NCT04234490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
912

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 21, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 2, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2022

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

2.1 years

First QC Date

January 13, 2020

Last Update Submit

May 17, 2022

Conditions

Parenteral Nutrition

Keywords

Intestinal failureQuality of lifeCarer burden

Outcome Measures

Primary Outcomes (1)

  • Patient reported outcomes

    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.

    Baseline, five, 10 and 15 months post entry

Secondary Outcomes (4)

  • Carer burden

    Baseline

  • Length of time receiving HPN

    Baseline, five, 10 and 15 months post entry

  • Change in number of weekly HPN infusions

    Baseline, five, 10 and 15 months post entry

  • Change in number of hours connected to HPN infusions each night

    Baseline, five, 10 and 15 months post entry

Study Arms (2)

Patient

Patients who are receiving Home Parenteral Support (HPN) (artificially fed through a vein) due to intestinal failure

Procedure: Parenteral nutrition

Carer

Family member or carer of patient who is receiving Home Parenteral Support

Interventions

Parenteral nutritionPROCEDURE

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

Also known as: Home parenteral nutrition, artificial tube feeding
Patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients:
  • Cannot give informed consent
  • Cannot read or write in English.
  • Carers:
  • Family members not directly involved with caring for participants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manchester

Manchester, United Kingdom

Location

Related Links

MeSH Terms

Conditions

HyperphagiaIntestinal Failure

Interventions

Parenteral NutritionParenteral Nutrition, Home

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition TherapyHome Care ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nutrition Research Associate

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 21, 2020

Study Start

March 2, 2020

Primary Completion

March 23, 2022

Study Completion

March 23, 2022

Last Updated

May 24, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)