High-dose Mass Practice Intervention to Reduce ADL Disability in Dementia

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.