CAre of Patients With PArenteral Nutrition At Home (CAPANAH)

July 18, 2017 updated by: Mira Dreesen, PhD student, KU Leuven

Prospective Non-interventional Non-controlled Multicenter Observational Study to Evaluate the Quality of Care for Adult Patients on Home Parenteral Nutrition (HPN)

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

Study Overview

Status

Completed

Conditions

Detailed Description

Adult patients on HPN will be contacted by phone at three different time moments after their discharge to ask them about indicators, quality of life and discrepancies in medication use. After the follow-up, medical dossiers will be consulted to know which indicators are followed in practice.

The role of the different health care providers will be investigated by face-to-face interviews with different healthcare professionals.

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
        • Antwerpen Middelheim
      • Antwerpen, Belgium
        • UZA Antwerpen Edegem
      • Bonheiden, Belgium
        • Imelda Ziekenhuizen Bonheide
      • Brugge, Belgium
        • AZ Sint-Lucas
      • Brussel, Belgium
        • University Centrum Brussel
      • Dendermonde, Belgium
        • Az Sint Blasius Dendermonde
      • Genk, Belgium
        • Ziekenhuis Oost Limburg
      • Gent, Belgium
        • UZ Gent
      • Gent, Belgium
        • AZ Sint Lucas en Volkskliniek
      • Hasselt, Belgium
        • Hasselt Jessa Ziekenhuizen
      • Leuven, Belgium, 3000
        • Catholic University
      • Oostende, Belgium
        • AZ Damiaan
      • Roeselare Menen, Belgium
        • Heilig Hart vzw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who are younger then 18 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 2 years
Quality of life will be investigated with the HPN-QoL(r) or FACIT-G (r).
2 years
Number of catheter related infections
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Collaborators

Jessa Hospital
University Hospital, Ghent
Universitair Ziekenhuis Brussel
Imelda Hospital, Bonheiden
Ziekenhuis Netwerk Antwerpen (ZNA)
Ziekenhuis Oost-Limburg
Universiteit Antwerpen
AZ Sint-Lucas Brugge
AZ Sint-Blasius Dendermonde
AZ Damiaan, Oostende
H.-Hartziekenhuis Roeselare-Menen vzw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

March 1, 2012

First Submitted That Met QC Criteria

March 5, 2012

First Posted (Estimate)

March 6, 2012

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S54137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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