The Value of Aritficial Diet and Complex Care in Home Nut... | NCT02122120

Studies
The Value of Aritficial Diet and Complex Care in Home Nutrition

NCT02122120

Sponsor

Stanley Dudrick's Memorial Hospital

Status

Completed

Last Update Posted

Apr 24, 2014Estimated

Enrollment

456Actual

Phase

Not provided

Conditions

Dietary Modification

Interventions

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Dec 2012Actual

Completion Date

Jan 2013Actual

First Submitted Date

Apr 19, 2014

First Submission Date that Met QC Criteria

Apr 23, 2014

First Posted Date

Apr 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2014

Last Update Posted Date

Apr 24, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stanislaw Klek, Head of the Departement, Stanley Dudrick's Memorial HospitalPrincipal Investigator

Lead Sponsor

Stanley Dudrick's Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Home enteral nutrition (HEN) has always been recognized as a life-saving procedure, but with the ongoing economic crisis influencing health care, its cost-effectiveness has been questioned recently.

Objective: The unique reimbursement situation in Poland enabled the otherwise ethically unacceptable, hence unavailable, comparison of the period of no-feeding and the long-term feeding and the subsequent analyses of the clinical value of the latter and its cost-effectiveness.

Detailed Description

Background: Home enteral nutrition (HEN) has always been recognized as a life-saving procedure, but with the ongoing economic crisis influencing health care, its cost-effectiveness has been questioned recently.

Design: The observational multicentre study in the group of 456 HEN patients was performed between January 2007 and July 2013. Two twelve-month periods were compared. During the first one patients were tube fed with home-made diet without monitoring, while during the other the complex HEN was carried out. The latter included tube feeding and complex monitoring by nutrition support team. Number of complications, hospital admissions, length of hospital stay (LOS), biochemical and anthropometric parameters and costs of hospitalization were compared.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

456Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Before HEN		Patients with tube feeding with kitchen diet for at least twelve months	Dietary Supplement: HEN

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HEN	Dietary Supplement	Patients with tube feeding with FSMP for at least twelve months	Before HEN

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of complications		24 moths

Secondary Outcomes

Measure	Description	Time Frame
Number of hospital admissions		24 months

Other Outcomes

Measure	Description	Time Frame
length of hospital stay		24 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

indications for home tube feeding (HTF),
complete present and past medical history,
tube feeding for at least twelve months before HEN and at least twelve months afterwards.

Exclusion Criteria:

doubtful indications for HEN, no access or an incomplete medical record,
treatment period shorter than 12 months either before or after enrolment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

456 patients during home tube feeding

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stanislaw Klek, MD PhD	Stanley Dudrick's Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanley Dudrick's Memorial Hospital		Skawina	Malopolska	32-050	Poland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23528323	Background	Majka AJ, Wang Z, Schmitz KR, Niesen CR, Larsen RA, Kinsey GC, Murad AL, Prokop LJ, Murad MH. Care coordination to enhance management of long-term enteral tube feeding: a systematic review and meta-analysis. JPEN J Parenter Enteral Nutr. 2014 Jan;38(1):40-52. doi: 10.1177/0148607113482000. Epub 2013 Mar 25.
24965306	Derived