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CAre of Patients With PArenteral Nutrition At Home (CAPANAH)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Katholieke Universiteit Leuven.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
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
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
  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:


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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Belgium
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 
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
Carcinoma
Enteritis
Intestinal Obstruction
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on December 07, 2016