- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06392113
Developing a Falls Management Tool for Adults With ID-POC
Developing a Falls Management Tool for Adults With Intellectual Disabilities- Proof of Concept Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adults with an intellectual disability
Completion of ACTION FALLS programme
|
Falls prevention advice including booklet and videos
|
Carers of adults with an intellectual disability
Completion of ACTION FALLS programme
|
Falls prevention advice including booklet and videos
|
Clinicians working with adults with an intellectual disability
Completion of ACTION FALLS programme
|
Falls prevention advice including booklet and videos
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number and types of falls risks identified
Time Frame: Through study completion, on average one month
|
The number and types of falls risks identified
|
Through study completion, on average one month
|
Time taken and level of completion of the programme
Time Frame: Through study completion, on average one month
|
Time taken and level of completion of the programme
|
Through study completion, on average one month
|
Barriers and facilitators to completing the programme
Time Frame: Through study completion, on average one month
|
Barriers and facilitators to completing the programme
|
Through study completion, on average one month
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- 22AS002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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