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NCT Number: NCT04234490

Longitudinal Evaluation of the Impact of Parenteral Nutrition

Patients with type 3 intestinal failure are completely reliant on artificial feeding and often manage this at home; home parenteral nutrition (HPN). HPN therapy is life saving for these patients.

The Parenteral Nutrition Impact Questionnaire (PNIQ) is a proven tool for measuring quality of life when receiving HPN.

This study will recruit HPN patients across the United Kingdom (UK) and ask them to complete the PNIQ survey at several different time points. This will assess the impact of HPN over time. Family members involved in the participants HPN care will also be asked to complete a carer burden survey (at one time point) to assess the impact of HPN on carers.

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Key information

Conditions

Parenteral Nutrition Digestive System Diseases Gastrointestinal Diseases Hyperphagia Intestinal Diseases Intestinal Failure Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Manchester

Manchester, United Kingdom

About this study

Providing a person with food through a vein is known as parenteral nutrition (PN) or artificial tube feeding. This process is used when nutrients from food can't be taken in by the intestine (intestinal failure). Patients with type 3 intestinal failure are completely reliant on artificial feeding and often manage this at home; home parenteral nutrition (HPN). HPN therapy is life saving for these patients.

It is important to assess patients quality of life and their own reported effects of the HPN. The Parenteral Nutrition Impact Questionnaire (PNIQ) is a proven tool for measuring quality of life when receiving HPN.

A recent study involving the use of the PNIQ in multiple hospitals in the UK, showed that those on fewer nights of HPN had better quality of life than those on more nights of HPN. Whilst this was useful for looking at quality of life at one time point, it is now important to assess change in quality life over time and any impact on family members quality of life.

This study will recruit HPN patients across the UK and ask them to complete the PNIQ survey at several different time points. This will assess the impact of HPN over time. Family members involved in the participants HPN care will also be asked to complete a carer burden survey (at one time point) to assess the impact of HPN on carers.

The study is being funded by Shire Pharmaceuticals Ltd.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients:

  • All people in receipt of HPN including new patients
  • Those 18 years and over.

Carers:

  • A family member or person involved in the healthcare of the participating patient. (We will ask patients to nominate their closest family member who in their opinion is potentially most effected by the parenteral feeding.)
  • Those 18 years and over.

Exclusion criteria

Patients:

  • Cannot give informed consent
  • Cannot read or write in English.

Carers:

  • Family members not directly involved with caring for participants

Treatment and study plan

Parenteral nutrition

Procedure

Impact of parenteral nutrition on patient quality of life over time and impact on carer burden

Other names: Home parenteral nutrition, artificial tube feeding

Primary outcomes

  1. Patient reported outcomes

    Time frame: Baseline, five, 10 and 15 months post entry

    Change in Patient reported outcomes (PNIQ score) in people receiving HPN. Score from 0-20, with 0 being high Quality of life and 20 being low quality of life.

Secondary outcomes

  1. Carer burden

    Time frame: Baseline

    Caregiver burden (carer burden survey) in family members/close friends providing HPN healthcare to a patient receiving HPN. Score from 0-84, with 0 being no symptoms and 84 being very severe symptoms

  2. Length of time receiving HPN

    Time frame: Baseline, five, 10 and 15 months post entry

    Amount of time the patient has been receiving HPN (months/years)

  3. Change in number of weekly HPN infusions

    Time frame: Baseline, five, 10 and 15 months post entry

    How often the patient is connected to an infusion each week (numerical)

  4. Change in number of hours connected to HPN infusions each night

    Time frame: Baseline, five, 10 and 15 months post entry

    How many hours the patient is connected to an infusion each night (hours)

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Collaborators

  • Shire International GmbH

Registry information

Official study title

Longitudinal Evaluation of Patient Outcomes and Impact Assessment on Family Members of Home Parenteral Nutrition: New Directions for Research

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 21, 2020
Registry last updated
May 24, 2022

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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