Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Indian Transforming Alzheimers Care Training (INTACT) (INTACT)

23 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

7

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Washington
      • Seattle, Washington, Förenta staterna, 98101
        • Washington State University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Övrig: 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
Övrig: 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
Övrig: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Clinic Level - new diagnoses of ADRD and MCI (Aim 2)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Washington State University

Samarbetspartners

University of Washington
University of Minnesota

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 oktober 2022

Primärt slutförande (Faktisk)

30 april 2026

Avslutad studie (Faktisk)

30 april 2026

Studieregistreringsdatum

Först inskickad

15 mars 2024

Först inskickad som uppfyllde QC-kriterierna

29 april 2024

Första postat (Faktisk)

2 maj 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 september 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 19630

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera