Mass Practice of Activities of Daily Living in Dementia (STOMP)
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 50 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | October 2014 |
| End Date: | September 2016 |
| Contact: | Carrie A Ciro, PhD, OTR/L |
| Email: | carrie-ciro@ouhsc.edu |
| Phone: | (405) 271-2131 |
High-dose Mass Practice Intervention to Reduce ADL Disability in Dementia
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.
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.
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.
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.
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
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