NCT02945865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2018

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

1.3 years

First QC Date

October 12, 2016

Last Update Submit

April 28, 2019

Conditions

PainDementiaQuality of Life

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    12 weeks

  • Change in NPS from baseline to 4, 8, 12 weeks. Will be assessed in both the Intervention and Control group

    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.

    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.

    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.

    12 weeks

  • +5 more secondary outcomes

Study Arms (2)

ITreatment arm: Pain Assessment

EXPERIMENTAL

Pain assessment by Doloplus-2 pain scale regularly and additional pain assessment in situations where pain is suspected.

Other: Pain assessment

Control arm: No treatment

NO INTERVENTION

Treatment us usual

Interventions

Pain assessmentOTHER

Pain assessment with assessment tools

ITreatment arm: Pain Assessment

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • Short term stay, \< 4 weeks
  • Primary psychiatric diagnosis
  • Delirium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Helath Science, Department of Nursing and Health Promotion

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

Location

MeSH Terms

Conditions

PainDementia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Liv Halvorsrud, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, PhD

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 26, 2016

Study Start

January 26, 2015

Primary Completion

June 1, 2016

Study Completion

March 17, 2018

Last Updated

April 30, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)