Validation of a STAMP in Hospitalized Children and the Effect of Its Use on the Awareness of the Medical Staff

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
raanan shamir, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01563393
First received: February 22, 2012
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

Children hospitalized due to an acute disease may suffer from acute malnutrition or chronic malnutrition caused by chronic diseases. According to various studies, about 10-20% of those admitted to hospitals in different countries suffer from malnutrition or are at risk of malnutrition.

Several pediatric nutritional screening tools were recently published. However, there is no conventional pediatric nutritional screening tool and the effect of the recently published tools on further nutritional risk and the behavior of the attending staff are unclear.

Study objectives: to test the validity and reliability of the STAMP nutritional screening tool (Screening Tool for the Assessment of Malnutrition in Pediatrics) among children hospitalized in a pediatric medical center and to examine the effect of the STAMP tool use on the attitude of the medical staff to the patient nutritional status.

An additional objective is to compare the skill of a nurse versus a dietician in performing the evaluation according to STAMP.

Methods: for the validation, 50 children between 1 and 17 years of age from internal medicine and surgical departments will undergo a complete evaluation by an investigating dietician and assessment by the STAMP tool in order to determine the extent of the nutritional risk on a numerical scale. All the children will undergo STAMP evaluation by a nurse and another investigating dietician as well.

In order to examine the effect of the tool on the medical staff awareness, 300 files of hospitalized children will be tested: 150 files at the beginning of the study and prior to using the tool and 150 after 6 months at the same ages and in the same departments.

The effect of using the STAMP questionnaire will be examined according to the results of data collection from the beginning of the study and after 6 months. Questionnaire use, recording of appropriate diagnoses, collection of blood tests demonstrating the nutritional status, weight, height and waist circumference measurements will be obtained from the patients' medical files.


Condition Intervention
Malnutrition
Other: questionnaire STAMP and dietary
Other: No intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Validation of a Nutritional Risk Screening Tool- STAMP in Hospitalized Children and the Effect of Its Use on the Awareness of the Medical Staff

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Validity and reliability [ Time Frame: one year ] [ Designated as safety issue: No ]
    The height / weight tables accepted in England, CDC (Centers for Disease Control) and WHO (World Health Organization) will be used in order to compare weight and height. The children will be divided into 3 nutritional risk groups: low, moderate and high according to the STAMP toll assessment and the results will be compared to the dietician's complete assessment.Nutritional assessment will include: demographic and medical data, daily nutritional intake, blood tests, anthropometric measurements, patient's ability to comply with the nutritional requirements related to his age etc.

  • Validity and efficiency [ Time Frame: one year ] [ Designated as safety issue: No ]
    Methods for testing the effect of STAMP tool use on the attitude of the medical staff to the nutritional status, measured by collection of data related to the nutritional status and recording them in the patient's file. In order to examine questionnaire acceptance by the medical staff, time period required to complete the questionnaire will be measured and in addition, the staff will be required to express their opinion regarding the speed and ease of using the questionnaire using the 4-point Likert scale. The staff will be asked about their subjective opinion about using the questionnaire.


Estimated Enrollment: 350
Study Start Date: May 2012
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: STAMP using
Children between 1 and 17 years of age from internal medicine and surgical departments will undergo a complete evaluation by an investigating dietician and assessment by the STAMP tool in order to determine the extent of the nutritional risk on a numerical scale.
Other: questionnaire STAMP and dietary
Children will undergo a complete evaluation by an investigating dietician and assessment by the STAMP tool in order to determine the extent of the nutritional risk on a numerical scale. According to findings children will get the dietary recommendations.
Other Name: STAMP using
Placebo Comparator: No STAMP using
In order to examine the effect of the tool on the medical staff awareness, 300 files of hospitalized children will be tested: 150 files at the beginning of the study and prior to using the tool and 150 after 6 months at the same ages and in the same departments.
Other: No intervention
The Placebo Comparator arm children got the classic care that practiced in hospitalization
Other Name: No STAMP using

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients hospitalized during the study,
  • patients hospitalized for more than 24 hours. The children will be enrolled from 3 internal medicine and surgical departments, children's parents will give their consent and will be able to understand and sign the consent forms

Exclusion Criteria:

  • children < 1 year of age,
  • children > 17 years of age,
  • children hospitalized for less than 24 hours,
  • children in the intensive care unit or following hospitalization in the intensive care unit.

Statistical analysis for STAMP validation will be performed using Kappa (K) test. Chi square test will be used in order to calculate the effect of STAMP use

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563393

Contacts
Contact: Luba Marderfeld, Mrs. +972-543173277 LubaMa@clalit.org.il
Contact: Chen Shnaiderman, Mrs. +972-528024685 chensh1@clalit.org.il

Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Raanan Shamir, Professor Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center of Israel
  More Information

No publications provided

Responsible Party: raanan shamir, Chairman, Institute of Gastroenterology, Nutrition and Liver Diseases, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01563393     History of Changes
Other Study ID Numbers: RMC12-6634
Study First Received: February 22, 2012
Last Updated: March 28, 2012
Health Authority: Israel: Clalit Health Services

Keywords provided by Rabin Medical Center:
tool for nutritional evaluation
children
malnutrition

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on July 23, 2014