Intellectual DisabilityNCT06392113
Developing a Falls Management Tool for Adults With ID-POC
An observational study of Intellectual Disability and Fall, run by Nottingham University Hospitals NHS Trust at 2 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intellectual Disability, Fall
- What is being tested?
- ACTION FALLS
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 13 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 19 Nov 2024to 18 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Clinicians working in an identified ID service in one locality in the UK and adults with ID and their carers identified from one geographical location in the UK.
Who may be able to join
- Component One:
- -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
Who cannot join
- Lack of capacity to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Nottingham University Hospitals NHS Trust
Nottingham
Nottinghamshire Healthcare NHS Foundation Trust
Nottingham
About this study
Official title: Developing a Falls Management Tool for Adults With Intellectual Disabilities- Proof of Concept Study
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. Adults with an intellectual disability, clinicians and carers will try out the programme and will be asked to give verbal feedback on their views on how easy it is to complete and what could be improved.
Read the 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. The clinicians will be working in the ID service within Nottinghamshire Healthcare NHS Foundation Trust and will be asked to review the updated ACTION FALLS programme . The 'Think Aloud' method will be used to explore the views of clinician in using the programme. The programme will be completed in addition to the standard clinical assessment. Completion of this programme will not interfere with the standard care received by the service users 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)
Component Two:
Up to 5 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 reviewed 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.
- Conditions
- Intellectual Disability, Fall
- Being tested
- ACTION FALLS
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTION FALLSBehavioural
Falls prevention advice including booklet and videos
| Study group | Role | What they receive |
|---|---|---|
| Adults with an intellectual disability | Review of ACTION FALLS programme Receives: Behavioral: ACTION FALLS | |
| Carers of adults with an intellectual disability | Review of ACTION FALLS programme Receives: Behavioral: ACTION FALLS | |
| Clinicians working with adults with an intellectual disability | Review of ACTION FALLS programme Receives: Behavioral: ACTION FALLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Views on the falls risk and actions included
Participant views on the falls risks in the programme and if they are clear and accurate
Measured: Through study completion, on average one month
Time taken and level of completion of the programme
Time taken and view on the length of the programme and details of the information included
Measured: Through study completion, on average one month
Barriers and facilitators to completing the programme
Barriers and facilitators to completing the programme
Measured: Through study completion, on average one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start19 Nov 2024
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392113
- Sponsor's protocol ID
- 22AS002
- Status last verified
- Mar 2026
- First submitted
- 22 Apr 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual sharing of participant data.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Falls Management Tool for Adults With Intellectual Disabilities- Proof of Concept Study
- ClinicalTrials.gov ID
- NCT06392113
- Acronym / sponsor ID
- 22AS002
- Conditions
- Intellectual Disability, Fall
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Adults with an intellectual disability, clinicians and carers will try out the programme 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. The clinicians will be working in the ID service within Nottinghamshire Healthcare NHS Foundation Trust and will be asked to review the updated ACTION FALLS programme . The 'Think Aloud' method will be used to explore the views of clinician in using the programme. The programme will be completed in addition to the standard clinical assessment. Completion of this programme will not interfere with the standard care received by the service users 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)
Component Two:
Up to 5 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 reviewed 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adults with an intellectual disability | – | Behavioral: ACTION FALLSReview of ACTION FALLS programme |
| Carers of adults with an intellectual disability | – | Behavioral: ACTION FALLSReview of ACTION FALLS programme |
| Clinicians working with adults with an intellectual disability | – | Behavioral: ACTION FALLSReview of ACTION FALLS programme |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Clinicians working in an identified ID service in one locality in the UK and adults with ID and their carers identified from one geographical location in the UK.
Key inclusion criteria (4 listed)
- -Clinicians working in identified clinical team for adults with ID
- Adults with an ID, 18 years and over, living in Nottinghamshire Family or paid carer of an adult with an ID living in Nottinghamshire
Key exclusion criteria (1 listed)
- Lack of capacity to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTION FALLSFalls prevention advice including booklet and videos | Behavioural | Adults with an intellectual disability, Carers of adults with an intellectual disability, Clinicians working with adults with an intellectual disability |
Primary outcome
Views on the falls risk and actions included
Time frame: Through study completion, on average one month
Participant views on the falls risks in the programme and if they are clear and accurate
Time taken and level of completion of the programme
Time frame: Through study completion, on average one month
Time taken and view on the length of the programme and details of the information included
Barriers and facilitators to completing the programme
Time frame: Through study completion, on average one month
Barriers and facilitators to completing the programme
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. No individual sharing of participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intellectual Disability and Fall, run by Nottingham University Hospitals NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Views on the falls risk and actions included (time frame: Through study completion, on average one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.