Developing a Falls Management Tool for Adults With ID-POC

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 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.

Study Overview

Status

Not yet recruiting

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

Observational

Enrollment (Estimated)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adults with ID and 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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual sharing of participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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