Systematic Pain Assessment in Nursing Home Residents With Advanced Dementia
Primary Purpose
Pain, Dementia, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Pain assessment
Sponsored by

About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
Inclusion Criteria:
- ≥ 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
Exclusion Criteria:
- Short term stay, < 4 weeks
- Primary psychiatric diagnosis
- Delirium
Sites / Locations
- Faculty of Helath Science, Department of Nursing and Health Promotion
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ITreatment arm: Pain Assessment
Control arm: No treatment
Arm Description
Pain assessment by Doloplus-2 pain scale regularly and additional pain assessment in situations where pain is suspected.
Treatment us usual
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Change in psychotropic drug use from baseline to 12 weeks. Will be assessed in both the Intervention and Control group
Change in NPS from baseline to 4, 8, 12 weeks. Will be assessed in both the Intervention and Control group
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.
Change in QoL measured with QUALID from baseline to 12 weeks. Will be assessed in both the Intervention and Control group.
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.
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
Pain management intervention applied when pain is detected with pain assessment tool Doloplus-2. Will be assessed for the Intervention group
Validity and reliability of the Doloplus-2 pain scale.
Convergent validity of three pain scales: the Doloplus-2, the Mobid-2 and the Checklist for non-verbal pain behavior.
Association between variables; pain, agitation, NPS, depression, ADL, QoL, analgesic use, psychotropic use Will be assessed in both the Intervention and Control group.
Full Information
NCT ID
NCT02945865
First Posted
October 12, 2016
Last Updated
April 28, 2019
Sponsor
Oslo Metropolitan University
1. Study Identification
Unique Protocol Identification Number
NCT02945865
Brief Title
Systematic Pain Assessment in Nursing Home Residents With Advanced Dementia
Official Title
Systematic Pain Assessment in Nursing Home Residents With Advanced Dementia; Effect on Pain Management and Patient Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 26, 2015 (Actual)
Primary Completion Date
June 1, 2016 (Actual)
Study Completion Date
March 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo Metropolitan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Dementia, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ITreatment arm: Pain Assessment
Arm Type
Experimental
Arm Description
Pain assessment by Doloplus-2 pain scale regularly and additional pain assessment in situations where pain is suspected.
Arm Title
Control arm: No treatment
Arm Type
No Intervention
Arm Description
Treatment us usual
Intervention Type
Other
Intervention Name(s)
Pain assessment
Intervention Description
Pain assessment with assessment tools
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Change in psychotropic drug use from baseline to 12 weeks. Will be assessed in both the Intervention and Control group
Time Frame
12 weeks
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Validity and reliability of the Doloplus-2 pain scale.
Time Frame
12 weeks
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 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
Exclusion Criteria:
Short term stay, < 4 weeks
Primary psychiatric diagnosis
Delirium
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liv Halvorsrud, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Helath Science, Department of Nursing and Health Promotion
City
Oslo
State/Province
PB 4 Saint Olavs Plass
ZIP/Postal Code
N-0130
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Systematic Pain Assessment in Nursing Home Residents With Advanced Dementia
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