Improving the Health Care in Inflammatory Bowel Disease.
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.
1 other identifier
observational
304
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2016
CompletedFirst Posted
Study publicly available on registry
May 12, 2016
CompletedStudy Start
First participant enrolled
May 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2025
CompletedMarch 14, 2023
March 1, 2023
8.9 years
April 4, 2016
March 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
during autumn of 2016
Secondary Outcomes (1)
Quality of care
during autumn of 2016
Other Outcomes (1)
Adherence associated to IBD medications
during autumn of 2016
Study Arms (2)
IBD multidisciplinary team model (MDT)
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.
Interventions
IBD multidisciplinary team model including IBD nurse
Eligibility Criteria
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.
You may qualify if:
- Diagnose duration \> 2 years, to ensure that the patients have some experience with IBD and their follow-up system, respectively
You may not qualify if:
- Non-Norwegian patients who will have difficulties understanding the questionnaires
- patients with cognitive disabilities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital of North Norwaylead
- University of Tromsocollaborator
Study Sites (1)
University Hospital of North Norway
Harstad, 9480, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ann-Ragnhild Broderstad, Ph.D
The Health Faculty, Institute of Community Health,
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2016
First Posted
May 12, 2016
Study Start
May 15, 2016
Primary Completion
March 20, 2025
Study Completion
July 20, 2025
Last Updated
March 14, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share