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Concordance of Pain Detection in Patients by Doloplus® and Algoplus® Behavioural Scales (CALDOL)

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ClinicalTrials.gov Identifier: NCT02174744
Recruitment Status : Unknown
Verified June 2014 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : June 26, 2014
Last Update Posted : June 26, 2014
Sponsor:
Collaborators:
Dr. Gisèle PICKERING (MCU, PH) Center of clinical pharmacology/CIC Inserm-1405 - Main investigator - Coordinating center
Ms Joëlle DEVOT - Collaborator
Dr Patrice RAT - Investigator
Dr Chandra COLOM - Investigator
Mr Dieudonné ENDOUGOU - Collaborator
Dr Cyril GUILLAUME - Investigator
Ms Nathalie ROUX - Collaborator
Dr Yves PASSADORI - Investigator
Ms Nathalie DANNENBERGER - Collaborator
Dr Micheline MICHEL - Investigator
Dr Sylvie CHAPIRO- Investigator
Dr Jean-François VILLARD - Investigator
Dr Bernard WARY- Investigator
Dr Anne-Cécile BOURJAL - Investigator
Dr Catherine BLUNTZ - Investigator
Dr Françoise CAPRIZ - Investigator
Dr Marie FLOCCIA - Investigator
Dr Jérôme BOHATIER – Investigator
Ms Linh NGUYEN PHUONG - Collaborator
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

The pain of the elderly is often trivialized and ignored in spite of its high frequency: the chronic pain affects 50 % of the elderly living at home, 49 to 83 % of those living in institution and 80 % of this population at the end of life.

The evaluation of pain appeals to the same strategy as to the younger subject but with some specificities, related more to the pathologies associated with the ageing than to the real age. For that purpose, the investigators have self-assessment scales as the Numeric Pain Rating Scale which is adapted to estimate acute and chronic pains, but this scale presents a bias because, some patients do not express spontaneously their pain.

So behavioural scales were elaborated to solve the difficulties of detection and to care the pain of the elderly. The Algoplus® scale (5 items which takes less than one minute to be completed) whose objective is the observation of behavioural changes caused by the acute pain in elderly having communication disorders. The Doloplus® scale (30 items which allow in few minutes a good evaluation of pain) whose objective is the observation of behavioural changes caused by the chronic pain in elderly having communication impairments.

In practice, because of its popularity, the Algoplus® scale is widely used out of the specificity in which it has been validated. Practitioners, worried about this misuse, suggested to Doloplus® group, to test the concordance between the two behavioural scales in order to develop recommendations more targeted. The risk is that the use of the Algoplus® scale may underestimate pain that would have been detected by Doloplus® scale, and lead to under-treatment or non-treatment of pain in elderly having communication disorders.

This study aims to establish the concordance between these two scales to generate advices and recommendations to assess efficiently the pain in this vulnerable population.

The main objective of this study is to assess whether the use of Algoplus® scale is in good concordance with Doloplus® scale.

The secondary objective of this study is to assess the concordance with different levels of Algoplus® pain scale: (0-1), (2-3), (4-5).


Condition or disease Intervention/treatment
Pain in Elderly Patients Having Communication Disorders. Other: numeric pain rating scale

Detailed Description:

The physician investigator will identify and include patients in the study according to the inclusion criteria. Management of patients do not differ from the usual care in the service concerned. During the usual patient care, several pain assessments will be performed: Numeric Pain Rating Scale, MMSE score if the patient is able to communicate, Algoplus® scale and Doloplus® scale will be performed by doctors and/or caregivers without patient's participation. The patient will be assessed by two doctors and or caregivers (the time interval between the two assessments must be as short as possible).

In a first step, 48 hours after patient admission in the care service, a first doctor/caregiver will assess pain with Numeric Pain Rating Scale and evaluate MMSE score if it is possible and then assess pain with the Algoplus® scale. The results of the Numeric Pain Rating Scale, the Algoplus® scale and the MMSE score will be recorded in the medical record and in the study Case Report Form.

In a second step, less than 3 hours after the first assessment, a second doctor/caregiver will assess pain with the Doloplus® scale and the result will be recorded in the medical record and in the study Case Report Form.

The Case Report Form (containing demographic data, the history of pain, analgesics treatment, scores of Numeric Pain Rating Scale, MMSE, Algoplus® scale and Doloplus® scale) will be faxed to the Coordinating Center at Clermont-Ferrand in the day.

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Study Type : Observational
Estimated Enrollment : 210 participants
Time Perspective: Cross-Sectional
Official Title: Concordance of Pain Detection in Patients by Doloplus® and Algoplus® Behavioural Scales.
Study Start Date : January 2014
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
numerical scale Other: numeric pain rating scale



Primary Outcome Measures :
  1. Pain scores on Algoplus® and Doloplus® pain scales [ Time Frame: at 48 hours after patients' admission in the care service. ]

Secondary Outcome Measures :
  1. Different levels of Algoplus® pain scale: (0-1), (2-3), (4-5) [ Time Frame: at 48 hours after patients' admission in the care service. ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
elderly patients
Criteria

Inclusion Criteria:

  • Patients of 65 or more years old
  • Patients having communication disorders
  • Hospitalization for at least 48 hours

Exclusion Criteria:

  • Patients of less than 65 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174744


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

Locations
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France
CHU 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. Gisèle PICKERING (MCU, PH) Center of clinical pharmacology/CIC Inserm-1405 - Main investigator - Coordinating center
Ms Joëlle DEVOT - Collaborator
Dr Patrice RAT - Investigator
Dr Chandra COLOM - Investigator
Mr Dieudonné ENDOUGOU - Collaborator
Dr Cyril GUILLAUME - Investigator
Ms Nathalie ROUX - Collaborator
Dr Yves PASSADORI - Investigator
Ms Nathalie DANNENBERGER - Collaborator
Dr Micheline MICHEL - Investigator
Dr Sylvie CHAPIRO- Investigator
Dr Jean-François VILLARD - Investigator
Dr Bernard WARY- Investigator
Dr Anne-Cécile BOURJAL - Investigator
Dr Catherine BLUNTZ - Investigator
Dr Françoise CAPRIZ - Investigator
Dr Marie FLOCCIA - Investigator
Dr Jérôme BOHATIER – Investigator
Ms Linh NGUYEN PHUONG - Collaborator
Investigators
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Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02174744    
Other Study ID Numbers: CHU-0190
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014
Keywords provided by University Hospital, Clermont-Ferrand:
Pain in elderly patients having communication disorders
Numerical scale
Algoplus® scale
Doloplus® scale
Additional relevant MeSH terms:
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Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders