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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):1-242HT

Abstract

BACKGROUND

Two-thirds of people with dementia live at home, receiving most care from family carers, about 40% of whom have clinically significant depression or anxiety. This impacts on the person with dementia, families and society, predicting care breakdown. There are currently no clinically effective and cost-effective NHS family carer interventions.

OBJECTIVES

To assess the STrAtegies for RelaTives (START) intervention in the short (4 and 8 months) and long term (1 and 2 years) compared with treatment as usual (TAU).

DESIGN

Randomised, parallel-group, superiority trial with blinded assessment recruiting participants 2:1 (intervention to TAU) to allow for therapist clustering.

SETTING

Three UK mental health services and one neurological service.

PARTICIPANTS

Family carers of people with dementia.

INTERVENTION

Eight-session manual-based coping intervention delivered by supervised psychology graduates to individuals.

MAIN OUTCOME MEASURES

Affective symptoms [Hospital Anxiety and Depression Scale-total (HADS-T)] and cost-effectiveness. Secondary measures: anxiety and depression symptoms and caseness, quality of life (QoL), abusive behaviour and long-term care home admission.

RESULTS

Two hundred and sixty participants were randomised (173 intervention, 87 TAU). We used intention-to-treat analysis in the short term (152 intervention, 77 TAU) and in the long term (140 intervention, 69 TAU). In the short term, the intervention group had lower HADS-T [mean difference -1.80, 95% confidence interval (CI) -3.29 to -0.31; p=0.02] and higher quality-adjusted life-years (QALYs) (mean difference 0.03, 95% CI -0.01 to 0.08). Costs were no different between groups [mean £ 252 (95% CI -£ 28 to £ 565) for intervention group]. The cost-effectiveness acceptability curve showed a greater than 99% chance of being cost-effectiveness at a £ 30,000/QALY willingness-to-pay threshold and a high probability of cost-effectiveness based on the HADS-T score. Carers in the intervention group had less case-level depression [odds ratio (OR) 0.24, 95% CI 0.07 to 0.76], a trend towards reduced case-level anxiety (OR 0.30, 95% CI 0.08 to 1.05), lower Hospital Anxiety and Depression Scale-anxiety (HADS-A) (-0.91, 95% CI -1.76 to -0.07; p = 0.03) and Hospital Anxiety and Depression Scale-depression (HADS-D) (-0.91, 95% CI -1.71 to -0.10; p = 0.03) and higher Health Status Questionnaire (HSQ) QoL (mean difference 4.09, 95% CI 0.34 to 7.83). Group differences in abusive behaviour (OR 0.48, 95% CI 0.18 to 1.27) and the person with dementia's quality of life-Alzheimer's disease (QoL-AD) (mean increase 0.59, 95% CI -0.72 to 1.89) were not significant. In the long term, the intervention group had lower HADS-T (mean difference -2.58, 95% CI -4.26 to -0.90; p = 0.03) and higher QALYs (mean difference 0.03, 95% CI -0.01 to 0.06). Carers in the intervention group had less case-level depression (OR 0.14, 95% CI 0.04 to 0.53), a trend towards reduced case-level anxiety (OR 0.57, 95% CI 0.26 to 1.24), lower HADS-A (-1.16, 95% CI -2.15 to -0.18) and HADS-D (1.45, 95% CI -2.32 to -0.57), and higher HSQ (mean difference 7.47, 95% CI 2.87 to 12.08). Thirty-two (18.7%) people with dementia in the intervention group and 17 (20.2%) in TAU were admitted to a care home (hazard ratio 0.83, 95% CI 0.44 to 1.56; p = 0.56). There were no significant differences between groups in abusive behaviour (OR 0.83, 95% CI 0.36 to 1.94), the person with dementia's QoL-AD (0.17, 95% CI -1.37 to 1.70) or costs (£ 336, 95% CI -£ 223 to £ 895) for intervention group. The probability that the intervention would be seen as cost-effective at £ 30,000/QALY threshold and cost-effectiveness on the HADS-T remained high.

CONCLUSIONS

The START intervention was clinically effective and cost-effective in the short and longer term. The results are robust to the sensitivity analyses performed. Future work is needed to consider mechanism of action; the effects on people with dementia in clinical terms (cognition, neuropsychiatric symptoms, longer-term care home admission); and on health and social care costs. In addition, we will explore the effects of carer abusive behaviour on the care recipient's care home admission and if this then reduces abusive behaviour. We would also like to implement START and evaluate this implementation in clinical practice.

TRIAL REGISTRATION

Current Controlled Trials ISCTRN70017938.

Authors+Show Affiliations

Division of Psychiatry, University College London, London, UK.Department of Statistical Science and PRIMENT Clinical Trials Unit, University College London, London, UK.Division of Psychiatry, University College London, London, UK.Personal Social Services Research Unit, London School of Economics and Political Science, London, UK.Division of Psychiatry, University College London, London, UK.Institute of Psychiatry, King's College London, London, UK.Personal Social Services Research Unit, London School of Economics and Political Science, London, UK.Division of Psychiatry, University College London, London, UK.Division of Psychiatry, University College London, London, UK.Queen Square, University College London Hospitals NHS Foundation Trust, London, UK.Division of Psychiatry, University College London, London, UK.Division of Psychiatry, University College London, London, UK.Division of Psychiatry, University College London, London, UK.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25300037

Citation

Livingston, Gill, et al. "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 Technology Assessment (Winchester, England), vol. 18, no. 61, 2014, pp. 1-242.
Livingston G, Barber J, Rapaport P, et al. 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.
Livingston, G., Barber, J., Rapaport, P., Knapp, M., Griffin, M., Romeo, R., ... Cooper, C. (2014). 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 Technology Assessment (Winchester, England), 18(61), pp. 1-242. doi:10.3310/hta18610.
Livingston G, et al. 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. PubMed PMID: 25300037.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Livingston,Gill, AU - Barber,Julie, AU - Rapaport,Penny, AU - Knapp,Martin, AU - Griffin,Mark, AU - Romeo,Renee, AU - King,Derek, AU - Livingston,Debbie, AU - Lewis-Holmes,Elanor, AU - Mummery,Cath, AU - Walker,Zuzana, AU - Hoe,Juanita, AU - Cooper,Claudia, PY - 2014/10/10/entrez PY - 2014/10/10/pubmed PY - 2015/6/4/medline SP - 1 EP - 242 JF - Health technology assessment (Winchester, England) JO - Health Technol Assess VL - 18 IS - 61 N2 - BACKGROUND: Two-thirds of people with dementia live at home, receiving most care from family carers, about 40% of whom have clinically significant depression or anxiety. This impacts on the person with dementia, families and society, predicting care breakdown. There are currently no clinically effective and cost-effective NHS family carer interventions. OBJECTIVES: To assess the STrAtegies for RelaTives (START) intervention in the short (4 and 8 months) and long term (1 and 2 years) compared with treatment as usual (TAU). DESIGN: Randomised, parallel-group, superiority trial with blinded assessment recruiting participants 2:1 (intervention to TAU) to allow for therapist clustering. SETTING: Three UK mental health services and one neurological service. PARTICIPANTS: Family carers of people with dementia. INTERVENTION: Eight-session manual-based coping intervention delivered by supervised psychology graduates to individuals. MAIN OUTCOME MEASURES: Affective symptoms [Hospital Anxiety and Depression Scale-total (HADS-T)] and cost-effectiveness. Secondary measures: anxiety and depression symptoms and caseness, quality of life (QoL), abusive behaviour and long-term care home admission. RESULTS: Two hundred and sixty participants were randomised (173 intervention, 87 TAU). We used intention-to-treat analysis in the short term (152 intervention, 77 TAU) and in the long term (140 intervention, 69 TAU). In the short term, the intervention group had lower HADS-T [mean difference -1.80, 95% confidence interval (CI) -3.29 to -0.31; p=0.02] and higher quality-adjusted life-years (QALYs) (mean difference 0.03, 95% CI -0.01 to 0.08). Costs were no different between groups [mean £ 252 (95% CI -£ 28 to £ 565) for intervention group]. The cost-effectiveness acceptability curve showed a greater than 99% chance of being cost-effectiveness at a £ 30,000/QALY willingness-to-pay threshold and a high probability of cost-effectiveness based on the HADS-T score. Carers in the intervention group had less case-level depression [odds ratio (OR) 0.24, 95% CI 0.07 to 0.76], a trend towards reduced case-level anxiety (OR 0.30, 95% CI 0.08 to 1.05), lower Hospital Anxiety and Depression Scale-anxiety (HADS-A) (-0.91, 95% CI -1.76 to -0.07; p = 0.03) and Hospital Anxiety and Depression Scale-depression (HADS-D) (-0.91, 95% CI -1.71 to -0.10; p = 0.03) and higher Health Status Questionnaire (HSQ) QoL (mean difference 4.09, 95% CI 0.34 to 7.83). Group differences in abusive behaviour (OR 0.48, 95% CI 0.18 to 1.27) and the person with dementia's quality of life-Alzheimer's disease (QoL-AD) (mean increase 0.59, 95% CI -0.72 to 1.89) were not significant. In the long term, the intervention group had lower HADS-T (mean difference -2.58, 95% CI -4.26 to -0.90; p = 0.03) and higher QALYs (mean difference 0.03, 95% CI -0.01 to 0.06). Carers in the intervention group had less case-level depression (OR 0.14, 95% CI 0.04 to 0.53), a trend towards reduced case-level anxiety (OR 0.57, 95% CI 0.26 to 1.24), lower HADS-A (-1.16, 95% CI -2.15 to -0.18) and HADS-D (1.45, 95% CI -2.32 to -0.57), and higher HSQ (mean difference 7.47, 95% CI 2.87 to 12.08). Thirty-two (18.7%) people with dementia in the intervention group and 17 (20.2%) in TAU were admitted to a care home (hazard ratio 0.83, 95% CI 0.44 to 1.56; p = 0.56). There were no significant differences between groups in abusive behaviour (OR 0.83, 95% CI 0.36 to 1.94), the person with dementia's QoL-AD (0.17, 95% CI -1.37 to 1.70) or costs (£ 336, 95% CI -£ 223 to £ 895) for intervention group. The probability that the intervention would be seen as cost-effective at £ 30,000/QALY threshold and cost-effectiveness on the HADS-T remained high. CONCLUSIONS: The START intervention was clinically effective and cost-effective in the short and longer term. The results are robust to the sensitivity analyses performed. Future work is needed to consider mechanism of action; the effects on people with dementia in clinical terms (cognition, neuropsychiatric symptoms, longer-term care home admission); and on health and social care costs. In addition, we will explore the effects of carer abusive behaviour on the care recipient's care home admission and if this then reduces abusive behaviour. We would also like to implement START and evaluate this implementation in clinical practice. TRIAL REGISTRATION: Current Controlled Trials ISCTRN70017938. SN - 2046-4924 UR - https://www.unboundmedicine.com/medline/citation/25300037/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_ L2 - https://doi.org/10.3310/hta18610 DB - PRIME DP - Unbound Medicine ER -