Condition category
Not Applicable
Date applied
03/09/2012
Date assigned
18/09/2012
Last edited
01/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Studies have shown that older people in residential living facilities suffer from pain. Pain can lead to reduced daily activities, extended need for nursing care and reduced quality of life. According to some studies, pain is often not identified and not fully treated, which can cause unnecessary suffering and reduce the quality of care. Assessing older people’s pain is basic to adequate pain treatment. To date, the use of pain assessment procedures in clinical practice has not been well investigated. The aim of the study is to examine whether a caregiver intervention, including education on pain, and pain assessments increase quality of life among older people in residential living facilities.

Who can participate?
Older people living permanently in one of the 10 residential living facilities

What does the study involve?
Participating residential living facilities are randomly allocated into the intervention or the control group. Staff working at facilities in the intervention group attend a course on pain and pain assessments. The course lasts 3.5 hours together with follow-ups at the respective facilities. The subjects dealt with are: pain among older people, nursing care interventions, pain treatment, and introduction of the pain assessment scales. Data is collected on three occasions (in both groups): at the start of the study followed by repeated assessments one and a half months and five months later. Physical and cognitive (mental) abilities, medication, pain and quality of life are assessed. The caregivers perform the assessments at the intervention group facilities and the corresponding assessments are performed by research nurses at the control group facilities.

What are the possible benefits and risks of participating?
The results of the study could lead to improved knowledge among caregivers and improved pain treatment in elderly care, thus benefiting the older residents. Because the study examines the effect of pain assessments, there are no added risks.

Where is the study run from?
University of Gävle (Sweden)

When is the study starting and how long is it expected to run for?
March to December 2012

Who is funding the study?
1. University of Gävle (Sweden)
2. Swedish Dementia Foundation (Sweden)

Who is the main contact?
Dr Anna-Greta Mamhidir

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anna-Greta Mamhidir

ORCID ID

Contact details

University of Gävle
Faculty of Health and Occupational Studies
Department of Health and Caring Sciences
Kungsbäcksvägen 47
Gävle
SE-801 76
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Systematic pain assessment in residential living facilities for older people: a cluster-randomized controlled trial

Acronym

Study hypothesis

Systematic pain assessment will reduce pain, increase quality of life, reduce signs of discomfort and increase signs of good mood.

The aim of the study is to examine whether a caregiver intervention in residential living facilities, including education on pain, and subsequent pain assessments will increase quality of life and change pain prevalence among older people (with and without cognitive deficits) compared to a control group.

Ethics approval

The Regional Ethical Review Board in Uppsala, 08/02/2012, ref: 2012/016

Study design

Cluster-randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Patient information material can be found at http://www.hig.se/Ext/Sv/Organisation/Akademier/Akademin-for-halsa-och-arbetsliv/Forskning-vid-akademin/Forskningsprojekt.html (Swedish)

Condition

Residential living facilities for older people.

Intervention

The residential living facilities will be grouped into smaller (n=20-30) and larger facilities (n=40-60). All residential living facilities meeting the inclusion criteria will be randomized into either the intervention or the control group.

The intervention includes two parts carried out within a three-week period, and starts with a course on pain and subsequent administration of pain assessments (Dolpolus 2 scale and Mobid 2 scale). The course for registered nurses, assistant nurses, occupational therapists, physiotherapists, physicians and managers comprises 3.5 hours together with follow-ups at the respective facilities. The subjects dealt with are: pain among older people, nursing care interventions, pain treatment, and introduction of the assessment scales.

Data collection will be performed at three occasions (in both groups) and start with a baseline assessment, followed by repeated assessments after one and a half months and finally five months post-intervention.

The data collection occasions include: patients’ demographical data, medical diagnoses, medication, physical (Katz-ADL index, Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL scale) and cognitive ability (MMSE scale), scores on the Quality of Life in Late-Stage Dementia scale (QUALID) and WHO-5 wellbeing index, as well as patient record reviews regarding pain and measurement. The pain assessments include visual analog pain assessments (Proxy-VAS), Doloplus 2 and Mobid 2 scales. All pain assessments begin with caregivers making visual analog pain assessments (Proxy-VAS) of the older people followed by the other assessments. At the start of the study, two pain assessments per resident will be conducted (Doloplus 2 and Mobid 2), and thereafter Doloplus 2 will be used once a month during the intervention period. In total about 380 caregivers will participate in the education.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Well-being (OUALID, WHO-5 index)
2. Proxy-VAS

Secondary outcome measures

1. Medication
2. Physical and cognitive ability
3. Documentation about pain

In addition, the psychometric properties of the pain assessment scales will be investigated.

Overall trial start date

15/03/2012

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Living permanently in one of the 10 residential living facilities in the municipality

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

A total of 270 older people in residential living facilities will be approached

Participant exclusion criteria

1. Newly moved into the residential living facility, i.e., the person has lived there less than one month
2. Short time and respite care
3. Palliative care status

Recruitment start date

15/03/2012

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Sweden

Trial participating centre

University of Gävle
Gävle
SE-801 76
Sweden

Sponsor information

Organisation

University of Gävle (Sweden)

Sponsor details

Kungsbäcksvägen 47
Gävle
SE-801 76
Sweden

Sponsor type

University/education

Website

http://www.hig.se/

Funders

Funder type

University/education

Funder name

University of Gävle (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swedish Dementia Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Anna-Greta Mamhidir

Intention to publish date

30/06/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28241785

Publication citations

Additional files

Editorial Notes

01/03/2017: Publication reference added.