Condition category
Mental and Behavioural Disorders
Date applied
18/05/2009
Date assigned
20/05/2009
Last edited
14/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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. We have adapted this for Britain (for example; seeing people individually rather than in groups). The purpose of our project 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 will conduct an initial interview. This will take about an hour. They will ask about:
- Personal details (age, where you live)
- Your relative /friend's memory and behavioural symptoms, and difficulties they may have with their daily routine
- You and your relative's/friend's health
- Services that provide assistance to your friend/relative
- Rewards and difficulties of caring including how you have coped with these difficulties over recent times
A researcher (the same person if possible) will visit you again 4, 8, 12 and 24 months after the initial interview. At these visits, they will ask some of the same questions again to see whether things have changed.
Participants will be allocated to one of two groups after the first interview. This will happen automatically and we do not know who will be in which group. One third of people will be in the first group (getting the usual treatment) and two thirds in the group which offer the additional help.
If you are allocated to the first group, you will not receive any additional visits apart from the researcher coming back to see how you are getting on. Whichever group you are in we would like you to keep it a secret from the researcher who sees how you are getting on.
If you are allocated to the second group, a psychological therapist will conduct eight talking therapy sessions. The first visit will be shortly after the first interview, and the meetings will be approximately weekly for eight sessions. The meetings will be scheduled for a time and place that is convenient to you, and most people prefer this to be at their home. Each will last about an hour. The psychological therapist will be someone who has received training to deliver this programme. You will be encouraged to discuss recent problems that have arisen while helping the person you know with memory problems and what to do. You will also be given brief exercises to do between sessions, for example, making a note of incidents which cause you stress. You will receive a copy of the manual the therapist uses with the blank pages you will have filled in about your own situation. With your consent we will tape record some of the sessions for later analysis, to ensure that the therapy is being delivered correctly.
The study will not involve the person with memory problems, nor be able to offer you any specific additional care. If you become unable to participate in the interviews or choose to withdraw from the study, we will keep and use the information we have already collected.

What are the possible benefits and risks of participating?
We cannot promise the study will help you. It will provide evidence regarding whether the programme we are evaluating 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.
We do not anticipate that there will be any disadvantages to taking part except for the inconvenience of making time for the interviews and the talking therapy sessions if you receive them, 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?
It started at the end of 2009 and finished recruiting in June 2011. Follow up will continue until 2020.

Who is funding the study?
NIHR-HTA (UK).

Who is the main contact?
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.

On 10/05/2013 the overall trial end date was updated from 31/12/2013 to 31/12/2018.

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 below to request a patient information sheet

Condition

Family carer of patient with dementia

Intervention

An eight session psychological manual based coping strategy intervention compared to treatment as usual.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

Patient

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 details

c/o Dr O. Avwenagha
Research Governance Co-ordinator
Joint UCLH/UCL Biomedical Research Unit
R&D Directorate (Maple House)
Rosenheim Wing (Ground Floor)
25 Grafton Way
London
WC1E 5DB
United Kingdom
+44 (0)20 7380 9928
o.avwenagha@ucl.ac.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

Federal/National Government

Location

United Kingdom

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

2013 clinical effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/24162942
2013 cost effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/24162943
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25300037
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/26361313

Publication citations

  1. Clinical effectiveness results

    Livingston G, Barber J, Rapaport P, Knapp M, Griffin M, King D, Livingston D, Mummery C, Walker Z, Hoe J, Sampson EL, Cooper C, Clinical effectiveness of a manual based coping strategy programme (START, STrAtegies for RelaTives) in promoting the mental health of carers of family members with dementia: pragmatic randomised controlled trial., BMJ, 2013, 347, f6276.

  2. Cost effectiveness results

    Knapp M, King D, Romeo R, Schehl B, Barber J, Griffin M, Rapaport P, Livingston D, Mummery C, Walker Z, Hoe J, Sampson EL, Cooper C, Livingston G, Cost effectiveness of a manual based coping strategy programme in promoting the mental health of family carers of people with dementia (the START (STrAtegies for RelaTives) study): a pragmatic randomised controlled trial., BMJ, 2013, 347, f6342.

  3. Results

    Livingston G, Barber J, Rapaport P, Knapp M, Griffin M, Romeo R, King D, Livingston D, Lewis-Holmes E, Mummery C, Walker Z, Hoe J, Cooper C, START (STrAtegies for RelaTives) study: a pragmatic randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of a manual-based coping strategy programme in promoting the mental health of carers of people with dementia., Health Technol Assess, 2014, 18, 61, 1-242, doi: 10.3310/hta18610.

  4. Results

    Livingston G, Barber J, Rapaport P, Knapp M, Griffin M, King D, Romeo R, Livingston D, Mummery C, Walker Z, Hoe J, Cooper C, Long-term clinical and cost-effectiveness of psychological intervention for family carers of people with dementia: a single-blind, randomised, controlled trial, Lancet Psychiatry, 2014, 1, 7, 539-548, doi: 10.1016/S2215-0366(14)00073-X.

Additional files

Editorial Notes