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Systematic Pain Assessment in Nursing Home Residents With Advanced Dementia

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ClinicalTrials.gov Identifier: NCT02945865
Recruitment Status : Unknown
Verified October 2016 by Liv Halvorsrud, Oslo and Akershus University College of Applied Sciences.
Recruitment status was:  Active, not recruiting
First Posted : October 26, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Liv Halvorsrud, Oslo and Akershus University College of Applied Sciences

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.

Condition or disease Intervention/treatment Phase
Pain Dementia Quality of Life Other: Pain assessment Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Systematic Pain Assessment in Nursing Home Residents With Advanced Dementia; Effect on Pain Management and Patient Outcomes
Study Start Date : January 2015
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : March 2018

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Arm Intervention/treatment
Experimental: ITreatment arm: Pain Assessment
Pain assessment by Doloplus-2 pain scale regularly and additional pain assessment in situations where pain is suspected.
Other: Pain assessment
Pain assessment with assessment tools

No Intervention: Control arm: No treatment
Treatment us usual



Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. Change in psychotropic drug use from baseline to 12 weeks. Will be assessed in both the Intervention and Control group [ Time Frame: 12 weeks ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. Validity and reliability of the Doloplus-2 pain scale. [ Time Frame: 12 weeks ]
  9. 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 ]
  10. 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 ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02945865


Locations
Norway
Faculty of Helath Science, Department of Nursing and Health Promotion
Oslo, PB 4 St. Olavs plass, Norway, N-0130
Sponsors and Collaborators
Oslo and Akershus University College of Applied Sciences
Investigators
Principal Investigator: Liv Halvorsrud, PhD Associate Professor

Responsible Party: Liv Halvorsrud, Associate Professor, PhD, Oslo and Akershus University College of Applied Sciences
ClinicalTrials.gov Identifier: NCT02945865     History of Changes
Other Study ID Numbers: REK 2014/1431
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders