Mass Practice of Activities of Daily Living in Dementia (STOMP)
Condition: Dementia; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia
Study type: Interventional

Summary: 
      People with Alzheimer's disease and related dementias present with changes in how they think,
      move and emotionally respond to daily life situations. While type of dementia will dictate
      how severe certain symptoms are, all people with dementia will report a gradual change in how
      they function in daily life skills. Losing the ability to do daily life tasks, such as using
      a cell phone, balance a checkbook or get dressed in the morning signifies loss for both the
      person with dementia and their caregiver. Caregivers that assist with daily life tasks report
      more depression and anxiety, as well as a higher burden of care. People with dementia that
      lose the ability to perform daily tasks report more depression and decreased satisfaction
      with life. Despite gains in research, researchers are still missing important pieces that
      will improve rehabilitation interventions for improving daily life skills.

      In order to address the needs of people with dementia, an intervention called Skill-building
      through Task-Oriented Motor Practice (STOMP) was developed by an occupational therapist. Our
      team proposes that improvement in daily life skills is possible under certain circumstances.
      First, the daily life task a person is addressing in rehabilitation should be
      personally-meaningful and should also be the task practiced in therapy which is called
      "task-oriented training". For example, a person that is having trouble making a sandwich
      should practice making a sandwich. Second, the investigators propose that people with
      dementia need a lot of "correct practice" so that the brain has time to "rewire" how to do
      the task correctly. Therefore, when patients practice tasks using STOMP, investigators do not
      allow our participants to make errors and patients practice for long periods of time.
      Investigators also incorporate and provide new technology into training such as medication
      reminder alarms and photo phones which allow you to dial a number by choosing a loved one's
      picture.

      In this pilot study, the investigators want to look more closely at the how the amount of
      time you practice influences study outcomes. The investigators believe that the findings from
      this study will support our belief that more time in therapy is needed to enhance how someone
      with dementia learns.
    

Detailed description: 
      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.
    

Intervention name(s): STOMP (Skill-building through Task-Oriented Motor Practice)
Intervention type(s): Behavioral
Intervention description(s): The STOMP intervention is a package including family-centered goals, task-specific training delivered through motor learning and errorless learning principles. It is unique in the use of massed practice (high-dosage) therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: activities of daily living; massed practice; occupational therapy