Clinical trial NCT05159869: User-Led Meaningful Activity and Early-Stage Dementia
Official title: Meaningful Activity Intervention for Individuals With Early-Stage Dementia: Involving the End User in Intervention Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Early Stage
well-being
control
neuropsychiatric symptoms
sense of self
cognitive domains
behavioral symptoms
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-12-16
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The third phase of the study will be a pilot randomized controlled trial exploring the design and feasibility of a novel approach to dementia intervention development. Using a two-group randomized, parallel design, 60 persons with dementia will be assigned to treatment (the collaborative creation of a tailored activity plan) or wait-list control. Treatment group participants will receive the activity plan intervention, and will be reassessed at six months from baseline as well as 12 months. There will also be a "check-in" after three months' time. After four months, wait-list controls will receive the same intervention and will be reassessed at six and 12 months from baseline. This design allows for estimation of effect sizes using a randomized two-group design at four months, confirmation of treatment gains for wait-listed participants from four to 12 months, and evaluation of intervention acceptability for all 60 participants.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Objectives:

The study aims are as follows: 1) To identify delivery characteristics of an activity intervention for persons with dementia at the early stage, 2) To evaluate the feasibility, acceptability, and initial potential benefits of this protocol, and 3) To evaluate the feasibility of the revised protocol and examine its effects on outcomes. An exploratory aim evaluates whether activities are used independently of the intervention. The first aim will be accomplished through a series of focus groups with persons with dementia using best practices for inclusion, where participants will assist in identifying the key delivery characteristics participants would like to see in an intervention involving purposeful and meaningful activity. This aim will result in a proto-type intervention protocol, which will be evaluated through the second aim with approximately 10 persons with early stage dementia. Findings of this open-label trial will then be shared with key informants and an expert panel, and the protocol revised as needed based on feedback. The revised, testable protocol will be submitted to further testing via a pilot, two-group randomized trial with 60 community-dwelling persons with early-stage dementia (aim 3). Outcomes examined will include well-being, sense of control, frequency and severity of NPS, sense of self, and cognition.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Premorbid cognitive function as assessed by the Wechsler Test of Adult Reading
timeFrame: Baseline and 12 months
measure: Change in global cognitive function as assessed by the Wechsler Memory Scale-III
timeFrame: Baseline and 12 months
measure: Change in the cognitive domain of attention as assessed by the Wechsler Adult Intelligence Scale
timeFrame: Baseline and 12 months
measure: Change in the cognitive domain of processing speed as assessed by the Trail-Making Test Part A
timeFrame: Baseline and 12 months
measure: Change in the cognitive domain of executive function as assessed by the Trail-Making Test Part B
timeFrame: Baseline and 12 months
measure: Change in the cognitive domain of executive function as assessed by the Stroop Color-Word Test
timeFrame: Baseline and 12 months
measure: Change in the cognitive domain of executive function as assessed by the Clock Drawing Test (CLOX)
timeFrame: Baseline and 12 months
measure: Change in the cognitive domain of memory and learning as assessed by the California Verbal Learning Test
timeFrame: Baseline and 12 months
measure: Change in the cognitive domain of immediate memory and learning as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status list learning subtest
timeFrame: Baseline and 12 months
measure: Change in the cognitive domains of memory and learning as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Story Memory subtest
timeFrame: Baseline and 12 months
measure: Change in the cognitive domain of delayed memory as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Recall subtest
timeFrame: Baseline and 12 months
measure: Change in the cognitive domain of delayed memory as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Recognition subtest
timeFrame: Baseline and 12 months
measure: Change in the cognitive domain of delayed memory as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Story Memory subtest
timeFrame: Baseline and 12 months
measure: Change in the cognitive domain of immediate visual memory as assessed by the Rey-Osterrieth Complex Figure test
timeFrame: Baseline and 12 months
measure: Change in the cognitive domain of delayed visual memory as assessed by the Rey-Osterrieth Complex Figure test
timeFrame: Baseline and 12 months
measure: Change in the cognitive domain of language as assessed by the Controlled Oral Word Association test
timeFrame: Baseline and 12 months
measure: Change in the cognitive domain of language as assessed by the Boston Naming Test
timeFrame: Baseline and 12 months
measure: Change in the cognitive domain of language as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status
timeFrame: Baseline and 12 months
measure: Change in the cognitive domain of visuospatial constructional ability as assessed by the Rey-Osterrieth Complex Figure test
timeFrame: Baseline and 12 months
measure: Frequency of neuropsychiatric symptoms in persons with dementia as assessed by the Neuropsychiatric Inventory
timeFrame: Up to 12 months
measure: Severity of neuropsychiatric symptoms in persons with dementia as assessed by the Neuropsychiatric Inventory
timeFrame: Up to 12 months
measure: Change in the cognitive domain of visuospatial ability as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change in Depression as assessed by the Geriatric Depression Scale
timeFrame: Baseline and 12 months
measure: Change in Anxiety as assessed by the Geriatric Anxiety Inventory
timeFrame: Baseline and 12 months
measure: Change in Sense of control as assessed by the Sense of Control Scale
timeFrame: Baseline and 12 months
measure: Change in Sense of control as assessed by the Wallhagen Perceived Control Questionnaire
timeFrame: Baseline and 12 months
measure: Change in sense of self as assessed by the Identity-Alzheimer Moderate Test
timeFrame: Baseline and 12 months
measure: Change in sense of self as assessed by the IMAGE Test
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Nursing
name: Natalie G Regier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Regier NG, Hodgson NA, Gitlin LN. Characteristics of Activities for Persons With Dementia at the Mild, Moderate, and Severe Stages. Gerontologist. 2017 Oct 1;57(5):987-997. doi: 10.1093/geront/gnw133.
citation: Cohen-Mansfield J, Thein K, Dakheel-Ali M, Regier NG, Marx MS. The value of social attributes of stimuli for promoting engagement in persons with dementia. J Nerv Ment Dis. 2010 Aug;198(8):586-92. doi: 10.1097/NMD.0b013e3181e9dc76.
citation: Cohen-Mansfield J, Marx MS, Dakheel-Ali M, Regier NG, Thein K, Freedman L. Can agitated behavior of nursing home residents with dementia be prevented with the use of standardized stimuli? J Am Geriatr Soc. 2010 Aug;58(8):1459-64. doi: 10.1111/j.1532-5415.2010.02951.x. Epub 2010 Jun 23.
citation: Regier NG, Gitlin LN. Dementia-related restlessness: relationship to characteristics of persons with dementia and family caregivers. Int J Geriatr Psychiatry. 2018 Jan;33(1):185-192. doi: 10.1002/gps.4705. Epub 2017 Mar 23.