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

Trial Summary

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 data supports the effectiveness of the INTACT Program treatment for Alzheimer's disease?

The Alzheimer's and Dementia Care Program (ADC Program) is a comprehensive care model that has been effective in providing care for Alzheimer's disease, and similar structured education and follow-up interventions have shown positive outcomes for both patients and caregivers. Additionally, programs that include multimodal interventions have demonstrated promise in supporting and improving the quality of life for individuals in the early stages of Alzheimer's disease. ^{1 2 3 4 5}

How is the INTACT Program treatment for Alzheimer's disease different from other treatments?

The INTACT Program is unique because it focuses on training caregivers and healthcare providers to improve care for Alzheimer's patients, rather than being a medication or direct medical intervention. This approach emphasizes education and skill-building to enhance the quality of care and support for individuals with Alzheimer's disease. ^{1 6 7 8 9}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dissemination of a successful dementia care program: Lessons from early adopters. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Systems Delivery Innovation for Alzheimer Disease. [2023]

3. Japan 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Review of exemplar programs for adults with early-stage Alzheimer's disease. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Staff training in assisted living: evaluating treatment fidelity. [2021]

6. Germany 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. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Competency-based training for in-home supportive services providers of consumers with ADRD. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Exemplars of successful Alzheimer's demonstration projects. [2021]