Inflammatory Bowel DiseasesNCT04488471
Impact of Isolation in Patients With IBD During the COVID-19 Crisis
An observational study of Inflammatory Bowel Diseases, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The coronavirus pandemic has changed healthcare dramatically in a short time. Individuals with chronic illnesses and services for them have had to adapt and change to deal with requirements for shielding and social isolation to reduce infection risk and management of medication investigation and ongoing review. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 232 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jun 2020to 30 Jun 2022
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a clinical diagnosis of IBD who are treated in the clinics of Sheffield Teaching Hosptials NHS FT
Who may be able to join
- IBD Patients who utilise the IBD Clinics at Sheffield Teaching Hospitals NHS FT
Who cannot join
- patients who are not part of the IBD clinics at STH NHS FT
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS FT
Sheffield, S10 2JF
About this study
Official title: Impact of Isolation in Patients With IBD During the 2020 COVID-19 Crisis: a Mixed Methods Study
The coronavirus pandemic has changed healthcare dramatically in a short time. Individuals with chronic illnesses and services for them have had to adapt and change to deal with requirements for shielding and social isolation to reduce infection risk and management of medication investigation and ongoing review.
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.
Read more
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.
Read the detailed description
This study will use both questionnaires and semi-structured interviews to understand how IBD patients have been impacted psychologically by the CoViD-19 pandemic and identify various factors that may affect the extent to which patients have been impacted. This study will also incorporate longitudinal questionnaire follow-up of the same patients, in order to try and understand the long-term impact of the pandemic, and to assess changes in psychological impact accompanying changes in the national situation.
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:
- An explanatory cover letter, with instructions on how to participate in the study
- Participant information sheet (PIS)
- Consent form
- Questionnaires
- 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:
- IBD symptoms: IBD control questionnaire
- Experience during the CoViD periods of isolation
- Impact of event scale (iES-15 questionnaire)
- 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:
- Age
- Ethnicity
- Postcode (used to calculate indices of deprivation scores, using the Indices of Multiple Deprivation [IMD] tool)
- Disease type
- Medication
- 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
- Inflammatory Bowel Diseases
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| high-risk group | IBD patients who were high risk of infection and were shielding | |
| low-risk group | IBD patients who were low risk of infection and were following standard quarantine guidance | |
| young people from affiliated study | 32 IBD patients from an affiliated study |
What is being measured
The primary outcome is the main question the study is designed to answer.
What impact has the isolation of patients during social isolation had in terms of psychological morbidity?
Psychological morbidity will be assessed through the 4 questionnaires
Measured: Changes in psychological morbidity at 12 months
Secondary outcomes (1)
Have levels of psychological morbidity in young people changed from levels prior to the CoViD pandemic?
psychological morbidity will be assessed via comparison of questionnaires from affiliated study against the time points of this study
Measured: Changes in psychological morbidity at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start30 Jun 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Lobo, MD, Study chair, Sheffield Teaching Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488471
- Sponsor's protocol ID
- STH21414
- Status last verified
- Apr 2026
- First submitted
- 24 Jul 2020
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Isolation in Patients With IBD During the 2020 COVID-19 Crisis: a Mixed Methods Study
- ClinicalTrials.gov ID
- NCT04488471
- Acronym / sponsor ID
- STH21414
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 28 Jul 2020 (actual)
- 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.
The coronavirus pandemic has changed healthcare dramatically in a short time. Individuals with chronic illnesses and services for them have had to adapt and change to deal with requirements for shielding and social isolation to reduce infection risk and management of medication investigation and ongoing review.
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.
Detailed description
This study will use both questionnaires and semi-structured interviews to understand how IBD patients have been impacted psychologically by the CoViD-19 pandemic and identify various factors that may affect the extent to which patients have been impacted. This study will also incorporate longitudinal questionnaire follow-up of the same patients, in order to try and understand the long-term impact of the pandemic, and to assess changes in psychological impact accompanying changes in the national situation.
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:
- An explanatory cover letter, with instructions on how to participate in the study
- Participant information sheet (PIS)
- Consent form
- Questionnaires
- 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:
- IBD symptoms: IBD control questionnaire
- Experience during the CoViD periods of isolation
- Impact of event scale (iES-15 questionnaire)
- 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:
- Age
- Ethnicity
- Postcode (used to calculate indices of deprivation scores, using the Indices of Multiple Deprivation [IMD] tool)
- Disease type
- Medication
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high-risk group | – | –IBD patients who were high risk of infection and were shielding |
| low-risk group | – | –IBD patients who were low risk of infection and were following standard quarantine guidance |
| young people from affiliated study | – | –32 IBD patients from an affiliated study |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a clinical diagnosis of IBD who are treated in the clinics of Sheffield Teaching Hosptials NHS FT
Key inclusion criteria (1 listed)
- IBD Patients who utilise the IBD Clinics at Sheffield Teaching Hospitals NHS FT
Key exclusion criteria (1 listed)
- patients who are not part of the IBD clinics at STH NHS FT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
What impact has the isolation of patients during social isolation had in terms of psychological morbidity?
Time frame: Changes in psychological morbidity at 12 months
Psychological morbidity will be assessed through the 4 questionnaires
1 secondary outcome
Have levels of psychological morbidity in young people changed from levels prior to the CoViD pandemic?
Time frame: Changes in psychological morbidity at 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 1 May 2026.
- Individual participant dataSharing planned: No. no IPD will be shared with other researchers
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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.
Alan Lobo, MD study chair
Sheffield Teaching Hospitals NHS FT
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 Inflammatory Bowel Diseases, run by Sheffield Teaching Hospitals NHS Foundation Trust 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 1 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 1 May 2026. 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?
What impact has the isolation of patients during social isolation had in terms of psychological morbidity? (time frame: Changes in psychological morbidity at 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 1 May 2026.