Mass Practice of Activities of Daily Living in Dementia (STOMP)

A. BACKGROUND: Progressive disability in activities of daily living (ADL) is inevitable for people with Alzheimer's disease and related dementias (ADRD). Attempts to slow or prevent ADL disability have been unsuccessful despite making progress in behavioral training methods. Missing from this research is an emphasis on how investigators maximize a patient's engagement during training and the rigorous examination of implementation protocols (dosing and training methods) which may advantage learning in people with ADRD. Our team addressed this gap with the development of the STOMP (Skill-building through Task-Oriented Motor Practice) intervention which creates methods for obtaining ADL goals that support "personhood" and tests high-intensity protocols that appear to advantage learning as well as sustained learning over time. Through our first specific aim, the investigators will examine the learning and retention of learning advantages offered through receipt of an intensive versus less-intensive STOMP protocol. In our second aim,the investigators will examine sustained attention to task during training as a differential contributor to our outcomes.

B. RESEARCH DESIGN/METHODS

1. Design: Randomized-controlled trial over a two-week intervention period and a 3-month post-intervention follow-up period that will occur over 24 months. The investigators will employ block randomization where participants are randomized in blocks of randomly chosen sets of two or four, ultimately resulting in eight participants randomized to each group in the first year and a total of 16 participants assigned to each group by the end of 20 months. Two occupational therapists (OT), blinded to group assignment will complete baseline, post-intervention and 3-month follow-up assessments. The treating occupational therapy assistant (OTA) will be given the group assignment by the PI after the baseline evaluation is complete.
2. Recruitment: The investigators intend to recruit 32 participants (through assent) and legally-authorized representatives (through informed consent) employing a variety of methods. The primary recruitment strategy will be the use of direct mailing which has been successfully used by other teams recruiting people with ADRD.9 A letter of invitation explaining the study and ways to participate will be mailed to zip codes adjacent to University of Oklahoma Health Sciences Center (OUHSC) through the United States Postal Service. Second, collaborating physicians (Drs. Hershey and Odenheimer) will refer appropriate candidates. Dr. Hershey, a neurologist specializing in dementia diagnosis and treatment with OUHSC, sees >200 people/year with various forms of dementia. Dr. Odenheimer, a neurologist with the VA sees 30 new patients/year with dementia and 45 unique return visits/year. Other forms of recruitment will include: media (e.g., campus emails, newspaper advertisements, websites, television news stories) and presentations at local chapters of the Alzheimer's Association support group. Previous recruitment has occurred primarily through media/presentations (60%) and physician recruitment (40%).
3. Procedures: Figure 2 clearly outlines the manualized study procedures which are taught to the OT/OTA through a 40-hour certification course. Protocol preparation: The Canadian Occupational Performance Measure (COPM) includes a semi-structured interview that will assist the OT in facilitating family/participant chosen ADL, home management or leisure goals that support retention of personhood for the person with dementia. Goals chosen through the COPM are performed by the participant and assessed by the OT in order to develop measurable GAS outcomes. Each goal must have an identifiable beginning and concluding step for creation of "practice-able" steps for task-oriented training. Practice-able steps will embed both task modifications and assistive technology determined by the OT to support performance and will be situated contextually within the participant's habits and environment. To enhance transfer of training to the caregivers, we will invite caregivers to watch the intervention daily and require hands-on training of the intervention one day/week. The intervention protocol incorporates important multi-component features of motor learning. Each group will practice the task as many times as possible during their allotted time in training. For the intensive protocol, each hour of training will focus on 1 of 3 identified goals and will include 50 minutes of intervention and a 10 minute break. The less-intensive protocol is based on home health treatment protocols where patients are seen 1-2 days/week for one hour/day. In the less-intensive protocol, each of the 3 ADL goals will be practiced as many times as possible within 20 minutes of the scheduled hour. In both protocols, the OTA will employ errorless learning where the participant is prevented from making errors through scaffolded trainer guidance progressing from hand-over-hand training, provision of tactile and verbal cues and, if possible, no cues for errorless performance. Continuous verbal feedback will be provided to the participant initially and minimized as training progresses. Post-intervention, caregiver support for questions and problems interfering with continued practice is provided monthly until the 3-month follow-up.

4. Statistical Methods A two-sided 0.05 alpha level will be used to define statistical significance. An intent-to-treat paradigm will be followed in which data from all randomized patients are analyzed to intervention assignment without regard to adherence or outcomes.

   Aim 1: Examine advantages to learning and retention of learning provided through receipt of the intensive STOMP protocol versus a less-intensive protocol.

   Plan: Changes in pre- and post-intervention (immediate and 90 day) GAS T-scores/COPM mean scores will be compared between intervention groups using a repeated measures ANOVA where time by intervention interaction term will be tested to determine if the estimated effect of the intervention program differs over the follow-up period. Analyses will be stratified by post-intervention time point if a significant interaction is found. Residual diagnostics will be created to assess adequacy of modeling assumptions. Non-parametric analyses will be used, focusing on 3-month differences, if ANOVA modeling assumptions are not satisfied.

   Aim 2: Examine sustained attention to task as a contributor to differential outcomes.

   Plan: Using data from the Sustained Attention to Task behavioral form (Sec.3f), we will tally the amount of time spent on each of 3 ADL goals over the 2 week intervention. Total minutes on task will be categorized by tertiles and plotted against change in GAS and COPM scores, both post-intervention and the 3-month follow-up.

5. Study Timeline*

   • Patient follow-up completed by month 23 to assure time for final data analysis.
6. Data Management: Data capture, quality assurance, management, and processing will be consolidated through the use of the well-established Research Electronic Data Capture (REDCap) system.10 REDCap is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. Online data capture forms will be created using REDCap, exported as pdf files, and printed for off-line use so that a hard copy will be available for data checks. REDCap will allow for multi-personnel access of project files and will be used by the PI, evaluators and trainer to capture data.

C. POTENTIAL PROBLEMS AND ALTERNATIVE APPROACHES Three hours of intervention daily may result in fatigue, refusals and displays of negative behaviors. Due to the repetitive nature of STOMP, we have tallied the number of negative behaviors to include wandering, purposeless movement, verbal and physical outburst and mood-related verbalizations and have averaged \<1/hour across 3 hours of treatment in both settings.1,2 We believe this success is in part due to 1) using licensed OT/OTAs; 2) training the interventionists through a manualized, STOMP protocol which includes the identification of behavioral signs with specific redirections for negative behaviors; and 3) engaging the presence of the caregiver. Recruitment for our home-based studies has proven to be more palatable to community-dwelling older adults than clinic-based. Based on our previous work, we believe that the 30 day phone calls have largely influenced our ability to retain 100% of our participants at 90-day post-intervention follow-up.

D. HUMAN PARTICIPANT SAFETY The risk for participating in this study is similar to doing ADL tasks at home. Strict safety principles will be observed such as walking with a safety belt as deemed necessary. The benefits of participating in the study include assessment of deficits with an occupational therapist, receiving two weeks of free intervention, and provision of adaptive equipment that will support functional skills in the home. The investigators believe the benefits of participating outweigh the risks.