iPath for CP Pilot (care partners)
12 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
15
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Lisa A Mistler, MD
- Número de telefone: 603-731-4422
- E-mail: lisa.a.mistler@hitchcock.org
Estude backup de contato
- Nome: Susan Tarczewski, CCRP
- Número de telefone: 603-646-7066
- E-mail: susan.m.tarczewski@dartmouth.edu
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
|
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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Usability of Intervention
Prazo: 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
Prazo: 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
Prazo: 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)
|
|
Appropriateness of Intervention
Prazo: 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
Prazo: 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
|
Assessed at end of study, T1 (2 weeks)
|
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Mental health literacy
Prazo: 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.
|
Change between T0 and T1 (2 weeks)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
PHQ-9 completion
Prazo: 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
Prazo: 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.
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Assessed at end of study, T1 (2 weeks)
|
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Treatment adherence
Prazo: 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
Prazo: 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.
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Assessed at end of study, T1 (2 weeks)
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Symptom monitoring - PHQ-9
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lisa A Mistler, MD, Dartmouth-Hitchcock Health
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de junho de 2026
Conclusão Primária (Estimado)
1 de janeiro de 2027
Conclusão do estudo (Estimado)
1 de fevereiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
2 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de junho de 2026
Primeira postagem (Real)
5 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY02003455
- R03AG088962-01 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
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