Home-Based Health Management of COPD Patients
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Sara Seifert

Official Title: Home-Based Health Management of COPD Patients 
NCT #: 02557178 
Document Date: 8.4.2014 
 
Study Protocol 
The study will be conducted by Dr. Benzo and his team at the Mayo Clinic. Following an initial 
home visit to consent the subject and ensure that all study inclusion and exclusion criteria are 
met, an individual appointment will be scheduled for each subject at the Mayo Clinic. The 
subjects will meet the health coach, receive training on using the system, and will perform one 
initial exercise session to ensure safety and cognitive acceptance of the intervention. The 
training on how to use the system will be conducted by the health coach and will include 
demonstration, practice, and written materials for subjects to take home.  During this initial 
session at the Mayo Clinic each subject will also provide demographic data and complete a 
Chronic Respiratory Disease Questionnaire (CRDQ).  For the eight week intervention period 
each subject will receive weekly health coaching plus activity monitoring. The health coaching is 
described below. For the activity monitoring each subject will be asked to wear the ankle and 
wrist monitor for the entire day, excluding bathing. Each subject will also be asked to wear a 
fingertip pulse oximeter while completing an exercise routine. Patients will be asked to perform 
the exercise routine six days a week, including at least a 5 minute walk and walking a total of 15 
to 20 minutes during the day for the sole purpose of rehabilitation. The exercise routine will be 
the same as phase I and each participant will be provided a DVD to follow. Each participant will 
also have a docking station with a tablet computer. The tablet will prompt the participant daily to 
answer a brief series of questions on their well-being at the time of taking off the monitors at the 
end of the day for charging. The subject’s daily steps will be available on the wrist monitor and 
the tablet computer. The tablet will also provide a simplified version of the report that goes to the 
health coach, including trend and detail data on the subject’s daily activity and physiological 
measures.  
 
During the eight week control period no health coaching will be provided or exercise 
prescription requested. Participants will not receive any information on their activity nor will they 
be asked to complete the well-being questions. During the last week of the control period all 
participants will be asked to wear the SenseWear Pro Armband for four days to collect data on 
their daily steps.  
 
During week 9 all participants (half of whom will be in the intervention period and half in the 
control period) will be asked to repeat the CRDQ via telephone. At the end of week 17 each 
participant will be asked to complete the CRDQ via telephone and return all of the equipment.  
 
 
 
 
 
Figure 10:  Diagrams showing a few representative low-dynamic exercises. 
 
 
Health Coaching 
Each subject will be asked in the first encounter to define a particular place and time in which 
they can perform rehabilitation. The environment (physical and mental) is a critical piece to 
adopt new behavior. Each subject will have a weekly coaching call to discuss their rehabilitation 
and health process with the coach. The calls will be structured using motivational interviewing 

and will follow the protocol published by Dr. Benzo.61 The coach will review with the patient the 
data from the activity monitoring system (daily steps, physiologic measures – oxygen saturation 
and heart rate, and duration, frequency, and time of day of the rehabilitation exercise). The 
coach will also review the daily answers to the well-being questions. Collaboratively, goals for 
rehabilitation exercise for the following week will be set, based on the information gathered and 
patients personal preferences (like modifying the exercises or the walking routine, for example, 
if the exercises initially proposed are not to the liking of the patient). In any case there will be a 
routine of upper extremity and balance exercises and a walking routine. Each call will last about 
12 minutes. All calls will be taped to ensure compliance with the protocol. To complete the 
intervention, each subject will need to complete phone calls with a health coach at least six out 
of the eight weeks. At the end of the eight weeks of intervention, a qualitative semi-structured 
interview will be conducted with each subject by the health coach to gather information on the 
pros and cons of the process and intervention. This will be in addition to the CRDQ. While the 
monitoring of the patient will not be real time, any significant physiologic abnormality measured 
during rehabilitation and transmitted to the server  (o2 saturation less than 80% or heart rate > 
140 or <40 beats per minute) will prompt a message to the coach to initiate a call to the 
participant to stop the process and investigate the event. Any time such a call is initiated, the 
health coach will also contact the subject’s health care provider at the Mayo Clinic COPD 
practice. Dr. Benzo will also be alerted anytime such a physiologic abnormality is measured and 
will ensure that the appropriate response is initiated. Detail of the training of the health coaches 
has been reported by Dr. Benzo.61 
 
Sample Size 
We calculated the sample size based on our previous published data.62 A total sample of 104  
patients (52 per group) is needed to detect a difference of 0.5 in the Chronic Respiratory 
Disease Questionnaire (the minimally clinical importance difference) with 80% power. See 
Figure 11. A sample of 104 patients is necessary to detect a difference of 1000 steps with 80% 
power. We plan to recruit 115 patients due to an expected attrition of 10% as seen in Dr 
Benzo’s published research in COPD rehabilitation. See Figure 12. 
 
 
Figure 11: Diagram for power sample size for 
quality of life outcome 
 
Figure 12: Diagram for power sample size 
for steps outcome 
 
Analysis Plan 

The primary outcomes of the study are: change in daily steps and change in quality of life 
between the intervention and control conditions. Change in daily steps will be measured by 
comparing the mean number of daily steps in weeks 1, 9, and 17 as measured by the activity 
monitoring system and the SenseWear Pro Armband. Quality of life will be measured by the 
CRDQ, which consists of 20 items across four dimensions. A change in the score of .5 on the 7 
point scale reflects a clinically significant change.  
 
Quantitative analysis: Descriptive and inferential statistics will be used. For daily steps 
descriptive statistics such as means, standard deviations, medians, ranges, and frequency 
distributions will be examined and calculated by condition (baseline versus intervention versus 
control period). The mean number of daily steps of each measurement period (baseline, 9 
weeks and 17 weeks in all subjects: intervention, and control) will be compared for differences. 
A difference of 1000 steps is considered clinically meaningful across all severities of COPD.63 
We will also compare quality of life measured by the CRDQ (baseline versus intervention versus 
control period). The CRDQ data will be examined for each question, domain, and the entire 
instrument. We will also analyze daily steps and quality of life trajectories from weeks 1, 9, and 
17 using repeated measures models. Regression equations and correlations will be performed 
to determine the impact of the system/coaching and adherence on outcomes adjusted by the 
most pertinent variables in COPD (age, dyspnea level, lung function, exacerbations and 
comorbidities measured by the Charlson comorbidity index).  
 
Multivariate, repeated-measures ANOVA will be used to analyze the main pre- and 
postintervention effects and interactions both between and within groups. If the overall ANOVA 
value was significant at the p < .05 level, post hoc independent-samples t tests will be 
conducted on the subscales of CRDQ 
 
Qualitative analysis: We will conduct semi-structured interviews in the last week of the 
intervention period with all subjects. These interviews will collect data on the participant’s 
experiences, opinions, perceived benefits and barriers, and impact on self-efficacy for behavior 
change and actual behavior change. An inductive coding approach will be used to condense 
these data and to identify themes. These data will be collected to identify potential 
improvements to study protocol or the system.