Impact of Isolation in Patients With IBD During the 2020 COVID-19 Crisis: a Mixed Methods Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 2
- 主要终点
- What impact has the isolation of patients during social isolation had in terms of psychological morbidity?
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IBD Patients who utilise the IBD Clinics at Sheffield Teaching Hospitals NHS FT
排除标准
- •patients who are not part of the IBD clinics at STH NHS FT
研究组 & 干预措施
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
结局指标
主要结局
What impact has the isolation of patients during social isolation had in terms of psychological morbidity?
时间窗: Changes in psychological morbidity at 12 months
Psychological morbidity will be assessed through the 4 questionnaires
次要结局
- Have levels of psychological morbidity in young people changed from levels prior to the CoViD pandemic?(Changes in psychological morbidity at 12 months)