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

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ClinicalTrials.gov Identifier: NCT02356055
Recruitment Status : Completed
First Posted : February 5, 2015
Last Update Posted : November 21, 2016
Sponsor:
Collaborators:
VA Office of Research and Development
OU Medical Center
Oklahoma Shared Clinical and Translational Resources
Alzheimer's Association
Information provided by (Responsible Party):
University of Oklahoma

Brief 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.


Condition or disease Intervention/treatment Phase
Dementia Alzheimer's Disease Behavioral: STOMP (Skill-building through Task-Oriented Motor Practice) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: High-dose Mass Practice Intervention to Reduce ADL Disability in Dementia
Study Start Date : October 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Intensive Protocol
Participants in this group will receive the Skill-building through Task-Oriented Motor Practice (STOMP) intervention 3 hours/day, 5 days/week for 2 weeks. Participants will choose functional goals that 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. 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.
Behavioral: STOMP (Skill-building through Task-Oriented Motor Practice)
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.

Active Comparator: Less-Intensive Protocol
Participants in this group will receive the Skill-building through Task-Oriented Motor Practice (STOMP) intervention 1 hour/day, 2 days/week for 2 weeks. Participants will choose goals that 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. Each group will practice the task as many times as possible during their allotted time in training. 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.
Behavioral: STOMP (Skill-building through Task-Oriented Motor Practice)
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.




Primary Outcome Measures :
  1. 5 point Observation of Activities of Daily Living [ Time Frame: Baseline ]

    The investigator observes ADL and then using an ordinal measure (-2, -1, 0, 1, 2), the

    researcher breaks the patient goal into five possible scenarios where "0" equals the intended goal (determined after researcher observation); negative scores represent "much less" and "somewhat less" than the expected outcome and positive scores represent "somewhat more" and "much more" than expected outcome.



Secondary Outcome Measures :
  1. Frequency of Behavioral Responses during the Trial [ Time Frame: Daily for 2 weeks ]
    Sustained attention to task" is recorded during each intervention using a stopwatch. When a participant stops practicing the task for any reason and does not return to task within 30 seconds, the stopwatch is stopped and sustained attention for each unit of engaged time is recorded. In the end, the episodes of time on task for each day are tallied. "Number of repetitions" is recorded as repetitions occur and tallied to represent the number of repetitions completed for each task in each hour. Neuropsychiatric behaviors, such as verbal and physical aggression, are recorded as they occur on a 3rd behavior tracking form.

  2. 10 point Caregiver Perception of Activity of Daily Living Performance and Satisfaction with Performance [ Time Frame: Baseline ]
    The caregiver or client identifies tasks that are most important and then reports performance and satisfaction with performance on each task on a scale of 1-10 (1=worst, 10=best).

  3. Change in 10 point Caregiver Perception of Activity of Daily Living Performance and Satisfaction with Performance [ Time Frame: Post-intervention (within 72 hours) ]
    The caregiver reports performance and satisfaction with performance on each task on a scale of 1-10 (1=worst, 10=best).

  4. Retention of 10 point Caregiver Perception of Activity of Daily Living Performance and Satisfaction with Performance [ Time Frame: 90 days ]
    The caregiver reports performance and satisfaction with performance on each task on a scale of 1-10 (1=worst, 10=best).

  5. Change in Observation of Activity of Daily Living [ Time Frame: Post-intervention (within 72 hours) ]
    Status of observed Activity of daily living after intervention within 72 hours

  6. Retention of Observed Activity of Daily Living at 90 Days [ Time Frame: 90 days ]
    Status of observed ADL using 5 point scale 90 days after the intervention is over



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Lives in the community and speaks English
  2. adult aged 50-90 years old
  3. lives with someone who can provide consent to be in the study
  4. diagnosed with some form of dementia
  5. cognitive score on the Mini-Mental Status Examination score >10 but ≤25
  6. able to understand and follow one step commands
  7. can move one arm sufficiently for practicing tasks
  8. participant or family member can identify three goal areas related to self-care or home management
  9. able to participate in 3 hours of daily therapy in their home environment for 2 consecutive weeks

Exclusion Criteria:

  1. Creutzfeldt-Jakob Dementia, delirium or a progressive neurological condition such as Parkinson's disease
  2. receptive or global aphasia
  3. uncorrected vision/hearing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356055


Sponsors and Collaborators
University of Oklahoma
VA Office of Research and Development
OU Medical Center
Oklahoma Shared Clinical and Translational Resources
Alzheimer's Association
Investigators
Principal Investigator: Carrie A Ciro, PhD, OTR/L University of Oklahoma

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT02356055     History of Changes
Other Study ID Numbers: 4648
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016

Keywords provided by University of Oklahoma:
activities of daily living
massed practice
occupational therapy

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders