Skip to main content
OpenTrials
Completed

NCT Number: NCT02945865

Systematic Pain Assessment in Nursing Home Residents With Advanced Dementia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Helath Science, Department of Nursing and Health Promotion

Oslo, PB 4 Saint Olavs Plass, N-0130, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pain assessment

Other

Pain assessment with assessment tools

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo Metropolitan University

Other

Registry information

Official study title

Systematic Pain Assessment in Nursing Home Residents With Advanced Dementia; Effect on Pain Management and Patient Outcomes

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Oct 26, 2016
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.