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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have dementia and I speak English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
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 moreSecondary 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 moreTrial 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.
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Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,993 Total Patients Enrolled
266 Trials studying Dementia
23,625,290 Patients Enrolled for Dementia
Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,710 Total Patients Enrolled
31 Trials studying Dementia
82,732 Patients Enrolled for Dementia
Natalie G Regier, PhDPrincipal InvestigatorJohns Hopkins School of Nursing
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have dementia and have been mostly bed-bound for the last week.I am not on neuroleptic medications and do not have restless legs, delirium, akathisia, Parkinson's, or essential tremor.I have dementia, am alert, and have been on stable medication for 60 days.My dementia is in the moderate or severe stage.My dementia is likely due to a head injury.I have dementia and I speak English.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental
- Group 2: Wait-List Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What aims is this trial striving to achieve?
"The primary outcome of this clinical trial, monitored over a period of Baseline and 12 months, is the alteration in global cognitive function evaluated via the Wechsler Memory Scale-III. Secondary outcomes include changes to perceived control as measured by Wallhagen's Perceived Control Questionnaire (PCQ), selfhood rated on Identity-Alzheimer Moderate Test (I-AM) and IMAGE Test respectively. The PCQ evaluates an individual’s ability to handle their environment or reach goals through a 5 point Likert scale ranging from strongly agree to strongly disagree; I-AM assesses sense of identity orally with responses placed"
Answered by AI
Is recruitment for this trial ongoing?
"Affirmative. Clinicaltrials.gov's data establishes that this clinical trial, initially unveiled on January 24th 2022, is actively searching for participants. Approximately 70 patients need to be recruited from 1 medical centre."
Answered by AI
What is the scope of participants receiving treatment in this medical research?
"Affirmative. Documentation available on clinicaltrials.gov verifies that this research study is currently enrolling subjects. This investigation was initially published on January 24th 2022 and has been modified since then - 70 participants are being accepted from a single centre of care."
Answered by AI
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