User-Led Meaningful Activity and Early-Stage Dementia

Johns Hopkins University

Status: Completed

Conditions: Dementia

Treatments: Behavioral: User-Led Meaningful Activity Plan

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05159869

IRB00191838

1K23AG05880901 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Dementia, a public health crisis, affects 47.5 million people worldwide and is projected to double in prevalence every 20 years. A degenerative disorder, dementia leads to a decreased ability to communicate and provide for oneself as the disease progresses, which often results in unmet needs. Unmet needs that are associated with dementia include boredom/sensory deprivation, loneliness, and the need for meaningful activity. The inability of persons with dementia to express or fulfill these needs has a range of adverse outcomes, including the manifestation of neuropsychiatric symptoms (NPS, e.g., agitation, aggression). As NPS 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.

The lack of involvement of persons with dementia as study partners in the co-construction of interventions results in interventions that may not be relevant to or address the needs of the very population being targeted. Greater involvement of persons with dementia in intervention development is now recognized as a critical strategy for enhancing the relevance, acceptability and reach of interventions. Research suggests that some aspects of the premorbid sense of self are preserved even in advanced stages of dementia. Failure to recognize a person with dementia's continued awareness of sense of self can result in missed opportunities for involvement as a study partner as well as for developing effective therapeutic interventions. Thus, engaging persons with dementia in intervention development in the early stages of the disease can increase the likelihood that interventions are meaningful and linked to a sense of self throughout disease progression.

This study includes persons with early-stage dementia in the development of a meaningful activity plan. Prior activity intervention studies have primarily targeted participants at a moderate or later stage of dementia; consequently, persons with early dementia have largely been underrepresented in this line of research. As meaningful activity is considered central to the well-being of persons with dementia and is known to decrease negative emotions, it is anticipated that activity rooted in the interests and values of persons with early dementia will facilitate well-being as the disease progresses. Consequently, this study evaluates the impact of a co-designed meaningful activity plan via a pilot, two-group randomized trial with a goal of 60 community-dwelling persons with early-stage dementia. Outcomes examined will include well-being, sense of control, frequency and severity of caregiver-reported NPS, sense of self, and cognition.

Enrollment: 61 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups

Experimental

Experimental group

Description:

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. There will be a check-in at 8 months. The neuropsychological battery that was administered at baseline will be re-administered 4 months and 12 months after baseline.

Treatment:

Behavioral: User-Led Meaningful Activity Plan

Wait-List Control

Active Comparator group

Description:

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. There will be a check-in at 8 months.The neuropsychological battery that was administered at baseline will be administered 4 months and 12 months after baseline.

Treatment:

Behavioral: User-Led Meaningful Activity Plan