Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2026-01-03 @ 8:18 PM
Study NCT ID:
NCT01916161
Status:
COMPLETED
Last Update Posted:
2016-03-22
First Post:
2013-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Information Sources on Knowledge and Anxiety in Inflammatory Bowel Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 307}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-21', 'studyFirstSubmitDate': '2013-07-31', 'studyFirstSubmitQcDate': '2013-08-02', 'lastUpdatePostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CCKNOW', 'timeFrame': '12 months', 'description': 'CCKNOW scores according to preferred information source'}], 'secondaryOutcomes': [{'measure': 'HADS-A', 'timeFrame': '12 months', 'description': 'HADS-A scores according to preferred information source'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Crohn's disease", 'ulcerative colitis', 'anxiety', 'patient knowledge', 'information sources'], 'conditions': ["Crohn's Disease", 'Ulcerative Colitis', 'Anxiety']}, 'descriptionModule': {'briefSummary': "Inflammatory Bowel Diseases (IBD) are life-long, incurable illnesses that can have a profound effect on the patients quality of life. Disease education is a corner stone of IBD care to enable patients to take up an active role in their disease management. While patient education is enshrined in the IBD standards, actual patient knowledge is often poor.3 Knowledge is not associated with the level of the patient's educational achievement, but member of patient organisations such as Crohn's and Colitis UK (CCUK) have significantly better knowledge than non-members. This may highlight the positive effects of education offered by CCUK, but it is also conceivable that patients with a greater interest in their disease are more like to join organisations like CCUK. Different sources of patient information may therefore influence what level of disease related knowledge a patient achieves.\n\nApart from high quality clinical information provided by professional organisation (British Society of Gastroenterology, European Crohn's and Colitis Organisation), the National Health Service and charities (CORE, CCUK), there is also a host of unregulated information available. The emerging dominance of the internet for information gathering has provided easy access for patients to a host of websites providing information on IBD. A number of these provide alternative (not evidence based) views, which could have a potentially negative impact on patient's knowledge. Furthermore patients often share their stories on internet forums and it is likely that those stories share are more likely to represent the extreme ends of disease rather than those experienced by the majority. This could potentially cause anxiety in patients with IBD. The quality of information found on the internet varies widely and up to 50% of websites have been judged as poor. The vast majority of patients with IBD have access to the internet and more than half use to search for health related information.7 We have previously also demonstrated that patients with anxiety have better disease related knowledge of IBD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ambulatory patients attending IBD clinics at Leeds Teaching Hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\npatients attending IBD clinics at Leeds Teaching Hospitals\n\nExclusion Criteria:\n\n* Individuals who are unable to give informed consent.\n* Individuals who do not speak English, as the questionanire is selfadministered.\n* Individuals under 18 years of age.\n* Individuals who are attending Gastroenterology clinics at Leeds General Infirmary and St. James's University Hospital because of a flare up of disease activity of their ulcerative colitis or Crohn's disease.\n* Individuals with Crohn's disease who have a stoma (ileostomy), due to practical difficulties in assessing clinical activity in this patient group (it is not actually possible to calculate the HarveyBradshaw index in patients with an ileostomy).\n* Individuals who, in the opinion of the investigator, are not suitable to participate in the study.\n* Individuals who refuse to give written, informed consent to be involved."}, 'identificationModule': {'nctId': 'NCT01916161', 'briefTitle': 'The Influence of Information Sources on Knowledge and Anxiety in Inflammatory Bowel Disease Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Health Service, United Kingdom'}, 'officialTitle': 'The Influence of Information Sources on Knowledge and Anxiety in Inflammatory Bowel Disease Patients', 'orgStudyIdInfo': {'id': 'IBDINFOSOURCE1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IBD patients', 'description': 'Ambulatory patients attending IBD clinics at Leeds Teaching Hospitals', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'armGroupLabels': ['IBD patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'Yorkshire', 'country': 'United Kingdom', 'facility': 'Leeds Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Health Service, United Kingdom', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Gastroenterologist', 'investigatorFullName': 'Christian Selinger', 'investigatorAffiliation': 'National Health Service, United Kingdom'}}}}