Transcript Accuracy of the Omron HEM-705 CP Oscillometric Device for

Quality of Life and
Depression as
Determinants of Treatment
Adherence in Hypertensive
Leonelo E. Bautista1; Paul Smith2; Cynthia Colombo2;
Dennis G. Fryback1; Lyn Y. Abramson2; Lina M. Vera1
1Department of Population Health Sciences
2Department of Family Medicine
Outline
Background
 Objective
 Study design
 Data analysis
 Preliminary Results
 Conclusions

Background
Hypertension affects almost one third of the
adults in the US.
 Being hypertensive increases the chance of
developing heart attacks, strokes, heart
failure and kidney failure.
 The chance of developing these diseases
decreases significantly if hypertension is
detected and treated.

Background
Only 53% of known hypertensives
receiving pharmacologic treatment have
their blood pressure controlled.
 Almost half of all patients stop taking their
antihypertensive drugs within 12 months
after they start treatment.
 Current adherence-enhancing
interventions are complex and laborintensive and have had little success.

Background
Antihypertensive drugs can have
significant positive and negative impact on
health related quality of life (QOL) and
depression symptoms severity (DSS).
 In turn, both QOL and DSS may influence
treatment adherence.
 There is little or no information on the roles
of QOL and DSS on treatment adherence.

Objective
To evaluate whether baseline levels and
changes in health-related quality of life
(QOL) and depression symptoms severity
(DSS) are predictive of treatment
adherence in newly treated hypertensive
patients.
 Long-term goal: to identify predictors of
treatment adherence useful to identify high
risk groups and to design effective
adherence-enhancing interventions.

Study Design


Longitudinal cohort study among newly
identified patients with essential
hypertension who require drug therapy.
QOL and DSS (exposure) and treatment
adherence (outcome) are evaluated at
baseline and at 3, 6, 9, and 12 months
after the start of treatment.
Study Design
Sample size: 280 newly-diagnosed
hypertensive men (n=140) and women
(n=140); 21% (n=60) from minority groups
 Eligibility criteria:

 20-69
years old.
 Not taking mood-modifying drugs

This cohort is being recruited and followed
at the UW-Department of Family Medicine
and WREN Clinics.
Study Design

Exposure measurements (QOL and DSS):
A
short version of the Physical Symptoms
Distress Index (PSDI).
 The Sexual Symptoms Distress Index (SSDI)
 The Psychological General Well-Being Index
(PGWB).
 The Sleep Dysfunction Scale (SDS).
 The Beck Depression Inventory-II (BDI-II).
 Self-administration of the PSDI, SSDI, PGWB
and SDS takes about 30-40 minutes.
Study Design

Outcome measurements (treatment
adherence):
 Pill

count  Primary outcome
Non-complier: <80% of prescribed pills
adherence  Secondary outcome
 Blood pressure level  Secondary outcome
 Self-reported

Trained study personnel measure the participant’s
blood pressure three times in each visit, with a 2minute wait between measurements, using an
automated device.
Study Design

Recruitment:
Clinics  Hypertensive patients who
are about to start or have recently started
antihypertensive medication are identified and
referred by their physicians or by clinic nurses
 Study personnel administer screening form to
verify eligibility.
 Eligible patients then are invited to participate.
 WREN
Study Design

Recruitment
 UW-DFM Clinics  Potentially eligible patients
are identified through the DFM Clinical Data
Warehouse (CDW).
 A DFM Research Specialist sends a letter to
potentially eligible patients informing them about
the study and asking whether they may be
interested in participating in the study.
 Informed consent and data collection are
conducted at DFM clinics.
Study Desing

Follow-up
 Participants
are evaluated at baseline and at 3,
6, 9, and 12 months after the start of treatment.
 If a participant misses a clinic visit he/she is
contacted and invited to come in for a study
visit at the DFM or WREN Clinic.
 Follow-up ends:
Participant stops taking his/her medication
 Drop out
 Completion of the follow-up period (4th follow-up
visit).

Data Analysis


Descriptive statistics
Survival analysis:

Rate of non-adherence in each quarter.
 Cumulative risk is calculated using the
estimated rates (risk=1-exp(-rate*time))
 Multivariate analysis

Cox regression for cluster data with a robust
estimate of the variance to account for the
presence of repeated observations.
Preliminary Results
Baseline data from 159 subjects
 Male 59.5% (95%CI: 51.8, 67.2)
 Average age: 49.1, Range: 23-69 years


Follow-up
 Baseline
159

F1 F2
114 67
F3
47
F4
29
Total FU
416
Person time: 807.1 person-months
Characteristics of the population
Characteristics
%
95% CI
Married
White
High school or less
73.6
91.8
26.4
66.0, 80.3
86.4, 95.6
19.8, 34.0
Full time employee
Income <$50,000
68.6
34.0
60.7, 75.7
26.7, 41.9
HMO/Other private
Copay for drugs
78.6
80.5
71.4, 84.7
73.5, 86.4
House tenency (own/mortgage)
78.0
70.7, 84.2
Current smoking
17.0
11.5, 23.7
Preliminary Results: Well-being

Self-reported health status:
 Excellent/Very
 Good
 Fair/Poor

good
60.0%
33.5%
6.5%
Psychological General Well-Being Index
(PGWB) :
 Average:
81.2, Range: 19-105
Preliminary Results: Depression

Beck Depression Inventory-II (BDI-II) :
Minimal (<14)
88.6%
 Mild (14-19)
5.6%
 Moderate (20-28)
3.2%
 Severe (29-63)
2.7%

 Average

5.4, Range: 0-59
Depression: 11.4% (95%CI: 8.5, 14.8)
Preliminary Results: Compliance
_________________________________________________________
Follow- Person- Failures
Rate
95% Conf.
Cumulative
up visit time
(100 pm) Interval
risk (%)
_________________________________________________________
1
354.0
45
12.7
9.5, 17.0
32.9
2
214.0
11
5.1
2.9, 9.3
14.7
3
146.9
11
7.5
4.2, 13.5
20.9
4
92.2
4
4.3
1.6, 11.6
12.6
Overall 807.1
71
8.8
6.9, 11.0
60.4
_________________________________________________________
Factors associated with non-compliance (adjusted
analysis)
Variables
Hazard Ratio
95%Confidence
Interval
P-Value
Gender: Male vs. Female
0.99
0.58, 1.67
0.957
Age:
60 – 69
50 – 59
40 – 49
30 – 39
20 – 29
1.00
1.25
0.80
1.64
0.83
0.61, 2.55
0.39, 1.63
0.61, 4.40
0.26, 2.69
0.547
0.540
0.322
0.757
Copay for prescription:
Yes/No
0.43
0.20, 0.93
0.032
Number of pills per day
1.33
1.12, 1.58
0.001
Well-being score:
85+/<85
0.48
0.28, 0.80
0.005
Depression:
Yes/No
0.85
0.45, 1.62
0.624
Conclusions
These are preliminary results.
 The risk of non-adherence (60% in 12
months) was slightly higher than that
reported in other cohort studies.
 Copayment for medication seemed to
improve while an increased number of pills
per day seemed to decrease adherence.

Conclusions
Better overall quality of life improved
adherence.
 Depression symptoms were not
associated to adherence.
 Age was not associated with adherence.

Questions?
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