International Validation Study Of The Algoplus Scale In Five Languages

NCT02018614 | Unknown

• 1 other identifier: CHU-0172
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Acute pain is responsible for unnecessary suffering. Among elderly patients, acute pain is frequent and underestimated, especially when these patients have cognitive disorders. The expression of pain is then modified and the conventional tools for evaluating pain cannot be used. Thus the existence of pain must be detected on the basis of a behavioural assessment. It is nonetheless necessary to have the assistance of standardised and validated tools. In France, the Doloplus Group has proposed a scale called Doloplus, validated in January 1999, and is now proposing a new scale for acute pain, Algoplus that has been validated in French (4). Doloplus has been recently translated and validated in 5 languages and an identical methodology will be used in this protocol. Internationally, although several teams are working on the development of scales that can be used for non-communicating elderly subjects, there is as yet no validated tool for acute pain assessment. Considering 1- the lack of tools at an international level and 2- the frequent request from many practitioners worldwide, the Doloplus group has offered to validate the Algoplus® scale in 5 foreign languages, English, German, Spanish, Italian, Portuguese. A rigorous methodology with the help of a statistician will be used in this validation process.

Conditions

Pain; Elderly; Communication Disorders

Keywords

Pain; elderly; aged 65 or above 65; communication disorders; Algoplus® scale

Outcome Measures

Primary Outcomes (1)

• Inter-rater scale and intra-rater comparisons of the filled Algoplus® scale.

  The scale includes five items (facial expression, sight expression, complaints, bodily attitudes and finally the general behaviour).. The presence of one behaviour in each of the items is sufficient to score "yes" for the item under consideration. Each item marked "yes" is scored one point and the sum of the items provides a total score out of five

  at time 1 (Physician N and M), at time 2 (t+4 hours) by physician M.

Study Arms (2)

testretest relaibility

Data from a sample of 50 patients will be used to explore the test-retest reliability of the scale administered by the same trained clinician, on two occasions four hours apart, without any treatment in between. The ALGOPLUS® scores obtained from the patients at a time t will be compared with their (t + 4 hours) scores to assess test-retest reliability

Other: algoplus

statistical test

For a sample of at least 50 patients, two physicians trained for the use of ALGOPLUS, will assess pain independently. A statistical test will be used to compare the results for the inter-rater reliability

Other: algoplus

Interventions

algoplus OTHER

statistical test; testretest relaibility

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

elderly patients

You may qualify if:

• \- males or females aged 65 or above 65, with communication disorders
• with or without suspected acute pain

You may not qualify if:

• \- are too agitated,
• have acute pain needing immediate pain management,
• change of treatment between the two evaluations ( t and t+4 hours ),
• refuse to participate

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Dr M Fisher Dr. Ulrike Bornschlegel: collaborator
• Dr M Schuler: collaborator
• Dr Pat Schofield: collaborator
• Dr D Lussier: collaborator
• Dr S Gibson: collaborator
• Dr Joan ESPAULELLA PANICOT: collaborator
• Dr Joan Manuel PEREZ CASTEJON: collaborator
• Gambassi, Giovanni, M.D.: collaborator
• Dr Patrizio ODETTI: collaborator
• Dr Fiametta MONACELLI: collaborator
• University Hospital, Grenoble: collaborator
• Dr Hirondina GUARDA, Dr Sónia SANTOS: collaborator
• Dr Gisèle PICKERING: collaborator
• Dr Valérie LEGOUT: collaborator
• Dr Patrice Rat: collaborator
• Dr Bernard WARY: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Pain; Communication Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Gisèle PICKERING

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

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

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 23, 2013
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: July 8, 2014

Record last verified: 2014-07

Locations

FR (1)