Pain in Elderly Patients Having Communication Disorders.CALDOLNCT02174744
Concordance of Pain Detection in Patients by Doloplus® and Algoplus® Behavioural Scales
An observational study of Pain in Elderly Patients Having Communication Disorders., run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pain in Elderly Patients Having Communication Disorders.
- What is being tested?
- numeric pain rating scale
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: elderly patients
Who may be able to join
- Patients of 65 or more years old
- Patients having communication disorders
- Hospitalization for at least 48 hours
Who cannot join
- Patients of less than 65 years
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
Official title: Concordance of Pain Detection in Patients by Doloplus® and Algoplus® Behavioural Scales.
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.
Read more
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).
Read the 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.
- Being tested
- numeric pain rating scale
- Keywords
- Pain in elderly patients having communication disorders, Numerical scale, Algoplus® scale, Doloplus® scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
numeric pain rating scaleOther
| Study group | Role | What they receive |
|---|---|---|
| numerical scale | Not described Receives: Other: numeric pain rating scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores on Algoplus® and Doloplus® pain scales
Measured: 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)
Measured: at 48 hours after patients' admission in the care service.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain in Elderly Patients Having Communication Disorders.Studies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Gisèle PICKERING, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174744
- Sponsor's protocol ID
- CHU-0190
- Acronym
- CALDOL
- Status last verified
- Jun 2014
- First submitted
- 23 May 2014
- Last updated
- 26 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance of Pain Detection in Patients by Doloplus® and Algoplus® Behavioural Scales.
- ClinicalTrials.gov ID
- NCT02174744
- Acronym / sponsor ID
- CALDOL / CHU-0190
- Keywords
- Pain in elderly patients having communication disorders, Numerical scale, Algoplus® scale, Doloplus® scale
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- 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
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| numerical scale | – | Other: numeric pain rating scale |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- elderly patients
Key inclusion criteria (3 listed)
- Patients of 65 or more years old
- Patients having communication disorders
- Hospitalization for at least 48 hours
Key exclusion criteria (1 listed)
- Patients of less than 65 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| numeric pain rating scale | Other | numerical scale |
Primary outcome
Pain scores on Algoplus® and Doloplus® pain scales
Time frame: at 48 hours after patients' admission in the care service.
1 secondary outcome
Different levels of Algoplus® pain scale: (0-1), (2-3), (4-5)
Time frame: at 48 hours after patients' admission in the care service.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisèle PICKERING principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain in Elderly Patients Having Communication Disorders., run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores on Algoplus® and Doloplus® pain scales (time frame: at 48 hours after patients' admission in the care service.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.