User-Led Meaningful Activity and Early-Stage Dementia

Completed · Not applicable

Conditions studied: Dementia

In brief

Neuropsychiatric symptoms are the most difficult, distressing, and burdensome aspects of dementia care and a catalyst for long-term care placement. Intervention studies have largely focused on helping caregivers manage these symptoms. However, little has been done with regard to persons at the earliest stages of dementia, nor have persons with dementia played a direct and active, central role in helping to design intervention studies. This study focuses on building, pilot testing, and evaluating a tailored activity plan developed with persons with early-stage dementia. The goal of the intervention is to provide persons at this early stage meaningful activities and a plan for adaptation with disease progression.

Key facts

Study ID

NCT05159869

Run by

Johns Hopkins University

People needed

61

Starts

2022-01-24

Expected to finish

2024-06-21

Last updated by the study team

2026-01-12

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Persons with dementia must:
• Be English-speaking
• Have a diagnosis of early-stage dementia based on standard assessments and diagnostic criteria [e.g., Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)]
• Be medically stable and responsive to the environment (e.g., not comatose). If participants with dementia are on any of four classes of psychotropic medications (antidepressant, benzodiazepines, antipsychotic, or anti-convulsant) or an anti-dementia medication (memantine or a cholinesterase inhibitor), the investigators will require that participants have been on a stable dose for 60 days prior to enrollment (typical time frame in clinical trials) to minimize possible confounding effects of concomitant medications.

You may not qualify if…

• Dementia in the moderate or severe stages
• Bed-boundedness, defined as confined to bed or chair for at least 22 hours a day for at least four of the previous seven days
• Are receiving palliative care or are at end-of-life
• A diagnosis of schizophrenia or a bipolar disorder
• Dementia secondary to probable head trauma
• The participant is taking any neuroleptic medications or has any of the following medical diagnosis: (a) restless legs syndrome, (b) delirium, or (c) akathisia, medication-induced, or other movement disorders such as Parkinson's disease or essential tremor.

Where it is running

• Johns Hopkins School of Nursing — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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