检查用于推进精神分裂症疾病自我管理和提供者参与的数字健康方法
由于多种因素,精神分裂症的有效治疗非常具有挑战性。
这些问题包括与治疗计划和护理提供者接触不佳、由于卫生服务资源不足而与提供者接触有限以及精神分裂症症状固有的挑战等问题。 这些问题的结果包括频繁、冗长和昂贵的再入院、生活质量低下、痛苦程度高以及难以发挥有价值的社区作用。 数字健康技术是一种很有前途的模式,可以帮助解决这些问题。 它们是一种低成本且易于获得的支持形式,尚未针对精神分裂症谱系疾病患者进行实质性开发或研究。 在这项研究中,将测试一种正在开发的此类技术的可行性:App4Independence (A4i)。 A4i 提供定制的应对提示、点对点网络和促进提供者更好参与的门户。 这项研究将为这项新技术的发展提供关键信息,以解决该领域的一个关键问题——如何在资源有限的情况下加强护理,在这种情况下,提供者与患者的接触是短暂的、不频繁的,并且依赖于当下的回忆和患者的自我宣传。 这些发现将为更大规模的研究和软件开发计划奠定基础,该计划将 (i) 跨多个站点验证该技术,以及 (ii) 促进与医疗保健系统和护理人员网络的互动,以扩大对这一有前途资源的访问。
研究概览
详细说明
问题陈述:在精神分裂症谱系人群中,治疗依从性差,社区支持有限,促进疾病自我管理的努力收效甚微。 这些挑战导致频繁、冗长且昂贵的再入院以及不良的功能结果。 反过来,数字健康战略在解决这些问题的努力中具有相当大的前景。 在整个医疗保健领域,数字健康是一个快速发展的领域,因为它具有潜在的覆盖面、可访问性、低成本以及对使用数据定制治疗和识别风险轨迹的影响。 尽管有这样的承诺,但出于不完全清楚的原因,与其他医疗保健领域相比,针对更严重的心理健康状况(如精神分裂症)的数字健康策略的开发和研究要少得多。
目的:该可行性试验将检验一个数字健康平台,该平台旨在加强精神分裂症患者的疾病自我管理和治疗参与度。
技术:研究人员和合作者开发并试用了一种名为 App4Independence (A4i) 的数字技术。 该平台旨在 (i) 通过行为激活提示和同伴策略共享帮助防止社会孤立,(ii) 通过利用基于证据的策略的功能(例如,来自认知和行为的文本提示)加强对精神分裂症症状的应对疗法),并提供一种有助于识别幻听的新技术,(iii)通过日程安排、文本和提醒功能提高治疗依从性,(iv)通过主动(自我)跟踪健康/风险水平和个人目标的进展评级)和被动(睡眠监测代理)指标,以及(v)通过提供者仪表板促进与护理提供者的沟通,该仪表板总结了在约会之间收集的平台收集的数据。
合作伙伴:这项研究建立在成瘾和心理健康中心(研究能力、心理健康服务和相关专业知识、接触患者群体)与 MEMOTEXT 之间的合作伙伴关系之上,MEMOTEXT 是一家健康技术公司,在数字健康方法方面有着成功的记录多种健康状况和护理环境。
研究设计:这项单盲、随机对照试验检验了 A4i 的可行性。 可行性指标包括研究招募和保留、技术使用率、安全性和临床交互中的实用性。 其他结果指标包括症状学、治疗依从性、患者-提供者联盟和生活质量。 在此试验中,研究参与者将被随机分配到治疗或对照条件,并在 6 个月的时间内测量前后结果。
影响:这项研究将为这项新技术的发展提供关键信息,以解决精神分裂症领域的一个关键问题——如何利用技术来加强疾病自我管理和资源有限服务环境中的护理参与。 这些发现将为评估 A4i 对医院再入院和功能的影响的更大规模试验奠定基础——为商业化和扩大对该工具的使用提供重要证据。 这项工作处于探索和验证精神分裂症数字健康方法的国际努力的前沿。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ontario
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Toronto、Ontario、加拿大、M6R2C4
- Centre for Addiction and Mental Health
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 参与者将是 18 岁或以上的成年人,并通过结构化诊断访谈 (SCID-5)40 确认图表诊断为 DSM-5 精神分裂症谱系疾病。
- 所有参与者都将接受门诊精神病治疗。
- 英语方面很熟练。
- 拥有并使用 Android 或 iOS 智能手机。
排除标准:
- 缺乏能力,没有确定的替代决策者。
- 智力残疾。
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:A4i 干预
App4独立(A4i) 实验:A4i Intervention App4Independence (A4i) 该研究干预是数字健康平台 A4i。 A4i 在个人自己的手机上运行,无论是否有数据。 具体的 A4i 功能包括:
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在个人自己的设备上提供 A4i 的 6 个月。
其他名称:
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无干预:照常治疗
与往常一样,治疗参与者将通过加拿大大型城市中心提供的标准支持(最典型的是病例管理和精神科支持)接受门诊心理保健。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Recruitment
大体时间:Through recruitment process an average of 1 week during a 21 month recruitment period.
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Number of individuals successfully recruited into the trial with a target of 91.
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Through recruitment process an average of 1 week during a 21 month recruitment period.
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Retention
大体时间:6 months per participant in a 27 month period.
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Number of participants retained in the study through to post-intervention evaluation.
The target is retaining 85% of participants recruited.
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6 months per participant in a 27 month period.
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App Interactions
大体时间:Up to 6 months.
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Number of interactions with the app will be collected including information on the combined time and frequency of use for each participant.
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Up to 6 months.
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Incidence of Treatment-Emergent Adverse Events
大体时间:Up to 6 months.
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Safety/tolerability will be assessed through information gathered via all study-related interactions with significant safety concerns operationalized as one or more critical incidents occurring in which there is evidence of an association between the incident and App use.
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Up to 6 months.
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App Likes
大体时间:Up to 6 months.
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Total number of posts liked for each participant will be collected.
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Up to 6 months.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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BSI: Psychiatric Symptoms
大体时间:Baseline-6 months.
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General symptomatology will be assessed using the 53-item, 5-point likert scale Brief Symptom Inventory.
Range 0-212.
Lower values are better.
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Baseline-6 months.
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BARS: Medication Adherence
大体时间:Baseline-6 months.
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Medication adherence will be measured using the 4-item Brief Adherence Rating Scale with responses obtained by both providers and participants to assess medication adherence. There are two indicators, both are pre-post changes, "days not taken" and "days taken less", and both are not scored as a percentage. The change scores for taking medication less (days taken less) and medication not taken (days not taken) were calculated as the difference from their 6 month score minus their baseline score. An value of "better" was assigned when the change score is > 0, value of "no change" was assigned when the change score is = 0, and a value of "worse" value was assigned when the change score is < 0. |
Baseline-6 months.
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STAR-P: Patient Relationship With Clinician
大体时间:Baseline-6 months.
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Provider-Patient Clinical Alliance will be assessed with Scale to Assess the Therapeutic Relationship - Patient to measure patient perspective of provider-patient relationship.
This 12-item measure employing a 5-point likert scale has been used extensively in studies of outpatient care for severe mental illness.
This measure supports patient and provider versions.
Higher values are better.
Range 0-48.
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Baseline-6 months.
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QLS: Heinrichs-Carpenter Quality of Life Scale
大体时间:Baseline-6 months.
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The Heinrichs-Carpenter Quality of Life Scale, has 21 items, is well validated for schizophrenia, and captures sense of purpose, motivation, emotional and social interaction, role functioning, and engagement in regular activities. Higher values are better. Range 0-126. Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre). |
Baseline-6 months.
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PANSS: Schizophrenia Symptoms
大体时间:Baseline-6 months.
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Schizophrenia-specific symptomatology will be assessed with the Positive and Negative Syndrome Scale. Lower values are better. Range 30-210. Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre). |
Baseline-6 months.
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GAIN-SS
大体时间:Baseline-6 months.
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Global Appraisal of Individual Needs- Short Screener (GAIN-SS) - Instrument used for screening possible internalizing or externalizing psychiatric disorders, substance use disorders, or crime and violence problems. Lower values are better. Range 0-20. Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre). |
Baseline-6 months.
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MOS: Treatment Adherence - General
大体时间:Baseline-6 months.
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The 5-item, 6-point likert scale Medical Outcomes Study general adherence scale to capture broader adherence to treatment recommendations (again triangulated with provider responses). Higher values are better. Range 5-26. Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre). |
Baseline-6 months.
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Appointment Attendance
大体时间:Baseline-6 months.
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The average rate of scheduled appointments attended through EMR audit at CAMH or provider report at non-CAMH sites.
No show vs. attending rates for both arms do not add up to 100% since an additional measure of cancelled rates was measured in the RCT.
However, this variable was excluded from analysis since in the client's medical records it is unclear whether the clinician or client cancelled the appointment.
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Baseline-6 months.
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STAR-C: Clinician Relationship With Patient
大体时间:Baseline - 6 months
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Provider-Patient Clinical Alliance will be assessed with Scale to Assess the Therapeutic Relationship - Patient to measure patient perspective of provider-patient relationship. This 12-item measure employing a 5-point likert scale has been used extensively in studies of outpatient care for severe mental illness. This measure supports patient and provider versions. Higher values are better. Range 0-48. Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre). |
Baseline - 6 months
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SUH - Patients
大体时间:baseline - 6 months
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Service Use History measure to assess past month service use history.
Number of visits due to physical health issues (in the past 6 months) included the sum of: family doctor, ER, walk-in clinic, and other services Number of visits due to mental health issues (in the past 6 months) included the sum of: sum of family doctor, outpatient, psychologist, social worker, community service There is no limit on the scale range since it is based on the number of visits to various services in the past 6 months.
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baseline - 6 months
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SUH - Clinicians
大体时间:Baseline - 6 months
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Service Use History measure to assess past month service use history of patient participant. Number of visits due to physical health issues (in the past 6 months) included the sum of: family doctor, ER, walk-in clinic, and other services for the patient participant Number of visits due to mental health issues (in the past 6 months) included the sum of: sum of family doctor, outpatient, psychologist, social worker, community service for the patient participant There is no limit on the scale range since it is based on the number of visits to various services in the past 6 months. |
Baseline - 6 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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