Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392113
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-22
Brief Title:
Developing a Falls Management Tool for Adults With ID-POC
Sponsor:
Nottingham University Hospitals NHS Trust
Organization:
Nottingham University Hospitals NHS Trust
Study Overview
Official Title:
Developing a Falls Management Tool for Adults With Intellectual Disabilities- Proof of Concept Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None