Trial record 2 of 101 for:    Open Studies | "Communication Disorders"

International Validation Study Of The Algoplus Scale In Five Languages (ALGOPLUS LE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Clermont-Ferrand
Sponsor:
Collaborators:
Dr M Fisher Dr. Ulrike Bornschlegel
Dr M Schuler
Dr Pat Schofield
Dr D Lussier
Dr S Gibson
Dr Joan ESPAULELLA PANICOT
Dr Joan Manuel PEREZ CASTEJON
Dr Giovanni GAMBASSI
Dr Patrizio ODETTI
Dr Fiametta MONACELLI
Dr José Antonio FERRAZ GONCALVES
Dr Hirondina GUARDA, Dr Sónia SANTOS
Dr Gisèle PICKERING
Dr Valérie LEGOUT
Dr Patrice Rat
Dr Bernard WARY
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT02018614
First received: December 6, 2013
Last updated: July 4, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Pain
Elderly
Communication Disorders
Other: algoplus

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: INTERNATIONAL VALIDATION STUDY OF THE ALGOPLUS SCALE IN FIVE LANGUAGES

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Inter-rater scale and intra-rater comparisons of the filled Algoplus® scale. [ Time Frame: at time 1 (Physician N and M), at time 2 (t+4 hours) by physician M. ] [ Designated as safety issue: Yes ]

    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



Estimated Enrollment: 250
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

elderly patients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02018614

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Dr M Fisher Dr. Ulrike Bornschlegel
Dr M Schuler
Dr Pat Schofield
Dr D Lussier
Dr S Gibson
Dr Joan ESPAULELLA PANICOT
Dr Joan Manuel PEREZ CASTEJON
Dr Giovanni GAMBASSI
Dr Patrizio ODETTI
Dr Fiametta MONACELLI
Dr José Antonio FERRAZ GONCALVES
Dr Hirondina GUARDA, Dr Sónia SANTOS
Dr Gisèle PICKERING
Dr Valérie LEGOUT
Dr Patrice Rat
Dr Bernard WARY
Investigators
Principal Investigator: Gisèle PICKERING CHU de Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02018614     History of Changes
Other Study ID Numbers: CHU-0172
Study First Received: December 6, 2013
Last Updated: July 4, 2014
Health Authority: France: The Commission nationale de l’informatique et des libertés

Keywords provided by University Hospital, Clermont-Ferrand:
Pain
elderly
aged 65 or above 65
communication disorders
Algoplus® scale

Additional relevant MeSH terms:
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014