Condition category
Not Applicable
Date applied
22/06/2012
Date assigned
22/06/2012
Last edited
06/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Most people prefer to be cared for and to die in the familiar surroundings of their own home. Being able to make this choice very much depends on the efforts of family carers. While taking on a caring role is normally done willingly, it can result in considerable burden and negative effects on carers’ health. Therefore it is important to ensure that carers are well supported to enable them to look after patients at home while also maintaining their own health and wellbeing. So far health professionals have had no clear guidelines to help them ensure that they assess and address carer support needs regularly and in detail. So we developed a simple assessment form, the Carer Support Needs Assessment Tool (CSNAT), based on what carers told us their main support needs were in end of life home care. The procedures for CSNAT assessment, prioritisation and follow-up together form the CSNAT intervention. The aim of the study is to find out whether the using the CSNAT intervention with carers during care giving makes a difference to carer outcomes in bereavement.

Who can participate?
All adult carers of patients looked after by the hospice home care (HHC) services can take part in the study.

What does the study involve?
We will ask six HHC services to use the CSNAT intervention with carers of patients under their care. We will then compare bereavement outcomes for carers who had usual care with those who had the intervention. The HHC services will start using the CSNAT at three month intervals so we can make a comparison between services who have started the intervention with those who have not, and also make a comparison before and after the start of the intervention within each service. We will measure outcomes using a postal survey of carers 4-5 months after bereavement. To reduce any potential risks, HHC will exclude carers that are believed to suffer particularly complicated grief in bereavement, and contact details to HHC bereavement support will be provided. The study will also ask the views of the HHC nurses and some of the carers who had the intervention on what made the intervention successful or not so successful. Finally, we will look at HHC CSNAT records to see whether some factors, such as how often assessments were done, seem to make a difference.

What are the possible benefits and risks of participating?
Participants in the CSNAT intervention group may receive better support during care giving and experience better health, well being and lower levels of grief in bereavement.

Where is the study run from?
University of Manchester (UK).

When is the study starting and how long is it expected to run for?
The study started in May 2012 and will run for 2 years.

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

Who is the main contact?
Gunn Grande
gunn.grande@manchester.ac.uk  

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gunn Grande

ORCID ID

Contact details

School of Nursing
Midwifery and Social Work
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 161 306 7695
gunn.grande@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12422

Study information

Scientific title

A randomised trial to evaluate the impact of a Carer Support Needs Assessment Tool (CSNAT) intervention in hospice home care

Acronym

CSNAT

Study hypothesis

To test whether a formalised, comprehensive procedure for carer support needs assessment, prioritisation and follow up (CSNAT intervention) improves quality of care and carer outcomes in end of life home care, compared to usual care.

Ethics approval

NRES Committee North West - Greater Manchester East, 23/03/2012, ref: 12/NW/0206

Study design

Stepped wedge cluster randomised trial

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

Topic: Primary Care Research Network for England, Generic Health Relevance and Cross Cutting Themes; Subtopic: Not Assigned, Generic Health Relevance (all Subtopics); Disease: All Diseases, Health Services Research

Intervention

CSNAT, Formalised, comprehensive procedure for carer support needs assessment, prioritisation and follow up using the Carer Support Needs Assessment Tool (CSNAT)

Control, informal carer assessment as usual

Follow Up Length: 5 month(s)

Intervention type

Other

Phase

Phase II/III

Drug names

Primary outcome measures

SF-12 4-5 months post bereavement

Secondary outcome measures

1. Quality of care; Timepoint(s): 4-5 months post bereavement
2. Patient's place of death; Timepoint(s): Date of death
3. Texas Revised Inventory of Grief; Timepoint(s): 4-5 months post bereavement

Overall trial start date

21/09/2012

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. The main bereaved carer of patients who have been supported by participating hospice home care services (HHCs)
2. Target Gender: Male & Female ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1003; UK Sample Size: 1003

Participant exclusion criteria

1. Age <18 years
2. Identified by HHCs as experiencing particularly complicated grief in bereavement

Recruitment start date

21/09/2012

Recruitment end date

31/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Nursing, Midwifery and Social Work
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

c/o Samantha Wade
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 208 843 8054
Samantha.Wade@nihr-ccf.org.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Central commissioning facility (CCF); Grant Codes: PB-PG-0610-22291

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

06/09/2016: No publications found in PubMed, verifying study status with principal investigator.