Condition category
Mental and Behavioural Disorders
Date applied
30/05/2017
Date assigned
21/06/2017
Last edited
20/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Currently it is thought that there will are 850,000 people with dementia in the UK, of these 320,000 live in care homes. The care sector has one of the highest turn overs of staff and which necessitates the recruitment of staff with little experience of working with residents with dementia, however, staff training rarely focuses on how to engage with, and enhance, the lives of residents with dementia. A brief dementia training workshop called PERSONABLE has been developed that helps staff to reflect on their caring role and to self-determine improvements they might make to better understand the people they care for and enable them as autonomous individuals living within a residential community. It is not known if it is possible to test the workshop formally in care homes so this study aims to see whether such a workshop is possible. The aim of this study is to understand whether a newly designed dementia workshop is practical and effective.

Who can participate?
Residential care house staff and residents who have dementia

What does the study involve?
Each care home is randomly allocated to one of two groups. Those in the first group receive the dementia workshop. This is a one hour workshop for staff that helps them explore concepts of personhood and citizenship in relation to dementia care. Those in the second group receive no additional training other than the training routinely provided within the care home. Participants are followed up ten weeks after randomisation in order to assess the care home resident’s well-being and staff understanding of people with dementia.

What are the possible benefits and risks of participating?
There are no notable risks and benefits with participating.

Where is the study run from?
This study is being run by University of East Anglia (UK) and takes place in Norfolk and Suffolk (UK)

When is the study starting and how long is it expected to run for?
October 2015 to April 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mr Jason Corner
J.Corner@uea.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Jason Corner

ORCID ID

http://orcid.org/0000-0003-3850-0417

Contact details

School of Health Sciences
University of East Anglia
Edith Cavell Building
Norwich Research Park
Norwich
NR4 7TJ
United Kingdom
+44 1603 456161
J.Corner@uea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Does a personhood and citizenship brief dementia workshop, delivered to residential care home staff, improve the wellbeing of residents with dementia? Testing the feasibility of a randomised controlled trial

Acronym

Study hypothesis

The aim of this study is to test whether it is feasible to deliver and measure the effect of a reflective dementia workshop, delivered to residential staff, on the wellbeing of residents with dementia living in care homes in Norfolk and Suffolk, using a cluster RCT.

Ethics approval

Granted by the Social Care Research Ethics Committee, 04/04/2017, ref: 17/IEC08/0008

Study design

Feasibility cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

Dementia

Intervention

Each care home will be randomly allocated to their staff to one of two groups. Randomisation of care homes is done using block randomisation.

Group 1: Participants in this group receive the dementia workshop called PERSONABLE. It is intended as a reflective workshop to help participants to explore the concepts of personhood and citizenship in relation to dementia care. The PERSONABLE dementia workshop takes the form of a one hour workshop with groups of participating staff members and facilitated by a registered mental health nurse. The reflective workshop to help staff explore the concepts of personhood and citizenship in relation to dementia care. The workshop will consist of five elements:

1. From waking to work (15 minutes). The purpose of this exercise is to help staff explore the everyday choices they make between waking up and arriving at work, and how these might be replicated for the person with dementia living in residential care.
2. Understanding the person with dementia (15 minutes). An adapted version of the Kitwood personhood model, which in a structured way asks participants to consider what makes them a person.
3. Exercise two will then be repeated but this time the participants will be asked to think of a resident with dementia, and using the same adapted Kitwood model to consider the components that make them a person.
4. From the outside to the inside (15 minutes). A reflective exercise to help participants consider the community outside of the care home on their last day off, and how this might be replicated within the care home.
5. The pledge (10 minutes). Participants will be asked to consider all the concepts they have explored in the previous four exercises and to pledge to change one thing about their work within the next thirty days.

Group 2: Participants in this group receive training as usual will involve no additional training other than the training routinely provided within the care home.

For care homes allocated to the PERSONABLE dementia workshop, the workshop will be delivered within three weeks of randomisation and all outcomes are measured at ten weeks after randomisation.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Care home resident well-being is measured as change in the mean Dementia Care Mapping Well/Ill being value (WIB), calculated as a mean score from up to six care home residents observed at baseline prior to randomisation and at ten weeks after randomisation

Secondary outcome measures

1. Care home staff understanding of personhood is measured as change in Personhood in Dementia Questionnaire Score of care home staff between baseline recorded prior to randomisation and follow-up ten weeks after randomisation.
2. Care home staff competence of dealing with residents with dementia is measured as change in visual analogue scale observed at baseline recorded prior to randomisation and follow-up ten weeks after randomisation.
3. Resident recruitment (feasibility outcome) calculated as the total number of residents who participate in the dementia care mapping at baseline
4. Care home staff recruitment (feasibility outcome) calculated as the total number of care home staff members who complete baseline measures
5. Resident attrition (feasibility outcome) calculated as the total number of residents who participate in the dementia care mapping at follow-up
6. Care home staff attrition (feasibility outcome) calculated as the total number of care home staff members who complete follow-up outcomes

Overall trial start date

01/10/2015

Overall trial end date

30/04/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Residential care homes:
1. Residential care homes in Norfolk and Suffolk
2. Have residents with dementia.

Resident inclusion criteria:
1. Have dementia
2. Demonstrate capacity to consent to participate in the study or have a consultee who can inform a decision to include them in the study

Staff inclusion criteria:
1. Employed at residential care home and work on a full or part time basis and are employed in any role
2. Have a minimum of weekly face-to-face contact

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

Residential care homes (n=6). Residential care staff (n=60% of total staff within each care home, in a care home with 40 staff this will be approximately 24 staff). Residents with dementia (n=6).

Participant exclusion criteria

Residential care home exclusion criteria:
1. Do not provide residential care for people with dementia
2. Only provide palliative care

Resident exclusion criteria:
Receiving palliative care.

Staff exclusion criteria:
1. Agency or bank staff
2. Work in a senior management position

Recruitment start date

03/05/2017

Recruitment end date

01/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of East Anglia
The School of Health Sciences Edith Cavell Building
Norwich
NR4 7TJ
United Kingdom

Sponsor information

Organisation

University of East Anglia

Sponsor details

Research and Enterprise Services
University of East Anglia
Norwich Research Park
Norwich
NR4 7TJ
United Kingdom

Sponsor type

University/education

Website

http://www.uea.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Publication of results within a Doctoral thesis and scientific journals. Presentations at conferences and directly within care home forums.

IPD sharing statement:
The datasets generated during and/or analysed during the current study is not expected to be made available due to the small number of homes involved in this feasibility study (n=6) we do not expect to make individual participant level data available due to the risk of identifying homes, staff members and residents. Those interested in access to participant level data should contact the chief investigator (Jason Corner) in the first instance and each request will be considered on a case by case basis.

Intention to publish date

30/09/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes