Developing an Intervention to Help Nurses Improve Sexual Healthcare in Men With Inflammatory Bowel Disease

NCT06562751 | Completed

• 1 other identifier: MenSH-IBD
• Study Type: observational
• Target: 792
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Prototype intervention

  A prototype intervention to improve the assessment and care of the sexual health needs of men with Inflammatory bowel disease (IBD). The intervention will provide nurses with the improved understanding of the support and knowledge and skills required to effectively assess the sexual health needs of men with Inflammatory Bowel Disease and provide appropriate patient-centred care.

  18 months

Secondary Outcomes (3)

• Survey 1 outcomes:

  18 months

• Survey 2 outcome

  18 months

• Survey 3 outcome

  18 months

Study Arms (6)

Survey 1 (National Health Service Inflammatory Bowel Disease services)

A survey designed by the investigators to ascertain current Inflammatory Bowel Disease service provision for sexual healthcare. A representative from each service will complete one online survey that should take approximately 15 minutes to complete.

Other: Questionnaire

Survey 2 (Inflammatory Bowel Disease nurses survey)

A survey designed by the investigators to ascertain current nursing practice for sexual healthcare within Inflammatory Bowel Disease (IBD) services. Registered nurses working with people with IBD will complete one online survey that should take approximately 15 minutes to complete.

Other: Questionnaire

Survey 3 (men with IBD)

A survey designed by the investigators to ascertain the needs of men with Inflammatory Bowel Disease (IBD). Men with a diagnosis of IBD will complete one online survey that should take approximately 15 minutes to complete.

Other: Questionnaire

Interviews

Men with a diagnosis of Inflammatory Bowel Disease (IBD) and the partners of men with IBD will undertake online, semi-structured interviews that will last no longer than 60 minutes. Participants can be interviewed with their partner or individually. Participants without a partner or whose partner does not wish to be interviewed will be interviewed individually.

Other: Interview

Focus Groups

Healthcare professionals and appropriate stakeholders (for example charitable organisations) will participate in focus groups. Each focus group will contain 6-8 members. There will be three groups in total.

Other: Focus group

Co-production workshops

A group of 8-12 inclusive of men with IBD, the partners of men with IBD and healthcare professionals and appropriate stakeholders will participate in three co-production workshops to develop a prototype intervention and logic model to patient benefit.

Other: Workshop

Interventions

Workshop OTHER

Online and face to face co-production workshops

Co-production workshops

Focus group OTHER

Online focus group

Focus Groups

Interview OTHER

Online semi-structured interview

Interviews

Questionnaire OTHER

Online questionnaire designed by the investigatory team.

Survey 1 (National Health Service Inflammatory Bowel Disease services); Survey 2 (Inflammatory Bowel Disease nurses survey); Survey 3 (men with IBD)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identify as male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

As above

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• York St John University: collaborator
• National Institute for Health Research, United Kingdom: collaborator
• York Teaching Hospitals NHS Foundation Trust: lead
• University of York: collaborator

Study Sites (1)

Sarah Ma

York, North Yorkshire, United Kingdom

Location

Related Publications (1)

• Ma S, Forshaw G, Kanaan M, Knapp P, Robinson W, Selinger C, Galdas P. Developing an Intervention to Improve Sexual Health Assessment and Care in Men With Inflammatory Bowel Disease. J Adv Nurs. 2025 Sep 5. doi: 10.1111/jan.70199. Online ahead of print.

  PMID: 40913018 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Surveys and Questionnaires; Focus Groups; Interviews as Topic

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sara Ma, MSc

  York St John University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: August 20, 2024
• Study Start: October 17, 2024
• Primary Completion: January 22, 2026
• Study Completion: January 22, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

GB (1)