Contracture Clinical Trial
Official title:
Development, Validation, and Evaluation of a Risk Assessment Tool for Contractures: the ORACLE Study
NCT number | NCT06042907 |
Other study ID # | 45572 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 11, 2023 |
Est. completion date | October 2024 |
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.
Status | Recruiting |
Enrollment | 206 |
Est. completion date | October 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Farway Grange Care Home | Bournemouth | |
United Kingdom | Muscliff Nursing Home | Bournemouth | Dorset |
United Kingdom | Stratfield Lodge Care Home | Bournemouth | Dorset |
United Kingdom | Avon view | Christchurch | Dorset |
United Kingdom | Highcliffe Nursing Care Home | Christchurch | Dorset |
United Kingdom | Fernhill Dementia Home | Ferndown | Dorset |
United Kingdom | Branksome Park Care Centre | Poole | Dorset |
United Kingdom | Colten Care-Newstone House (Residential, Nursing and Dementia Care) | Sturminster Newton | Dorset |
Lead Sponsor | Collaborator |
---|---|
Bournemouth University | Dorset HealthCare University NHS Foundation Trust |
United Kingdom,
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Born CT, Gil JA, Goodman AD. Joint Contractures Resulting From Prolonged Immobilization: Etiology, Prevention, and Management. J Am Acad Orthop Surg. 2017 Feb;25(2):110-116. doi: 10.5435/JAAOS-D-15-00697. — View Citation
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Forster A, Airlie J, Birch K, Cicero R, Cundill B, Ellwood A, Godfrey M, Graham L, Green J, Hulme C, Lawton R, McLellan V, McMaster N, Farrin A; REACH Programme Team. Research Exploring Physical Activity in Care Homes (REACH): study protocol for a randomised controlled trial. Trials. 2017 Apr 19;18(1):182. doi: 10.1186/s13063-017-1921-8. — View Citation
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Offenbacher M, Sauer S, Riess J, Muller M, Grill E, Daubner A, Randzio O, Kohls N, Herold-Majumdar A. Contractures with special reference in elderly: definition and risk factors - a systematic review with practical implications. Disabil Rehabil. 2014;36(7):529-38. doi: 10.3109/09638288.2013.800596. Epub 2013 Jun 17. — View Citation
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Tariq H, Collins K, Dunn J, Tait D, Porter S. The Delphi of ORACLE: An Expert Consensus Survey for the Development of the Observational Risk Assessment of Contractures (Longitudinal Evaluation). Clin Rehabil. 2024 Feb 8:2692155241229285. doi: 10.1177/0269 — View Citation
Tariq H, Collins K, Tait D, Dunn J, Altaf S, Porter S. Factors associated with joint contractures in adults: a systematic review with narrative synthesis. Disabil Rehabil. 2023 Jun;45(11):1755-1772. doi: 10.1080/09638288.2022.2071480. Epub 2022 May 11. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Screening Questionnaire and Demographics | 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 | |
Primary | Observational Risk Assessment for Contractures: Longitudinal Evaluation (ORACLE) | 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 | Barthel Index | 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 |
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