- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02770599
Improving the Health Care in Inflammatory Bowel Disease.
March 13, 2023 updated by: University Hospital of North Norway
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
304
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Harstad, Norway, 9480
- University Hospital of North Norway
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Diagnose duration > 2 years, to ensure that the patients have some experience with IBD and their follow-up system, respectively
Exclusion Criteria:
- Non-Norwegian patients who will have difficulties understanding the questionnaires
- patients with cognitive disabilities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
IBD multidisciplinary team model (MDT)
IBD multidisciplinary team model including IBD nurse
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
during autumn of 2016
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of care
Time Frame: during autumn of 2016
|
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".
|
during autumn of 2016
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence associated to IBD medications
Time Frame: during autumn of 2016
|
The questionnaire Morisky Medication Adherence Scale (MMAS) is a validated 8-question measuring scale for medication adherence in IBD patients.
The patients can score from 0-8 points, where score > 2 = low adherence and a score of 1 or 2 = medium adherence.
|
during autumn of 2016
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2016
Primary Completion (Anticipated)
March 20, 2025
Study Completion (Anticipated)
July 20, 2025
Study Registration Dates
First Submitted
April 4, 2016
First Submitted That Met QC Criteria
May 11, 2016
First Posted (Estimate)
May 12, 2016
Study Record Updates
Last Update Posted (Actual)
March 14, 2023
Last Update Submitted That Met QC Criteria
March 13, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/1397(REK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Crohn Disease
-
ProgenaBiomeRecruitingCrohn Disease | Crohn Colitis | Crohn's Ileocolitis | Crohn's Gastritis | Crohn's Jejunitis | Crohn's Duodenitis | Crohn's Esophagitis | Crohn's | Crohn Disease of Ileum | Crohn Ileitis | Crohn's Disease Relapse | Crohns Disease Aggravated | Crohn Disease in Remission | Crohn's Disease of PylorusUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CelltrionRecruitingBowel Disease | Inflammatory Disease | Disease CrohnNetherlands
-
Chinese University of Hong KongTerminatedCrohn Disease | Perianal Crohn DiseaseHong Kong
-
SandozCompletedCrohn´s DiseaseAustria, Germany, Poland, Spain, Sweden
-
Dr. Falk Pharma GmbHCompleted
-
University of Erlangen-Nürnberg Medical SchoolCompleted
-
Groupe Hospitalier Paris Saint JosephCompleted
-
Ferring PharmaceuticalsTerminatedCrohn´s DiseaseUnited Kingdom, United States, Germany, Belgium, Denmark, France, Sweden
-
Jinling Hospital, ChinaCompletedCrohn Disease in RemissionChina
-
Boehringer IngelheimTerminatedFibrostenotic Crohn´s DiseaseUnited States, Canada, Japan, Sweden
Clinical Trials on IBD multidisciplinary team model including IBD nurse
-
London North West Healthcare NHS TrustKing's College London; Queen Mary University of LondonCompletedFecal Incontinence | Inflammatory Bowel Disease (IBD)United Kingdom
-
National Institute of Diabetes and Digestive and...Completed
-
Hendrick Medical CenterAbbottNot yet recruitingPeripheral Arterial Disease | Amputation | Critical Limb Ischemia
-
The University of Texas Health Science Center,...DHR Health Institute for Research and DevelopmentCompletedType 2 DiabetesUnited States
-
Mount Sinai Hospital, CanadaCrohn's and Colitis CanadaUnknownInflammatory Bowel Diseases | Crohn Disease | Medication Adherence | Ulcerative ColitisCanada