User-Led Meaningful Activity and Early-Stage Dementia

Dementia Clinical Trial

Official title:

Meaningful Activity Intervention for Individuals With Early-Stage Dementia: Involving the End User in Intervention Design

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05159869
• Other study ID #: IRB00191838
• Secondary ID: 1K23AG05880901
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2022
• Est. completion date: November 2024

Study information

• Verified date: June 2024
• Source: Johns Hopkins University
• Contact: Natalie G Regier, PhD
• Phone: 410-502-6876
• Email: nregier1[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• User-Led Meaningful Activity Plan
The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression. For example, (1) an individual who is/was a researcher may continue to maintain a job, conduct research, and even publish papers in the early stages of dementia. (2) As the dementia progresses, he or she may be able to continue to run analyses and read/access literature in his or her field. (3) In the moderate stages of dementia, this participant may read his or her existing publications or go to museums showcasing research of interest. As the disease approaches the severe stage, the participant may read very basic books about his or her former profession. (4) In the severe stages of dementia, this study participant may watch videos related to the former profession, e.g., British Broadcasting Corporation (BBC) or National Geographic.

Locations

Country	Name	City	State
United States	Johns Hopkins School of Nursing	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Premorbid cognitive function as assessed by the Wechsler Test of Adult Reading	General intellectual abilities/premorbid cognitive functioning will be assessed via the Wechsler Test of Adult Reading (WTAR). The WTAR is composed of 50 irregularly spelled words and takes approximately 10 minutes to complete. The test is discontinued when the participant provides 12 consecutive incorrect pronunciations. Each correct pronunciation is given a score of 1, and raw scores range from 0-50 with higher scores indicating higher premorbid cognitive function. The raw score is standardized by age and a scaled score is obtained by comparing to the participant's score to normative data based on their demographic classification.	Baseline and 12 months
Primary	Change in global cognitive function as assessed by the Wechsler Memory Scale-III	Global cognitive function will be measured by the Wechsler Memory Scale-III (WMS-III) information/orientation subtest, which assesses general personal information and orientation to person, place, and time. Scores range from 0-14, with higher scores indicating more intact global cognitive function.	Baseline and 12 months
Primary	Change in the cognitive domain of attention as assessed by the Wechsler Adult Intelligence Scale	Attention will be assessed via the Wechsler Adult Intelligence Scale (WAIS-IV) digit span subtests. Digit Span Forward requires participants to repeat series of digits of increasing length in the same order as the examiner (score range: 0-12, with higher scores indicating better attention). Digit Span Backward requires participants to repeat series of digits of increasing length in the reverse order of the examiner (score range: 0-12, with higher scores indicating better attention). Digit Span Sequencing requires participants to sequentially order the numbers presented by the examiner (score range: 0-12, with higher scores indicating better attention and working memory). Every series on each digit span subtest consists of two trials, each of which is scored 1 or 0 points. Administration is discontinued when the participant scores 0 on both trials of an item. Raw scores are converted to a scaled score and percentile rank based on normative data.	Baseline and 12 months
Primary	Change in the cognitive domain of processing speed as assessed by the Trail-Making Test Part A	Processing speed will be assessed via the Trail-Making Test Part A (Trails A). Participants must draw lines connecting 25 numbered circles in sequential order within a maximum time of 150 seconds (score range: 0-150 seconds, with higher scores indicating slower processing speed). Raw scores are converted to a scaled score and percentile rank based on normative data.	Baseline and 12 months
Primary	Change in the cognitive domain of executive function as assessed by the Trail-Making Test Part B	Executive function will be assessed via the Trail-Making Test Part B (Trails B). Participants must draw lines connecting 13 numbered circles alternately with 12 letters of the alphabet, all in ascending order. Participants are given a maximum time of 300 seconds (score range: 0-300 seconds, with higher scores indicating poorer executive function). Raw scores are converted to a scaled score and percentile rank based on normative data.	Baseline and 12 months
Primary	Change in the cognitive domain of executive function as assessed by the Stroop Color-Word Test	Executive function will be assessed via the Stroop Color-Word Test. The Stroop contains a word page (the names of colors printed in black ink), a color page (rows of Xs printed in colored ink), and a word-color page (the words from the first page are printed in the colors from the second page, but the word meanings and ink colors are mismatched). Each page has five columns containing 20 items. The participant must look at each sheet and move down the columns, reading words or naming the ink colors as quickly as possible, within a time limit of 45 seconds. Three scores, as well as an interference score, are generated using the number of items completed on each page, with higher scores reflecting better performance and less interference on reading ability. Raw scores are converted to a scaled score and percentile rank based on normative data.	Baseline and 12 months
Primary	Change in the cognitive domain of executive function as assessed by the Clock Drawing Test (CLOX)	Executive function will be assessed via the Clock Drawing Test. Participants will be asked to draw a clock, put in all the numbers, and set the hands to a specific time. The results will be scored using the CLOX method, which specifically evaluates executive function. CLOX scores range from 0-15. Lower scores reflect greater impairment.	Baseline and 12 months
Primary	Change in the cognitive domain of memory and learning as assessed by the California Verbal Learning Test	Executive function will be assessed via the California Verbal Learning Test (CVLT-II). Participants will hear a list of 16 nouns, read at one-second intervals, in fixed order, over five learning trials (list A). After each trial, the subject is asked to recall as many words as they can in any order. List B, an interference list that shares two categories from List A and has two unshared categories, is then presented. Free and cued recall of list A are tested immediately (short-delay), and again after 20 minutes (long-delay). A higher number of words (range 0-16) recalled for free and cued immediate and delayed recall indicate more intact memory and new learning abilities.	Baseline and 12 months
Primary	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	Immediate memory and new learning will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest of list learning. In list learning, 10 semantically unrelated words are orally and visually presented to the subject. The words are presented visually in lowercase letters at a two-second rate. Within the two seconds, each word is visible to the subject for 1.25 seconds, followed by a 0.75-second interval between one word and the next. The examiner reads the words aloud when they appear on the screen so the subject receives audio-visual information. The subject is asked to repeat as many words as possible after each of four learning trials. A higher number of words recalled (range 0-16) indicate more intact immediate memory. Raw scores are converted to a scaled score and percentile rank based on normative data.	Baseline and 12 months
Primary	Change in the cognitive domains of memory and learning as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Story Memory subtest	Memory and new learning will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest story memory. Story Memory is a twelve-item short story presented over two trials. The story is presented visually in three separate parts and read aloud simultaneously at a slow reading speed. After each presentation, the subject is asked to recall as much of the story as he or she can remember, with more items recalled indicating more intact immediate memory. A verbatim criterion is used. Raw scores are converted to a scaled score and percentile rank based on normative data.	Baseline and 12 months
Primary	Change in the cognitive domain of delayed memory as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Recall subtest	Delayed memory will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest of list recall. List recall requires the participant to remember as many words (range 0-16) from the list learning test as possible after a delay, with a higher number of words recalled indicating more intact delayed recall. Raw scores are converted to a scaled score and percentile rank based on normative data.	Baseline and 12 months
Primary	Change in the cognitive domain of delayed memory as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Recognition subtest	Delayed memory will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest of List Recognition. List recognition require the participant to remember as many words (range 0-16) from the list learning task as possible when given visual cues, with a higher number of words recalled indicating more intact delayed recall. Raw scores are converted to a scaled score and percentile rank based on normative data.	Baseline and 12 months
Primary	Change in the cognitive domain of delayed memory as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Story Memory subtest	Delayed memory will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest of Story Recall. In Story Recall, participants are asked to recall as many specific details as possible from the story learned in the story memory subtest, with more details indicating more intact delayed recall. Raw scores are converted to a scaled score and percentile rank based on normative data.	Baseline and 12 months
Primary	Change in the cognitive domain of immediate visual memory as assessed by the Rey-Osterrieth Complex Figure test	Immediate visual (non-verbal) memory will be assessed via the Rey-Osterrieth Complex Figure (ROCF) test. Participants will first copy a complex geometric figure and then immediately reproduce it from memory. Scoring of drawings is based on the widely used 36-point scoring system, with higher scores indicating more intact immediate visual memory. Each of the 18 scoring units is scored based on accuracy and placement criteria. Raw scores are converted to a scaled score and percentile rank based on normative data.	Baseline and 12 months
Primary	Change in the cognitive domain of delayed visual memory as assessed by the Rey-Osterrieth Complex Figure test	Delayed visual (non-verbal) memory will be assessed via the Rey-Osterrieth Complex Figure (ROCF) test. Participants are asked to draw all the elements of the figure from the initial figure copy that he or she can recall without visual display of the figure. Scoring of drawings is based on the widely used 36-point scoring system, with higher scores indicating more intact delayed visual memory. Each of the 18 scoring units is scored based on accuracy and placement criteria. Raw scores are converted to a scaled score and percentile rank based on normative data.	Baseline and 12 months
Primary	Change in the cognitive domain of language as assessed by the Controlled Oral Word Association test	Language, specifically verbal fluency, will be assessed via the Controlled Oral Word Association (COWA) test. Participants are asked to come up with as many words as possible that begin with a given letter within a one-minute time period. Participants are also instructed to exclude proper nouns, numbers, and the same word with a different suffix. The number of correct responses is totaled, with higher numbers indicating greater verbal fluency, and the sum compared with normative data.	Baseline and 12 months
Primary	Change in the cognitive domain of language as assessed by the Boston Naming Test	Language will be assessed via the Boston Naming Test (BNT). Participants are asked to name 60 line drawings of objects of graded difficulty, ranging from very common objects to less familiar ones. Objects must be spontaneously named within a 20-second period. If this time limit expires, two kinds of prompting cues (one phonemic, one semantic) may be given. Rules allow for discontinuation and for starting the test at an advanced level, thus saving considerable time for subjects without obvious impairment. The examiner will then total the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. A higher number of correct spontaneous responses indicates more intact language skills. Scores will be compared to normative data.	Baseline and 12 months
Primary	Change in the cognitive domain of language as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status	Language will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) semantic fluency subtest. This test involves the generation of as many examples as possible from a given semantic category within one minute. Scoring is based on comparison with normative data.	Baseline and 12 months
Primary	Change in the cognitive domain of visuospatial constructional ability as assessed by the Rey-Osterrieth Complex Figure test	Visuospatial constructional ability will be assessed via the Rey-Osterrieth Complex Figure (ROCF) test. Scoring of drawings is based on the widely used 36-point scoring system, with higher scores indicating more intact visuospatial constructional ability. Each of the 18 scoring units is scored based on accuracy and placement criteria. Raw scores are converted to a scaled score and percentile rank based on normative data.	Baseline and 12 months
Primary	Frequency of neuropsychiatric symptoms in persons with dementia as assessed by the Neuropsychiatric Inventory	Frequency of neuropsychiatric symptoms is measured by the Neuropsychiatric Inventory (NPI) as reported by the primary care partner. The NPI is comprised of twelve domains, and each of the domains contains a survey question that reflects key symptoms of that domain. Initial responses to each domain question are "Yes" (present) or "No" (absent). If the response to the domain question is "No", the examiner proceeds to the next question.	Up to 12 months
Primary	Severity of neuropsychiatric symptoms in persons with dementia as assessed by the Neuropsychiatric Inventory	Frequency of neuropsychiatric symptoms is measured by the Neuropsychiatric Inventory (NPI) as reported by the primary care partner. The NPI is comprised of twelve domains, and each of the domains contains a survey question that reflects key symptoms of that domain. Initial responses to each domain question are "Yes" (present) or "No" (absent). If the response to the domain question is "No", the examiner proceeds to the next question. If "Yes", the examiner asks the proxy informant to rate both the Severity of the symptoms present within the last month on a 3-point scale and the associated impact of the symptom manifestations on care partner distress level using a 5-point scale. The NPI-Q provides symptom Severity and Distress ratings for each symptom reported, and total Severity and Distress scores reflecting the sum of individual domain scores.	Up to 12 months
Primary	Change in the cognitive domain of visuospatial ability as assessed by the Repeatable Battery for the Assessment of Neuropsychological Status	Visuospatial ability will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest of Line Orientation. Line Orientation measures the ability to match the angle and orientation of lines in space. Participants are asked to match two angled lines to a set of 13 lines radiating from a single point in a semicircular fan shape. Below, there are two lines and the participant must determine what lines they match by placement and direction over 10 trials. Higher scores indicate more intact visuospatial ability. Raw scores are converted to a scaled score and percentile rank based on normative data.	Baseline and 12 months
Secondary	Change in Depression as assessed by the Geriatric Depression Scale	Depression in persons with dementia will be measured by the Geriatric Depression Scale (GDS-15). The GDS-15 is a 15-item self-report scale tested and used extensively with older adults. Scores of 0-4 are considered normal, while scores of 5-8 signify mild depression, 9-11 signify moderate depression, and 12-15 indicate severe depression.	Baseline and 12 months
Secondary	Change in Anxiety as assessed by the Geriatric Anxiety Inventory	Anxiety in persons with dementia will be measured by the Geriatric Anxiety Inventory (GAI). The GAI is comprised of 20 "Agree/Disagree" items designed to assess typical common anxiety symptoms. Scores range from zero (low anxiety) to 63 (high anxiety). The following cutoff scores are supported in the literature: 0-7 (normal anxiety), 8-15 (mild-moderate anxiety), 16-25 (moderate-severe anxiety), and 26-63 (severe anxiety).	Baseline and 12 months
Secondary	Change in Sense of control as assessed by the Sense of Control Scale	Sense of control in persons with dementia will be measured by the Sense of Control Scale. This scale has 12 items that measure a person's sense of control over her or his life. Items are scored on a seven-point Likert scale (1=strongly disagree' 2=disagree somewhat' 3=disagree a little' 4=don't know' 5=agree a little, 6=agree somewhat' and 7=strongly agree). Scores range from 12-84, with higher scores indicating greater perceived control.	Baseline and 12 months
Secondary	Change in Sense of control as assessed by the Wallhagen Perceived Control Questionnaire	Sense of control in persons with dementia will be measured by the Wallhagen Perceived Control Questionnaire. The Perceived Control Questionnaire (PCQ) is a 20-item questionnaire that measures two dimensions of perceived control: a) manageability, or the belief that one can handle the demands imposed by oneself or one's environment and b) goal attainment, or the belief that expectations or goals derived from self-generated or environmental demands can be accomplished. The PCQ has a 5-point Likert-type response format ranging from strongly agree to strongly disagree. Higher scores indicate greater perceived control.	Baseline and 12 months
Secondary	Change in sense of self as assessed by the Identity-Alzheimer Moderate Test	Sense of self in persons with dementia will be measured by the Identity-Alzheimer Moderate test (I-AM). This requires participants to complete 20 sentences beginning with "I Am..." Due to the population under study, the sentences will be completed orally, i.e., dictated to the examiner. Responses will be scored according to the scheme developed by Watkins et al. Scoring categories include idiocentric, small-group, large-group, and allocentric responses. Scores are calculated for the overall number of statements generated, the number of responses belonging to each category or subcategory, the emotional valence, and the number of different categories/subcategories.	Baseline and 12 months
Secondary	Change in sense of self as assessed by the IMAGE Test	Sense of self in persons with dementia will be measured by the IMAGE test (denoted only by the acronym IMAGE). This test is comprised of 24 descriptive statements, 21 of which refer to the concepts of identity, behavior, and self-satisfaction. Each component contains seven statements belonging to one of seven self-concept domains (moral-ethical, social, personal, physical, family, cognition, emotion). Responses are scored on a four-point Likert scale as follows: 1=totally false, 2=partly false, 3=partly true, and 4=totally true. The total score was obtained by summing all items (maximum score = 96), with higher scores indicating more intact sense of self in a given domain.	Baseline and 12 months