Deprescribing Program for Dementia and Diabetes

Overseen By Christine Slyne

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Joslin Diabetes Center

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 help healthcare providers in long-term care facilities manage medications for residents with dementia and diabetes. It focuses on reducing the use of certain diabetes drugs that could cause low blood sugar, posing risks for these residents. The trial will introduce a program called STRIDE, which educates clinicians on safely reducing or stopping these medications. The trial seeks clinical staff at these facilities, such as doctors and pharmacists, who have participated in the STRIDE program. As an unphased trial, this study offers healthcare providers a unique opportunity to contribute to improving medication safety for vulnerable populations.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on reducing certain diabetes medications that have a high risk of causing low blood sugar. It's best to discuss with the trial team or your doctor.

What prior data suggests that the STRIDE educational program is safe for long term care facility residents with dementia and diabetes?

Research has shown that the STRIDE program, which simplifies diabetes treatment plans, is generally safe. Although specific safety details for STRIDE are not available, the program focuses on educating healthcare providers rather than introducing a new drug or treatment to patients.

Similar programs aim to change how doctors prescribe medications, usually posing little risk to participants. Since STRIDE seeks to reduce the use of medications that can cause low blood sugar, it may actually enhance safety by lowering the chance of such episodes.

Overall, as an educational program, STRIDE likely presents a low risk of side effects for participants. However, individual experiences may vary. Participants should consult their healthcare providers if they have any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STRIDE intervention because it offers a fresh approach to managing dementia and diabetes by focusing on deprescribing. Unlike traditional treatments that often involve adding medications to manage symptoms, STRIDE is an educational program for clinicians aimed at safely reducing unnecessary medications. This can help minimize potential side effects and interactions, potentially improving overall patient health and quality of life. By empowering healthcare providers with targeted knowledge, STRIDE stands out as a proactive method to streamline medication regimens, making it a promising step forward in patient care.

What evidence suggests that the STRIDE program is effective for deprescribing in dementia and diabetes?

Research shows that the STRIDE program, provided to participants in this trial, aims to simplify diabetes treatment and offer personalized education. It may reduce the use of high-risk diabetes medications in individuals with both dementia and diabetes. Previous studies found that patients in diabetes management programs had a 28% lower risk of developing dementia. The educational component of STRIDE assists healthcare providers in safely reducing the use of these risky medications, which can be dangerous for older adults. Although direct data on STRIDE's effectiveness is limited, its methods are based on principles that have shown promise in similar areas. ^{1 4 6 7 8}

Who Is on the Research Team?

Medha Munshi, MD

Principal Investigator

Joslin Diabetes Center

Are You a Good Fit for This Trial?

This trial is for clinical staff at long-term care facilities, including doctors, physician assistants, nurse practitioners, and clinical pharmacists. They must have participated in the STRIDE program aimed at educating on deprescribing diabetes medication for residents with Alzheimer's.

Inclusion Criteria

This criterion is not related to a clinical trial exclusion criteria. It appears to be related to the targeted providers for a specific program. If you need help with clinical trial exclusion criteria, please provide additional information.

Staff who took part in the STRIDE program (Providers doing stakeholder exit interviews).

Exclusion Criteria

Consistent with the pragmatic nature of the trial, there are no exclusion criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the STRIDE educational program to increase deprescribing of high hypoglycemia risk glucose-lowering medications among LTCF residents with ADRD

6 months

Follow-up

Participants are monitored for changes in HRM use and assessed for acceptability, appropriateness, and feasibility of the STRIDE program

6 months

What Are the Treatments Tested in This Trial?

Interventions

• STRIDE

Trial Overview The STRIDE educational program is being tested to see if it helps reduce the use of diabetes medications that carry a high risk of causing low blood sugar in elderly patients with dementia. The study will also evaluate how well the program is accepted and implemented by healthcare providers.

How Is the Trial Designed?

Group I: STRIDE Intervention Experimental Treatment 1 Intervention

Educational intervention for clinicians

Who Is Running the Clinical Trial?

Joslin Diabetes Center

Lead Sponsor

Trials

98

Recruited

26,500+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Theoria Medical

Collaborator

Trials

2

Recruited

320+

Published Research Related to This Trial

Deprescribing, or reducing unnecessary medications, is a recognized priority for improving the health of older adults with dementia, but there is limited direct evidence on its safety and efficacy specifically for this group.

A review of nineteen studies showed that most focused on medication-related outcomes rather than patient-centered results, highlighting a need for more comprehensive research that includes the perspectives of patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of deprescribing in older adults with dementia: a narrative review. Sawan, MJ., Moga, DC., Ma, MJ., et al.[2021]

A systematic review of 26 studies found that the prevalence of potentially inappropriate prescribing in older people with dementia ranges from 14% to 74%, highlighting a significant risk for adverse events in this population.

The Beers criteria were the most commonly used tool for identifying inappropriate prescriptions, but many studies did not utilize the full criteria, suggesting a need for more standardized and comprehensive application of these tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying potentially inappropriate prescribing in older people with dementia: a systematic review. Hukins, D., Macleod, U., Boland, JW.[2022]

In a study of 46,737 Medicare beneficiaries and 29,496 Danish participants, cholinesterase inhibitors like donepezil showed similar cardiovascular safety profiles, with no significant differences in the risk of myocardial infarction (MI) or heart failure compared to other medications.

Memantine was linked to a higher risk of fatal or nonfatal MI and cardiac death in the Danish cohort, as well as increased all-cause mortality in both cohorts, suggesting that patients prescribed memantine may have been sicker overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative cardiovascular safety of dementia medications: a cross-national study. Fosbøl, EL., Peterson, ED., Holm, E., et al.[2018]

A systematic review of 5 studies found that the prevalence of adverse drug events (ADEs) in older inpatients with dementia is alarmingly high at 81.5%, indicating a significant safety concern for this population.

The prevalence of adverse drug reactions (ADRs) varied between 12.7% and 24.0%, highlighting the need for better assessment methods and tailored tools to prevent these reactions in older patients with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of adverse drug events and adverse drug reactions in hospital among older patients with dementia: A systematic review. Sakiris, MA., Sawan, M., Hilmer, SN., et al.[2021]

In a study of 123 patients treated with donepezil for Alzheimer's dementia, 21% discontinued treatment due to adverse events (AEs), highlighting the need for careful monitoring during the initial months of therapy.

The most common AEs leading to discontinuation were nausea/vomiting, diarrhea, and loss of appetite, indicating that these side effects are significant considerations in the management of patients on donepezil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse events causing discontinuation of donepezil for Alzheimer's dementia]. Carøe, TK., Moe, C.[2018]

A national survey of 890 primary care physicians revealed that the two main barriers to deprescribing medications for older adults with moderate dementia are the perception of symptomatic benefit reported by patients or families, and the fact that the medication was prescribed by another physician.

Understanding these ethical concerns can help improve clinician education on medication management and deprescribing practices for older adults, ensuring safer and more effective treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethical Aspects of Physician Decision-Making for Deprescribing Among Older Adults With Dementia. Norton, JD., Zeng, C., Bayliss, EA., et al.[2023]

A study of 422 people with dementia revealed that 87% were willing to stop one or more of their medications, indicating a strong openness to deprescribing, which could enhance their quality of life.

Among those taking six or more medications, 29% believed they were on unnecessary medications, and 92% expressed willingness to deprescribe, suggesting that higher medication burden correlates with a desire to reduce medication use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes toward deprescribing among older adults with dementia in the United States. Growdon, ME., Espejo, E., Jing, B., et al.[2023]

A scoping review identified 12 studies that evaluated various tools for deprescribing medications in people with severe dementia, highlighting the complexity of this task and its potential to improve patient safety and quality of life.

Despite the development of several deprescribing tools, only one study showed a clear clinical benefit from medication withdrawal, indicating a need for more evidence-based research to assess the effectiveness of these tools in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tools for deprescribing in severe dementia: A scoping review. Wang, C., Roberts, E., Smith, G., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05535478?term=DIABINESE&rank=2

Deprescribing of Diabetes Regimens in Long Term Care ... Objectives To 1) examine the ability of the STRIDE (Simplification of Treatment Regimens and Individualized Diabetes Education) educational program to increase ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10862158/

Risk of Dementia Among Patients With Diabetes in a ... This cohort study of 55 618 participants in Hong Kong found patients with T2D who attended the diabetes primary care management program had a 28% lower risk of ...

3. stride-dementia.org stride-dementia.org/wp-content/uploads/2021/12/STRiDE_Research_Tool_3.pdf

in-depth situational analysis 5 The aim of the database is to provide access to contextual information in relation to the dementia care situation in both the original. STRiDE project ...

4. vascularnews.com vascularnews.com/stride-trial-analysis-confirms-potential-impact-of-semaglutide-on-quality-of-life-metrics-for-pad-patients-with-diabetes/

STRIDE trial analysis confirms potential impact of ... The findings of a new analysis from the STRIDE trial demonstrate the potential vascular benefits of semaglutide in patients with peripheral ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/gps.70054

Effectiveness of Interventions to Support Carers of People ... This review built on the Strengthening Responses to Dementia in Developing Countries (STRiDE) program's systematic mapping of dementia ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4282602/

The STRIDE Weight Loss and Lifestyle Intervention for ... STRIDE assessed whether a lifestyle intervention, tailored for individuals with serious mental illnesses, reduced weight and diabetes risk.

7. alzint.org alzint.org/what-we-do/research/stride/

ADI - STRiDE STRiDE is a four-year project to build capacity in dementia research in seven developing countries, in order to support development, financing, planning, ...

8. adameetingnews.org adameetingnews.org/stride-is-a-first-step-in-addressing-unmet-needs-in-comorbid-pad-and-type-2-diabetes-2/

STRIDE is a first step in addressing unmet needs ... STRIDE was a phase 3b double-blind randomized study of semaglutide in people with comorbid type 2 diabetes and PAD.