Developing a Falls Management Tool for Adults With ID-POC

Fall Clinical Trial

Official title:

Developing a Falls Management Tool for Adults With Intellectual Disabilities- Proof of Concept Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06392113
• Other study ID #: 22AS002
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Falls can have a significant impact on the lives of adults with intellectual disabilities. The ACTION FALLS programme is a systematic falls management intervention that has been shown to be of benefit for older people however this programme in its current form needs to be adapted for use with adults with intellectual disabilities who have specific risk factors for falling and specific actions to reduce these risks. An adapted version of the programme to account for the different needs of adults with intellectual disabilities and the different services and support networks they access will be developed. A draft programme has been developed based on the views of adults with learning disabilities, carers and clinicians. This programme will now be tried out to see how easy it is to use and whether it can identify the falls risk factors relevant to adults with learning disabilities. Adults with an intellectual disability, clinicians and carers will t try out the programme and will be observed using it and will be asked to give verbal feedback on their views on how easy it is to complete and what could be improved.

Description:

The draft ACTION FALLS programme that will be used in this proof-of-concept study includes the following sections:

• Section One: A falls checklist, videos, and resource booklet for adults with an ID and carers.

• Section Two: A falls checklist for clinicians and a clinician manual for use in a clinical service.

Section one has been designed to be able to be used by adults with an ID and their carers independently of a clinical service. Additionally, section one could be used to support a clinical assessment in a clinical team to capture the views of adults with an ID. Section two has been designed to be used by a healthcare professional undertaking a more detailed assessment with adults with an ID.

There will be two components of work to explore views and acceptability of both the sections of the programme and how they work independently and together.

Component One:

Up to 10 clinicians will be recruited, to collect data with up to 15 adults with ID. The clinicians will be working in the ID service within Nottinghamshire Healthcare NHS Foundation Trust and will be asked to use the updated ACTION FALLS programme with adults with an ID accessing this service who give consent. The 'Think Aloud' method will be used to explore the views of the adult with ID and clinician in using the programme. The programme will be completed in addition to the standard clinical assessment and at a separate time convenient to both the clinician and participant. Completion of this programme will not interfere with the standard care received by the participant and clinical care will remain the responsibility of the usual care team and existing processes.

The following data will be collected and analysed:

• Researcher field notes observing the completion of the programme. This will include the time taken to complete the programme and any barriers and facilitators (analysed thematically)

• Research field notes on the verbal feedback given by participants when completing the programme (analysed thematically)

• Completed programme (personal information will be removed by the researcher) - the number and type of risk factors identified will be extracted (analysed using descriptive statistics and themes)

Component Two:

Up to 15 adults with an ID and 5 carers supporting adults with an ID in Nottinghamshire will be asked to use section one of the programme. This will be done without any clinician involvement. The programme will be completed as part of the workshop.

The following data will be collected and analysed:

• Researcher field notes observing the participants using the programme, this will include the time taken to complete the checklist and any barriers and facilitators (analysed thematically). These will be anonymous.- Research field notes on the verbal feedback given by participants when reviewing the programme (analysed thematically). These will be anonymous.

• Completed programme (personal information will be removed by the clinical researcher) - the number and type of risk factors identified will be extracted (and analysed using descriptive statistics and themes).

Email addresses of participants who would like to be provided with a lay summary at the end of the study will be collected. This will be collected on the consent form optionally.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Component One:

• Adults with ID, 18 years and over, accessing the ID service in identified clinical team

• Clinicians working in identified clinical team for adults with ID

Component Two:

Adults with an ID, 18 years and over, living in Nottinghamshire Family or paid carer of an adult with an ID living in Nottinghamshire

Exclusion Criteria:

• Lack of capacity to provide informed consent

Related Conditions & MeSH terms

• Fall
• Intellectual Disability

Intervention

Behavioral:
• ACTION FALLS
Falls prevention advice including booklet and videos

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust	National Institute for Health Research, United Kingdom

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number and types of falls risks identified	The number and types of falls risks identified	Through study completion, on average one month
Primary	Time taken and level of completion of the programme	Time taken and level of completion of the programme	Through study completion, on average one month
Primary	Barriers and facilitators to completing the programme	Barriers and facilitators to completing the programme	Through study completion, on average one month

External Links

•   Study website