Alzheimer DiseaseINTACTNCT06397339
Indian Transforming Alzheimer's Care Training (INTACT)
A study testing INTACT Program in people with Alzheimer Disease, run by Washington State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- INTACT Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2022to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
CLINIC Eligibility criteria
To be eligible to participate in INTACT a clinic must be:
- A primary care clinic
- Have at least 20 AI/AN active patients 55 years or older
- Have an EHR system
- Not intending to change EHR systems in the next year
- 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:
- have a title of MD, DO, Nurse Practitioner, or PA, and
- regularly provides care to AI/ANs aged 65 and older.
PATIENTS
We will only collect patient EHR data from eligible patients who:
- Recorded as AI/AN in the EHR system
- Active clinic patient with prevalent ADRD as of the first day of the time period each data extraction will cover
- Age 55 or older at the start of the surveillance interval
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington State University
Seattle, Washington, 98101
About this study
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.
Read the detailed description
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.
- Conditions
- Alzheimer Disease
- Being tested
- INTACT Program
- Keywords
- ADRD, MCI
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTACT ProgramOther
The INTACT Program has three components:
- provide a training for Primary Care Providers (PCPs) training in screening, diagnosis, and care for ADRD,
- 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.
- 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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Other: INTACT Program |
| Waitlist | Other | 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 Receives: Other: INTACT Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinic Level - new diagnoses of ADRD and MCI (Aim 2)
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.
Measured: Baseline and 12-month follow-up
PCP level - care confidence (Aim 1)
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:
- Confidence in Clinical Abilities for which a lower score means a better outcome
- Attitude to Care for which a lower score means a better outcome
- Engagement for which a higher score means a better outcome
Measured: Baseline and a 12-month follow-up
Patient level - quality of care 1 (Aim 3)
Primary outcome (as obtained directly from EHRs) will reflect the number and type of ADRD diagnostic tests.
Measured: Baseline and a 12-month follow-up
Patient level - quality of care 2 (Aim 3)
Primary outcome (as obtained directly from EHRs) will reflect the number of prescriptions of appropriate medications for cognitive and mood symptoms.
Measured: Baseline and a 12-month follow-up
Patient level - quality of care 3 (Aim 3)
Primary outcome (as obtained directly from EHRs) will reflect the number of annual cognitive assessments.
Measured: Baseline and a 12-month follow-up
Patient level - quality of care 4 (Aim 3)
Primary outcome (as obtained directly from EHRs) will reflect the number advance care directive.
Measured: Baseline and a 12-month follow-up
Patient level - quality of care 5 (Aim 3)
Primary outcome (as obtained directly from EHRs) will reflect the number of annual evauations of functional status.
Measured: Baseline and a 12-month follow-up
Patient level - quality of care 5 (Aim 3)
Primary outcome (as obtained directly from EHRs) will reflect the number of pharmacoligical treatment changes.
Measured: Baseline and a 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start5 Oct 2022
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group Randomized Trial with 28 urban and rural clinics that serve AI/ANs in 11 states. INTACT will be randomized at the clinic level and delivered to PCPs in clinics. Most outcome data will be derived from EHRs and PCP surveys. The study will use an immediate intervention and waitlist control randomization pattern with clinics randomized to the immediate intervention group receiving the INTACT program after the baseline data collection and the waitlist control group after the 12-month follow-up data collection is complete.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, University of Washington
- Responsible party
- Principal investigator, Patrik Johansson, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397339
- Sponsor's protocol ID
- 19630
- Acronym
- INTACT
- Status last verified
- Jun 2026
- First submitted
- 15 Mar 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indian Transforming Alzheimer's Care Training (INTACT)
- ClinicalTrials.gov ID
- NCT06397339
- Acronym / sponsor ID
- INTACT / 19630
- Conditions
- Alzheimer Disease
- Keywords
- ADRD, MCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- University of Minnesota, University of Washington
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group Randomized Trial with 28 urban and rural clinics that serve AI/ANs in 11 states. INTACT will be randomized at the clinic level and delivered to PCPs in clinics. Most outcome data will be derived from EHRs and PCP surveys. The study will use an immediate intervention and waitlist control randomization pattern with clinics randomized to the immediate intervention group receiving the INTACT program after the baseline data collection and the waitlist control group after the 12-month follow-up data collection is complete.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: INTACT ProgramThe 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 |
| Waitlist | Other | Other: INTACT ProgramThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTACT ProgramThe 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 | Other | Intervention, Waitlist |
Primary outcome
Clinic Level - new diagnoses of ADRD and MCI (Aim 2)
Time frame: 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.
PCP level - care confidence (Aim 1)
Time frame: 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
Patient level - quality of care 1 (Aim 3)
Time frame: Baseline and a 12-month follow-up
Primary outcome (as obtained directly from EHRs) will reflect the number and type of ADRD diagnostic tests.
Patient level - quality of care 2 (Aim 3)
Time frame: 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.
Patient level - quality of care 3 (Aim 3)
Time frame: Baseline and a 12-month follow-up
Primary outcome (as obtained directly from EHRs) will reflect the number of annual cognitive assessments.
Patient level - quality of care 4 (Aim 3)
Time frame: Baseline and a 12-month follow-up
Primary outcome (as obtained directly from EHRs) will reflect the number advance care directive.
Patient level - quality of care 5 (Aim 3)
Time frame: Baseline and a 12-month follow-up
Primary outcome (as obtained directly from EHRs) will reflect the number of annual evauations of functional status.
Patient level - quality of care 5 (Aim 3)
Time frame: Baseline and a 12-month follow-up
Primary outcome (as obtained directly from EHRs) will reflect the number of pharmacoligical treatment changes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTACT Program in people with Alzheimer Disease, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinic Level - new diagnoses of ADRD and MCI (Aim 2) (time frame: Baseline and 12-month follow-up). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.