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神经性厌食症患者后期护理的数字化增强:TRIANGLE随机对照试验及经济评估

Digital augmentation of aftercare for patients with anorexia nervosa: the TRIANGLE RCT and economic evaluation.

作者信息

Treasure Janet, Rowlands Katie, Cardi Valentina, Ambwani Suman, McDaid David, Lord Jodie, Clark Bryan Danielle, Macdonald Pamela, Bonin Eva, Schmidt Ulrike, Arcelus Jon, Harrison Amy, Landau Sabine

机构信息

Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.

Department of Psychology, University of Padova, Padova, Italy.

出版信息

Health Technol Assess. 2025 Jul;29(31):1-162. doi: 10.3310/ADLS3672.

Abstract

BACKGROUND

High-risk patients with complex anorexia nervosa are managed in inpatient/day patient care, but re-admission rates are high, and new treatments are needed.

OBJECTIVE(S): To examine the effectiveness of a digital augmentation of aftercare (ECHOMANTRA).

DESIGN

Transition Care In Anorexia Nervosa through Guidance Online from Peer and Carer Expertise was a multicentre, parallel-group, superiority randomised controlled trial. ECHOMANTRA augmented treatment as usual was compared with treatment as usual. Patient-carer dyads were randomised using minimisation on a 1 : 1 ratio into ECHOMANTRA + treatment as usual (ECHOMANTRA) or treatment as usual alone.

SETTING

Specialised United Kingdom inpatient/day patient sites ( = 31) participated.

PARTICIPANTS

Patient-carer dyads were randomised ( = 185 in ECHOMANTRA and  = 186 in treatment as usual).

INTERVENTIONS

The digital ECHOMANTRA intervention included self-management tools (recovery tips videos) for patients and task-sharing materials for carers (skill-sharing video), supplemented with guided group chat sessions. All participants randomised to ECHOMANTRA + treatment as usual had access to the psychoeducational materials and joint patient/carer chat sessions were also offered.

MAIN OUTCOME MEASURES

The primary outcome was patient distress at 12 months. Other outcomes included patient distress at 18 months, and eating disorder symptoms, social and work adjustment, and carer distress and skills at 12 and 18 months.

RESULTS

There was no evidence of an intervention effect on the Depression Anxiety Stress Scale-21 outcome for patients ( = 370) at 12 months, estimated effect 0.48, 95% confidence interval -0.20 to 0.23, standardised estimate (0.02,  = 0.87). In the economic analysis, the intervention was dominated by treatment as usual from both a health system and wider societal perspective, as ECHOMANTRA cost more and resulted in fewer quality-adjusted life-years gained. However, the uptake of the interactive component of the intervention (i.e. the facilitated and moderated online groups) was limited, with only 20% of the dyad members attending the pre-set minimal adherence level (i.e. both the patient and carer attending at least four online forum group sessions). The feedback about the intervention was predominantly positive. For example, the group facilitators were rated highly. However, some feedback was that the intervention offered too little, too late, and that a more personalised intervention would be more helpful.

LIMITATIONS

Participants were diverse (e.g. 20% were being treated under the Mental Health Act), and a large proportion had a range of comorbidities (depression, anxiety, obsessive-compulsive disorder and autistic spectrum disorders), all factors impacting prognosis. Although efforts were made to enhance inclusion, diversity in terms of gender, sexuality and race was limited, and technological barriers and/or lack of a carer may have led to exclusion. The high level of non-adherence to the group support (80% dyads) may have contributed to the non-significant findings.

CONCLUSIONS

This guided self-management and task-sharing intervention was reviewed positively by some patients and supporters; however, there was no evidence that the intervention improved outcomes over usual aftercare.

FUTURE WORK

Identifying mechanisms to increase engagement such as a more personalised approach to aftercare to address the diverse needs of this patient group are needed. Greater integration between intensive and step-down services with guidance from peer workers providing support may optimise care.

TRIAL REGISTRATION

This trial is registered as ISRCTN14644379.

FUNDING

This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/68/09) and is published in full in ; Vol. 29, No. 31. See the NIHR Funding and Awards website for further award information.

摘要

背景

患有复杂神经性厌食症的高危患者在住院/日间护理机构接受治疗,但再入院率很高,因此需要新的治疗方法。

目的

研究一种数字化强化后续护理(ECHOMANTRA)的有效性。

设计

通过同伴和护理专家在线指导实现神经性厌食症的过渡护理是一项多中心、平行组、优效性随机对照试验。将ECHOMANTRA强化常规治疗与常规治疗进行比较。患者-护理二元组按1∶1比例使用最小化法随机分为ECHOMANTRA+常规治疗(ECHOMANTRA组)或单纯常规治疗组。

地点

英国31个专门的住院/日间护理机构参与了研究。

参与者

患者-护理二元组被随机分组(ECHOMANTRA组185对,常规治疗组186对)。

干预措施

数字化ECHOMANTRA干预包括为患者提供的自我管理工具(康复小贴士视频)和为护理人员提供的任务分担材料(技能分享视频),并辅以引导式群组聊天会话。所有随机分配到ECHOMANTRA+常规治疗组的参与者都可以使用心理教育材料,同时也提供患者/护理人员联合聊天会话。

主要结局指标

主要结局指标是12个月时患者的痛苦程度。其他结局指标包括18个月时患者的痛苦程度,以及12个月和18个月时的饮食失调症状、社会和工作适应情况、护理人员的痛苦程度和技能。

结果

没有证据表明干预措施对12个月时患者(n=370)的抑郁焦虑压力量表-21结局有干预效果,估计效应为0.48,95%置信区间为-0.20至0.23,标准化估计值(0.02,P=0.87)。在经济分析中,从卫生系统和更广泛的社会角度来看,该干预措施被常规治疗所主导,因为ECHOMANTRA成本更高,且获得的质量调整生命年更少。然而,干预措施中互动部分(即有引导和主持的在线群组)的参与度有限,只有20%的二元组成员达到预设的最低参与水平(即患者和护理人员至少参加四次在线论坛群组会议)。关于该干预措施的反馈主要是积极的。例如,群组主持人得到了高度评价。然而,一些反馈表明该干预措施提供的内容太少、太晚,而且更个性化的干预措施会更有帮助。

局限性

参与者具有多样性(例如,20%的参与者根据《精神健康法》接受治疗),并且很大一部分人有一系列合并症(抑郁症、焦虑症、强迫症和自闭症谱系障碍),所有这些因素都会影响预后。尽管努力提高纳入率,但在性别、性取向和种族方面的多样性仍然有限,技术障碍和/或缺乏护理人员可能导致部分人被排除。对群组支持的高不依从率(80%的二元组)可能导致了无显著结果。

结论

一些患者和支持者对这种引导式自我管理和任务分担干预措施给予了积极评价;然而,没有证据表明该干预措施比常规后续护理能改善结局。

未来工作

需要确定提高参与度的机制,例如采用更个性化的后续护理方法来满足该患者群体的多样化需求。在同伴工作者提供支持的指导下,加强强化服务和逐步降级服务之间的整合可能会优化护理。

试验注册

本试验已注册为ISRCTN14644379。

资金来源

本研究由英国国家卫生与保健研究院(NIHR)卫生技术评估项目资助(NIHR资助编号:14/68/09),并全文发表于;第29卷,第31期。有关更多资助信息,请访问NIHR资助与奖项网站。

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