Decision Aid for Dementia

Overseen By Kaitlynn Walton, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Moderate dementia, Severe dementia, 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 focuses on creating a tool to assist patients and families in making decisions about dementia treatments. It aims to develop a decision aid to guide users in understanding and choosing medications for dementia. The trial seeks individuals diagnosed with mild cognitive issues or early dementia and their primary caregiver who assists with medical decisions. Both should speak English or Spanish. Participants will provide feedback to improve this decision aid.

As an unphased trial, this study offers participants the chance to contribute to a tool that could significantly aid others in making informed decisions about dementia care.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this decision aid is safe for patients and families?

Research shows that decision aids in dementia care are safe and helpful. Studies have found that these aids can increase understanding and improve discussions about care options. For instance, researchers created a web-based tool called "Safety in Dementia" to help caregivers make safer choices about issues like firearm access. These aids primarily provide information and support decision-making, posing little risk. Overall, users receive them well, and they do not cause harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Aid for dementia because it offers a novel approach to treatment selection. Unlike traditional methods that focus solely on medications or therapies, this Decision Aid empowers patients and caregivers by helping them understand and choose the best available dementia therapies tailored to their specific needs. This approach prioritizes personalized care and informed decision-making, enhancing the overall treatment experience for individuals with dementia.

What evidence suggests that this decision aid is effective for dementia?

Research shows that decision aids, like the one developed in this trial, can assist in making choices about dementia care. Studies find that they clarify decisions and reduce stress for caregivers. They also enhance understanding and improve family discussions about options. Additionally, these aids help older adults better comprehend their healthcare choices. Overall, decision aids prove to be a useful tool in managing dementia care decisions. ^{2 5 6 7 8}

Who Is on the Research Team?

Dan Matlock, MD, MPH

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for UCHealth patients aged 60 or older with mild cognitive impairment or early dementia, as well as their caregivers and healthcare providers involved in dementia care. Participants must speak English or Spanish.

Inclusion Criteria

I am over 18, have memory problems as diagnosed by my doctor, and speak English or Spanish.

My caregiver is over 18 and speaks English or Spanish.

I am a healthcare professional involved in dementia care and speak English or Spanish.

Exclusion Criteria

I am a clinician who does not speak English or Spanish.

Patients who are not English or Spanish-speaking, have neurocognitive deficits suggestive of moderate or severe cognitive impairment or late-stage dementia, or are not able to consent for themselves

My caregiver is under 18 or doesn't speak English/Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development

Development of a decision aid based on international standards and user-centered design

11 months

Qualitative Assessment

Conduct a qualitative decision needs assessment of pharmacologic therapies for dementia

11 months

Pilot Feasibility

Pilot study to determine the feasibility and acceptability of a decision aid

12 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Decision Aid

Trial Overview

The study aims to create a decision aid tool to help patients with dementia and their families decide on medication treatments. It involves patients, their primary support person, and healthcare professionals.

How Is the Trial Designed?

Group I: Decision Aid Experimental Treatment 1 Intervention

Participants provide feedback on the development of a decision aid for dementia therapies.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31347482/

Decision aids to support decision-making in dementia care

The meta-analysis demonstrated that decisions are effective in reducing decisional conflict among caregivers (standardized mean difference = -0.50, 95% ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1041610224023792

Decision aids to support decision-making in dementia care

The decision aids were shown to be effective, increasing knowledge and the quality of communication. The meta-analysis demonstrated that decisions are effective ...

3.

jamanetwork.com

jamanetwork.com/journals/jamainternalmedicine/fullarticle/2587643

Effect of the Goals of Care Intervention for Advanced ...

The GOC decision aid intervention was effective to improve quality of communication for nursing home residents with advanced dementia, and to ...

4.

bmcmedinformdecismak.biomedcentral.com

bmcmedinformdecismak.biomedcentral.com/articles/10.1186/s12911-016-0281-8

Decision aids to help older people make health decisions

This review shows promising results on the effectiveness of decision aids for older adults. Decision aids improve older adults' knowledge, ...

5.

jmir.org

jmir.org/2025/1/e71479

Digital Decision Aids to Support Decision-Making in ...

This systematic review aimed to critically evaluate and synthesize evidence on the effectiveness of digital decision aids to support decision-making in ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40549433/

Digital Decision Aids to Support Decision-Making in ...

Patient decision aids could provide information on potential options about risks and benefits, incorporate individual values and preferences, ...

7.

researchprotocols.org

researchprotocols.org/2023/1/e43702

A Web-Based Decision Aid for Caregivers of Persons With ...

The “Safety in Dementia” (SiD) web-based decision aid was developed to support caregivers in addressing firearm access; the efficacy of SiD is ...

8.

alz-journals.onlinelibrary.wiley.com

alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.70636

Supporting decision making for individuals living with ...

In our umbrella review, we assessed existing KT interventions aimed at helping individuals living with dementia and their care partners make ...