Clinical trial NCT02018614: International Validation Study Of The Algoplus Scale In Five Languages
Official title: INTERNATIONAL VALIDATION STUDY OF THE ALGOPLUS SCALE IN FIVE LANGUAGES
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Elderly
Communication Disorders
Keywords: Pain
elderly
aged 65 or above 65
communication disorders
Algoplus® scale
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Dr M Fisher Dr. Ulrike Bornschlegel
name: Dr M Schuler
name: Dr Pat Schofield
name: Dr D Lussier
name: Dr S Gibson
name: Dr Joan ESPAULELLA PANICOT
name: Dr Joan Manuel PEREZ CASTEJON
name: Gambassi, Giovanni, M.D.
name: Dr Patrizio ODETTI
name: Dr Fiametta MONACELLI
name: University Hospital, Grenoble
name: Dr Hirondina GUARDA, Dr Sónia SANTOS
name: Dr Gisèle PICKERING
name: Dr Valérie LEGOUT
name: Dr Patrice Rat
name: Dr Bernard WARY
First posted: 2013-12-23
Enrollment: 250
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elderly patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inter-rater scale and intra-rater comparisons of the filled Algoplus® scale.
timeFrame: at time 1 (Physician N and M), at time 2 (t+4 hours) by physician M.
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Gisèle PICKERING
role: PRINCIPAL_INVESTIGATOR
References: