← Back to Search

Meaningful Activity Plan for Dementia

N/A
Recruiting
Led By Natalie G Regier, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Persons with dementia must be English-speaking
Be older than 18 years old
Must not have
Persons with dementia who are bed-bounded, defined as confined to bed or chair for at least 22 hours a day for at least four of the previous seven days
Persons who are taking any neuroleptic medications or have any of the following medical diagnoses: (a) restless legs syndrome, (b) delirium, or (c) akathisia, medication-induced, or other movement disorders such as Parkinson's disease or essential tremor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Summary

This trial focuses on helping those with early-stage dementia by providing them with tailored activity plans.

Who is the study for?
This trial is for English-speaking individuals with an early-stage dementia diagnosis, as per DSM-5 criteria. They must be medically stable and not bed-bound or in palliative care. Participants should have been on a consistent medication dose for at least 60 days if they're taking certain drugs.
What is being tested?
The study tests a user-led activity plan tailored for people with early-stage dementia. It aims to provide meaningful activities that can adapt as the disease progresses, with direct input from the participants themselves.
What are the potential side effects?
Since this intervention involves non-medical activities, traditional side effects like those seen with medications are not expected. However, there may be emotional or psychological responses to new activities which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have dementia and I speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have dementia and have been mostly bed-bound for the last week.
Select...
I am not on neuroleptic medications and do not have restless legs, delirium, akathisia, Parkinson's, or essential tremor.
Select...
My dementia is in the moderate or severe stage.
Select...
My dementia is likely due to a head injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Premorbid cognitive function as assessed by the Wechsler Test of Adult Reading
Change in global cognitive function as assessed by the Wechsler Memory Scale-III
Change in the cognitive domain of attention as assessed by the Wechsler Adult Intelligence Scale
+19 more
Secondary outcome measures
Anxiety
Change in Depression as assessed by the Geriatric Depression Scale
Change in Sense of control as assessed by the Sense of Control Scale
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
Group II: Wait-List ControlActive Control1 Intervention
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,704 Previous Clinical Trials
28,033,187 Total Patients Enrolled
278 Trials studying Dementia
23,628,793 Patients Enrolled for Dementia
Johns Hopkins UniversityLead Sponsor
2,285 Previous Clinical Trials
14,842,995 Total Patients Enrolled
31 Trials studying Dementia
82,459 Patients Enrolled for Dementia
Natalie G Regier, PhDPrincipal InvestigatorJohns Hopkins School of Nursing

Media Library

User-Led Meaningful Activity Plan Clinical Trial Eligibility Overview. Trial Name: NCT05159869 — N/A
Dementia Research Study Groups: Experimental, Wait-List Control
Dementia Clinical Trial 2023: User-Led Meaningful Activity Plan Highlights & Side Effects. Trial Name: NCT05159869 — N/A
User-Led Meaningful Activity Plan 2023 Treatment Timeline for Medical Study. Trial Name: NCT05159869 — N/A
~2 spots leftby Nov 2024
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.
Back to top