ISRCTN - ISRCTN70017938: START (STrAtegies for RelaTives) study

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gill Livingston

ORCID ID

Contact details

University College London
Holborn Union Building
Archway Campus
Highgate Hill
London
N19 5NL
United Kingdom
+44 (0)20 7561 4218
g.liivngston@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 08/14/06

Study information

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

Acronym

START

Study hypothesis

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

East London and the City Research Ethics Committee 1, 11/08/2009, ref: 09/H0703/84
Approval for substantial amendment on 11/09/2011

Study design

Randomised multi-centre single-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measure

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.

Secondary outcome measures

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

Overall trial start date

01/08/2009

Overall trial end date

31/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Carer

Age group

Adult

Gender

Both

Target number of participants

258

Participant 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

Recruitment start date

01/08/2009

Recruitment end date

01/06/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
London
N19 5NL
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor type

University/education

Website

http://www.ucl.ac.uk

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

National government

Location