Condition category
Not Applicable
Date applied
20/05/2015
Date assigned
20/05/2015
Last edited
14/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
End of life care is support given to people who are considered likely to die within the next 12 months. The aim of end of life care is to improve the quality of life of the patient, and also to provide support to their family or carers. End of life care also includes palliative care given to patients with an incurable illness. There is a need to provide services which use the Social Action Model to support end of life care in community settings. The goal of the Social Action Model is to enable everybody to have access to community resources, and also to engage members of the community to help give back to society (e.g. by volunteering). Such services could work to reduce patient isolation, help meet emotional needs and maintain a sense of connectedness to the community. It is also important to robustly evaluate these models to see if they have a positive influence on the patient experience of end of life care. The UK Cabinet Office’s Centre for Social Action proposed, and launched, The Social Action End of Life Support Fund which aims to support a range of social action initiatives, including befriending (e.g. companionship, emotional and peer support), practical support (e.g. house/garden work, walking pets, picking up prescriptions) and provision of information/navigation towards relevant services. The aim of this study is to see what impact access to projects associated with the The Social Action End of Life Support Fund has on the quality of life of people in the last year of life.

Who can participate?
Adults in the last year of life.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) are given access to volunteer-provided Social Action services straight away following any service related administrative procedures. Those in group 2 (control group) are put on a 4 week waitlist before being given access to volunteer-provided Social Action services. The impact of having access to the Social Action services intervention on end of life experience (i.e. quality of life, loneliness, social support and carer burden) is measured using a predetermined set of outcome measurement tools in the form of an A4 self-reporting questionnaire booklet. Repeated assessments are carried out at weeks 4 and 8 for the intervention group, and at weeks 4, 8 and 12 for the control group. A selection of participating end of life care sites are selected for case study evaluation. These sites have interviews, observation and documentary analyses to understand the mechanisms underpinning any found impact on patient quality of life.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
1. Saint Michael’s Hospice (UK)
2. Aquarius (UK)
3. Peace Hospice (UK)
4. St Joseph’s Hospice (UK)
5. Hampshire Hospitals NHS Foundation Trust (UK)
6. Six Sue Ryder hospices across the UK

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

Who is funding the study?
Cabinet Office (UK)

Who is the main contact?
Dr C Walshe

Trial website

Contact information

Type

Public

Primary contact

Dr Catherine Walshe

ORCID ID

Contact details

Lancaster University
International Observatory on End of Life Care
Furness Building
Lancaster
LA1 4YW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18742

Study information

Scientific title

End-of-Life Social Action Study (ELSA): a randomised wait-list controlled trial and embedded qualitative case study evaluation assessing the causal impact of social action services on end-of-life experience

Acronym

ELSA

Study hypothesis

Receiving care from a social action volunteer service plus usual care significantly improves patient quality of life in the last year of life.

Ethics approval

NRES Committee Yorkshire & The Humber - South Yorkshire, 12/03/2015, ref: 15/YH/0206.

Study design

Randomised interventional process of care study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

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

Condition

Health services and delivery research

Intervention

1. Intervention group: patients are given access to volunteer-provided social action services at the end of life tailored to individual needs of patients e.g. befriending, social support straight away.
2. Control group: patients are put on a 4 week waitlist before being given access to the volunteer-provided social action services.

Intervention type

Other

Phase

Drug names

Primary outcome measures

The World Health Organization Quality of Life (WHOQOL)-BREF questionnaire will be used at baseline, 4 weeks and 8 weeks in the intervention group. For the control group, the WHOQOL-BREF will be used at baseline, 4 weeks, 8 weeks and 12 weeks.

Secondary outcome measures

Taken at baseline, 4 weeks and 8 weeks in the intervention group. For the control group, the measures are taken at baseline, 4 weeks, 8 weeks and 12 weeks:
1. Loneliness is measured using the De John Greiveld 6-item Loneliness Scale, a short, well-used, reliable and valid measurement instrument for overall, emotional, and social loneliness, chosen for brevity and relevance of the items when mapped onto anticipated outcomes
2. Social Support is measured using the 8-item modified Medical Outcomes Study Social Support Survey (mMOS-SS), a short validated scale covering two domains (emotional and instrumental social support) designed to identify potentially modifiable social support deficits, chosen for brevity and relevance of the items when mapped onto anticipated outcomes
3. Carer Burden is measured using the Caregiver Burden Scale-End of Life Care (CBS-EOLC), a reliable and valid measurement tool designed to specifically assess family caregivers’ burden within the palliative care context, chosen for brevity and relevance of the items when mapped onto anticipated outcomes
Social network (network size, number of confidante, number and percentage of relatives in network and number and type of main helpers) will also be measured as mediator/moderator (not outcome) using an adapted Hirsch matrix.
Socio-demographic data (age, gender, disease diagnosis, education, marital status, living status, spirituality and ethnicity) in the form of a questionnaire will be collected from both patients and informal carers at baseline.

Overall trial start date

30/04/2015

Overall trial end date

15/04/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Sites participating in this study will be selected as part of a government Cabinet Office funded initiative to support social action at the end of life in England. Twelve sites that provide these services will be shortlisted for interview. Selection considerations at shortlisting and interview will include the sites’ match to the tender, their capacity to deliver the proposed service, and their ability and willingness to contribute to the evaluation of these services. All sites will be made aware at interview that they are providing their services in the context of this study design (wait list RCT and case study evaluation).

Patient inclusion criteria:
1. Those eligible to be referred to an end of life care service determined by the referring organisation/individual. They should be able to answer 'no' to the 'surprise question': ‘would you be surprised if the patient dies within a year?’
2. Able to give informed consent
Carer inclusion criteria
1. Those identified by participating patients as people who provide lay or unpaid support. These may be family, friends or other informal carers
2. Able to give informed consent

Volunteer/staff inclusion criteria (for interview):
1. Those volunteering for a participating befriending service, and providing support to a trial participant (who was allocated to either trial arm) OR those working for a participating befriending service who are involved in the provision or management of these services
2. Able to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 700

Participant exclusion criteria

Patient exclusion criteria:
1. Age <18
2. Those who only who only understand or speak a language in which our main outcome measure (the WHOQOL BREF) is unavailable. This is anticipated to be a very small number of potential participants as the WHOQOL BREF is available in a wide range of languages, including the main languages spoken in the participating sites
3. Those with an anticipated prognosis of <4 weeks

Carer exclusion criteria:
1. Age <18 years
2. Those who only who only understand or speak a language in which our carer outcome measure is unavailable

Recruitment start date

08/06/2015

Recruitment end date

08/01/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Saint Michael’s Hospice
Crimple House Hornbeam Park Avenue
Harrogate
HG2 8QL
United Kingdom

Trial participating centre

Aquarius
236 Bristol Road
Birmingham
B5 7SL
United Kingdom

Trial participating centre

Peace Hospice
Peace Drive
Watford
WD17 3PH
United Kingdom

Trial participating centre

St. Joseph’s Hospice
Mare Street
London
E8 4SA
United Kingdom

Trial participating centre

Hampshire Hospitals NHS Foundation Trust
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom

Trial participating centre

Leckhampton Court Hospice
Church Road Leckhampton
Cheltenham
GL53 0QJ
United Kingdom

Trial participating centre

Sue Ryder Manorlands Hospice
Hebden Road
Oxenhope
BD22 9HJ
United Kingdom

Trial participating centre

Sue Ryder Nettlebed and Dutchess of Kent Hospice
Joyce Grove Nettlebed
Henley on Thames
RG9 5DF
United Kingdom

Trial participating centre

St John's Hospice
St John's Road
Moggarhanger
MK44 3RJ
United Kingdom

Trial participating centre

Thorpe Hall
Longthorpe
Peterborough
PE3 6LW
United Kingdom

Trial participating centre

Sue Ryder Wheatfields Hospice
Grove Road
Leeds
LS6 2AE
United Kingdom

Sponsor information

Organisation

Lancaster University

Sponsor details

Research Support Office B58
Bowland Main
Bailrigg
Lancaster
LA1 4YT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Cabinet Office (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results of the research will be made available to research participants and the communities and sites from which they are drawn. A written summary of the results of the study will be distributed to all participating referring agencies and relevant community groups. Oral presentation of the results to the relevant local professional and social action communities will be arranged. Submissions to peer reviewed conferences and journals to disseminate findings of this project in an accessible way will also be performed.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 protocol in: http://bmcpalliatcare.biomedcentral.com/articles/10.1186/s12904-016-0134-3

Publication citations

Additional files

Editorial Notes

14/07/2016: Publication reference added. 22/04/2016: the following changes were made to the trial record: 1. The recruitment start date was changed from 01/06/2015 to 08/06/2015. 2. The recruitment end date was changed from 31/12/2015 to 08/01/2016. 3. The overall trial end date was changed from 30/12/2015 to 15/04/2016.