NCT01545063

Brief Summary

This research aims to give an overview of a number of aspects related to the quality of care for adult patients on home parenteral nutrition. Concretely this study follows up different aspects on different moments in the care of the patient pathways:

  • process indicators concerning indication, parenteral nutrition, training, team access roads and the succession of complications
  • Outcome indicators
  • the health-related quality of life
  • discrepancies in medication use
  • the role of the different health care providers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2012

Shorter than P25 for all trials

Geographic Reach
1 country

13 active sites

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

March 1, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

March 1, 2012

Last Update Submit

July 18, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Quality of life

    Quality of life will be investigated with the HPN-QoL(r) or FACIT-G (r).

    2 years

  • Number of catheter related infections

    2 years

Eligibility Criteria

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

Adult HPN patients with peritoneal carcinomatosis with intestinal occlusion or with crohn's disease, radiation enteritis, chronic diarrhea, intestinal lymphomas.

You may qualify if:

  • Patients in Flanders who speak Dutch, are older then 18 years and are able to give an informed consent.

You may not qualify if:

  • Patients who are younger then 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Antwerpen Middelheim

Antwerp, Belgium

Location

UZA Antwerpen Edegem

Antwerp, Belgium

Location

Imelda Ziekenhuizen Bonheide

Bonheiden, Belgium

Location

AZ Sint-Lucas

Bruges, Belgium

Location

University Centrum Brussel

Brussels, Belgium

Location

AZ Sint Blasius Dendermonde

Dendermonde, Belgium

Location

Ziekenhuis Oost Limburg

Genk, Belgium

Location

AZ Sint Lucas en Volkskliniek

Ghent, Belgium

Location

UZ Gent

Ghent, Belgium

Location

Hasselt Jessa Ziekenhuizen

Hasselt, Belgium

Location

Catholic University

Leuven, 3000, Belgium

Location

AZ Damiaan

Ostend, Belgium

Location

Heilig Hart vzw

Roeselare Menen, Belgium

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 6, 2012

Study Start

May 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

July 19, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations