Development, Validation, and Evaluation of a Risk Assessment Tool for Contractures: the ORACLE Study

Sponsor
Bournemouth University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06042907
Collaborator
Dorset HealthCare University NHS Foundation Trust (Other)
206
2
8.7
103
11.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    206 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Development, Validation, and Evaluation of a Risk Assessment Tool for Contractures: the ORACLE Study
    Actual Study Start Date :
    Sep 11, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Observational Risk Assessment for Contractures: Longitudinal Evaluation (ORACLE) [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

    Secondary Outcome Measures

    1. Barthel Index [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.

    Other Outcome Measures

    1. Screening Questionnaire and Demographics [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fernhill Dementia Home Ferndown Dorset United Kingdom BH22 9AW
    2 Colten Care-Newstone House (Residential, Nursing and Dementia Care) Sturminster Newton Dorset United Kingdom DT10 1FF

    Sponsors and Collaborators

    • Bournemouth University
    • Dorset HealthCare University NHS Foundation Trust

    Investigators

    • Principal Investigator: Hina Tariq, Bournemouth University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Bournemouth University
    ClinicalTrials.gov Identifier:
    NCT06042907
    Other Study ID Numbers:
    • 45572
    First Posted:
    Sep 21, 2023
    Last Update Posted:
    Sep 26, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 26, 2023