Chronic Intestinal FailureNCT05857254
Treatment Adherence of Home Parenteral Nutrition in Patients With Chronic Intestinal Failure. (QANPIC)
An observational study of Chronic Intestinal Failure, run by University Hospital, Bordeaux at 6 sites in France.
Trial summary
This observational, cross-sectionnal, multicentric study evaluates treatment adherence of home parenteral nutrition in patients with chronic intestinal failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Intestinal Failure
- What is being tested?
- Patient with chronic intestinal failure
- How many people
- 126 participants
- Where
- 6 sitesFrance
- Study dates
- 29 Jun 2023to 25 Jan 2024
- 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: Patient with chronic intestinal failure
Who may be able to join
- Age 18 or older.
- Diagnosis of CIF (insufficiency of intestinal absorptive, motor or vascular functions that require parenteral nutrition).
- Home parenteral nutrition treatment for at least 6 months.
- With home parenteral nutrition treatment stable for at least 3 months.
- Agreeing to participate in research protocol.
Who cannot join
- Any condition that does not let a telephone interview (example : deafness, severe neurocognitive impairment).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU de Grenoble
Grenoble, 38043
CHU Limoges
Limoges
Institut régional du cancer Montpellier
Montpellier
CHU de Nantes
Nantes
Hôpital de l'Archet
Nice, 06202
CHU Bordeaux
Pessac, 33600
About this study
Official title: What Treatment Adherence for Home Parenteral Nutrition in Patients With Chronic Intestinal Failure ?
This observational, cross-sectionnal, multicentric study evaluates treatment adherence of home parenteral nutrition in patients with chronic intestinal failure.
Read the detailed description
Chronic intestinal failure (CIF) is a chronic disease and its main treatment is home parenteral nutrition. This disease is defined by a small bowel dysfunction preventing absorption of nutrients and water inputs. A " normal " oral diet is then insufficient, and must be supplied by an " artificial " parenteral nutrition. This treatment is administered at home, by a central veinous catheter, with varying volumes and frequencies.
The quality of life of patients treated by home parenteral nutrition is significatively altered .
The constraints linked to this treatment may make it difficult to follow. The patients can be lead to ask their doctor for a relief or a modification of this treatment during office visits, to improve their quality of life.
Poor treatment adherence concerns 25% of patients with chronic disease . It has never been assessed in France in CIF.
The goal of this study is to evaluate the treatment adherence for home parenteral nutrition in two of its components: negotiation during office visits, and compliance at home.
The negociation component will be assessed during an office visit with the help of forms, by the difference between " ideal " parenteral nutrition prescription proposed by prescriber and the " final " prescription, that the patient ultimately receives at the end of the office visit.
The compliance component will be assessed by a telephone interview, 8 weeks after the office visit.
- Conditions
- Chronic Intestinal Failure
- Being tested
- Patient with chronic intestinal failure
- Keywords
- Chronic intestinal failure, Treatment adherence
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient with chronic intestinal failureOther
The negociation component will be assessed during an office visit with the help of forms, by the difference between " ideal " parenteral nutrition prescription proposed by prescriber and the " final " prescription, that the patient ultimately receives at the end of the office visit.
The compliance component will be assessed by a telephone interview, 8 weeks after the office visit.
| Study group | Role | What they receive |
|---|---|---|
| Chronic intestinal failure patient | Patient with chronic intestinal failure and with home parenteral nutrition treatment stable for at least 3 months and with home parenteral nutrition treatment for at least 6 months. Receives: Other: Patient with chronic intestinal failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the volume of parenteral nutrition
A 10% (or more) difference between " ideal " and " final " prescriptions (one week's assessment of volume difference in mL) And/or During telephone survey, highlighting a 10% (or more) difference in nutrition received, compared to what is indicated on the prescription (assessment done on the difference in volume in mL over a week).
Measured: Inclusion visit, 8 weeks
Secondary outcomes (3)
Patient's compliance
Evaluation of the " perception of patients'compliance " by the coordinating nurse of the nutrition center by an analog visual scale. Analog visual scale is scored from 0 (good compliance) to 10 (poor compliance)
Measured: Inclusion visit
Anxiety and depression symptom
Identification of signs of anxiety and depression symptoms by the HADS form. The anxiety and depression scale consists of 14 questions that assess how subjects feel at the time and generally.
Measured: Inclusion visit
Patient's trust
Evaluation of patient's trust in their specialist physician by the WFPTS form. This scale assesses the patient trust's in their specialist ; it consists in 10 questions.
Measured: Inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start29 Jun 2023
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Intestinal FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florian POULLENOT, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857254
- Sponsor's protocol ID
- CHUBX 2023/09
- Status last verified
- Apr 2024
- First submitted
- 20 Apr 2023
- Last updated
- 29 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Treatment Adherence for Home Parenteral Nutrition in Patients With Chronic Intestinal Failure ?
- ClinicalTrials.gov ID
- NCT05857254
- Acronym / sponsor ID
- CHUBX 2023/09
- Conditions
- Chronic Intestinal Failure
- Keywords
- Chronic intestinal failure, Treatment adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 12 May 2023 (actual)
- 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 observational, cross-sectionnal, multicentric study evaluates treatment adherence of home parenteral nutrition in patients with chronic intestinal failure.
Detailed description
Chronic intestinal failure (CIF) is a chronic disease and its main treatment is home parenteral nutrition. This disease is defined by a small bowel dysfunction preventing absorption of nutrients and water inputs. A " normal " oral diet is then insufficient, and must be supplied by an " artificial " parenteral nutrition. This treatment is administered at home, by a central veinous catheter, with varying volumes and frequencies.
The quality of life of patients treated by home parenteral nutrition is significatively altered .
The constraints linked to this treatment may make it difficult to follow. The patients can be lead to ask their doctor for a relief or a modification of this treatment during office visits, to improve their quality of life.
Poor treatment adherence concerns 25% of patients with chronic disease . It has never been assessed in France in CIF.
The goal of this study is to evaluate the treatment adherence for home parenteral nutrition in two of its components: negotiation during office visits, and compliance at home.
The negociation component will be assessed during an office visit with the help of forms, by the difference between " ideal " parenteral nutrition prescription proposed by prescriber and the " final " prescription, that the patient ultimately receives at the end of the office visit.
The compliance component will be assessed by a telephone interview, 8 weeks after the office visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic intestinal failure patient | – | Other: Patient with chronic intestinal failurePatient with chronic intestinal failure and with home parenteral nutrition treatment stable for at least 3 months and with home parenteral nutrition treatment for at least 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with chronic intestinal failure
Key inclusion criteria (5 listed)
- Age 18 or older.
- Diagnosis of CIF (insufficiency of intestinal absorptive, motor or vascular functions that require parenteral nutrition).
- Home parenteral nutrition treatment for at least 6 months.
- With home parenteral nutrition treatment stable for at least 3 months.
- Agreeing to participate in research protocol.
Key exclusion criteria (1 listed)
- Any condition that does not let a telephone interview (example : deafness, severe neurocognitive impairment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient with chronic intestinal failureThe negociation component will be assessed during an office visit with the help of forms, by the difference between " ideal " parenteral nutrition prescription proposed by prescriber and the " final " prescription, that the patient ultimately receives at the end of the office visit. The compliance component will be assessed by a telephone interview, 8 weeks after the office visit. | Other | Chronic intestinal failure patient |
Primary outcome
Difference in the volume of parenteral nutrition
Time frame: Inclusion visit, 8 weeks
A 10% (or more) difference between " ideal " and " final " prescriptions (one week's assessment of volume difference in mL) And/or During telephone survey, highlighting a 10% (or more) difference in nutrition received, compared to what is indicated on the prescription (assessment done on the difference in volume in mL over a week).
3 secondary outcomes
Patient's compliance
Time frame: Inclusion visit
Anxiety and depression symptom
Time frame: Inclusion visit
Patient's trust
Time frame: Inclusion visit
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 29 Apr 2024.
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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.
Florian POULLENOT, MD principal investigator
University Hospital, Bordeaux
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Intestinal Failure, run by University Hospital, Bordeaux at 6 sites in France.
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 5 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 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
Difference in the volume of parenteral nutrition (time frame: Inclusion visit, 8 weeks). 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 29 Apr 2024.