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

NCT06042907 | Completed

• 1 other identifier: 45572
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 8

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.

Conditions

Contracture; Joint Contracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Barthel Index

  Barthel Index will be administered once (approx 10 minutes) in a 12 hour shift

Other Outcomes (1)

• Screening Questionnaire and Demographics

  Screening questions and documents will be completed once within a 12 hour shift- approx 5 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Care home residents will be recruited for this study

You may qualify if:

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

You may not qualify if:

• Adults receiving end of life care

Sponsors & Collaborators

• Bournemouth University: lead
• Dorset HealthCare University NHS Foundation Trust: collaborator

Study Sites (8)

Stratfield Lodge Care Home

Bournemouth, Dorset, BH88JL, United Kingdom

Location

Muscliff Nursing Home

Bournemouth, Dorset, BH9 3RE, United Kingdom

Location

Avon view

Christchurch, Dorset, BH23 2GZ, United Kingdom

Location

Highcliffe Nursing Care Home

Christchurch, Dorset, BH235JS, United Kingdom

Location

Fernhill Dementia Home

Ferndown, Dorset, BH22 9AW, United Kingdom

Location

Branksome Park Care Centre

Poole, Dorset, BH13 7BY, United Kingdom

Location

Colten Care-Newstone House (Residential, Nursing and Dementia Care)

Sturminster Newton, Dorset, DT10 1FF, United Kingdom

Location

Farway Grange Care Home

Bournemouth, BH8 9EA, United Kingdom

Location

Related Publications (10)

• Bartoszek G, Fischer U, von Clarenau SC, Grill E, Mau W, Meyer G, Strobl R, Thiesemann R, Nadolny S, Muller M. Development of an International Classification of Functioning, Disability and Health (ICF)-based standard set to describe the impact of joint contractures on participation of older individuals in geriatric care settings. Arch Gerontol Geriatr. 2015 Jul-Aug;61(1):61-6. doi: 10.1016/j.archger.2015.03.005. Epub 2015 Mar 25.

  PMID: 25937031 BACKGROUND

• 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.

  PMID: 28027065 BACKGROUND

• Fergusson D, Hutton B, Drodge A. The epidemiology of major joint contractures: a systematic review of the literature. Clin Orthop Relat Res. 2007 Mar;456:22-9. doi: 10.1097/BLO.0b013e3180308456.

  PMID: 17179779 BACKGROUND

• 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.

  PMID: 28424088 BACKGROUND

• Muller M, Fischer U, Bartoszek G, Grill E, Meyer G. Impact of joint contractures on functioning and social participation in older individuals--development of a standard set (JointConFunctionSet): study protocol. BMC Geriatr. 2013 Feb 21;13:18. doi: 10.1186/1471-2318-13-18.

  PMID: 23432774 BACKGROUND

• 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.

  PMID: 23772994 BACKGROUND

• Skalsky AJ, McDonald CM. Prevention and management of limb contractures in neuromuscular diseases. Phys Med Rehabil Clin N Am. 2012 Aug;23(3):675-87. doi: 10.1016/j.pmr.2012.06.009.

  PMID: 22938881 BACKGROUND

• Wagner LM, Clevenger C. Contractures in nursing home residents. J Am Med Dir Assoc. 2010 Feb;11(2):94-9. doi: 10.1016/j.jamda.2009.04.010. Epub 2010 Jan 15.

  PMID: 20142063 BACKGROUND

• 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.

  PMID: 35544581 RESULT

• 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 May;38(5):664-677. doi: 10.1177/02692155241229285. Epub 2024 Feb 8.

  PMID: 38332642 RESULT

MeSH Terms

Conditions

Contracture

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Muscular Diseases

Study Officials

• Hina Tariq

  Bournemouth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: September 11, 2023
• Primary Completion: September 10, 2024
• Study Completion: October 1, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

GB (8)