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CAre of Patients With PArenteral Nutrition At Home (CAPANAH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01545063
Recruitment Status : Completed
First Posted : March 6, 2012
Last Update Posted : July 19, 2017
Information provided by (Responsible Party):

Study Description
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

Condition or disease
Crohn's Disease Peritoneal Carcinomatosis With Intestinal Occlusion Radiation Enteritis Chronic Diarrhea Intestinal Lymphomas

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 Design

Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Non-interventional Non-controlled Multicenter Observational Study to Evaluate the Quality of Care for Adult Patients on Home Parenteral Nutrition (HPN)
Actual Study Start Date : May 2012
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Quality of life [ Time Frame: 2 years ]
    Quality of life will be investigated with the HPN-QoL(r) or FACIT-G (r).

  2. Number of catheter related infections [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545063

Antwerpen Middelheim
Antwerpen, Belgium
UZA Antwerpen Edegem
Antwerpen, Belgium
Imelda Ziekenhuizen Bonheide
Bonheiden, Belgium
AZ Sint-Lucas
Brugge, Belgium
University Centrum Brussel
Brussel, Belgium
AZ Sint Blasius Dendermonde
Dendermonde, Belgium
Ziekenhuis Oost Limburg
Genk, Belgium
AZ Sint Lucas en Volkskliniek
Gent, Belgium
UZ Gent
Gent, Belgium
Hasselt Jessa Ziekenhuizen
Hasselt, Belgium
Catholic University
Leuven, Belgium, 3000
AZ Damiaan
Oostende, Belgium
Heilig Hart vzw
Roeselare Menen, Belgium
Sponsors and Collaborators
Katholieke Universiteit Leuven
Ziekenhuis Netwerk Antwerpen (ZNA)
AZ Sint-Lucas
Universiteit Antwerpen
AZ Sint-Blasius Dendermonde
Imelda Hospital, Bonheiden
Ziekenhuis Oost-Limburg
AZ Damiaan, Oostende
H.-Hartziekenhuis Roeselare-Menen vzw
Universitair Ziekenhuis Brussel
University Hospital, Ghent
Jessa Hospital
More Information

Responsible Party: Mira Dreesen, PhD student, PhD Student, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01545063     History of Changes
Other Study ID Numbers: S54137
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Crohn Disease
Intestinal Obstruction
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type