- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01584310
Validation of the STAMP Screening Tool (STAMP2)
Validation of the STAMP Screening Tool For Pediatric Nutritional Risk To Be Used in the Ambulatory Setting.
Insufficient nutritional intake, with or without concomitant morbidity, leads to weight loss or insufficient weight gain, is related to an increase in morbidity and mortality and exposes the child to medical complications. In addition, obesity is also related to complications during hospitalization and complications in general, and therefore early identification of these children is extremely important. Studies show that malnutrition is frequent among children upon hospitalization, where the risk of pediatric nutritional deterioration increases, even in the presence of mild stress factors. This risk is frequent mainly among children that arrive at the hospital with an initial poor nutritional status. Improving the nutritional status as part of the standard of care already at the ambulatory setting might improve the prognosis of children when ill. In Israel, nutritional screening in not conducted among children since there is no proper validated screening tool. Study objectives: To test the accuracy of the STAMP Screening Tool for pediatric nutritional risk which is designed to be used by nurses, and to compare it to a complete nutritional assessment conducted by a dietician in Clalit Health Care Services clinics. In addition, the investigators wish to examine the effects of using a screening tool for nutritional risk on the medical staff's attention to the nutritional status; this is measured by the collection of nutritional status-related data and their recording in the patient file.
Methods: 100 boys and girls aged 1 to 6, attending Clalit Health Care Services Pediatric Centers, will undergo an assessment using the STAMP Tool; a questionnaire including 3 questions with a summary score, according to which the nutritional risk level shall be determined. These children shall also undergo a complete dietician assessment in order to examine the validity of the STAMP Tool. In addition, 150 files shall be reviewed in the beginning of the research and after 6 months in order to estimate the change in medical staff's attention to nutritional status, by way of noting relevant diagnoses, reference to nutritional status- related tests and recording of anthropometric measurements.
A statistical analysis to examine the validity of the STAMP Tool shall be carried out using the kappa test (K) (30). The effect of the STAMP Tool use shall be calculated using the chi square test.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- children between 1 and 6 years old
- children treated at the clinics participating in the study
Exclusion Criteria:
- Lack of consent or lack of Hebrew proficiency
- children that not receiving treatment in day hospitalization at any hospital
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: STAMP using
100 boys and girls aged 1 to 6, attending Clalit Health Care Services Pediatric Centers, will undergo an assessment using the STAMP Tool; a questionnaire including 3 questions with a summary score, according to which the nutritional risk level shall be determined.
These children shall also undergo a complete dietician assessment in order to examine the validity of the STAMP Tool.
|
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.
|
Placebo Comparator: No STAMP using
150 files shall be reviewed in the beginning of the research and after 6 months in order to estimate the change in medical staff's attention to nutritional status, by way of noting relevant diagnoses, reference to nutritional status- related tests and recording of anthropometric measurements.
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validity and reliability
Time Frame: 1 year
|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validity and efficiency
Time Frame: one year
|
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.
|
one year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMC206-2011KCTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malnutrition
-
HAN University of Applied SciencesFrieslandCampina; HAS Hogeschool; Centre of Expertise Food (CoE Food); SligroCompletedMalnutrition; Protein | Protein MalnutritionNetherlands
-
International Centre for Diarrhoeal Disease Research...GlaxoSmithKline; Stanford UniversityCompletedMalnutrition | Malnutrition in Children | Child MalnutritionBangladesh
-
University of Nove de JulhoUnknownMalnutrition, ChildBrazil
-
International Centre for Diarrhoeal Disease Research...UNICEFNot yet recruitingMalnutrition SevereBangladesh
-
UNICEFSave the ChildrenCompletedSevere MalnutritionCongo, The Democratic Republic of the
-
University of Erlangen-Nürnberg Medical SchoolPfrimmer Nutricia GmbH, Erlangen , GermanyCompletedNursing Home Residents | Malnutrition or Risk of MalnutritionGermany
-
Action Against Hunger USAUniversity of Washington; Ethiopian Public Health InstituteNot yet recruitingModerate Acute Malnutrition | Severe Acute Malnutrition
-
Academy of Nutrition and DieteticsHartford Hospital; University of New Mexico; Meals on Wheels Central TexasNot yet recruiting
-
Diego MorettiSwiss Federal Institute of Technology; Wageningen University and Research; St... and other collaboratorsCompletedMalnutrition; ProteinSwitzerland
-
International Centre for Diarrhoeal Disease Research...CompletedProtein MalnutritionBangladesh
Clinical Trials on questionnaire STAMP and dietary
-
Rabin Medical CenterCompleted
-
Meir Medical CenterCompleted
-
Dana-Farber Cancer InstituteThe Fund for Innovation in Cancer InformaticsNot yet recruitingPain | Advanced CancerUnited States
-
Dana-Farber Cancer InstituteNational Palliative Care Research Center (NPCRC)RecruitingAdvanced Cancer | Palliative Care | Active Cancer | Active Cancer Treatment | Chronic Pain Due to CancerUnited States
-
International Centre for Diarrhoeal Disease Research...Karolinska Institutet; Georgetown University; University Hospital, Basel, SwitzerlandCompleted
-
Russian Academy of Medical SciencesRussian Science FoundationRecruitingGastroesophageal Reflux | Esophagitis | GERD | Heartburn | Non-erosive Reflux Disease | Gastroesophageal; Reflux With EsophagitisRussian Federation
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedCancer SurvivorUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedMalignant NeoplasmUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Recruiting
-
Assiut UniversityNot yet recruitingNutrition Disorder, Child