Crohn's DiseaseCAPANAHNCT01545063
CAre of Patients With PArenteral Nutrition At Home
An observational study of Crohn's Disease and Peritoneal Carcinomatosis With Intestinal Occlusion, run by KU Leuven at 13 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Peritoneal Carcinomatosis With Intestinal Occlusion, Radiation Enteritis
- How many people
- 39 participants
- Where
- 13 sitesBelgium
- Study dates
- May 2012to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult HPN patients with peritoneal carcinomatosis with intestinal occlusion or with crohn's disease, radiation enteritis, chronic diarrhea, intestinal lymphomas.
Who may be able to join
- Patients in Flanders who speak Dutch, are older then 18 years and are able to give an informed consent.
Who cannot join
- Patients who are younger then 18 years.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Belgium13 sites
Antwerpen Middelheim
Antwerp
UZA Antwerpen Edegem
Antwerp
Imelda Ziekenhuizen Bonheide
Bonheiden
AZ Sint-Lucas
Bruges
University Centrum Brussel
Brussels
AZ Sint Blasius Dendermonde
Dendermonde
Ziekenhuis Oost Limburg
Genk
AZ Sint Lucas en Volkskliniek
Ghent
UZ Gent
Ghent
Hasselt Jessa Ziekenhuizen
Hasselt
Catholic University
Leuven, 3000
AZ Damiaan
Ostend
Heilig Hart vzw
Roeselare Menen
About this study
Official title: 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
Read the 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.
- Conditions
- Crohn's Disease, Peritoneal Carcinomatosis With Intestinal Occlusion, Radiation Enteritis, Chronic Diarrhea, Intestinal Lymphomas
- Medical subject headings
- Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Quality of life will be investigated with the HPN-QoL(r) or FACIT-G (r).
Measured: 2 years
Number of catheter related infections
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Netwerk Antwerpen (ZNA), AZ Sint-Lucas Brugge, 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
- Responsible party
- Principal investigator, Mira Dreesen, PhD student, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545063
- Sponsor's protocol ID
- S54137
- Acronym
- CAPANAH
- Status last verified
- Jul 2017
- First submitted
- 1 Mar 2012
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non-interventional Non-controlled Multicenter Observational Study to Evaluate the Quality of Care for Adult Patients on Home Parenteral Nutrition (HPN)
- ClinicalTrials.gov ID
- NCT01545063
- Acronym / sponsor ID
- CAPANAH / S54137
- Conditions
- Crohn's Disease, Peritoneal Carcinomatosis With Intestinal Occlusion, Radiation Enteritis, Chronic Diarrhea, Intestinal Lymphomas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Ziekenhuis Netwerk Antwerpen (ZNA), AZ Sint-Lucas Brugge, 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
- Study start
- May 2012 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 6 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult HPN patients with peritoneal carcinomatosis with intestinal occlusion or with crohn's disease, radiation enteritis, chronic diarrhea, intestinal lymphomas.
Key inclusion criteria (1 listed)
- Patients in Flanders who speak Dutch, are older then 18 years and are able to give an informed consent.
Key exclusion criteria (1 listed)
- Patients who are younger then 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life
Time frame: 2 years
Quality of life will be investigated with the HPN-QoL(r) or FACIT-G (r).
Number of catheter related infections
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Peritoneal Carcinomatosis With Intestinal Occlusion, run by KU Leuven at 13 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.