Meaningful Activity Intervention for Individuals With Early-Stage Dementia: Involving the End User in Intervention Design
Phase: NA
Conditions: Dementia
Sponsor: Johns Hopkins University

Protocol Title: User-Led Meaningful Activity and Early-Stage Dementia 
 
Document Title: Study Protocol  
 
NCT: NCT05159869 
 
Document Date: 03DEC2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol 
 
The clinical trial phase will be a pilot randomized, controlled trial exploring the design 
and feasibility of a novel approach to dementia intervention development. The 
randomized, controlled pilot study compares the efficacy of the co-creation of a tailored 
activity plan with a wait-list control group. Using a two-group randomized, parallel 
design, 60 persons with early-stage dementia will be assigned to treatment or wait-list 
control. 
 
Recruitment: Potential participants will be recruited through 1) the Johns Hopkins 
University Maximizing Independence (MIND) at Home study, 2) the Johns Hopkins 
Bayview Medical Center Memory Clinic, 3) community-based social agencies such as 
the Alzheimer’s Association, and 4) independent and semi-independent residences 
designed for older adults including continuing care retirement communities and assisted 
living facilities. Recruitment efforts are aimed at persons living with early-stage 
dementia and their informal/unpaid caregivers using three main forms of messaging: (a) 
flyers, (b) a description of the study that was prepared originally for clinicaltrials.gov, 
and (c) in-person recruitment presentations. All recruitment materials describe the 
general nature and goals of the research and provide information about what 
participation involves and monetary compensation. The Principal Investigator (PI) is 
listed as the source for additional information and addressing questions in all materials. 
 
Pre-Screening: Contact with potential participants will primarily be made through the 
potential participant contacting the study phone number on advertisements or speaking 
with the PI following recruitment presentations. Interested persons who believe they 
have early-stage dementia must: 1) be English-speaking, 2) be medically stable and 
responsive to the environment (e.g., not comatose), and 3) have a designated caregiver 
or care partner who lives within close proximity or resides with them. If potential 
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), it is required that he/she be on a 
stable dose for 60 days prior to enrollment (typical time frame in clinical trials) to 
minimize possible confounding effects of concomitant medications. Individuals are 
excluded if: 1) they are bed-bound, defined as confined to bed or chair for at least 22 
hours a day for at least four of the previous seven days, 2) are receiving palliative care 
or are at end-of-life, 3) have schizophrenia or a bipolar disorder, 4) their cognitive 
decline is secondary to probable head trauma, or 5) they are taking any neuroleptic 
medications or have 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. The primary criteria for inclusion in the study is 
a diagnosis of early-stage dementia, but this is not ascertained during pre-screening as 
it is contingent on the results of baseline neuropsychological assessment as described 
below. 
 
Consent: For those identified as potentially eligible at during pre-screening, the PI will 
obtain informed consent in-person immediately prior to the neuropsychological 

assessment. For caregiver and PLWD interviews, the PI introduces herself, explains the 
study purpose and procedures and reviews the Johns Hopkins University IRB approved 
informed consent. Informed consent guidelines of the Johns Hopkins University’s 
Review Board will be followed. The informed consent details the study objectives, 
procedures, steps to maintain confidentiality, and the risks and benefits of this study and 
will be presented to each participant and their caregiver in their home. The informed 
consent procedure will emphasize that participation is strictly voluntary and may be 
withdrawn at any time.  
 
Participant Remuneration: Participants will be compensated for their time based on 
length of study participation, and all persons who complete the baseline 
neuropsychological assessment will receive a minimum of $100. The maximum amount 
of remuneration is $500 at the 12-month, final data collection time point. 
 
Baseline Assessment and Screening Procedures: Following in-person informed 
consent, all potential participants will undergo in-person neuropsychological testing prior 
to randomization in order to establish baseline cognitive functioning and verify that they 
are indeed in the early stages of dementia (i.e., “mild” dementia). This testing will take 
approximately two hours and will be administered and scored/interpreted by the PI, who 
previously received extensive training in neuropsychological assessment, interpretation, 
and feedback. Cognitive domains evaluated will include global cognitive status, learning 
and memory, attention, processing speed, executive function, visuospatial skills, and 
language. If test results indicate that a participant has early-stage dementia, he or she 
will then be randomly assigned to the intervention group or wait-list control. For those 
individuals who meet criteria, assessments measuring aspects of well-being, sense of 
self, sense of control, and frequency/severity of neuropsychiatric symptoms will also be 
administered. Specifically, various subtests from the following protocols will be used: 
Test of Premorbid Function, Wechsler Memory Scale-III, Wechsler Adult Intelligence 
Scale-Fourth Edition, Trail-Making Test Parts A and B, Stroop Color-Word Test, 
Controlled Oral Word Association Test, Boston Naming Test, Rey-Osterrieth Complex 
Figure Test, and Repeatable Battery for the Assessment of Neuropsychological Status. 
The purpose of the home clinical assessment is to confirm dementia diagnosis and 
staging, review medication use, and exclude delirium and other conditions as described 
above. The Neuropsychiatric Inventory, Geriatric Depression Scale, Geriatric Anxiety 
Inventory, MIDI Sense of Control Scale, Wallhagen Perceived Control Questionnaire, 
Identity-Alzheimer Moderate Test, and IMAGE Test will also be administered.   
 
Feedback Session: The potential participant and his/her caregiver will be provided with 
feedback from the neuropsychological assessment within one week of testing. If the 
results indicate that the potential participant is cognitively healthy, meets criteria for mild 
cognitive impairment, or meets criteria for dementia that has advanced beyond the 
early, or mild, stage, this will be the final session with the potential participant. If the 
results of the assessment indicate that the potential participant is indeed at a mild stage 
of dementia, he or she and the PI will work together in a subsequent session to co-
design a meaningful activity plan and map out a gradation plan to correspond with 

disease progression. The caregiver will be advised on how to modify/grade the 
activity(ies) as the disease advances.  
 
Randomization and Study Arm Protocol: Persons randomized to the User-Led 
Meaningful Activity intervention group will begin the treatment protocol (described 
below) right after randomization. The intervention will consist of 2-3 sessions lasting 60-
90 minutes each in which participants 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. 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. 
 
Co-Design of Meaningful Activity Plan: The first co-design session will involve an 
assessment of the person living with dementia’s (PLWD) interests, values, and 
cherished “roles” (e.g., position at work, role within the family, hobby) using a range of 
performance based and self-report elicitation methods. The goal of this session is to 
identify 1-3 important interests, hobbies, or roles that the person with dementia is 
concerned about losing or disconnecting from as the disease progresses. While, ideally, 
the identification of this interest, hobby, or role should come directly from the participant, 
it is possible that some participants may need prompts or suggestions. If necessary, the 
Activity Card Sort will be used to facilitate the discussion of participant interests and 
valued roles, which will also be informed by principles from studies examining the 
values and preferences of PLWD as they relate to care. Development of the activity 
plan may take more than one session. 
 
During the second co-design session, the completed meaningful activity plan will be 
reviewed with the PLWD and their caregiver and modified if necessary. The 1-3 
meaningful activities identified in the first session will have an associated gradation plan 
to accommodate disease progression. An example gradation plan, based on the PI’s 
work with participants in the Treatment Routes for Exploring Agitation (TREA; PI: Jiska 
Cohen-Mansfield) study, is as follows: (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, the nature of the person with 
dementia’s relationship to the research will likely change. 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., BBC or National Geographic.   
 
In the final session with the PLWD and his or her caregiver, the PI will provide 
psychoeducation on the stages of dementia. This is designed to help the caregiver 
recognize signs of progression, and prepare the PLWD for greater involvement of the 

caregiver as the dementia progresses. This session will also involve a discussion of 
how to modify the activity and follow the gradation plan through the stages of dementia. 
Carer participation is essential for the delivery and sustainability of the intervention, as 
the PLWD will have increasing difficulty with activity initiation over time.   
 
Study Reminders: The PI and study staff will contact study participants monthly via 
phone to inquire about how the implementation of the meaningful activity plan is going, 
answer any questions, and elicit feedback related to intervention feasibility and 
acceptability. For persons in the wait-list control group, these phone check-ins will also 
occur each month during the four months prior to co-design and intervention 
implementation, but the focus will be reminding them of their start-date and that they are 
still enrolled in the study and study staff are looking forward to working with them. 
 
Follow-Up Data Collection Periods: Treatment group participants will receive the 
intervention, and will be reassessed at 4 months and 12 months from baseline. There 
will also be a "check-in" after 8 months' time. Four months after their baseline, wait-list 
controls will receive the same intervention and will be reassessed, and again at 12 
months from baseline. There will be an 8-month visit for wait-list controls. 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 4-12 months, 
and evaluation of intervention acceptability. 
 
Feasibility and Acceptability: Feasibility and acceptability as perceived by the PLWD 
and the caregiver will be assessed through semi-structured interviews and rating scales. 
Regarding rating scales, the PLWD and caregiver will separately be asked to rate 
intervention feasibility and acceptability using the following questions on a three-point 
Likert scale (1 = not at all, 2 = somewhat, 3 = very): 1) Was the meaningful activity plan 
useful? 2) How easy was it to incorporate the activities into your routine? 3) How easy 
was it to follow the instructions for adjusting the activities if needed? 4) Did the 
meaningful activity plan increase the amount you did enjoyable activities? 5) How 
satisfied were you with the meaningful activity plan? 6) Was participation in this study 
burdensome? 7) Do you think you will continue using the activity plan now that you are 
done with the study? 
In addition to these seven questions, the caregiver will be asked to rate the 
following on the same Likert scale: 1) Did this meaningful activity plan relieve any 
caregiving-related stress? 2) Were there any insurmountable barriers to incorporating 
these activities into your care recipient’s routine? 3) Did participation in this study 
positively impact your relationship with your care recipient?  
Feedback from the semi-structured interviews and follow-up questions in 
response to the rating scale responses will be evaluated and used in concert to capture 
the multidimensional aspects of feasibility and acceptability.