START (STrAtegies for RelaTives) study

ISRCTN	ISRCTN70017938
DOI	https://doi.org/10.1186/ISRCTN70017938
Protocol serial number	HTA 08/14/06
Sponsor	University College London (UK)
Funder	Health Technology Assessment Programme

Submission date: 18/05/2009
Registration date: 20/05/2009
Last edited: 25/08/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Family carers of people with dementia are a group at high risk of mental health problems like depression and anxiety. As they provide most of the care received by people with dementia in this country, and the number of people with dementia is projected to increase substantially, there is an urgent need within society to develop ways to decrease their distress. The UK government has recognised that family dementia carers need dedicated psychological therapies, and that this should be a key component of high quality dementia care, but in practice resources are not available. The only studies that have demonstrated efficacy of a manual based psychological therapy in this group were carried out in the
USA and the therapy was conducted by clinical psychologists. Clinical psychologists are a highly trained and finite resource within the NHS. Researchers in the USA have developed a talking therapy programme to help family or friends of people with memory problems. This has been adapted this for Britain (for example; seeing people individually rather than in groups). The aim of this study is to test whether this programme is effective in friends and relatives of people with memory problems in the UK.

Who can participate?
Family carers who provide emotional or practical support at least weekly and identify themselves as the primary carer of someone with dementia not living in 24 hour care and who are carers of patients referred in the last year.

What does the study involve?
An interviewer conducts an initial interview. This takes about an hour. They ask participants about their relative/friend's memory and behavioural symptoms, difficulties they may have with their daily routine, their and their relative's/friend's health, services that provide assistance to their friend/relative, and the rewards and difficulties of caring including how they have coped with these difficulties over recent times. A researcher (the same person if possible) visits again 4, 8, 12 and 24 months after the initial interview. At these visits, they ask some of the same questions again to see whether things have changed. Participants are randomly allocated to one of two groups after the first interview. The first group do not receive any extra visits apart from the researcher coming back to see how they are getting on. In the second group a psychological therapist conducts eight talking therapy sessions. The first visit is shortly after the first interview, and the meetings are weekly for eight sessions. The meetings are scheduled for a time and place that is convenient, and most people prefer this to be at their home. Each lasts about an hour. The psychological therapist is someone who has received training to deliver this programme. Participants are encouraged to discuss recent problems that have arisen while helping the person with memory problems and what to do. Participants are also given brief exercises to do between sessions, for example, making a note of incidents which cause stress. With consent some of the sessions are tape recorded for later analysis, to ensure that the therapy is being delivered correctly. The study does not involve the person with memory problems, and no specific additional care is offered. Participants are followed up every six months from 2 years until the person with dementia goes into a care home or dies, or for 6 years.

What are the possible benefits and risks of participating?
It cannot be promised that the study will help the participants. It will provide evidence regarding whether the programme is helpful for family and friends of people with memory problems. If it is, then knowing this could help improve the support offered to family and friends of people with memory problems. It is not anticipated that there will be any disadvantages to taking part except for the inconvenience of making time for the interviews and the talking therapy sessions, but it is possible that some topics discussed concerning the stresses of caring may be upsetting.

Where is the study run from?
University College London (UK)

When is the study starting and how long is it expected to run for?
August 2009 to December 2018

Who is funding the study?
Health Technology Assessment Programme (UK)

Who is the main contact?
Prof. Gill Livingston
g.livingston@ucl.ac.uk

Contact information

Prof Gill Livingston
Scientific

University College London
Holborn Union Building
Archway Campus
Highgate Hill
London
N19 5NL
United Kingdom

Phone	+44 (0)20 7561 4218
Email	g.liivngston@ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised multi-centre single-blind controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	START (STrAtegies for RelaTives) study: a pragmatic randomised controlled trial to determine the effectiveness of a manual based coping strategy programme in promoting the mental health of carers of people with dementia
Study acronym	START
Study objectives	That eight sessions of manual based coping strategy therapy, delivered over 8-14 weeks by supervised graduate mental health workers is clinically (in terms of anxiety and depressive symptoms) and cost-effectiveness for family carers, compared to usual care.
Ethics approval(s)	East London and the City Research Ethics Committee 1, 11/08/2009, ref: 09/H0703/84 Approval for substantial amendment on 11/09/2011
Health condition(s) or problem(s) studied	Family carer of patient with dementia
Intervention	An interviewer conducts an initial interview. This takes about an hour. They ask participants about their relative/friend's memory and behavioural symptoms, difficulties they may have with their daily routine, their and their relative's/friend's health, services that provide assistance to their friend/relative, and the rewards and difficulties of caring including how they have coped with these difficulties over recent times. A researcher (the same person if possible) visits again 4, 8, 12 and 24 months after the initial interview. At these visits, they ask some of the same questions again to see whether things have changed. Participants are randomly allocated to one of two groups after the first interview. The first group do not receive any extra visits apart from the researcher coming back to see how they are getting on. In the second group a psychological therapist conducts eight talking therapy sessions. The first visit is shortly after the first interview, and the meetings are weekly for eight sessions. The meetings are scheduled for a time and place that is convenient, and most people prefer this to be at their home. Each lasts about an hour. The psychological therapist is someone who has received training to deliver this programme. Participants are encouraged to discuss recent problems that have arisen while helping the person with memory problems and what to do. Participants are also given brief exercises to do between sessions, for example, making a note of incidents which cause stress. With consent some of the sessions are tape recorded for later analysis, to ensure that the therapy is being delivered correctly. The study does not involve the person with memory problems, and no specific additional care is offered. Added 24/08/2017: Participants are followed up every six months from 2 years until the person with dementia goes into a care home or dies, or for 6 years.
Intervention type	Other
Primary outcome measure(s)	Current primary outcome measures as of 10/05/2013: 1. Carer HADS Total 2. Cost-effectiveness: Cost of care for each group will be measured using the Client Service Receipt Inventory (CSRI). The EQ5D is a generic measure to generate QALYs (quality of life adjusted health years); societal weights will be applied. At 2 years: 1. Carer HADS Total 2. Cost-effectiveness: Cost of care for each group will be measured using the Client Service Receipt Inventory (CSRI). The EQ5D is a generic measure to generate QALYs (quality of life adjusted health years); societal weights will be applied. At 7 years: Time to entry to 24 care Previous primary outcome measures until 10/05/2013: 1. Carer HADS depression and anxiety scores 2. Cost-effectiveness: Cost of care for each group will be measured using the Client Service Receipt Inventory (CSRI). The EQ5D is a generic measure to generate QALYs (quality of life adjusted health years); societal weights will be applied.
Key secondary outcome measure(s)	Current secondary outcome measures as of 10/05/2013: At 8 months: 1 Depression and anxiety caseness and scores on the HADS 2. Carer (HSQ mental health) and care recipient (QoL-AD) quality of life 3. Modified Conflict Tactics Scale At 2 years: 1 Time to entry of the person with dementia to 24-hr care 2 Depression and anxiety caseness and scores on the HADS 3 Carer (HSQ mental health) and care recipient (QoL-AD) quality of life 4. Modified Conflict Tactics Scale Previous secondary outcome measures until 10/05/2013: 1. Time to entry of the person with dementia to 24-hr care 2. Depression and anxiety caseness on the HADS 3. Carer (HSQ) and care recipient (QoL-AD) quality of life 4. Modified Conflict Tactics Scale
Completion date	31/12/2018

Eligibility

Participant type(s)	Carer
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	258
Key inclusion criteria	1. Family carers who provide emotional or practical support at least weekly and identify themselves as the primary carer of someone with dementia not living in 24 hour care referred in the last year 2. Participants must be over 18 years of age and can be of either sex
Key exclusion criteria	1. Carers who are unable to give informed consent to the trial, for example because they have dementia themselves 2. Carers who are currently taking part in a randomised clinical trial in their capacity as a family carer 3. Carers who live more than 1.5 hours from the researchers' base
Date of first enrolment	01/08/2009
Date of final enrolment	01/06/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University College London

London
N19 5NL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	clinical effectiveness results	25/10/2013		Yes	No
Results article	cost effectiveness results	25/10/2013		Yes	No
Results article	coping strategies results	01/10/2014		Yes	No
Results article	main results	01/12/2014		Yes	No
Results article	reducing abuse results	01/06/2016		Yes	No
Results article	dissemination results	21/08/2017		Yes	No
HRA research summary			28/06/2023	No	No
Other publications	participants' views	04/06/2014		Yes	No
Other publications	HTA report	01/10/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/08/2017: Publication and dissemination plan, IPD sharing statement and publication references added.
10/05/2013: The overall trial end date was updated from 31/12/2013 to 31/12/2018.