Impact of Isolation in Patients With IBD During the COVID-19 Crisis
NCT ID: NCT04488471
Last Updated: 2020-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
232 participants
OBSERVATIONAL
2020-06-30
2022-06-30
Brief Summary
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It is increasingly recognised that the pandemic and the changes to daily life will have had a series of impacts on patients and health care services, including impacts on patients psychological well-being and the opportunity to seek medical care for non-CoViD illness.
Psychological symptoms such as depression, anxiety and hopelessness is well described in adults and young people with inflammatory bowel disease. Quarantine has also been associated with these psychological symptoms and also post-traumatic stress. It is important to identify the extent of and factors that influence negative psychological consequences of isolation in patients with inflammatory bowel disease.
This study will aim to assess what impact the isolation of patients during social isolation had in terms of psychological well-being - and what are the factors affecting this impact, particularly in younger and old age groups.
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Detailed Description
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Patients identified from those attending the IBD clinic will be contacted. As part of the NHSE and local Trust CoViD response, lists of all patients attending the IBD clinics and those deemed to be at high risk of infection have been created.
This study aims to recruit 100 patients from the high-risk group and 100 patients from the non-high-risk group. Basedon an approximately 33% response rate, we have therefore elected to identify 300 patients from the high-risk groups and 300 from non-high-risk groups. These 600 patients in total will be contacted via the post, and mailed:
1. An explanatory cover letter, with instructions on how to participate in the study
2. Participant information sheet (PIS)
3. Consent form
4. Questionnaires
5. A stamped and addressed return envelope
Completion of questionnaire and return to site will constitute as consent for this data to be used. Postal recruitment is being used to maximise the chances of reaching those who may have been most affected by isolation and may have limited access to the internet. The consent form will apply to the optional interview component.
The PIS will include information signposting patients to help and support should they have difficulties or concerns relating to the study or the psychological impact of their condition or current situation.
Record of who has been contacted to participate will be kept on NHS computers, with patient hospital numbers corresponding to anonymous and non-identifiable study identification numbers. Keeping record will permit there to be available data regarding the questionnaire return rate. This will also potentially allow for demographic details to be retrieved from patient records regarding those who did not return responses, to facilitate both assessment of differences between responders and non-responders and provide information about those who elected not to participate.
In addition, a sub-set of 32 young people will be contacted and recruited. This sub-set have already undertaken the assessment of psychological morbidity, outlined below, during a previous, pre-CoViD outbreak study (STH20960 IRAS: 269881) and have agreed to further follow-up. These patients will also be contacted via the post to complete the same set of questionnaires and therefore provide follow-up, to assess whether measures of psychological morbidity changed following the onset of the CoViD crisis.
Patients will be asked to complete the following questionnaires:
1. IBD symptoms: IBD control questionnaire
2. Experience during the CoViD periods of isolation
3. Impact of event scale (iES-15 questionnaire)
4. Depression Anxiety Stress Scale-21 (DASS-21)
Background information, as listed below, will be collected in order to try and identify demographic and disease related details which may affect the level of psychological impact for IBD patients:
1. Age
2. Ethnicity
3. Postcode (used to calculate indices of deprivation scores, using the Indices of Multiple Deprivation \[IMD\] tool)
4. Disease type
5. Medication
6. BSG risk group
The same patients will be contacted and asked to complete the questionnaires again after 6 and 12 months to assess changes in psychological impact and relationship to societal requirements for isolation.
Semi structured interviews will be undertaken with approximately 20 participants. More may be undertaken until saturation point is reached.
Semi-structured interviews will be undertaken to provide further detail about the experience of isolation during the pandemic to explore issues to include factors which improve or worsen the experience of isolation including:
* The effect of the isolation itself
* The effect of variations in information provision
* Concern about infection risk and its variation during the period of "lock-down"
* Delays to presentation with flare symptoms
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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high-risk group
IBD patients who were high risk of infection and were shielding
No interventions assigned to this group
low-risk group
IBD patients who were low risk of infection and were following standard quarantine guidance
No interventions assigned to this group
young people from affiliated study
32 IBD patients from an affiliated study
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
ALL
No
Sponsors
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Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Alan Lobo, MD
Role: STUDY_CHAIR
Sheffield Teaching Hospitals NHS FT
Locations
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Sheffield Teaching Hospitals NHS FT
Sheffield, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STH21414
Identifier Type: -
Identifier Source: org_study_id
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