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START (STrAtegies for RelaTives) study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN70017938
Enrollment
258
Registered
2009-05-20
Start date
2009-08-01
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Family carer of patient with dementia Mental and Behavioural Disorders Dementia

Interventions

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

Sponsors

University College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026