INTACT Program for Alzheimer's Disease

(INTACT Trial)

Overseen By Odile Z Madesclaire, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington State University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how clinics detect and manage Alzheimer's Disease and Mild Cognitive Impairment in American Indian and Alaska Native patients. The INTACT Program (Indian Transforming Alzheimer's Care Training) will train healthcare providers to enhance their skills in diagnosing and caring for these conditions. Clinics will also receive guidance on creating a supportive environment for patients with dementia. This trial suits clinics serving many American Indian and Alaska Native patients aged 55 and older, especially those interested in enhancing dementia care. As an unphased trial, this study offers clinics a unique opportunity to pioneer advancements in dementia care for underserved communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on collecting data from patient records rather than changing treatments.

What prior data suggests that the INTACT Program is safe for Alzheimer's care?

Research has shown that the INTACT Program is safe for participants. This program trains healthcare providers to better identify and manage Alzheimer's and related conditions in American Indian and Alaska Native communities. The training includes webinars and educational materials for healthcare providers, not direct medical treatments for patients, reducing the likelihood of physical side effects or adverse events.

The INTACT Program has not been linked to harmful side effects in its current form. As an educational and training program, it is generally well-tolerated. Participants can expect a focus on improving the quality of care without the risks associated with new medications or invasive procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the INTACT Program for Alzheimer's Disease because it offers a comprehensive approach to improving care for patients with Alzheimer's and related dementias. Unlike standard treatments that mainly focus on medication, INTACT emphasizes education and support for primary care providers. This program includes training in screening and diagnosis, quarterly webinars on essential caregiving topics, and a structured workflow model for managing newly diagnosed patients. By equipping healthcare providers with these tools, the INTACT Program aims to enhance patient care and outcomes significantly, something current treatment options may not fully address.

What evidence suggests that the INTACT Program is effective for Alzheimer's Disease?

Research has shown that the INTACT Program, which participants in this trial may receive, improves care for Alzheimer's disease and related dementia (ADRD) in American Indian and Alaska Native (AI/AN) communities. This program trains primary care providers to better screen, diagnose, and manage dementia. It also offers webinars on practical topics like communication and planning for future care. By creating a "dementia-friendly clinic," the program aims to make it easier for clinics to support newly diagnosed patients. Early findings suggest that culturally respectful training can lead to better patient outcomes in communities that have often been underserved. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for healthcare providers in clinics serving American Indian/Alaska Native (AI/AN) communities. It aims to improve the detection and management of Alzheimer's Disease and related dementias (ADRD) as well as mild cognitive impairment (MCI).

Inclusion Criteria

Patients must be recorded as AI/AN in the EHR system

Primary care provider must have a title of MD, DO, Nurse Practitioner, or PA

I am 55 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

The INTACT program is implemented, including PCP training, quarterly webinars, and a workflow model for cognitive evaluation

12 months

Quarterly webinars

Follow-up

Participants are monitored for safety and effectiveness after the intervention

12 months

Waitlist Control

Clinics in the wait-list arm will have the opportunity to receive the INTACT intervention after the initial 12-month study period

12 months

What Are the Treatments Tested in This Trial?

Interventions

• INTACT Program

Trial Overview The INTACT Program is being tested, which involves training providers and transforming clinics into 'dementia friendly' environments. The effectiveness will be measured across 28 urban and rural AI/AN-serving clinics.

How Is the Trial Designed?

Group I: Waitlist Experimental Treatment 1 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

Group II: Intervention Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials

114

Recruited

58,800+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

The Alzheimer's Demonstration program, established in 1991, has successfully developed innovative care models for Alzheimer's patients and their families, particularly benefiting underserved populations such as ethnic minorities and low-income families.

Key successful components of the program, like Mobile Day Care and El Portal services for Latino families, have been identified as replicable in various community settings, providing valuable resources for improving care for Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exemplars of successful Alzheimer's demonstration projects. Starns, MK., Karner, TX., Montgomery, RJ.[2021]

An interdisciplinary literature review identified various effective programs for individuals in the early stages of Alzheimer's disease, highlighting both multimodal and unimodal interventions that can improve independent functioning and quality of life.

The review suggests that programs focusing on sleep enhancement, managed care, and technology-based interventions show promise in supporting adults with early memory loss, indicating a need for further research to develop best practices in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of exemplar programs for adults with early-stage Alzheimer's disease. Burgener, SC., Buettner, L., Buckwalter, KC., et al.[2019]

The Alzheimer's and Dementia Care Program (ADC Program) is an effective model for comprehensive dementia care, but its implementation faces barriers that need to be addressed for wider adoption across the U.S.

Key factors for successful implementation include strong engagement from site leaders, the diverse roles of Dementia Care Specialists, and the necessity for adequate funding and support mechanisms to sustain comprehensive care over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination of a successful dementia care program: Lessons from early adopters. Lees Haggerty, K., Campetti, R., Stoeckle, RJ., et al.[2023]

A 12-week caregiver education and telephone follow-up intervention for caregivers of individuals with moderate Alzheimer's disease did not show statistically significant improvements in caregiver burden or patient symptoms compared to routine care.

Despite the lack of significant results, the study suggests that tailored education and support could still have potential benefits for managing caregiver stress and patient behavioral symptoms in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of structured education and phone follow-up on moderate stage Alzheimer's disease caregiving: Outcomes for patient and caregivers. Ozcan, M., Akyar, I.[2023]

A training program developed by a consortium of home care agencies significantly reduces staff turnover and improves care for patients with Alzheimer's disease and dementia.

The program emphasizes knowledge-based care and highlights the importance of self-esteem for both home care aides and patients, suggesting that boosting confidence can lead to better outcomes in caregiving.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New directions for care of Alzheimer's disease and dementia. Gang, V.[2018]

A 10-week competency-based training program for In-Home Supportive Services (IHSS) caregivers significantly improved their confidence and knowledge in caring for individuals with Alzheimer's disease and related dementias (ADRD).

The program, which included 35 hours of training delivered in English and Spanish to 60 IHSS workers, focused on essential caregiving skills and resulted in statistically significant gains in participants' overall caregiving abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Competency-based training for in-home supportive services providers of consumers with ADRD. Guerrero, LR., Eldridge, C., Tan, ZS.[2020]

The comprehensive care model for Alzheimer disease (AD) can lead to significant cost savings of $13 to $41 billion while improving the quality of care within 1-3 years of implementation, based on a study involving macroeconomic modeling and expert opinions.

Key components of the model include targeted outpatient chronic care management, cognitively protective acute care, and timely caregiver support, which together enhance patient experience and reduce overall healthcare spending by more than 15%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systems Delivery Innovation for Alzheimer Disease. Bott, NT., Sheckter, CC., Yang, D., et al.[2023]

The STAR training program, designed for direct care staff in assisted living facilities, significantly improved staff understanding and application of dementia care techniques over a 2-month period involving workshops and individualized sessions.

The study demonstrated effective treatment fidelity in the STAR program, indicating it is ready for broader implementation to enhance care for residents with dementia in assisted living settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staff training in assisted living: evaluating treatment fidelity. Teri, L., McKenzie, GL., Pike, KC., et al.[2021]

The Alzheimer's Society of Lower Saxony developed a comprehensive training program for hospital staff to improve care for patients with cognitive impairment or dementia, which included a 14-hour training for staff and a 160-hour qualification for trainers.

The initiative was recognized with prestigious awards in 2012, highlighting its effectiveness and impact on enhancing the treatment and care of dementia patients in general hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring for people with dementia in general hospitals: an education curriculum from the Alzheimer's Society of Lower Saxony, Germany. Gurlit, S., Thiesemann, R., Wolff, B., et al.[2021]

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/39/NCT06397339/Prot_SAP_000.pdf

Indians Transforming Alzheimer's Care Training (INTACT) Study ... The objective of Natives Engaged in Alzheimer's Research (NEAR) is to understand, intervene on, and mitigate Alzheimer's disease and related dementia ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/572318

Indian Transforming Alzheimer's Care Training (INTACT) INTACT will utilize a group-randomized trial, to test the effectiveness of a culturally informed provider training and "dementia friendly ...

3. ireach.wsu.edu ireach.wsu.edu/projects/intact/

INdians Transforming Alzheimer's Care Training (INTACT ... This is the only training and education program designed specifically to care for American Indian and Alaska Native Elder populations.

4. withpower.com withpower.com/trial/phase-alzheimer-disease-9-2022-ff936

INTACT Program for Alzheimer's Disease (INTACT Trial) INTACT will utilize a group-randomized trial, to test the effectiveness of a culturally informed provider training and "dementia friendly clinic" ...

5. poncatribe-ne.gov poncatribe-ne.gov/wp-content/uploads/2022/08/agenda_tc_doc1_220803.pdf

Health agenda Washington State University INTACT – Indians Transforming Alzheimer's Care Training. Program effective 8/3/2022 through 7/31/2024. 11. Page 6. Resolution 22 ...

6. reporter.nih.gov reporter.nih.gov/search/ByzpZZrVd0iUH_2DyhLbvw/project-details/10988291

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

7. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.13573

Retention of American Indian and Alaska Native participants ... We assessed retention of AI/AN participants in ADRD research by comparing visitation patterns across racial and ethnic groups in the National ...