Crohn's DiseaseNCT01916161
The Influence of Information Sources on Knowledge and Anxiety in Inflammatory Bowel Disease Patients
An observational study of Crohn's Disease and Ulcerative Colitis, run by National Health Service, United Kingdom at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis, Anxiety
- What is being tested?
- Questionnaire
- How many people
- 307 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Feb 2016
- 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: ambulatory patients attending IBD clinics at Leeds Teaching Hospitals
Who may be able to join
- patients attending IBD clinics at Leeds Teaching Hospitals
Who cannot join
- Individuals who are unable to give informed consent.
- Individuals who do not speak English, as the questionanire is selfadministered.
- Individuals under 18 years of age.
- 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.
- 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).
- Individuals who, in the opinion of the investigator, are not suitable to participate in the study.
- Individuals who refuse to give written, informed consent to be involved.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals NHS Trust
Leeds, Yorkshire, LS9 7TF
About this study
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.
Apart 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.
- Conditions
- Crohn's Disease, Ulcerative Colitis, Anxiety
- Being tested
- Questionnaire
- Keywords
- Crohn's disease, ulcerative colitis, anxiety, patient knowledge, information sources
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| IBD patients | Ambulatory patients attending IBD clinics at Leeds Teaching Hospitals Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
CCKNOW
CCKNOW scores according to preferred information source
Measured: 12 months
Secondary outcomes (1)
HADS-A
HADS-A scores according to preferred information source
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Service, United Kingdom
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Christian Selinger, National Health Service, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916161
- Sponsor's protocol ID
- IBDINFOSOURCE1
- Status last verified
- Mar 2016
- First submitted
- 31 Jul 2013
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Information Sources on Knowledge and Anxiety in Inflammatory Bowel Disease Patients
- ClinicalTrials.gov ID
- NCT01916161
- Acronym / sponsor ID
- IBDINFOSOURCE1
- Conditions
- Crohn's Disease, Ulcerative Colitis, Anxiety
- Keywords
- Crohn's disease, ulcerative colitis, anxiety, patient knowledge, information sources
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- National Health Service, United KingdomOther government
- Study start
- Oct 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 5 Aug 2013 (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 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.
Apart 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD patients | – | Other: QuestionnaireAmbulatory patients attending IBD clinics at Leeds Teaching Hospitals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ambulatory patients attending IBD clinics at Leeds Teaching Hospitals
Key inclusion criteria (1 listed)
- patients attending IBD clinics at Leeds Teaching Hospitals
Key exclusion criteria (7 listed)
- Individuals who are unable to give informed consent.
- Individuals who do not speak English, as the questionanire is selfadministered.
- Individuals under 18 years of age.
- 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.
- 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).
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 |
|---|---|---|
| Questionnaire | Other | IBD patients |
Primary outcome
CCKNOW
Time frame: 12 months
CCKNOW scores according to preferred information source
1 secondary outcome
HADS-A
Time frame: 12 months
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 22 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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's Disease and Ulcerative Colitis, run by National Health Service, United Kingdom at 1 site in United Kingdom.
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 7 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 22 Mar 2016. 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 United Kingdom. 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?
CCKNOW (time frame: 12 months). 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 22 Mar 2016.