-1

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Play Back Sessions

Control

NO INTERVENTION

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

Interventions

Play Back Sessions BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. Eli Hershkovitz: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 29, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2018
• Last Updated: December 29, 2016

Record last verified: 2016-12