Condition category
Not Applicable
Date applied
03/09/2012
Date assigned
18/09/2012
Last edited
27/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

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

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Patient information material can be found athttp://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

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

27/05/2016: Ethics approval date changed from 15/11/2012 to 08/02/2012