International Validation Study Of The Algoplus Scale In Five Languages

Pain Clinical Trial

— ALGOPLUS LE  

Official title:

INTERNATIONAL VALIDATION STUDY OF THE ALGOPLUS SCALE IN FIVE LANGUAGES

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02018614
• Other study ID #: CHU-0172
• Status: Recruiting
• Phase: N/A
• First received: December 6, 2013
• Last updated: July 4, 2014
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: July 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Communication Disorders
• Elderly
• Pain

Intervention

Other:
• algoplus

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (17)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes