Development, Validation and Evaluation of the Feasibility of the Observational Risk Assessment of Contractures (Longitudinal Evaluation) Tool: The ORACLE Study

November 25, 2024 updated by: Bournemouth University

The Observational Risk Assessment for Contractures- Longitudinal Evaluation (ORACLE) is a risk assessment tool for contractures. The tool was originally designed and developed by a group of multidisciplinary health professionals within Dorset Healthcare University NHS Foundation Trust (DHUFT). Bournemouth University and DHUFT sponsored a match funded studentship to establish the academic validation of the tool.

The results from the previously conducted studies (Phase One) as part of this project: (i) a systematic review of the literature and an (ii) online Delphi survey with field experts provided initial evidence for further development, content validity, and modification of the tool.

The current study (Phase Two) aims to establish the psychometric validation, acceptability, and usability of the modified tool through formal testing on adult care home residents in Dorset. It consists of two streams of work: Stream A aims to establish the psychometric validation by completing the ORACLE assessments on adult care home residents. The assessments will be performed by the care home staff. In Stream B, a realist evaluation will be performed to explore the usability and practicality of ORACLE with selected care home managers and staff who were involved in organising and completing the assessments on ORACLE respectively.

The results from this two-phase design will then inform further revisions of the tool if required.

Study Overview

Status

Completed

Conditions

Detailed Description

Joint contractures are described as any degree of reduction in the passive range of motion within a joint due to muscle or connective tissue shortening eventually leading to structural abnormalities within the affected joint. ). This can lead to further deterioration in limb and joint flexibility, mobility, and activities of daily living (ADL's).

It has been reported that the care home residents spend most of their time remaining sedentary. Reduced mobility or lack of physical activity adversely affects the residents' physical and psychological well-being of the residents, including reduced motivation to engage in physical and social activities, pain, increased risk of pressure sores, contractures, and physical dependency.

Structured risk assessments play an important role in referring patients to the appropriate health care practitioner and enacting early treatment strategies to reduce the risk of the condition progressing. However, there is a clear lack of a standardised, evidence-based measure that can actively identify the risk of contractures and trigger appropriate and timely referrals to healthcare professionals.

The tool, Observational Risk Assessment for Contractures- Longitudinal Evaluation (ORACLE) was initially designed with the aim to address the gap mentioned above by a group of healthcare professionals (physiotherapists, occupational therapists, and nurses within Dorset Healthcare, Bournemouth Borough Council, Poole Borough Council, Dorset County Council, and Dorset CCG. The working party discussed the potential causes and factors associated with contracture development and/or progression based on their clinical experience and developed relevant themes to define the construct of the tool. The original construct developed underwent a series of transformations before a face-to-face consensus over a series of meetings to finally include eight items in the tool.

To establish the academic validation of the tool before widespread use and implementation, Dorset Health Care collaborated with Bournemouth University and sponsored a match-funded PhD Studentship. The PhD project has been structured into two main phases: Phase One: content validation and phase II: external validation.

Phase One:

In the first phase, first a systematic review of literature was conducted collate evidence on factors associated with contractures in literature. Based on the findings of this review, an online two-round Delphi consensus survey was designed and conducted with a group of purposively sampled 30 panel experts to determine which items were significant for inclusion in ORACLE. The collective data provided by the systematic review and Delphi survey was then used to further develop and modify ORACLE.

Phase Two:

The current study (Phase Two) aims to establish the psychometric validation, acceptability, and usability of the modified tool through formal testing on adult care home residents in Dorset. It consists of two streams of work: Stream A aims to establish the psychometric validation by completing the ORACLE assessments on adult care home residents. The assessments will be performed by the care home staff. In Stream B, a realist evaluation will be performed to explore the acceptability and usability of ORACLE with selected care home managers and staff who were involved in organising and completing the assessments on ORACLE respectively. The results from this two-phase design will then inform further revisions of the tool if required.

Study Type

Observational

Enrollment (Actual)

224

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bournemouth, United Kingdom, BH8 9EA
        • Farway Grange Care Home
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH88JL
        • Stratfield Lodge Care Home
      • Bournemouth, Dorset, United Kingdom, BH9 3RE
        • Muscliff Nursing Home
      • Christchurch, Dorset, United Kingdom, BH23 2GZ
        • Avon view
      • Christchurch, Dorset, United Kingdom, BH235JS
        • Highcliffe Nursing Care Home
      • Ferndown, Dorset, United Kingdom, BH22 9AW
        • Fernhill Dementia Home
      • Poole, Dorset, United Kingdom, BH13 7BY
        • Branksome Park Care Centre
      • Sturminster Newton, Dorset, United Kingdom, DT10 1FF
        • Colten Care-Newstone House (Residential, Nursing and Dementia Care)

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

Yes

Sampling Method

Probability Sample

Study Population

Care home residents will be recruited for this study

Description

Inclusion Criteria:

• Care home residents aged 18 or above residing in residential and/ or nursing care homes located in Dorset.

Exclusion Criteria:

• Adults receiving end of life care

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observational Risk Assessment for Contractures: Longitudinal Evaluation (ORACLE)
Time Frame: ORACLE (approx 10 minutes) will be administered thrice (twice by the same carer and once by a different carer) with a period of a 12-hour shift.
The primary outcome measure in this study will be the newly developed contracture risk assessment tool (ORACLE) to evaluate its validity, reliability and acceptability in care homes
ORACLE (approx 10 minutes) will be administered thrice (twice by the same carer and once by a different carer) with a period of a 12-hour shift.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel Index
Time Frame: Barthel Index will be administered once (approx 10 minutes) in a 12 hour shift
Barthel index is a standard measure of physical disability and assessment of performance in activities of daily living. This will be used to evaluate the convergent validity of ORACLE.
Barthel Index will be administered once (approx 10 minutes) in a 12 hour shift

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screening Questionnaire and Demographics
Time Frame: Screening questions and documents will be completed once within a 12 hour shift- approx 5 minutes

A screening document will be completed to assess the eligibility of the residents.

Non-identifiable demographics of the residents will also be recorded (e.g., age, gender, established contractures, co-morbidities etc).
Screening questions and documents will be completed once within a 12 hour shift- approx 5 minutes

Collaborators and Investigators

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

Sponsor

Bournemouth University

Collaborators

Dorset HealthCare University NHS Foundation Trust

Investigators

  • Principal Investigator: Hina Tariq, Bournemouth University

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.

General Publications

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 (Actual)

September 11, 2023

Primary Completion (Actual)

September 10, 2024

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45572

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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