Quality of Life and Depression as Determinants of Treatment Adherence in Hypertensive

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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

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Outline

• Background
• Objective
• Study design
• Data analysis
• Preliminary Results
• Conclusions

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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.

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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 labor-intensive and have had little
  success.

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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.

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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.

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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.

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Study Design

• Sample size 280 newly-diagnosed hypertensive men
  (n140) and women (n140) 21 (n60) 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.

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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.

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Study Design

• Outcome measurements (treatment adherence)
• Pill count ? Primary outcome
• Non-complier lt80 of prescribed pills
• Self-reported adherence ? Secondary outcome
• Blood pressure level ? Secondary outcome
• Trained study personnel measure the participants
  blood pressure three times in each visit, with a
  2-minute wait between measurements, using an
  automated device.

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Study Design

• Recruitment
• WREN 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.

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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.

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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).

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Data Analysis

• Descriptive statistics
• Survival analysis
• Rate of non-adherence in each quarter.
• Cumulative risk is calculated using the estimated
  rates (risk1-exp(-ratetime))
• Multivariate analysis
• Cox regression for cluster data with a robust
  estimate of the variance to account for the
  presence of repeated observations.

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Preliminary Results

• Baseline data from 159 subjects
• Male 59.5 (95CI 51.8, 67.2)
• Average age 49.1, Range 23-69 years
• Follow-up
• Baseline F1 F2 F3 F4 Total FU
• 159 114 67 47 29 416
• Person time 807.1 person-months

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Characteristics of the population
Characteristics 95 CI
Married 73.6 66.0, 80.3
White 91.8 86.4, 95.6
High school or less 26.4 19.8, 34.0
Full time employee 68.6 60.7, 75.7
Income lt50,000 34.0 26.7, 41.9
HMO/Other private 78.6 71.4, 84.7
Copay for drugs 80.5 73.5, 86.4
House tenency (own/mortgage) 78.0 70.7, 84.2
Current smoking 17.0 11.5, 23.7
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Preliminary Results Well-being

• Self-reported health status
• Excellent/Very good 60.0
• Good 33.5
• Fair/Poor 6.5
• Psychological General Well-Being Index (PGWB)
• Average 81.2, Range 19-105

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Preliminary Results Depression

• Beck Depression Inventory-II (BDI-II)
• Minimal (lt14) 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 (95CI 8.5, 14.8)

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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 _______________________________________
__________________
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Factors associated with non-compliance (adjusted
analysis)
Variables Hazard Ratio 95Confidence 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/lt85 0.48 0.28, 0.80 0.005
Depression Yes/No 0.85 0.45, 1.62 0.624
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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.

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Conclusions

• Better overall quality of life improved
  adherence.
• Depression symptoms were not associated to
  adherence.
• Age was not associated with adherence.

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Questions?
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THANK YOU