Clinician-Facilitated Intervention for Dementia

JW
Overseen ByJames Wilkins, MD, DPhil
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mclean Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find a safe and effective way to reduce neuropsychiatric symptoms, such as depression or anxiety, in people with mild to moderate dementia. The study focuses on enhancing communication between individuals with dementia and their care partners to better align on everyday decisions and needs. Eligible participants include community-dwelling individuals diagnosed with mild cognitive impairment or dementia who frequently experience neuropsychiatric symptoms and have a care partner who knows them well. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve the quality of life for those with dementia.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this clinician-facilitated intervention is safe for dementia patients?

Research has shown that educational programs for dementia are generally safe and well-received. In one study, participants in a dementia education program felt more confident and better equipped to understand those with memory and thinking problems, indicating these programs can be offered without causing harm.

Additionally, lifestyle programs that include education have shown good results. Specifically, one study found that these programs improved thinking skills in older adults at risk of memory loss, without causing major side effects.

Overall, these findings suggest that educational programs led by healthcare professionals for dementia are safe for participants. There have been no major reports of negative effects in similar programs, indicating they are well-tolerated.12345

Why are researchers excited about this trial?

Researchers are excited about the clinician-facilitated educational intervention for dementia because it offers a personalized approach to care that current treatments do not typically provide. Unlike standard options, which often focus on medication or broad caregiving strategies, this intervention zeroes in on the individual preferences and social engagement of persons living with dementia or cognitive impairment. By actively involving both the patient and their care partner in identifying and addressing discrepancies in care preferences, this method aims to enhance the quality of life for those affected. This approach could pave the way for more tailored and effective dementia care practices.

What evidence suggests that this trial's treatments could be effective for reducing neuropsychiatric symptoms in dementia?

Research has shown that educational programs can help manage dementia symptoms. These programs improve the identification and handling of memory and thinking problems, which may alleviate issues like restlessness and sadness. In this trial, participants will receive a clinician-facilitated educational intervention designed to align with everyday living preferences. One study found that when caregivers learn more about dementia, the people they care for tend to fare better. This suggests that well-informed caregivers can positively affect the well-being of those with dementia. Additionally, when caregivers use specific activities to support thinking skills, it can enhance memory and focus. These findings suggest that structured educational programs, involving both people with dementia and their caregivers, can help reduce symptoms by better meeting their needs.25678

Who Is on the Research Team?

JW

James Wilkins, MD, DPhil

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

This trial is for individuals aged 55 or older with mild cognitive impairment or mild to moderate dementia, who show signs of neuropsychiatric symptoms. They must have a MoCA score above 10 and an involved care partner (family, friend, caregiver) in regular contact at least three times a week.

Inclusion Criteria

I am 55 or older with mild to moderate memory problems and a MoCA score over 10.
I experience symptoms of dementia.
I have a care partner who knows me well and contacts me at least three times a week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Intervention

Participants complete the PELI assessment to articulate preferences, and care partners complete proxy assessments. A clinician facilitates alignment of preferences.

8 weeks
3 visits (in-person or virtual)

Follow-up

Participants are monitored for changes in neuropsychiatric symptoms and alignment of preferences.

4 weeks
1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Clinician-facilitated educational intervention
  • Enhanced usual care
Trial Overview The study tests a new intervention where clinicians help align the everyday living preferences between people with dementia/cognitive impairment and their care partners. The goal is to reduce neuropsychiatric symptoms by addressing unmet needs through better decision-making alignment.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Templated, clinician-facilitated intervention to align everyday living preferences assessmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials
221
Recruited
22,500+

Citations

Educational interventions to improve detection and ...Our results show an overall successful effect of an educational intervention addressed to FPs on detection and management of cognitive decline, ...
Effectiveness of a health education program for people with ...This study assesses the effectiveness of a health education program on caregiving outcomes for people with dementia and their families.
Improving knowledge, identification, support, and care for ...The current review summarizes the educational interventions for dementia detection and management. The findings may help to reduce the burden on ...
Effectiveness of Caregiver-Provided Individual Cognitive ...Caregiver-provided individual cognitive interventions had several beneficial effects in cognitive domains, including memory, verbal fluency, attention, problem ...
Education to Improve Dementia CareThe purpose of this study was to examine the impact of this approach on self-perceived changes in knowledge, confidence, and ability to assess and manage memory ...
Effective Dementia Education and Training for the Health and ...This review aimed to identify features of effective dementia educational programs. Critical interpretive synthesis underpinned by Kirkpatrick's return on ...
U.S. POINTER Study shows lifestyle program improves ...A new study published in JAMA finds lifestyle interventions like diet and exercise improved cognition in older adults at risk of cognitive ...
Dementia Prevention Internet-Based Intervention ...In this proposal, the investigators plan to study the effectiveness of a web-based intervention on dementia prevention knowledge, intentions, and behaviour ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security