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International Validation Study Of The Algoplus Scale In Five Languages

INTERNATIONAL VALIDATION STUDY OF THE ALGOPLUS SCALE IN FIVE LANGUAGES

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02018614
Acronym
ALGOPLUS LE
Enrollment
250
Registered
2013-12-23
Start date
2014-01-31
Completion date
2015-01-31
Last updated
2014-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Communication Disorders, Elderly, Pain

Keywords

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

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.

Detailed description

50 patients per language will be explored : t1 = time t Physician M Physician N t2 = time t+4 hours Physician M The methodology of the validation of our translation procedure consists of studying the reliability of the scale in two major steps: * 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. * 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.

Interventions

OTHERalgoplus

Sponsors

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

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* \- 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

Design outcomes

Primary

MeasureTime frameDescription
Inter-rater scale and intra-rater comparisons of the filled Algoplus® scale.at time 1 (Physician N and M), at time 2 (t+4 hours) by physician M.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

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026