Livingston Gill, Barber Julie, Rapaport Penny, Knapp Martin, Griffin Mark, Romeo Renee, King Derek, Livingston Debbie, Lewis-Holmes Elanor, Mummery Cath, Walker Zuzana, Hoe Juanita, Cooper Claudia
Division of Psychiatry, University College London, London, UK.
Department of Statistical Science and PRIMENT Clinical Trials Unit, University College London, London, UK.
Health Technol Assess. 2014 Oct;18(61):1-242. doi: 10.3310/hta18610.
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.
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).
Randomised, parallel-group, superiority trial with blinded assessment recruiting participants 2:1 (intervention to TAU) to allow for therapist clustering.
Three UK mental health services and one neurological service.
Family carers of people with dementia.
Eight-session manual-based coping intervention delivered by supervised psychology graduates to individuals.
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.
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.
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.
Current Controlled Trials ISCTRN70017938.
三分之二的痴呆症患者居家生活，主要由家庭护理人员提供照料，其中约40%患有具有临床意义的抑郁症或焦虑症。这对痴呆症患者本人、家庭和社会都有影响，预示着护理可能中断。目前，英国国民医疗服务体系（NHS）中尚无临床有效且具有成本效益的针对家庭护理人员的干预措施。
评估与常规治疗（TAU）相比，亲属策略（START）干预措施在短期（4个月和8个月）及长期（1年和2年）的效果。
随机、平行组、优效性试验，采用盲法评估，按2:1比例招募参与者（干预组与TAU组），以考虑治疗师分组情况。
英国的三个心理健康服务机构和一个神经科服务机构。
痴呆症患者的家庭护理人员。
由受过督导的心理学专业毕业生为个体提供基于手册的八节应对干预课程。
情感症状[医院焦虑抑郁量表总分（HADS - T）]和成本效益。次要指标：焦虑和抑郁症状及病例情况、生活质量（QoL）、虐待行为和长期入住养老院情况。
260名参与者被随机分组（173人接受干预，87人接受TAU）。我们在短期（152名干预组，77名TAU组）和长期（140名干预组，69名TAU组）采用意向性分析。短期内，干预组的HADS - T得分较低[平均差值 - 1.80，95%置信区间（CI）- 3.29至 - 0.31；p = 0.02]，质量调整生命年（QALYs）较高（平均差值0.03，95% CI - 0.01至0.08）。两组成本无差异[干预组平均252英镑（95% CI - 28英镑至565英镑）]。成本效益可接受性曲线显示，在每QALY支付意愿阈值为30,000英镑时，具有成本效益的可能性大于99%，基于HADS - T得分也有很高的成本效益概率。干预组的护理人员病例级抑郁情况较少[优势比（OR）0.24，95% CI 0.07至0.76]，病例级焦虑有降低趋势（OR 0.30，95% CI 0.08至1.05），医院焦虑抑郁量表焦虑（HADS - A）得分较低（- 0.91，95% CI - 1.76至 - 0.07；p = 0.03），医院焦虑抑郁量表抑郁（HADS - D）得分较低（- 0.91，95% CI - 1.71至 - 0.10；p = 0.03），健康状况问卷（HSQ）生活质量较高（平均差值4.09，95% CI 0.34至7.83）。虐待行为的组间差异（OR 0.48，95% CI 0.18至1.27）以及痴呆症患者的生活质量 - 阿尔茨海默病（QoL - AD）差异（平均增加0.59，95% CI - 0.72至1.89）不显著。长期来看，干预组的HADS - T得分较低（平均差值 - 2.58，9
