Clinical trial NCT04234490: Longitudinal Evaluation of the Impact of Parenteral Nutrition
Official title: Longitudinal Evaluation of Patient Outcomes and Impact Assessment on Family Members of Home Parenteral Nutrition: New Directions for Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parenteral Nutrition
Keywords: Intestinal failure
Quality of life
Carer burden
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Shire International GmbH
First posted: 2020-01-21
Enrollment: 912
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 1400 eligible participants from at least 15 NHS sites who are receiving HPN will be invited to participate. Close family relatives or friends who are carers for the eligible participants will also be invited to participate.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient reported outcomes
timeFrame: Baseline, five, 10 and 15 months post entry
Secondary outcomes:
measure: Carer burden
timeFrame: Baseline
measure: Length of time receiving HPN
timeFrame: Baseline, five, 10 and 15 months post entry
measure: Change in number of weekly HPN infusions
timeFrame: Baseline, five, 10 and 15 months post entry
measure: Change in number of hours connected to HPN infusions each night
timeFrame: Baseline, five, 10 and 15 months post entry
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University of Manchester
Study officials:
References: