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Completed

NCT Number: NCT02122120

The Value of Aritficial Diet and Complex Care in Home Nutrition

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.

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Key information

Conditions

Dietary Modification

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanley Dudrick's Memorial Hospital

Skawina, Malopolska, 32-050, Poland

About this study

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.

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HEN

Dietary Supplement

Patients with tube feeding with FSMP for at least twelve months

Primary outcomes

  1. Number of complications

    Time frame: 24 moths

Secondary outcomes

  1. Number of hospital admissions

    Time frame: 24 months

Other outcomes

  1. length of hospital stay

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Stanley Dudrick's Memorial Hospital

Other

Registry information

Official study title

Home Enteral Nutrition (HEN) Reduces Complications, Length of Stay and Health-care Costs: Results From the Multicenter Study.

Important dates

Study start
2007
Primary completion
2012
Study completion
2013
First posted
Apr 24, 2014
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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