AC
Comparison
i
off L
Low- and
Lowd HighHigh
Hi hIntensity
y Remote Monitoring
g in
Veterans with CoCo-Morbid Diabetes
and Hypertension
Bonnie J. Wakefield, PhD, RN, FAAN
VA HSR&D C
Center
t ffor Research
R
h on
Implementation of Innovative Strategies in
Practice ((CRIISP),
), Iowa Cityy
VA HSR&D NRI 0303-312
HSR&D Advanced Career Development Award
Background
• Diabetes and hypertension
yp
common chronic
conditions in VA patients
• Diabetes in VA twice as high as general US
population
• Hypertension rates higher in VA
• Two
Two--thirds of VA patients with diabetes also
h
have
h
hypertension
t
i
• Blood p
pressure control in diabetes may
y be the
most important factor in decreasing vascular
complications
Background
• Most
M t disease
di
managementt programs h
have
focused on single disease populations, e.g.,
heart failure or mental illness
• No controlled clinical trials have evaluated
remote monitoring plus nurse care management
on coco-morbid conditions or investigated dosedoseresponse effects
Objective
• To
T evaluate
l t dosedose
d
-response effects
ff t off
remote monitoring plus nurse care
management on improving outcomes in
veterans with coco-morbid diabetes and
hypertension
• Primary outcomes
– Hemoglobin A1c (A1c)
– Systolic blood pressure (SBP)
Design
•
•
Randomized controlled trial
3 treatment groups
–
–
–
•
Usual care
Low intensity remote monitoring with nurse care
management
High intensity remote monitoring with nurse care
management
Nurse care management
–
–
–
Study nurses monitored responses M
M--F
Contacted subjects by phone,
phone mail
mail, or device advice
function
Care changes coordinated with PCP as needed
Remote Monitoring
• Low Intensity
y
– BP daily; BG patient
patient--specific recommendations
– Patients answered 2 questions daily:
• General health
• taken all medications as ordered? “yes/no”
• High Intensity
– BP daily; BG patient
patient--specific recommendations
– Responded to a wide range of questions
focused on diabetes and hypertension
– Received educational tips
High Intensity Content
•
•
•
•
•
•
•
•
Medication taking
Diet
Exercise
Eye care
Foot care
General health
Smoking
Weight management
Medication Question
Did y
you take all of yyour medications as
ordered?
• Yes
• Yes, but I have questions or concerns
• No
– Concerns about low BP, BG
– Concerns about other side effects
– I don’t need them
– I forgot
– I am out of medication
Data Collection Protocol
• Data collection period: 9/05 to 3/08
• Enrolled / baseline data during a PC visit
• Intervention subjects trained on use of
d i att th
device
the enrollment
ll
t visit
i it
– instructed to enter data dailyy
– given information on how to contact study
nurses
Sample
• 302 subjects randomized to three groups
– Usual care control group
– Low
Low--intensity monitoring + NCM
– High
High--intensity monitoring + NCM
• Baseline demographics
–
–
–
–
Male ((98%))
Caucasian (96%)
Mean age 68 years (range 4040-89 years)
HS education or higher (89%)
Sample
Data based on n=246 (81%) who completed
12--month data collection
12
• Usual care group (88%)
– 1 death; 2 dropouts; 2 lost to follow up
• High Intensity (78%)
– 13 dropouts; 1 lost to follow
follow--up
• Low
L
IIntensity
t
it (77%)
– 4 deaths; 13 dropouts; 3 lost to follow
follow--up
Baseline Comparison
Mean
A1
A1c
Mean
SBP
Usual
Care
Low
Intensity
High
Intensity
p
7.1
7.2
7.1
0.80
134
134
139
0 16
0.16
Changes in Mean A1c
73
7.3
7.2
A1c
7.1
Usual Care
7
Low
6.9
High
6.8
6.7
6.6
Baseline A1c
6-month A1c
12-month A1c
*p=0.02
p
Changes in Mean SBP
150
145
SBP
140
Usual Care
135
Low
High
130
125
120
Baseline
6-month
12-month
*p=0.003
% of Patients with Control of Both A1c & SBP
40
35
% A1c + SBP Contrrolled
30
25
Usual Care
20
Low
15
10
High
5
0
Baseline
6-months
12-months
*
*p=0.02
Frequency of Remote Data Entry
• Low Intensity
– Mean 125 days
y / 182 days
y (69%)
( %)
• High Intensity
– Mean
M
127 d
days / 182 d
days (70%)
Summaryy
• Both low and high intensity intervention
improved HbA1c at 6 months; effect lost at 1212months
• High intensity group showed a mean
improvement in systolic blood pressure
• High intensity group significantly improved on
combined outcomes
– high percentage remained out
out--of
of--control
• No differences in medication adherence
• Patient
P ti t engagementt with
ith d
data
t entry
t nott different
diff
t
between two intervention groups
Conclusions
• High
Hi h iintensity
t
it iintervention
t
ti iis efficacious
ffi
i
• Intervention should focus on higher risk
patients
ti t (i
(i.e., outt off control)
t l)
• Design further refinement of remote
monitoring
it i iinterventions
t
ti
ffor primary
i
care
patients