iPath for CP Pilot (care partners)
2026年6月12日 更新者:Lisa A. Mistler、Dartmouth-Hitchcock Medical Center
Improving Screening and Access to Treatment for Depression in Care Partners of People Living With Dementia
Depression is a significant problem in care partners of people living with dementia; despite the expansion of options for accessing evidence-based treatments, most care partners of people living with dementia are not screened for depression and do not receive treatment.
The objective of this project is to identify a screening method for depression that is feasible and acceptable to care partners and to adapt an innovative pathway to online evidence-based treatment for depression (iPath*D) as a means of increasing mental health literacy, screening rates and treatment access for care partners of people living with dementia.
The results are expected to have a major positive impact by providing proof-of-principle for the use of an online pathway to evidence based treatment with the potential for reaching an unprecedented number of care partners who have unmet mental health needs.
研究概览
详细说明
Depression affects up to 34% of care partners (CP) of people living with dementia (PLWD) each year and despite the expansion of treatments, most individuals do not receive treatment.
Three key barriers to treatment exist: low detection, low mental health literacy (MHL) and limited treatment accessibility, exacerbated in rural settings.
Innovative informatics solutions to barriers exist including automating screening, enhancing MHL through decision aids (DA) and increasing accessibility via location-independent, online treatments.
Yet there is a gap in identifying strategies to screen and connect CP of PLWD with unmet mental health needs to treatments.
The objective for this GEMSSTAR is to modify an innovative application, iPATH*D, developed previously by the research team, for CP of PLWD.
iPath*D is an online platform that connects patients screening positive for clinically significant depression in rural cancer settings to a range of online and in-person evidence-based treatments.
Investigators plan to adapt both the content and implementation of iPath*D, then establish its acceptability, usability, and feasibility, overcoming the unique challenges to help-seeking CP of PLWD.
The specific aims are: Aim 1. Optimize and assess feasibility and acceptability of a pathway to identify care partners of persons living with dementia at risk for depression; and Aim 2. Determine feasibility, acceptability, and usability of implementing iPath*D with care partners of persons living with dementia and its preliminary impact on MHL, screening and treatment rates.
The study tests the hypotheses that: (1) iPath*D will be acceptable and highly usable and will demonstrate preliminary impact of increased MHL, screening rates and treatment access.
The development of iPath*D follows a user centered design model.
In Aim 1 care partners (n=15) will co-design iPath*D via participatory design activities to inform the adaptations needed to the design and functionality of iPath*D, and development of low and high-fidelity iPath*D prototypes, which will go through rounds of iterative development, with extensive usability evaluations, ensuring iPath*D surpasses usability metrics.
In Aim 2, an open label, single arm pilot, 15 care partners screening positive for depression will receive iPath*D.
Real world usability, acceptability and feasibility will be assessed, and preliminary data on MHL, rates of screening and treatment access, treatment initiation, adherence, change in caregiver burden, and depression symptom improvement will be gathered.
This research is innovative in developing and testing a novel services delivery model (iPath*D) that addresses existing barriers to care.
The results are expected to have a major positive impact by providing proof-of-principle for the use of an online pathway to treatment with the potential for reaching an unprecedented number of individuals in rural settings with unmet mental health needs by understanding and implementing the optimal design of an innovative model of services delivery for CP of PLWD who experience depression.
研究类型
介入性
注册 (估计的)
15
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Lisa A Mistler, MD
- 电话号码:603-731-4422
- 邮箱:lisa.a.mistler@hitchcock.org
研究联系人备份
- 姓名:Susan Tarczewski, CCRP
- 电话号码:603-646-7066
- 邮箱:susan.m.tarczewski@dartmouth.edu
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
For 2 Week iPath*CP Pilot:
- Adults (≥18 years)
- Care partners of persons with dementia who score ≥5 on the PHQ-8 AND PHQ-9 screen
- Can communicate in English
- Have access to an Android based or Apple iOS based phone or tablet capable of running the iPath application.
For Debrief Interviews:
- Care partners: Interviews will be conducted with a purposeful sample of 6 patients already consented into the study at the completion of T1 data collection, ensuring representation by sex (male/female), perceived usability (low/high) of iPath*CP and race/ethnicity.
- Clinicians: Interviews will be conducted with clinicians and clinical staff who had patients involved in the project.
Exclusion Criteria:
Care partners with:
- PHQ-8 score <5
- Answering positively for question 9 of the PHQ-9 who also screen positive for suicidal ideation with method, intent, plan or a recent prior suicide/self-harm attempt, as determined by a positive endorsement of items 3, 4, 5 or 6b ("Past 3 Months") on the Columbia-Suicide Severity Rating Scale (C-SSRS) and determined by Dr. Mistler, Psychiatrist at DH, not to be eligible.
- With bipolar disorder or psychosis (documented in the electronic medical record [EMR])
- With significant cognitive impairment (documented in the EMR or self-reported during eligibility screening)
- With no access to an Android or Apple device
For Debrief Interviews:
- Patients: Participants withdrawn from the 2 Week iPath*CP Pilot.
- Clinicians: None.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:iPath*CP app intervention arm
Care partners will upload the iPath*CP app and use it for 2 weeks.
The app itself will screen for depression, provide information about depression in care partners of persons with dementia, offer a decision aid regarding depression treatments, and provide a curated list of treatment options.
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iPath*CP is an app designed to screen for depression in care partners of persons with dementia, provide specific information about depression in care partners of persons with dementia, offers a decision aid to assist in deciding on treatment and also offers a curated list of potential treatment options, sortable by cost and time to access.
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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 |
|---|---|---|
|
Usability of Intervention
大体时间:Assessed after initial use of iPath app at T1 (2 weeks)
|
System Usability Scale --a widely used, free questionnaire that measures the perceived usability of a product, system, or website.
Developed by John Brooke in 1986, it provides a quick, reliable, and standardized way to capture subjective user feedback after they interact with a product.
10 items.
Each item uses a 5-point Likert scale, ranging from 1 (Strongly Disagree) to 5 (Strongly Agree).
Score ranges from 0 - 100 points, with lower scores indicating less perceived usability.
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Assessed after initial use of iPath app at T1 (2 weeks)
|
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Acceptability of Intervention
大体时间:Assessed at end of study, T1 (2 weeks)
|
Acceptability of Intervention Measure -- A 4-item measure of perceived intervention acceptability.
Items are measured on a 5-point Likert scale (1=Completely Disagree- 5=Completely Agree).
Score is calculated mean, with higher scores indicating greater acceptability.
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Assessed at end of study, T1 (2 weeks)
|
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Feasibility of Intervention
大体时间:Assessed at end of study, T1 (2 weeks)
|
Feasibility of Intervention Measure.
A 4-item measure of perceived intervention feasibility.
Items are measured on a 5-point Likert scale (1=Completely Disagree- 5=Completely Agree).
Score is calculated mean, with higher scores indicating greater perceived feasibility.
|
Assessed at end of study, T1 (2 weeks)
|
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Appropriateness of Intervention
大体时间:Assessed at end of study, T1 (2 weeks)
|
Appropriateness of Intervention Measure.
A 4-item measure of perceived intervention appropriateness.
Items are measured on a 5-point Likert scale (1=Completely Disagree- 5=Completely Agree).
Score is calculated mean, with higher scores indicating greater perceived appropriateness.
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Assessed at end of study, T1 (2 weeks)
|
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Treatment access
大体时间:Assessed at end of study, T1 (2 weeks)
|
Proportion of participants selecting a treatment path to access e.g., participants clicked on link to access online treatment service or indicated in self-report survey that they accessed local resources
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Assessed at end of study, T1 (2 weeks)
|
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Mental health literacy
大体时间:Change between T0 and T1 (2 weeks)
|
A modified 10-item version for the validated multiple choice questionnaire (MCQ) for depression assesses treatment knowledge, understanding & beliefs.
Some questions are "true-false" and some are 4 choice multiple choice.
Higher overall score (number correct out of 10 total) indicates better understanding of depression and its treatments.
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Change between T0 and T1 (2 weeks)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PHQ-9 completion
大体时间:Assessed at T0 and at 2 weeks (T1)
|
Proportion of participants out of total completing the PHQ-9 survey in iPath*CP app at T0 and T1 (≥70% completing PHQ-9 is our target).
PHQ-9 itself is a standard depression screen with 9 items.
Each of the 9 items is rated on a scale of 0 to 3 based on how often the problem has bothered the participant: 0=Not at all; 1=Several days; 2=More than half the days; 3=Nearly every day.
Overall score ranges from 0 to 27, with 27 indicating severe depression.
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Assessed at T0 and at 2 weeks (T1)
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Treatment initiation
大体时间:Assessed at end of study, T1 (2 weeks)
|
Proportion of participants that self-report treatment initiation e.g., filled antidepressant prescription, visited with psychiatrist or therapist for talk therapy, began a cCBT program.
|
Assessed at end of study, T1 (2 weeks)
|
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Treatment adherence
大体时间:Assessed at end of study, T1 (2 weeks)
|
Proportion of participants that self-report continuing to adhere to treatment e.g., antidepressant refill (yes/no), number of talk therapy sessions completed, number of cCBT modules completed.
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Assessed at end of study, T1 (2 weeks)
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Decisional regret
大体时间:Assessed at end of study, T1 (2 weeks)
|
The Decisional Regret Scale assesses decisional regret with a healthcare decision.
The Decisional Regret Scale is a 5-item Likert scale.
Respondents read each statement and use the response options to indicate how much they agree or disagree with the statement.
The scale numbers range from strongly agree (1) to strongly disagree (5).
A total of 0 = no regret and 100 indicates high regret.
|
Assessed at end of study, T1 (2 weeks)
|
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Symptom monitoring - PHQ-9
大体时间:Change across 2 week period
|
Response, 5-point reduction in baseline PHQ-9 score.
PHQ-9 is a standard depression screen with 9 items.
Each of the 9 items is rated on a scale of 0 to 3 based on how often the problem has bothered the participant: 0=Not at all; 1=Several days; 2=More than half the days; 3=Nearly every day.
Overall score ranges from 0 to 27, with 27 indicating severe depression.
Remission; PHQ-9 score of <5.
|
Change across 2 week period
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Lisa A Mistler, MD、Dartmouth-Hitchcock Health
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2027年1月1日
研究完成 (估计的)
2027年2月1日
研究注册日期
首次提交
2026年6月2日
首先提交符合 QC 标准的
2026年6月2日
首次发布 (实际的)
2026年6月5日
研究记录更新
最后更新发布 (实际的)
2026年6月16日
上次提交的符合 QC 标准的更新
2026年6月12日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.