Crohn DiseaseNCT02770599
Improving the Health Care in Inflammatory Bowel Disease.
An observational study of Crohn Disease and Colitis, Ulcerative, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Inflammatory Bowel Disease (IBD) refers to two chronic diseases (Crohn's disease and Ulcerative colitis) both complex disorders requiring a long-term management, with significant healthcare resource consumption. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease, Colitis, Ulcerative
- What is being tested?
- IBD multidisciplinary team model including IBD nurse
- How many people
- 304 participants
- Where
- 1 siteNorway
- Study dates
- 15 May 2016to 20 Jul 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Inflammatory bowel disease belonging two different out patient follow-up models; IBD multidisciplinary team including IBD specialist nurse or conventionally follow -up model, respectively.
Who may be able to join
- Diagnose duration > 2 years, to ensure that the patients have some experience with IBD and their follow-up system, respectively
Who cannot join
- Non-Norwegian patients who will have difficulties understanding the questionnaires
- patients with cognitive disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IMPROVING THE HEALTH CARE IN INFLAMMATORY BOWEL DISEASE. A Clinical Study Comparing Two Different Outpatient Follow-up Models by Measuring Patient Reported Health Related Quality of Life, Quality of Care, Adherence and Clinical Outcomes.
Inflammatory Bowel Disease (IBD) refers to two chronic diseases (Crohn's disease and Ulcerative colitis) both complex disorders requiring a long-term management, with significant healthcare resource consumption. Traditionally IBD patients has been treated by a variety of health care professional including doctors with specialist qualifications, assistant doctors, general practitioner or scarcity of follow-up-service. Lately there has been a shift in the health care service from conventional follow - up (CF) to a rising numbers of health care models in term of Multidisciplinary team (MDT) also including care for IBD patients. MDT- models have been identified as important for continuity in patient centred care where nurses have a key role within the team by enhancing patient care. Patients have directly access to the IBD nurse who performing independently consultations at the IBD - Policlinic. This study will test the hypothesis that MDT including an IBD - nurse is preferable concerning; patient reported Health Related Quality of Life (HRQoL) Quality of Care (QoC), and clinical outcomes including adherence. This will be a retrospective clinical quality survey with a single time point measurement, with consecutive recruitments of patients in the course of a 12-month period. Data will be collected from medical records and patient questionnaires. Investigators plan involving 300 participants aged >18 and < 80 recruited from Medical departments in North Norway and from Diakonhjemmet in Oslo. Half will be from CF-models and half from the IBD - MDT. The study have approval from the local Ethics committee and application to the Data protection Officer has been submitted. All participants are asked for provide written consent. The results can potentially contribute; to a better utilization of health care resources, improve quality of health and quality of care. In a nurse-perspective, this organising model can be valuable in recruiting nurses by presenting a new challenging task concept, and identify the gaps in their own knowledge and skills. A well-established MDT can also be reasonable in a cost effective way by decreasing hospitalisation and fee up clinical spaces for the gastroenterologist.
- Conditions
- Crohn Disease, Colitis, Ulcerative
- Being tested
- IBD multidisciplinary team model including IBD nurse
- Keywords
- IBD, HRQoL, QoC, Adherence, IBD nurse, MDT
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBD multidisciplinary team model including IBD nurseOther
IBD multidisciplinary team model including IBD nurse
| Study group | Role | What they receive |
|---|---|---|
| IBD multidisciplinary team model (MDT) | IBD multidisciplinary team model including IBD nurse Receives: Other: IBD multidisciplinary team model including IBD nurse | |
| IBD conventionally follow up model (CF) | IBD patient treated by doctors with specialist qualifications, assistant doctors, general practitioner or scarcity of follow-up-service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
Health Related Quality of Life measured by The inflammatory Bowel Disease Questionnaire (IBDQ). This is a disease specific valid, reliable and sensitive instrument for clinical trials designed to measure the effects of the IBD on daily function and quality of life during the past two weeks. An absolute change on 16 of 224 points in total score has been used to define a minimum clinically important difference.
Measured: during autumn of 2016
Secondary outcomes (1)
Quality of care
The questionnaire QUOTE IBD focus on GP-care and medical specialist care. This is a short, valid and reliable questionnaire. The answers is divided into four categories: "not important" - fairly important - important - extremely important" and " no - not really - on the whole yes - yes".
Measured: during autumn of 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start15 May 2016
- Primary completion20 Mar 2025 (estimated)
- Study completion20 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso
- Responsible party
- Sponsor
- Investigators
- Ann-Ragnhild Broderstad, Ph.D, Principal investigator, The Health Faculty, Institute of Community Health,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770599
- Sponsor's protocol ID
- 2013/1397(REK)
- Status last verified
- Mar 2023
- First submitted
- 4 Apr 2016
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPROVING THE HEALTH CARE IN INFLAMMATORY BOWEL DISEASE. A Clinical Study Comparing Two Different Outpatient Follow-up Models by Measuring Patient Reported Health Related Quality of Life, Quality of Care, Adherence and Clinical Outcomes.
- ClinicalTrials.gov ID
- NCT02770599
- Acronym / sponsor ID
- 2013/1397(REK)
- Conditions
- Crohn Disease, Colitis, Ulcerative
- Keywords
- IBD, HRQoL, QoC, Adherence, IBD nurse, MDT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- University of Tromso
- Study start
- 15 May 2016 (actual)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 20 Jul 2025 (estimated)
- First posted
- 12 May 2016 (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.
Inflammatory Bowel Disease (IBD) refers to two chronic diseases (Crohn's disease and Ulcerative colitis) both complex disorders requiring a long-term management, with significant healthcare resource consumption. Traditionally IBD patients has been treated by a variety of health care professional including doctors with specialist qualifications, assistant doctors, general practitioner or scarcity of follow-up-service. Lately there has been a shift in the health care service from conventional follow - up (CF) to a rising numbers of health care models in term of Multidisciplinary team (MDT) also including care for IBD patients. MDT- models have been identified as important for continuity in patient centred care where nurses have a key role within the team by enhancing patient care. Patients have directly access to the IBD nurse who performing independently consultations at the IBD - Policlinic. This study will test the hypothesis that MDT including an IBD - nurse is preferable concerning; patient reported Health Related Quality of Life (HRQoL) Quality of Care (QoC), and clinical outcomes including adherence. This will be a retrospective clinical quality survey with a single time point measurement, with consecutive recruitments of patients in the course of a 12-month period. Data will be collected from medical records and patient questionnaires. Investigators plan involving 300 participants aged >18 and < 80 recruited from Medical departments in North Norway and from Diakonhjemmet in Oslo. Half will be from CF-models and half from the IBD - MDT. The study have approval from the local Ethics committee and application to the Data protection Officer has been submitted. All participants are asked for provide written consent. The results can potentially contribute; to a better utilization of health care resources, improve quality of health and quality of care. In a nurse-perspective, this organising model can be valuable in recruiting nurses by presenting a new challenging task concept, and identify the gaps in their own knowledge and skills. A well-established MDT can also be reasonable in a cost effective way by decreasing hospitalisation and fee up clinical spaces for the gastroenterologist.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD multidisciplinary team model (MDT) | – | Other: IBD multidisciplinary team model including IBD nurseIBD multidisciplinary team model including IBD nurse |
| IBD conventionally follow up model (CF) | – | –IBD patient treated by doctors with specialist qualifications, assistant doctors, general practitioner or scarcity of follow-up-service. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Inflammatory bowel disease belonging two different out patient follow-up models; IBD multidisciplinary team including IBD specialist nurse or conventionally follow -up model, respectively.
Key inclusion criteria (1 listed)
- Diagnose duration > 2 years, to ensure that the patients have some experience with IBD and their follow-up system, respectively
Key exclusion criteria (2 listed)
- Non-Norwegian patients who will have difficulties understanding the questionnaires
- patients with cognitive disabilities
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 |
|---|---|---|
| IBD multidisciplinary team model including IBD nurseIBD multidisciplinary team model including IBD nurse | Other | IBD multidisciplinary team model (MDT) |
Primary outcome
Health related quality of life
Time frame: during autumn of 2016
Health Related Quality of Life measured by The inflammatory Bowel Disease Questionnaire (IBDQ). This is a disease specific valid, reliable and sensitive instrument for clinical trials designed to measure the effects of the IBD on daily function and quality of life during the past two weeks. An absolute change on 16 of 224 points in total score has been used to define a minimum clinically important difference.
1 secondary outcome
Quality of care
Time frame: during autumn of 2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- 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.
Ann-Ragnhild Broderstad, Ph.D principal investigator
The Health Faculty, Institute of Community Health,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Colitis, Ulcerative, run by University Hospital of North Norway at 1 site in Norway.
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 2 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: status not confirmed, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Results are not available in the source record.
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?
Health related quality of life (time frame: during autumn of 2016). 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 14 Mar 2023.