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临床试验/NCT07631247
NCT07631247尚未招募不适用

Improving Screening and Access to Treatment for Depression in Care Partners of People Living With Dementia

Dartmouth-Hitchcock Medical Center0 个研究点目标入组 15 人开始时间: 2026年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
15
主要终点
Usability of Intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

iPath*CP app intervention arm

Experimental

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.

干预措施: depression app for care partners of persons with dementia (Other)

结局指标

主要结局

Usability of Intervention

时间窗: 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.

Acceptability of Intervention

时间窗: 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.

Feasibility of Intervention

时间窗: 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.

Appropriateness of Intervention

时间窗: 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.

Treatment access

时间窗: 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

Mental health literacy

时间窗: 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.

次要结局

  • PHQ-9 completion(Assessed at T0 and at 2 weeks (T1))
  • Treatment initiation(Assessed at end of study, T1 (2 weeks))
  • Treatment adherence(Assessed at end of study, T1 (2 weeks))
  • Decisional regret(Assessed at end of study, T1 (2 weeks))
  • Symptom monitoring - PHQ-9(Change across 2 week period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisa A. Mistler

Principal Investigator

Dartmouth-Hitchcock Medical Center

相似试验

iPath for CP Pilot | 临床试验