Collaborative-care Rehabilitation to Improve Functional Outcomes After Dysvascular Amputation
Phase: NA
Conditions: Diabetes Complications, Peripheral Arterial Disease
Sponsor: University of Colorado, Denver

Collaborative-Care Rehabilitation to 
Improve Functional Outcomes after 
Dysvascular Amputation
Protocol Version: January 5, 2014

1 
w 
COMIRB Protocol 
PROTOCOL #: 
13-0179 
COLORADO MULTIPLE INSTITUTIONAL REVIEW BOARD 
CAMPUS BOX F-490    TELEPHONE:  303-724-1055  Fax:  303-724-0990 
Title:  Collaborative-Care Rehabilitation to Improve Functional Outcomes after 
Dysvascular Amputation 
Principal Investigator: 
Cory Christiansen, PT, Ph.D. 
V1.3 
 
SYNOPSIS 
Objectives 
The objective of this study is to determine the efficacy of a collaborative-care, home-based 
rehabilitation program for improving functional outcomes following dysvascular transtibial 
amputation.  The primary aim is to determine if the rehabilitation program improves 
performance-based and participant-report measures of physical function, compared to standard 
of care, for participants with dysvascular transtibial amputation.   The secondary aim is to 
determine if the rehabilitation program improves daily physical activity, compared to standard of 
care, for participants with dysvascular transtibial amputation.  Two exploratory aims are: 1) 
determine the efficacy of the intervention for promoting health self-management, measured as 
participant-reported self-efficacy for managing chronic disease, motivation for exercise, and 
health-care resource use and 2) identify factors at initial testing that are predictive of physical 
activity level and disability 24 weeks after intervention. 
Design and Outcomes  
This will be a randomized, controlled clinical trial on the effects of 12 weeks of collaborative-
care, home-based rehabilitation on physical function outcomes.  Outcome variables include: 
1. Performance-Based Physical Function Measures:
a. Timed Up-and-Go (TUG)1
b. Two-Minute Walk (2MW)2
c. Five-meter Walk (5mW)3
2. Self-Report Physical Function Measures:
a. Prosthesis Evaluation Questionnaire – Mobility Section (PEQ-MS)4
b. Houghton Scale5
c. Patient-Specific Functional Scale (PSFS)6
3. Activity Measurement:
a. Physical activity monitors (Actigraph) worn for 1 week following each test session
(baseline, 12-week, 24-week). These monitors are valid tools for measuring
relative level of activity (e.g., sedentary, light, moderate, vigorous) for various
patient populations7-9 and are valid and reliable spatiotemporal gait measures for
patients with lower limb amputation.10,11
4. Self-Efficacy and Motivation:
a. Self-Efficacy in Managing Chronic Disease (SEMCD) questionnaire12,13
b. Intrinsic Motivation Inventory (IMI) Interest and Enjoyment Subscales14
c. Participant compliance with exercise will be tracked as number of exercise
sessions missed/possible sessions.
5. Healthcare Use:

 
 
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a. Number of healthcare provider visits scheduled and attended; from electronic 
medical record. 
b. Number of hospital contacts (emergency department visits and hospital 
admissions); from electronic medical record. 
 
Interventions and Duration 
Forty-four participants will be randomly assigned to two groups: 1) experimental (EXP) or 2) 
control (CTL).  The entire intervention period is 12 weeks, with the primary end point at 12 
weeks. At 24 weeks after initiation of intervention, each group will be asked to return for a 
follow-up test session.  
 
Evaluations will take place using the following schedule: 
Baseline, 12 and 24 weeks: Physical Performance Tests, Self-Report Physical Function 
Measures, Activity Measurement, Self-Efficacy questionnaire, Motivation questionnaire, Health 
Status questionnaire, and healthcare use assessment.   
 
Baseline only: At Baseline testing, participants will also complete the following 
tests/measures/forms: 1) Folstein Mini-Mental State Examination,15 2) Geriatric Depression 
Scale SF,16,17 3) Chakrabarty scoring of residual-limb quality,18 4) Residual limb length, 5) lower 
extremity sensory testing, 6) pre-amputation ambulatory status report, 7) type of prosthesis 
(socket, suspension, and foot), and 8) demographic information.  Hemoglobin A1c 
measurements (for DM) and confirmation of PAD will be extracted from the participant medical 
records. 
 
Continuously:  Falls, Adverse Events (AEs), and Serious Adverse Events (SAEs) will be 
recorded and reported as needed. 
 
Sample Size and Population 
The target sample is 44 persons with recent transtibial amputation, resulting from PAD or DM 
complications.  
Participants will be recruited from the University of Colorado Hospital and Denver Health.   
 
 

 
 
3 
 
Title: Collaborative-care rehabilitation to improve functional outcomes after dysvascular 
amputation 
 
 A. Abstract & Specific Aims 
The primary objective of this project is to determine the efficacy of a collaborative-care, 
home-based exercise program for improving physical function, activity level, and health 
self-management within the first year following dysvascular transtibial amputation. 
Over 1 million Americans currently live with lower limb amputation, and the number is expected 
to more than double by 2050.19  The increasing amputation rate is attributed to an aging 
population and increased incidence of underlying causes such as peripheral artery disease 
(PAD) and diabetes mellitus (DM).19-22  Unfortunately, under-representation of people with 
dysvascular amputation in rehabilitation research has led to a gap in knowledge of how to 1) 
optimize physical rehabilitation and 2) facilitate successful health self-management for these 
patients.23 
Due to the lack of research on rehabilitation following dysvascular lower limb amputations, 
optimal physical rehabilitation is largely undefined.24  Traditional rehabilitation goals focus 
narrowly on the episode of care surrounding amputation, emphasizing prosthetic function, 
mobility/gait training, and targeted remediation of physical impairments.24-27  However, this 
approach neglects underlying comorbidities, chronic 
physical inactivity, and history of poor health self-
management which are all risk factors and contribute 
to poor outcomes of dysvascular amputation. As a 
consequence, patients typically experience chronic 
function limitations.28-31   
Considering the large, under-represented population 
with dysvascular transtibial amputation and evidence 
of poor long-term functional outcomes, there is an 
immediate need to address rehabilitation practice.  
This intervention study will address impaired physical 
function, activity limitation, and health self-
management for people recovering from dysvascular 
transtibial amputation using innovative collaborative-care, home-based rehabilitation (Figure 1).  
Collaborative-care will pair the participant and therapist to promote responsibility in participant 
management of his/her physical rehabilitation and health.  In addition, home-based intervention 
will promote carry-over of rehabilitation gains into the functional setting of the home.  
Participants will self-monitor progress and communicate regularly with the research team to 
advance the intervention and address barriers to successful goal achievement.  While outcome 
measures are standardized for all participants, intervention selection and incremental goals will 
be participant-tailored, within specific guidelines, with therapist collaboration to optimize 
rehabilitation progress. 
Results of this study will quantify the effect size of the proposed intervention and inform future 
research designed to optimize intervention, focus examination based on the dominant 
pathophysiology (i.e., DM, PAD, or both), and examine efficacy in other populations (e.g., 
patients with trans-femoral amputation). 
Specific Aim 1: The Primary Aim (PA1), on which this trial is powered, and the Primary 
Hypotheses (H1.1 and H1.2) are: 
a) PA1: Determine if the collaborative-care, home-based rehabilitation program improves 
performance-based and participant-report measures of physical function compared to 
standard of care for participants with dysvascular transtibial amputation.   

 
 
4 
 
b) H1.1: The rehabilitation program will result in greater improvements in the 
performance-based measures of the Timed Up-and-Go, 2-Minute Walk, and 5-meter 
Walk tests than standard of care at 12 weeks (primary end-point) and persist at 24 weeks 
following initiation of intervention. 
c) H1.2: The rehabilitation program will result in higher ratings of participant-reported 
physical function on the Prosthesis Evaluation Questionnaire – Mobility Section, 
Houghton Scale, and Patient-Specific Functional Scale than standard of care at 12 weeks 
(primary end-point) and persist at 24 weeks following initiation of intervention. 
Specific Aim 2: The Secondary Aim (SA) and Hypothesis (H2) are: 
a) SA: Determine if the collaborative-care, home-based rehabilitation program improves 
physical activity when compared to standard of care for participants with dysvascular 
transtibial amputation. 
b) H2: The rehabilitation program will result in greater increases in physical activity than 
standard of care at 12 weeks (primary end-point) and persist at 24 weeks following 
initiation of intervention. 
Exploratory Aims:  
1. Exploratory Aim 1 (EA1) and Hypotheses (H3 & H4) are: 
a) EA1: Determine if the collaborative-care, home-based rehabilitation program 
influences the health self-management factors of  self-efficacy for managing chronic 
disease, motivation for exercise, and healthcare use. 
b) While the study will likely be under-powered to find differences related to this aim, the, 
if trends in group differences are seen, data will provide a means for performing a 
statistical power analysis to determine sample size for future study.  The hypothesized 
trends for group differences are: 
(1)  H3: The rehabilitation program group will tend to have greater positive change in 
ratings on the Self-Efficacy in Managing Chronic Disease (SEMCD) questionnaire and 
Intrinsic Motivation Inventory (IMI) Interest and Enjoyment Subscales, compared to the 
standard of care group at 12 and 24 weeks following initiation of intervention.  
(2) H4: The rehabilitation program group will tend to have higher numbers of attended 
healthcare provider appointments and lower numbers of hospital contacts at 12 weeks 
and 24 weeks, compared to the standard of care group.  
2. Exploratory Aim 2 (EA2) and Hypothesis (H4) are: 
a) EA2: Identify factors predictive of physical activity level and disability measured by 
activity monitors and self-reported disability (World Health Organization Disability 
Assessment Schedule 2.0), respectively. 
b) H5: Significant predictors of physical activity and disability will be identified from the 
categories of demographic/anthropometric, activity/mobility, health behaviors, physical 
health, amputated-limb health, contralateral-limb health, cognitive/affective health, and 
healthcare use factors for participants at 24 weeks following intervention, regardless of 
group assignment. 
 
B. Background and Significance  
B1. Significance.  Limitations in physical function are common following dysvascular major lower 
limb amputation.28,29,31  This is a significant issue considering that dysvascular amputation is 
becoming increasingly more common in the United States.  Dysvascular amputation is 
operationally defined as amputation resulting from severe PAD with critical limb ischemia or 
severe DM with dense distal sensory and motor neuropathy leading to a non-healing wound (or 
a combination of these two related, but separate pathophysiologies).  The projection of 2.3 
million people living with amputation in the United States by the year 2050 represents an 
increase of nearly 100% from current values.19  As a result, dysvascular amputation has 
become a major healthcare issue in the U.S, including an economic problem.32   

 
 
5 
 
Compounding the problem of increasing prevalence and cost is that rehabilitation following 
dysvascular amputation is neither well-defined nor well-studied.24  While the majority of lower 
limb amputations (>80%) are dysvascular,20 available research evidence on functional 
outcomes is largely based on relatively younger populations with traumatic, congenital, or 
cancer-related amputations.  This study bias limits the knowledge needed to develop 
rehabilitation guidelines for people following dysvascular amputation.23,24,33 
B2. Clinical Importance.  Traditional rehabilitation emphasizes prosthetic function, mobility/gait 
training, and targeted remediation of physical impairments,24-27,34 neglecting the underlying 
comorbidities and poor health self-management that contribute to dysvascular amputation.  
While physical impairments and functional limitation can show modest improvement across the 
course of rehabilitation after amputation,35 long-term functional outcomes are poor.28,29,36-40  For 
example, 40-50% of patients are not community ambulators 1 year following dysvascular 
lower limb amputation.28,41  These poor functional outcomes are likely linked to pre-
existing comorbidities and poor vascular health self-management.40,42 
Patients typically receive treatment to manage chronic vascular problems prior to and 
concurrent with physical rehabilitation following dysvascular amputation.  However, health 
management is not typically coordinated with physical rehabilitation and is often prescriptive, 
rather than collaborative between patient and health-care provider.  The presence of vascular 
comorbidities that lead to amputation is an indication in itself of poor patient health self-
management.  Using a patient/therapist collaborative intervention approach may improve upon 
current standard of rehabilitation following dysvascular amputation.  Evidence indicates 
collaborative approaches to promoting health self-management improve vascular risk factor 
outcomes.43,44  In addition, home-based intervention can effectively improve physical function 
and activity in people with chronic health problems.45,46  As an example, Vernooij and 
colleagues44 found patient/provider collaboration for managing vascular risk factors led to 
reduced risk factors over a 12 month period for people with atherosclerosis.  
This study will use a collaborative-care rehabilitation program combining traditional 
physical rehabilitation goals with patient self-management techniques to improve 
functional outcomes following dysvascular amputation.  In addition to the potential for 
improving long-term physical function, this study is designed to shift current practice paradigm 
by using a collaborative-care, home-based approach to promote physical function, activity and 
patient health self-management. 
 
C. Preliminary Studies  
C1. Clinical Research Experience.  Dr. Cory Christiansen (PI) has experience in design, 
implementation, and publication of clinical research studies involving older adult patients with 
activity limitations related to a variety of age- and health-related problems.47-52  Dr. Christiansen 
is the PI of an ongoing randomized controlled trial involving outpatient and home intervention for 
patients following total knee arthroplasty, and has successfully completed all intervention and 
data collection phases.49,53  In addition, he is currently the PI of an ongoing pilot study 
examining activity and mobility limitations related to dysvascular amputation (Section C2). Dr. 
Christiansen is also currently serving as co-investigator in a nearly-complete study examining 
physical activity and biomechanical outcome measures for patients following traumatic 
transtibial amputation.54,55   
C2. Physical Function Outcomes Related to Prosthetic Rehabilitation after Dysvascular 
Transtibial Amputation (PI: Christiansen).  This in-progress pilot study examines physical 
function recovery early (first 3 months) after dysvascular transtibial amputation.  The study 
involves collaboration between rehabilitation clinics at five large regional hospitals in Colorado 
(The University of Colorado Hospital, Denver Health, The VA, Memorial Hospital, and Poudre 
Valley Hospital); with the PI coordinating from CU Anschutz Medical Campus.  This pilot study 
has 1) demonstrated the PI’s ability to coordinate a multi-site study for a population similar to 

 
 
6 
 
the proposed study and 2) begun to characterize 
physical function over the course of rehabilitation 
following dysvascular transtibial amputation.  Initial data 
illustrate that patients with dysvascular transtibial 
amputation achieve meaningful gains in physical 
function measures with standard of care rehabilitation 
(Table 1).  Yet, gains are not typically maintained; 
reported function is significantly lower 1-3 years after 
amputation.29,36-40 
The pilot study also examines the comorbidity profile 
and rehabilitation dose for patients.  Data collected to 
this point have guided development of the proposed 
intervention (Table 2). 
D. Research Design and Methods  
D1. Subjects.  Forty-four participants with 
dysvascular transtibial amputation.   
D2. Inclusion/Exclusion Criteria.  Inclusion criteria: 1) 
DM and/or PAD, 2) unilateral transtibial amputation < 
6 months prior to baseline testing, 3) household 
ambulation using definitive prosthesis prior to 
baseline testing, 4) participation in physical 
rehabilitation at time of baseline testing and 5) live 
within 45 minutes of a participating clinic. 
Exclusion criteria: 1) require wheelchair for mobility 
(use prosthesis only for transfers), 2) ankle-level or 
above amputation on contralateral limb, 3) traumatic 
or cancer-related amputation, 4) uncontrolled heart 
condition, 5) acute systemic infection, 6) pregnancy, 
7) decisionally challenged, and 8) prisoners.   
Confounding variables will be tracked to allow better 
delineation of the “dysvascular amputation” 
population in future studies including: medications, 
cognitive function (Folstein Mini-Mental State 
Examination15), depression (Geriatric Depression 
Scale SF16,17), residual limb quality (Chakrabarty 
scoring of residual-limb quality18), residual limb 
length, ankle-brachial index of the non-amputated 
limb, lower extremity sensory testing, pre-amputation 
ambulatory status (self-report), and type of prosthesis 
(socket, suspension, and foot). A Comorbidity 
Assessment tool56 will be used to document and 
account for comorbidities.   
D3. Screening.  Participants will be recruited at the 
rehabilitation site and screened with a phone call 
interview.  After consent, participants will have an 
initial test session at their home (or the research lab, whichever is more convenient for the 
participant) and be randomized to group: 1) experimental (EXP) or 2) control (CTL), stratified by 
sex.  
D4. Intervention.  Experimental (EXP) Group: Objectives for the collaborative-care, home-

 
 
7 
 
based rehabilitation program are to: 1) improve physical impairments with targeted 
exercise, 2) increase physical activity through a home walking program and 3) optimize 
patient health self-management.  The collaborative-care, home-based rehabilitation program 
was developed based on self-management programs for patients with chronic disease,45,46,57 
common physical impairments and functional 
limitations following dysvascular transtibial 
amputation,36,58-62 published standard of care 
guidelines based on professional opinion,34,63,64 and 
clinician input from the participating hospital 
systems (Table 3).  Physical impairments and 
functional limitations will be individually identified at 
initial testing and interventions chosen with 
collaboration of participant and researcher.  
Participants will be contacted once/week via phone 
to discuss progress toward individual intervention 
goals.  Barriers to achieving goals will be discussed 
and new goals created on a weekly basis during the 
phone or home visits.   
The exercise program will be tailored to each 
participant and includes targeted exercise to 
strengthen trunk, hip, knee, and ankle musculature 
(Table 3).  Weakness in these muscle groups is 
identified in the literature36,65 and by collaborating 
clinicians for this study.  Therapists treating the 
participant prior to enrollment will help prioritize the 
targeted muscle groups for each participant, based 
on participant-specific muscle weakness identified during rehabilitation.  The participant (along 
with researcher collaboration) will then identify specific exercises from a menu of progressive 
exercises to target each muscle.  Exercises will be performed at home independently by the 
participant, assessed weekly and advanced through participant-researcher interaction, with the 
goal of performing strengthening exercises 3 days/week for 20 minutes/session. 
Other exercises target hip and knee joint contracture prevention, two common joint mobility 
problems for patients with transtibial amputation.63  Presence of contractures of the hip and/or 
knee are predictors of poor physical rehabilitation outcome.35  Included are static stretches (e.g., 
prone lying and seated with knee propped into extension) performed 2-3 X/week for 2 minutes 
each (total 4 minutes). 
The walking program will be performed all 12 weeks, with the goal of walking at least 3X/week.  
Initial walk duration will be determined at the first visit and goals set weekly by the participant 
with a guideline of at least 5 minutes of increased walking weekly.  Once 30 minute duration is 
achieved, intensity will be progressed based on targeted heart rate or other health-specific 
parameters such as claudication intensity.  Similar programs have improved symptoms, walking 
distance, and quality of life for people with PAD.45,46   
Health self-management will be promoted in 3 primary ways: 1) action plan development with 
participant-directed goal setting, 2) participant self-tracking of activity (pedometers and exercise 
diary), and 3) participant education on problem-solving skills to manage chronic health 
conditions.  Participants will also monitor their individual health condition (e.g., heart rate, time 
to claudication with walking, blood sugar, and blood pressure).  These data will focus the weekly 
discussions (home or phone) over the 12-weeks.44,66,67 
Control (CTL) Group: CTL group participants will be contacted at the same interval (phone and 
home visits) as the EXP group (Figure 2) to ensure attention control between groups.  Visits will 

 
 
8 
 
consist of recording problems reported by the participant.  If health or rehabilitation questions 
arise that require professional advice during participant-researcher visits, the participant will be 
referred to his/her healthcare provider. 
D5. Data Analysis.  Data will be managed using REDCap (Research Electronic Data Capture; 
which is HIPAA compliant).68  Primary analysis will be group differences in TUG times (primary 
outcome) at the 12-week time point.  As a pilot feasibility study, data will only be analyzed for 
participants with sufficient intervention exposure, defined as six weeks.  For participants who 
withdraw at or beyond six weeks of intervention, an early termination test will be performed and 
carried forward as the end-point.  Participants who withdraw before completing six weeks will be 
lost to follow-up and no imputation will be performed for missing data.  Attempts will be made to 
test all participants at 24-weeks.  However, missing 24-week data will not be imputed from the 
12 week measurement, as this would bias the effect following the primary end-point (i.e., it is 
expected that both groups would have worse 24- compared to 12-week outcomes).  Group 
differences will be based on a linear model with TUG as the outcome and explanatory variables 
being primary medical diagnosis (PAD, DM, or both), rehabilitation site, treatment group, and 
baseline TUG. Group differences will be determined by this single test to protect against Type I 
error (α level: 0.05). 
Secondary analyses will include differences at 12-weeks in the other outcomes (2MW, 5mW, 
PEQ-MS 12/5, Houghton Scale, PSFS, Activity level, number of healthcare provider visits, and 
number of hospital encounters) using the same method as for the primary outcome.  A mixed-
effects model with time as a fixed covariate across baseline, 12-, and 24-weeks will be used to 
evaluate long-term outcomes (24-week) and make inferences regarding the effectiveness of the 
intervention up to 12-weeks after intervention is complete.  As with the other analyses, 
evaluation of the time trajectory will be conditioned on stratification variables and baseline 
values of the outcome measure.  Also the mixed-effects model will not include data from 
subjects who drop prior to 6 weeks.   
The exploratory aim of identifying predictors of physical activity and disability will be analyzed by 
regression analysis.  First, variables will be grouped into demographic/anthropometric, 
activity/mobility, health behaviors, physical health, amputated-limb health, contralateral-limb 
health, and cognitive/affective health, and healthcare use factors.  A hierarchical process will be 
used to screen variables within each group of factors to identify the best predictors within each 
group.  Finally, the best predictor variables from each group will be entered into a regression 
model to determine models containing subsets of the variables that predict the outcome, based 
on R2adj.  The most parsimonious model will be identified by comparing the 10 best models, 
using partial F-tests 
D6. Sample Size Estimate.  Sample size was estimated using TUG means and variances at 
discharge from the ongoing pilot study.  In addition, literature was used to estimate long-term (> 
3 months post-amputation) TUG scores for the population.60-62,69,70  Using 12.4 (3.9) seconds 
mean (SD) TUG time at rehabilitation discharge from the first 14 participants in the pilot study 
and 19.3 seconds as the average of TUG time reported for patients several months to years 
after amputation, a group difference of approximately 6.0 seconds was expected in TUG times 
at the 12-week time-point (primary end-point).  With this group difference and an estimated SD 
of 6.0 (effect size = 1.0), 17 participants per group would provide 80% power to identify 
differences.  The assumption is the EXP group will maintain or improve TUG times after the 12-
week intervention and the CTL group will decline toward levels reported in the literature. A 3.4 
second change in TUG represents a minimal detectable change for patients with lower limb 
amputation.69  
The goal is to enroll 44 participants and graduate 17 participants per group (n=34) at the 12-
week test point.  Based on data from the four participating hospitals, 150 patients will complete 
rehabilitation and achieve functional ambulation following dysvascular transtibial amputation 

 
 
9 
 
over the next 3 years.  Based on the pilot study (Section C2), 60% of these patients are 
expected to meet inclusion/exclusion criteria (n = 90) and 50% of those will agree to participate 
(n = 45).  A 20% loss to follow-up at 12 weeks (n=34) is estimated, which is twice the observed 
rates of studies with 12-week end-points that the PI has been involved with for other patient 
populations.   
D7 Outcome Measures.  Participants will have three test sessions of 1.5 hours each (initial, 12-
week (primary end-point), 24-week) beginning within three weeks of completing outpatient 
rehabilitation.  All sessions will occur at the participant’s home or Interdisciplinary Movement 
Science Lab (IMSL), whichever is more convenient for the participant, using standardized 
protocols by research assistants.   
• Physical Function Outcomes: Three physical performance tests will be used: the Timed Up-
and-Go (TUG)1, 2-Minute Walk (2MW)2, 5-meter Walk (5mW)3, and Single-Limb Stance 
tests.  Self-report measures of physical function include the Prosthesis Evaluation 
Questionnaire – Mobility Section (PEQ-MS)4,71, Houghton Scale5, Patient-Specific Functional 
Scale (PSFS)6, and the World Health Organization Disability Assessment Schedule 2.0.  
Each of these are reliable and valid measures for people with chronic disease.4,62,69,72-76  
• Activity Measurement: Physical activity will be assessed with physical activity monitors 
(Actigraph) worn for 1 week following each test session.  These monitors are valid tools for 
measuring relative level of activity (e.g., sedentary, light, moderate, vigorous) for various 
patient populations7-9 and are valid and reliable spatiotemporal gait measures for patients 
with lower limb amputation.11,77  
• Self-Efficacy and Motivation: Self-efficacy and exercise motivation will be used as 
descriptive measures related to health self-management.  The Self-Efficacy in Managing 
Chronic Disease (SEMCD) questionnaire has been used as an outcome for self-
management of various chronic diseases.12,13  The Intrinsic Motivation Inventory (IMI) 
Interest and Enjoyment Subscale measures participant-reported interest and enjoyment 
related to the intervention.14  Participant compliance with daily health monitoring will be 
tracked as number of days missed/possible days. 
Procedural reliability is critical to the success of the proposed and future studies with multiple 
clinical sites.  The PI will oversee standardization and implementation of testing and 
intervention.  The PI will provide 2-3 training sessions, including a training manual, for each 
designated tester. If procedural reliability is below 0.90, additional training sessions will be 
scheduled.   
E. Study Timeline and Enrollment Goals  
Task 
Year 1 
Total 
Year 2 
Total 
Year 3 
Total 
Training of Personnel 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Screening & Enrollment 
 
3 
3 
4 
n=10 
5 
5 
5 
5 
n=30 
5 
5 
4 
 
n=44 
Intervention 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Reduction & 
Analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dissemination 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
10 
 
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