PainNCT02945865
Systematic Pain Assessment in Nursing Home Residents With Advanced Dementia
A study testing Pain assessment in people with Pain and Dementia, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
It is estimated that 45-80 % of nursing home residents have substantial pain at any given time. Residents with impaired cognition have been found to report chronic pain more often, more frequent and more severe, compared to residents with normal cognition. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pain, Dementia, Quality of Life
- What is being tested?
- Pain assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteNorway
- Study dates
- 26 Jan 2015to 17 Mar 2018
- Phase
- Interventional
- 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
Who may be able to join
- ≥ 65 years old
- Dementia diagnosis
- Severe language impairment/non-communicative
- Clinically significant pain and/or behavioral symptoms: a score of at least 44 on the Norwegian version of the Cohen-Mansfield Agitation Inventory (CMAI),
- or a score of at least 4 (frequency × severity) on items of the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH),
- or an indication of clinically significant pain (≥ 5) according to the DOLOPLUS-2 at baseline
Who cannot join
- Short term stay, < 4 weeks
- Primary psychiatric diagnosis
- Delirium
Trial locations and contacts
1 site in 1 country.
Norway1 site
Faculty of Helath Science, Department of Nursing and Health Promotion
Oslo, PB 4 Saint Olavs Plass, N-0130
About this study
Official title: Systematic Pain Assessment in Nursing Home Residents With Advanced Dementia; Effect on Pain Management and Patient Outcomes
It is estimated that 45-80 % of nursing home residents have substantial pain at any given time. Residents with impaired cognition have been found to report chronic pain more often, more frequent and more severe, compared to residents with normal cognition. Approximately 3/4 of permanent residents in nursing homes in Norway have developed dementia. The burden of dementia is often compounded by painful conditions. Despite over a decade of research on the subject, inadequate pain assessment and management remain significant problems among institutionalized older adults, with and without dementia. The poor pain management in patients with dementia has been attributed, at least in part, to difficulties with, and lack of, pain assessment in this population. Therefore, this study seek to determine the effect of regular pain assessment.
Read the detailed description
The aim of the study is to determine the effect of regular pain assessment on pain management interventions applied and patient outcomes among patient with severe dementia.
A cluster randomized controlled trial will be conducted. A cluster is defined as a single independent nursing home. The clusters will be randomly assigned to either the experimental or control condition. Appropriate information will be given to both the intervention and the control group. All nurses in the experimental conditions will be taught how to administer the DOLOPLUS-2. The study will start after the initial education session. During the 3-month study period, the participating nursing staff will be asked to complete the DOLOPLUS-2 regularly. The control groups will receive standard methods of care. Data collection at baseline and at 4, 8 and 12 months.
- Conditions
- Pain, Dementia, Quality of Life
- Being tested
- Pain assessment
- Medical subject headings
- Pain, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain assessmentOther
Pain assessment with assessment tools
| Study group | Role | What they receive |
|---|---|---|
| ITreatment arm: Pain Assessment | Experimental | Pain assessment by Doloplus-2 pain scale regularly and additional pain assessment in situations where pain is suspected. Receives: Other: Pain assessment |
| Control arm: No treatment | No intervention | Treatment us usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in analgesic intake measured in Defined Daily Dose (DDD) or a similar measure from baseline to 12 weeks. Will be assessed in both the Intervention and Control group.
Measured: 12 weeks
Change in pain score on the Dolplus-2 pain scale, and change in proportion scoring ≥ 5 on the Doloplus-2 scale from baseline to 12 week. Will be assessed in both the Intervention and Control group.
Measured: 12 weeks
Secondary outcomes (10)
Change in psychotropic drug use from baseline to 12 weeks. Will be assessed in both the Intervention and Control group
Measured: 12 weeks
Change in NPS from baseline to 4, 8, 12 weeks. Will be assessed in both the Intervention and Control group
Measured: 4, 8, 12 weeks
Change in agitation measured with Brief Agitation Rating Scale (BARS) from baseline to 4 to 8 to 12 weeks. Will be assessed in both the Intervention and Control group.
Measured: 4, 8, 12 weeks
Change in QoL measured with QUALID from baseline to 12 weeks. Will be assessed in both the Intervention and Control group.
Measured: 12 weeks
Change in personal activity of daily living measured with the Physical Self Management Scale from baseline to 12 weeks. Will be assessed in both the Intervention and Control group.
Measured: 12 weeks
Nurses evaluation of systematic pain assessment tools by using a questionnaire developed for this study. Will be assessed in both the Intervention and Control group
Measured: 12 weeks
Pain management intervention applied when pain is detected with pain assessment tool Doloplus-2. Will be assessed for the Intervention group
Measured: 12 weeks
Validity and reliability of the Doloplus-2 pain scale.
Measured: 12 weeks
Convergent validity of three pain scales: the Doloplus-2, the Mobid-2 and the Checklist for non-verbal pain behavior.
Measured: Baseline - 12 weeks
Association between variables; pain, agitation, NPS, depression, ADL, QoL, analgesic use, psychotropic use Will be assessed in both the Intervention and Control group.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start26 Jan 2015
- Primary completion1 Jun 2016
- Study completion17 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liv Halvorsrud, Oslo Metropolitan University
- Investigators
- Liv Halvorsrud, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945865
- Sponsor's protocol ID
- REK 2014/1431
- Status last verified
- Apr 2019
- First submitted
- 12 Oct 2016
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Pain Assessment in Nursing Home Residents With Advanced Dementia; Effect on Pain Management and Patient Outcomes
- ClinicalTrials.gov ID
- NCT02945865
- Acronym / sponsor ID
- REK 2014/1431
- Conditions
- Pain, Dementia, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- 26 Jan 2015 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 17 Mar 2018 (actual)
- First posted
- 26 Oct 2016 (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.
It is estimated that 45-80 % of nursing home residents have substantial pain at any given time. Residents with impaired cognition have been found to report chronic pain more often, more frequent and more severe, compared to residents with normal cognition. Approximately 3/4 of permanent residents in nursing homes in Norway have developed dementia. The burden of dementia is often compounded by painful conditions. Despite over a decade of research on the subject, inadequate pain assessment and management remain significant problems among institutionalized older adults, with and without dementia. The poor pain management in patients with dementia has been attributed, at least in part, to difficulties with, and lack of, pain assessment in this population. Therefore, this study seek to determine the effect of regular pain assessment.
Detailed description
The aim of the study is to determine the effect of regular pain assessment on pain management interventions applied and patient outcomes among patient with severe dementia.
A cluster randomized controlled trial will be conducted. A cluster is defined as a single independent nursing home. The clusters will be randomly assigned to either the experimental or control condition. Appropriate information will be given to both the intervention and the control group. All nurses in the experimental conditions will be taught how to administer the DOLOPLUS-2. The study will start after the initial education session. During the 3-month study period, the participating nursing staff will be asked to complete the DOLOPLUS-2 regularly. The control groups will receive standard methods of care. Data collection at baseline and at 4, 8 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITreatment arm: Pain Assessment | Experimental | Other: Pain assessmentPain assessment by Doloplus-2 pain scale regularly and additional pain assessment in situations where pain is suspected. |
| Control arm: No treatment | No intervention | –Treatment us usual |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- ≥ 65 years old
- Dementia diagnosis
- Severe language impairment/non-communicative
- Clinically significant pain and/or behavioral symptoms: a score of at least 44 on the Norwegian version of the Cohen-Mansfield Agitation Inventory (CMAI),
- or a score of at least 4 (frequency × severity) on items of the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH),
Key exclusion criteria (3 listed)
- Short term stay, < 4 weeks
- Primary psychiatric diagnosis
- Delirium
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 |
|---|---|---|
| Pain assessmentPain assessment with assessment tools | Other | ITreatment arm: Pain Assessment |
Primary outcome
Change in analgesic intake measured in Defined Daily Dose (DDD) or a similar measure from baseline to 12 weeks. Will be assessed in both the Intervention and Control group.
Time frame: 12 weeks
Change in pain score on the Dolplus-2 pain scale, and change in proportion scoring ≥ 5 on the Doloplus-2 scale from baseline to 12 week. Will be assessed in both the Intervention and Control group.
Time frame: 12 weeks
10 secondary outcomes
Change in psychotropic drug use from baseline to 12 weeks. Will be assessed in both the Intervention and Control group
Time frame: 12 weeks
Change in NPS from baseline to 4, 8, 12 weeks. Will be assessed in both the Intervention and Control group
Time frame: 4, 8, 12 weeks
Change in agitation measured with Brief Agitation Rating Scale (BARS) from baseline to 4 to 8 to 12 weeks. Will be assessed in both the Intervention and Control group.
Time frame: 4, 8, 12 weeks
Change in QoL measured with QUALID from baseline to 12 weeks. Will be assessed in both the Intervention and Control group.
Time frame: 12 weeks
Change in personal activity of daily living measured with the Physical Self Management Scale from baseline to 12 weeks. Will be assessed in both the Intervention and Control group.
Time frame: 12 weeks
Nurses evaluation of systematic pain assessment tools by using a questionnaire developed for this study. Will be assessed in both the Intervention and Control group
Time frame: 12 weeks
Pain management intervention applied when pain is detected with pain assessment tool Doloplus-2. Will be assessed for the Intervention group
Time frame: 12 weeks
Validity and reliability of the Doloplus-2 pain scale.
Time frame: 12 weeks
Convergent validity of three pain scales: the Doloplus-2, the Mobid-2 and the Checklist for non-verbal pain behavior.
Time frame: Baseline - 12 weeks
Association between variables; pain, agitation, NPS, depression, ADL, QoL, analgesic use, psychotropic use Will be assessed in both the Intervention and Control group.
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Liv Halvorsrud, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain assessment in people with Pain and Dementia, run by Oslo Metropolitan University at 1 site in Norway.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 30 Apr 2019. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in analgesic intake measured in Defined Daily Dose (DDD) or a similar measure from baseline to 12 weeks. Will be assessed in both the Intervention and Control group. (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 30 Apr 2019.