Clinical trial NCT06562751: Developing an Intervention to Help Nurses Improve Sexual Healthcare in Men With Inflammatory Bowel Disease
Official title: Developing an Intervention to Help Nurses Improve the Assessment and Care of the Sexual Health Needs of Men With Inflammatory Bowel Disease: a Mixed Methods Study Using Co-production
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Lead sponsor: York Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of York
name: York St John University
name: National Institute for Health Research, United Kingdom
First posted: 2024-08-20
Enrollment: 639
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As above

Brief summary: Inflammatory Bowel Disease (IBD) is a chronic, relapsing and remitting disease that can greatly impact health and personal well-being. Sexual health, relationships and intimacy have been raised as key concerns for those living with the disease. Men's sexual health and well-being has been identified as a neglected area. This study will lead to the development of an intervention that will help nurses to improve the assessment and care of the sexual health and well-being needs of men with IBD.

Detailed description: This research aims to develop an intervention to help nurses improve the assessment and care of the sexual health needs of men with Inflammatory Bowel Disease (IBD). This is a long-term digestive condition that is often diagnosed between the ages of 15-30 years. Patients often have bloody diarrhoea, abdominal pain, incontinence, and fatigue.

When severe, the disease can lead to hospital admission and surgery. There is growing recognition that IBD can negatively affect sexual health and impact on patients' relationships and quality of life, but men's needs have been neglected in research. Men report that their sexual health is rarely discussed at National Health Service (NHS) IBD clinic appointments, and specialist information and support are lacking. In this study the investigators will work with men with IBD, the partners of men with IBD, nurses, and other healthcare professionals to develop a nursing intervention that addresses this unmet need through information, assessment, and support.

This study consists of three main parts which have been labelled workstreams. In Workstream One the investigators will identify how the sexual health of men with IBD is currently assessed and cared for in the NHS using three large scale surveys that will include; (1) NHS Trusts (2) Nurses (3) People with IBD.

In Workstream Two the investigators will gather ideas on appropriate ways to improve the healthcare of men with IBD by conducting interviews with men with IBD and partners of men with IBD. The investigators will also conduct focus groups with healthcare professionals to hear their ideas of how services can be improved.

In Workstream Three the investigators will hold a series of workshops with patients and healthcare professionals to develop an intervention and consider how and why it could help patients.

The design of the study has been developed with a patient advisory group and input from IBD health professionals.

Eligibility criteria: Inclusion Criteria:

A diagnosis of Crohn's Disease, Ulcerative Colitis or IBD-U who identifies as male OR Currently in (or in the last 5 years) an intimate partnership with a person who identifies as male and has a diagnosis for Crohn's Disease, Ulcerative Colitis or IBD-U.

OR An NHS employee whose current employment involves oversight of the delivery and provision of a secondary care IBD patient service within their employing organisation. This may be a healthcare professional or non-clinical manager.

OR A registered nurse who as part of their current role is responsible of the provision of care to patients with IBD.

OR A health professional registered with the GMC, NMC or HCPC whose professional role is considered part of the IBD multidisciplinary team. Currently or previously employed in a role that directly provides care, support or advice to men with a diagnosis of IBD.

OR A representative of a charitable, not-for profit, professional, public or governmental organisation that is engaged with men who suffer from long term conditions or IBD specifically.

Exclusion criteria:

Unable to provide informed consent Less than 18 years old Does not speak English Not able to participate in the research activity (questionnaire, interview, focus group or workshop)

Primary outcomes:
measure: Prototype intervention
timeFrame: 18 months
Secondary outcomes:
measure: Survey 1 outcomes:
timeFrame: 18 months
measure: Survey 2 outcome
timeFrame: 18 months
measure: Survey 3 outcome
timeFrame: 18 months
Other outcomes:
Locations:
city: York
country: United Kingdom
facility: Sarah Ma
state: North Yorkshire
Study officials:
affiliation: York St John University
name: Sara Ma, MSc
role: PRINCIPAL_INVESTIGATOR
References: