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iPath for CP Pilot (care partners)

12 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

15

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • For 2 Week iPath*CP Pilot:

    1. Adults (≥18 years)
    2. Care partners of persons with dementia who score ≥5 on the PHQ-8 AND PHQ-9 screen
    3. Can communicate in English
    4. 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:

    1. PHQ-8 score <5
    2. 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.
    3. With bipolar disorder or psychosis (documented in the electronic medical record [EMR])
    4. With significant cognitive impairment (documented in the EMR or self-reported during eligibility screening)
    5. With no access to an Android or Apple device

For Debrief Interviews:

  • Patients: Participants withdrawn from the 2 Week iPath*CP Pilot.
  • Clinicians: None.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: depression app for care partners of persons with dementia
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Usability of Intervention
Tijdsspanne: 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.
Assessed after initial use of iPath app at T1 (2 weeks)
Acceptability of Intervention
Tijdsspanne: 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.
Assessed at end of study, T1 (2 weeks)
Feasibility of Intervention
Tijdsspanne: 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
Tijdsspanne: 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.
Assessed at end of study, T1 (2 weeks)
Treatment access
Tijdsspanne: 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)
Mental health literacy
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
PHQ-9 completion
Tijdsspanne: 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.
Assessed at T0 and at 2 weeks (T1)
Treatment initiation
Tijdsspanne: 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)
Treatment adherence
Tijdsspanne: 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.
Assessed at end of study, T1 (2 weeks)
Decisional regret
Tijdsspanne: 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)
Symptom monitoring - PHQ-9
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Dartmouth-Hitchcock Medical Center

Medewerkers

National Institute on Aging (NIA)

Onderzoekers

  • Hoofdonderzoeker: Lisa A Mistler, MD, Dartmouth-Hitchcock Health

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 januari 2027

Studie voltooiing (Geschat)

1 februari 2027

Studieregistratiedata

Eerst ingediend

2 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

12 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY02003455
  • R03AG088962-01 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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