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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02018614
Other study ID # CHU-0172
Secondary ID
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


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
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