Educational Program for Alzheimer's Disease

(DPRESCRIBE-AD2 Trial)

Overseen By Cassie L Saphirak, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Must be taking: Alzheimer's medications

Must not be taking: Sedatives, Antipsychotics, Anticholinergics

Disqualifiers: Nursing home, Palliative care, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce the risks of inappropriate medication use in people with Alzheimer's disease or related dementias. It tests whether educational materials sent to patients, their caregivers, and healthcare providers can improve medication safety. Two groups receive educational mailings, with one group receiving a follow-up mailing, while a control group receives usual care. Participants must have been diagnosed with Alzheimer's or related dementias and prescribed certain potentially unsuitable medications. This trial may be relevant for those with Alzheimer's who are taking medications like sedatives or antipsychotics. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance medication safety for Alzheimer's patients.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it focuses on reducing potentially inappropriate prescriptions. It might involve discussions with your healthcare provider about the safety of your current medications.

What prior data suggests that this educational program is safe for patients with Alzheimer's disease?

Research has shown that the educational materials used in the study do not involve medications or physical treatments. Instead, they provide information to patients and caregivers. As these are purely educational resources, no reports of side effects or issues like those in drug trials have emerged.

Educational programs are generally considered safe because they aim to inform and guide rather than physically alter the body. The goal is to help patients and caregivers make informed decisions about medications. This approach seeks to improve communication with healthcare providers without introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this educational program for Alzheimer's disease because it offers a novel approach by directly involving both patients and caregivers with targeted educational materials. Unlike standard treatments that primarily focus on medication to manage symptoms, this program emphasizes empowerment through information, potentially enhancing understanding and management of the disease. The unique aspect of delivering these materials through mailings—either as a single or two-part series—provides a simple yet potentially impactful way to improve communication and care coordination between patients, caregivers, and healthcare providers. This method could lead to better quality of life and care outcomes without the side effects associated with drug treatments.

What evidence suggests that this educational program is effective for reducing inappropriate prescribing in Alzheimer's patients?

Research has shown that educational programs can greatly improve medication safety for people with Alzheimer's. In this trial, participants will receive educational materials tailored to the cultural and language needs of caregivers and patients. These materials teach caregivers about the dangers of incorrect prescriptions, potentially reducing medication-related problems. For Alzheimer's patients, this education enhances communication between caregivers and healthcare providers, promoting safer medication use. Early results suggest that these educational efforts can reduce the use of potentially harmful medications, improving health outcomes for those with Alzheimer's disease. ^{1 3 5 6 7}

Who Is on the Research Team?

Jerry H Gurwitz, MD

Principal Investigator

UMass Chan Medical School; UMass Memorial Medical Center;

Are You a Good Fit for This Trial?

This trial is for older adults with Alzheimer's Disease who live in the community, have been diagnosed based on specific codes or are taking Alzheimer's medication, and may be receiving potentially inappropriate medications like sedatives or antipsychotics.

Inclusion Criteria

I have been diagnosed with Alzheimer's or related dementia and have been treated with specific medications for it in the last year.

I am 50 years old or older.

I have been prescribed antipsychotics, sedatives, or strong anticholinergics in the last 3 months.

Exclusion Criteria

Incomplete/missing prescriber ID or incomplete contact information for either patient or prescribing provider

On 'do not contact' list

I live in a nursing home or receive palliative care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a combined patient/caregiver and provider educational intervention with one or two mailings to spur communication about medication safety

6 weeks

Observation

Participants are monitored for the absence of inappropriate medication prescription dispensing and other secondary outcomes

6 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Educational Materials

Trial Overview The study tests an educational program designed to inform patients with Alzheimer's and their caregivers about the risks of certain medications. The goal is to see if this education can reduce unnecessary or harmful prescriptions compared to usual care.

How Is the Trial Designed?

Group I: Two Mailings Experimental Treatment 1 Intervention

A combined patient/caregiver and provider educational intervention with a second identical mailing, following the first within 45 days

Group II: Single Mailing Experimental Treatment 1 Intervention

A combined patient/caregiver and provider educational intervention with one mailing to each.

Group III: Usual Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Carelon Research

Collaborator

Trials

76

Recruited

125,000+

Harvard Pilgrim Health Care

Collaborator

Trials

61

Recruited

27,990,000+

Humana Healthcare Research, Inc.

Collaborator

Trials

2

Recruited

15,600+

Published Research Related to This Trial

An 11-minute educational DVD combined with a group discussion led by an oncology nurse effectively improved patients' understanding of chemotherapy side effects and self-care management.

Surveys conducted after the class and at an eight-week follow-up indicated that this approach empowered patients and families, enhancing their confidence in managing side effects of chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering individuals to self-manage chemotherapy side effects. Fee-Schroeder, K., Howell, L., Kokal, J., et al.[2022]

A study assessing printed cancer education materials (PCEMs) for African Americans found that over half (56.2%) were culturally insensitive, particularly in their visual messaging.

To improve effectiveness, future PCEMs should incorporate culturally sensitive visuals, and the newly developed assessment tool can help ensure these materials resonate better with African American audiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing cultural sensitivity in printed cancer materials. Guidry, JJ., Walker, VD.[2022]

About one-third of the 251 adult patients surveyed at a public hospital clinic had low literacy levels, which significantly impacted their ability to correctly interpret prescription medication warning labels.

Patients with low literacy were 3.4 times less likely to understand these labels correctly, highlighting the need for clearer, simpler warning labels that are easier for all patients to comprehend, especially those with lower literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low literacy impairs comprehension of prescription drug warning labels. Davis, TC., Wolf, MS., Bass, PF., et al.[2022]

Current medication labeling standards in the U.S. pose significant safety risks for immigrant and language-minority families, particularly those with limited English proficiency and literacy in their native language.

There is a pressing need for new research and policy changes to improve medication understanding and adherence among recent Latin American immigrants, as existing regulations do not adequately address their cultural and linguistic needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lost in translation: Medication labeling for immigrant families. Smith, MC., Yin, HS., Sanders, LM.[2021]

A participatory approach involving over 200 health providers and clients led to the creation of culturally targeted cancer education brochures for Native Hawaiians, focusing on various types of cancer.

The new brochures, featuring culturally relevant imagery and language, were found to be more appealing and comprehensible, especially to younger Hawaiians, suggesting they could effectively improve cancer education in this community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a participatory four-step protocol to develop culturally targeted cancer education brochures. Kulukulualani, M., Braun, KL., Tsark, JU.[2021]

Culturally sensitive cancer prevention education materials are essential for effectively reaching ethnically diverse populations, as most existing resources focus primarily on breast cancer and target African American communities.

There is a lack of standardized definitions and reliable measures for assessing cultural sensitivity in cancer education materials, highlighting the need for best practice guidelines that incorporate the specific cancer knowledge and beliefs of ethnic minority groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of culturally sensitive cancer prevention resources for ethnic minorities. Hoffman-Goetz, L., Friedman, DB.[2021]

Citations

1. withpower.com withpower.com/trial/phase-alzheimer-disease-5-2024-6f735

Educational Program for Alzheimer's Disease ... What data supports the effectiveness of the treatment Educational Materials, Culturally and Linguistically Tailored Cancer Education Materials for Alzheimer's ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6543161/

Developing education materials for caregivers of culturally ... To explore the information needs of caregivers of culturally and linguistically diverse (CALD) patients, and how they access and understand health information.

3. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.14211

Community recruitment of underrepresented populations to ... Moreover, previous studies showed that culturally and linguistically tailored educational interventions could effectively increase awareness and ...

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/14713012231213911

A culturally and linguistically tailored Community-Engaged ... This paper reports on the results of the key informants' perception of the Houston Vietnamese American community's health literacy on dementia/ ...

5. aspe.hhs.gov aspe.hhs.gov/reports/national-plan-2021-update

National Plan to Address Alzheimer's Disease: 2021 Update Goal 1: Prevent and Effectively Treat Alzheimer's Disease and Related Dementias by 2025. Goal 2: Enhance Care Quality and Efficiency.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11712139/

The process of creating culturally and linguistically ... We started by researching existing educational materials on dementia for individuals with various health literacies. A draft of a 3‐panel brochure was drawn up ...

7. apha.confex.com apha.confex.com/apha/2025/meetingapi.cgi/Session/74316?filename=2025_Session74316.pdf&template=Word

Session supporting culturally tailored apps that improve access to resources and help seeking. The PIC Health Study identified key components of a culturally ...