NCT02174744

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

6 months

First QC Date

May 23, 2014

Last Update Submit

June 23, 2014

Conditions

Pain in Elderly Patients Having Communication Disorders.

Keywords

Pain in elderly patients having communication disordersNumerical scaleAlgoplus® scaleDoloplus® scale

Outcome Measures

Primary Outcomes (1)

  • Pain scores on Algoplus® and Doloplus® pain scales

    at 48 hours after patients' admission in the care service.

Secondary Outcomes (1)

  • Different levels of Algoplus® pain scale: (0-1), (2-3), (4-5)

    at 48 hours after patients' admission in the care service.

Study Arms (1)

numerical scale

Other: numeric pain rating scale

Interventions

numeric pain rating scaleOTHER
numerical scale

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

elderly patients

You may qualify if:

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

You may not qualify if:

  • Patients of less than 65 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Study Officials

  • Gisèle PICKERING

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2014

First Posted

June 26, 2014

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Study Completion

September 1, 2014

Last Updated

June 26, 2014

Record last verified: 2014-06

Locations

FR(1)