- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07631247
iPath for CP Pilot (care partners)
2 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
15
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Lisa A Mistler, MD
- Numero di telefono: 603-731-4422
- Email: lisa.a.mistler@hitchcock.org
Backup dei contatti dello studio
- Nome: Susan Tarczewski, CCRP
- Numero di telefono: 603-646-7066
- Email: susan.m.tarczewski@dartmouth.edu
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Usability of Intervention
Lasso di tempo: Assessed after initial use of iPath app at T1 (2 weeks)
|
System Usability Scale (10 items; mean ≥68/100)
|
Assessed after initial use of iPath app at T1 (2 weeks)
|
|
Acceptability of Intervention
Lasso di tempo: Assessed at end of study, T1 (2 weeks)
|
Acceptability of Intervention Measure (4 items).
|
Assessed at end of study, T1 (2 weeks)
|
|
Feasibility of Intervention
Lasso di tempo: Assessed at end of study, T1 (2 weeks)
|
Feasibility of Intervention Measure (4 items)
|
Assessed at end of study, T1 (2 weeks)
|
|
Appropriateness of Intervention
Lasso di tempo: Assessed at end of study, T1 (2 weeks)
|
Appropriateness of Intervention Measure (4 items)
|
Assessed at end of study, T1 (2 weeks)
|
|
Treatment access
Lasso di tempo: Assessed at end of study, T1 (2 weeks)
|
Proportion of patients selecting a treatment path to access e.g., click on link to access online treatment service | indicate in self-report survey accessing local resources
|
Assessed at end of study, T1 (2 weeks)
|
|
Mental health literacy
Lasso di tempo: 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
|
Change between T0 and T1 (2 weeks)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
PHQ-9 completion
Lasso di tempo: Assessed at T0 and at 2 weeks (T1)
|
Proportion of patients completing in iPath*CP (≥70%, DH target)
|
Assessed at T0 and at 2 weeks (T1)
|
|
Treatment initiation
Lasso di tempo: Assessed at end of study, T1 (2 weeks)
|
Proportion of patients self-report treatment initiation e.g., filled antidepressant prescription | visited with psychiatrist for talk therapy | began a cCBT program | other service
|
Assessed at end of study, T1 (2 weeks)
|
|
Treatment adherence
Lasso di tempo: Assessed at end of study, T1 (2 weeks)
|
Proportion of patients self-report continued to adhere to treatment e.g., antidepressant refill (yes/no) | number of talk therapy sessions completed | cCBT modules completed
|
Assessed at end of study, T1 (2 weeks)
|
|
Decisional regret
Lasso di tempo: Assessed at end of study, T1 (2 weeks)
|
The Decisional Regret Scale assesses decisional regret with a healthcare decision (5-item).
|
Assessed at end of study, T1 (2 weeks)
|
|
Symptom monitoring - PHQ-9
Lasso di tempo: Change across 2 week period
|
Response, 5-point reduction in baseline PHQ-9 score.
Remission; PHQ-9 score of <5.
|
Change across 2 week period
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Lisa A Mistler, MD, Dartmouth-Hitchcock Health
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 giugno 2026
Completamento primario (Stimato)
1 gennaio 2027
Completamento dello studio (Stimato)
1 febbraio 2027
Date di iscrizione allo studio
Primo inviato
2 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
2 giugno 2026
Primo Inserito (Effettivo)
5 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STUDY02003455
- R03AG088962-01 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .