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CAre of Patients With PArenteral Nutrition At Home (CAPANAH)

This study is currently recruiting participants.
Verified May 2012 by Katholieke Universiteit Leuven
Sponsor:
Collaborators:
Ziekenhuis Netwerk Antwerpen (ZNA)
AZ Sint-Lucas Brugge
Universiteit Antwerpen
AZ Sint-Blasius Dendermonde
Imelda Ziekenhuis, Bonheiden
Ziekenhuis Oost-Limburg
AZ Sint-Lucas & Volkskliniek, Gent
AZ Damiaan, Oostende
H.-Hartziekenhuis Roeselare-Menen vzw
Universitair Ziekenhuis Brussel
University Hospital, Ghent
Jessa Hospital
Information provided by (Responsible Party):
Mira Dreesen, PhD student, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01545063
First received: March 1, 2012
Last updated: May 25, 2012
Last verified: May 2012
History of Changes
  Purpose

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

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Quality of life will be investigated with the HPN-QoL(r) or FACIT-G (r).

  • Number of catheter related infections [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: May 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545063

Locations
Belgium
UZA Antwerpen Edegem Recruiting
Antwerpen, Belgium
Contact: Hilde De Bosscher, PharmD         mira.dreesen@uzleuven.be    
Principal Investigator: Hilde De Bosscher, PharmD            
Antwerpen Middelheim Recruiting
Antwerpen, Belgium
Contact: Els Verschueren, PharmD         mira.dreesen@uzleuven.be    
Principal Investigator: Els Verschueren, PharmD            
Imelda Ziekenhuizen Bonheide Recruiting
Bonheiden, Belgium
Contact: Freija Verbiest         mira.dreesen@uzleuven.be    
Principal Investigator: Freija Verbiest, PharmD            
AZ Sint-Lucas Recruiting
Brugge, Belgium
Contact: Katrien Derouck, PharmD         mira.dreesen@uzleuven.be    
Principal Investigator: Katrien Derouck, PharmD            
University Centrum Brussel Recruiting
Brussel, Belgium
Contact: Kenny Noerens, PharmD         mira.dreesen@uzleuven.be    
Principal Investigator: Kenny Noerens, PharmD            
AZ Sint Blasius Dendermonde Recruiting
Dendermonde, Belgium
Contact: Kristien Claes         mira.dreesen@uzleuven.be    
Principal Investigator: Kristien Claes            
Ziekenhuis Oost Limburg Recruiting
Genk, Belgium
Contact: Evy Hendrickx         mira.dreesen@uzleuven.be    
Principal Investigator: Evy Hendrickx, PharmD            
UZ Gent Active, not recruiting
Gent, Belgium
AZ Sint Lucas en Volkskliniek Recruiting
Gent, Belgium
Contact: Céline De Slooveren         mira.dreesen@uzleuven.be    
Principal Investigator: Celine De Sloovere, PharmD            
Hasselt Jessa Ziekenhuizen Recruiting
Hasselt, Belgium
Contact: Caroline Devolder, PharmD         mira.dreesen@uzleuven.be    
Principal Investigator: Caroline De Volder, PharmD            
Catholic University Recruiting
Leuven, Belgium, 3000
Contact: Mira Dreesen         mira.dreesen@uzleuven.be    
Principal Investigator: Ludo Willems, PhD            
AZ Damiaan Recruiting
Oostende, Belgium
Contact: Sabrina Commeyne, PharmD         mira.dreesen@uzleuven.be    
Principal Investigator: Sabrina Commeyne, PharmD            
Heilig Hart vzw Recruiting
Roeselare Menen, Belgium
Contact: Beatrijs Deboutte, PharmD         mira.dreesen@uzleuven.be    
Principal Investigator: Beatrijs Deboutte, PharmD            
Sponsors and Collaborators
Katholieke Universiteit Leuven
Ziekenhuis Netwerk Antwerpen (ZNA)
AZ Sint-Lucas Brugge
Universiteit Antwerpen
AZ Sint-Blasius Dendermonde
Imelda Ziekenhuis, Bonheiden
Ziekenhuis Oost-Limburg
AZ Sint-Lucas & Volkskliniek, Gent
AZ Damiaan, Oostende
H.-Hartziekenhuis Roeselare-Menen vzw
Universitair Ziekenhuis Brussel
University Hospital, Ghent
Jessa Hospital
  More Information

No publications provided

Responsible Party: Mira Dreesen, PhD student, PhD Student, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01545063     History of Changes
Other Study ID Numbers: S54137
Study First Received: March 1, 2012
Last Updated: May 25, 2012
Health Authority: Belgium: ethical committee of Leuven

Additional relevant MeSH terms:
Crohn Disease
Diarrhea
Enteritis
Intestinal Obstruction
Lymphoma
Carcinoma
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Intestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 23, 2013