Impact of Isolation in Patients With IBD During the COVID-19 Crisis

NCT04488471 | Completed

• 1 other identifier: STH21414
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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

  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?

  Changes in psychological morbidity at 12 months

Study Arms (3)

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a clinical diagnosis of IBD who are treated in the clinics of Sheffield Teaching Hosptials NHS FT

You may qualify if:

• IBD Patients who utilise the IBD Clinics at Sheffield Teaching Hospitals NHS FT

You may not qualify if:

• patients who are not part of the IBD clinics at STH NHS FT

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS FT

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Alan Lobo, MD

  Sheffield Teaching Hospitals NHS FT

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 28, 2020
• Study Start: June 30, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)