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
Study website
Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study 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, Alzheimers 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
Primary outcome measure
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 study start date
15/03/2012
Overall study end date
31/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Living permanently in one of the 10 residential living facilities in the municipality
Participant type(s)
Patient
Age group
Senior
Sex
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
Study 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
ROR
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
Intention to publish date
30/06/2017
Individual participant data (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
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/02/2017 | Yes | No |