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Formazione indiana sulla cura dell'Alzheimer per la trasformazione (INTACT) (INTACT)

23 settembre 2026 aggiornato da: Patrik Johansson, Washington State University

INTACT will utilize a group-randomized trial, to test the effectiveness of a culturally informed provider training and "dementia friendly clinic" intervention for detection and appropriate management of AI/AN patients with ADRD and MCI in 28 urban and rural clinics serving AI/ANs.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The INTACT team will conduct a group-randomized trial (GRT) to test the effectiveness of the INTACT program, a culturally informed primary care provider training and clinic level workflow intervention for detection and appropriate management of AI/AN patients with Mild Cognitive Impairment (MCI) and ADRD in 28 urban and rural clinics serving AI/ANs. The clinics are the primary unit of randomization. Within each participating clinic, PCPs who are routinely seeing AI/AN patients ages 55 years and older will be recruited for data collection at baseline and 1-year follow-up. Each clinic will be randomized either to the immediate intervention or to a wait-list control arm. Data will be collected from PCP questionnaires, Electronic Health Records (EHR) data extraction and manual medical chart reviews. At the clinic level, we will rely on EHRs to document INTACT's effect on new ADRD diagnoses. At the PCP level, we will test whether INTACT increases knowledge and confidence in dementia assessment, ADRD care, and caregiver support. Patient-level data will be collected from the EHR and by manual chart review.

Once enrolled, clinics will complete a clinic profile interview and clinic and patient population information form, PCPs will be consented and complete a baseline survey. Next the clinics will be randomized into the immediate intervention or the wait-list control arms. Data collection will be conducted at baseline and 1-year follow-up. After completing the 1-year study period, clinics in the wait-list arm will have the opportunity to receive the INTACT intervention.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

7

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.

Luoghi di studio

  • Stati Uniti
    • Washington
      • Seattle, Washington, Stati Uniti, 98101
        • Washington State University

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

CLINIC Eligibility criteria

To be eligible to participate in INTACT a clinic must be:

  1. A primary care clinic
  2. Have at least 20 AI/AN active patients 55 years or older
  3. Have an EHR system
  4. Not intending to change EHR systems in the next year
  5. Willing to conduct a total of 40 limited patient chart reviews to assess quality of care metrics for AI/AN patients with MCI and ADRD, staff permitting

PCP

Eligibility criteria:

To be eligible to participate in the baseline and follow-up surveys a primary care provider must be:

  1. have a title of MD, DO, Nurse Practitioner, or PA, and
  2. regularly provides care to AI/ANs aged 65 and older.

PATIENTS

We will only collect patient EHR data from eligible patients who:

  1. Recorded as AI/AN in the EHR system
  2. Active clinic patient with prevalent ADRD as of the first day of the time period each data extraction will cover
  3. Age 55 or older at the start of the surveillance interval
  4. At least one primary care clinic visit during the time period each data extraction will cover.

There are no exclusion criteria for the clinic, PCPs and patients.

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: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention

The INTACT Program has three components:

  1. provide a training for Primary Care Providers (PCPs) training in screening, diagnosis, and care for ADRD,
  2. at the PCP level, provide quarterly webinars. Topics will address driving and dementia; communication tips for someone with dementia; eating and drinking in advanced dementia; and advanced care planning for dementia.
  3. At the clinic level, provide a workflow model for cognitive evaluation and setting a plan for the newly diagnosed patient. The INTACT intervention lasts 12 months and Continuing Medical Education credits will be available to PCPs who complete the INTACT training program
Altro: INTACT Program

The INTACT Program has three components:

  1. provide a training for Primary Care Providers (PCPs) training in screening, diagnosis, and care for ADRD,
  2. at the PCP level, provide three optional webinars scheduled within the intervention time period. Webinars will address topics such as driving and dementia; communication tips for someone with dementia; and eating and drinking in advanced dementia.
  3. At the clinic level, provide a workflow model for cognitive evaluation and setting a plan for the newly diagnosed patient. The INTACT intervention lasts 12 months and Continuing Medical Education credits will be available to PCPs who complete the INTACT training program
Altro: Waitlist

The INTACT Program has three components:

  1. provide a training for Primary Care Providers (PCPs) training in screening, diagnosis, and care for ADRD,
  2. at the PCP level, provide quarterly webinars. Topics will address driving and dementia; communication tips for someone with dementia; eating and drinking in advanced dementia; and advanced care planning for dementia.
  3. At the clinic level, provide a workflow model for cognitive evaluation and setting a plan for the newly diagnosed patient. The INTACT intervention lasts 12 months and Continuing Medical Education credits will be available to PCPs who complete the INTACT training program
Altro: INTACT Program

The INTACT Program has three components:

  1. provide a training for Primary Care Providers (PCPs) training in screening, diagnosis, and care for ADRD,
  2. at the PCP level, provide three optional webinars scheduled within the intervention time period. Webinars will address topics such as driving and dementia; communication tips for someone with dementia; and eating and drinking in advanced dementia.
  3. At the clinic level, provide a workflow model for cognitive evaluation and setting a plan for the newly diagnosed patient. The INTACT intervention lasts 12 months and Continuing Medical Education credits will be available to PCPs who complete the INTACT training program

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Clinic Level - new diagnoses of ADRD and MCI (Aim 2)
Lasso di tempo: Baseline and 12-month follow-up

Primary outcome (as obtained directly from EHRs) will reflect the aggregate counts of new diagnoses (MCI, ADRD, other dementia) during the study period, based on the ICD-10 codes for these diagnoses.
Baseline and 12-month follow-up
PCP level - care confidence (Aim 1)
Lasso di tempo: Baseline and a 12-month follow-up

Within each clinic, each participating PCP will complete a baseline and a 12-month follow-up survey. The PCP level primary outcome is care confidence in providing dementia care to patients and their families. Care confience wil be measured using the General Practitioners Confidence and Attitude scale for Dementia (GPACS-D) whic uses a 5 point Likert scale from 1 (strongly agree) to 5 (strongly disagree). The GPACS-D scale has 3 subscales:

  1. Confidence in Clinical Abilities for which a lower score means a better outcome
  2. Attitude to Care for which a lower score means a better outcome
  3. Engagement for which a higher score means a better outcome
Baseline and a 12-month follow-up
Patient level - quality of care 1 (Aim 3)
Lasso di tempo: Baseline and a 12-month follow-up

Primary outcome (as obtained directly from EHRs) will reflect the number and type of ADRD diagnostic tests.
Baseline and a 12-month follow-up
Patient level - quality of care 2 (Aim 3)
Lasso di tempo: Baseline and a 12-month follow-up

Primary outcome (as obtained directly from EHRs) will reflect the number of prescriptions of appropriate medications for cognitive and mood symptoms.
Baseline and a 12-month follow-up
Patient level - quality of care 3 (Aim 3)
Lasso di tempo: Baseline and a 12-month follow-up

Primary outcome (as obtained directly from EHRs) will reflect the number of annual cognitive assessments.
Baseline and a 12-month follow-up
Patient level - quality of care 4 (Aim 3)
Lasso di tempo: Baseline and a 12-month follow-up

Primary outcome (as obtained directly from EHRs) will reflect the number advance care directive.
Baseline and a 12-month follow-up
Patient level - quality of care 5 (Aim 3)
Lasso di tempo: Baseline and a 12-month follow-up

Primary outcome (as obtained directly from EHRs) will reflect the number of annual evauations of functional status.
Baseline and a 12-month follow-up
Patient level - quality of care 5 (Aim 3)
Lasso di tempo: Baseline and a 12-month follow-up

Primary outcome (as obtained directly from EHRs) will reflect the number of pharmacoligical treatment changes.
Baseline and a 12-month follow-up

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Washington State University

Collaboratori

University of Washington
University of Minnesota

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 (Effettivo)

5 ottobre 2022

Completamento primario (Effettivo)

30 aprile 2026

Completamento dello studio (Effettivo)

30 aprile 2026

Date di iscrizione allo studio

Primo inviato

15 marzo 2024

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2024

Primo Inserito (Effettivo)

2 maggio 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 settembre 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

  • 19630

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

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 .

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