- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06562751
Developing an Intervention to Help Nurses Improve Sexual Healthcare in Men With Inflammatory Bowel Disease (MenSH-IBD)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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North Yorkshire
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York, North Yorkshire, United Kingdom
- Sarah Ma
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Online questionnaire designed by the investigatory team.
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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.
|
Online questionnaire designed by the investigatory team.
|
|
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.
|
Online questionnaire designed by the investigatory team.
|
|
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.
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Online semi-structured interview
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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.
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Online focus group
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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.
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Online and face to face co-production workshops
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prototype intervention
Time Frame: 18 months
|
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.
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18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survey 1 outcomes:
Time Frame: 18 months
|
Determine provision of sexual healthcare, assessment and support services to men with IBD in UK National Health Services including whether these differ between male and female patients.
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18 months
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Survey 2 outcome
Time Frame: 18 months
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Facilitators, barriers and confidence of nurses to delivery sexual health assessment, care and advice to male patients.
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18 months
|
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Survey 3 outcome
Time Frame: 18 months
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Perceived needs, preferences and barriers in regards to sexual health in men with Inflammatory Bowel Disease.
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18 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sara Ma, MSc, York St John University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Intestinal Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Inflammatory Bowel Diseases
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Interviews as Topic
- Surveys and Questionnaires
- Focus Groups
Other Study ID Numbers
- MenSH-IBD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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