Quality of Life and Quality of Life and Depression as Depression as Determinants of Treatment Determinants of Treatment Adherence in HypertensiveAdherence in HypertensiveLeonelo E. BautistaLeonelo E. Bautista11; Paul Smith; Paul Smith22; Cynthia Colombo; Cynthia Colombo22; ; Dennis G. FrybackDennis G. Fryback11; Lyn Y. Abramson; Lyn Y. Abramson22; ; Lina M. VeraLina M. Vera11 11Department of Population Health SciencesDepartment of Population Health Sciences22Department of Family MedicineDepartment of Family Medicine

OutlineOutline

BackgroundBackground ObjectiveObjective Study designStudy design Data analysisData analysis Preliminary ResultsPreliminary Results ConclusionsConclusions

BackgroundBackground

Hypertension affects almost one third of the Hypertension affects almost one third of the adults in the US.adults in the US.

Being hypertensive increases the chance of Being hypertensive increases the chance of developing heart attacks, strokes, heart developing heart attacks, strokes, heart failure and kidney failure.failure and kidney failure.

The chance of developing these diseases The chance of developing these diseases decreases significantly if hypertension is decreases significantly if hypertension is detected and treated.detected and treated.

BackgroundBackground Only 53% of known hypertensives Only 53% of known hypertensives

receiving pharmacologic treatment have receiving pharmacologic treatment have their blood pressure controlled.their blood pressure controlled.

Almost half of all patients stop taking their Almost half of all patients stop taking their antihypertensive drugsantihypertensive drugs within 12 months within 12 months after they start treatment.after they start treatment.

Current adherence-enhancing Current adherence-enhancing interventions are complex and labor-interventions are complex and labor-intensive and have had little success.intensive and have had little success.

BackgroundBackground

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.

ObjectiveObjective To evaluate whether To evaluate whether baseline levels and

changes in health-related quality of life health-related quality of life (QOL) and depression symptoms severity (QOL) and depression symptoms severity (DSS) are (DSS) are predictive of treatment adherence in newly treated hypertensive patients.

Long-term goal: to identify predictors of Long-term goal: to identify predictors of treatment adherence useful to identify high treatment adherence useful to identify high risk groups and to design effective risk groups and to design effective adherence-enhancing interventions.adherence-enhancing interventions.

Study DesignStudy Design

Longitudinal cohort study among Longitudinal cohort study among newly identified patients with newly identified patients with essential hypertension who require essential hypertension who require drug therapy. drug therapy.

QOL and DSS (exposure) and QOL and DSS (exposure) and treatment adherence (outcome) are treatment adherence (outcome) are evaluated at baseline and at 3, 6, 9, evaluated at baseline and at 3, 6, 9, and 12 months after the start of and 12 months after the start of treatment.treatment.

Study DesignStudy Design

Sample size: 280 newly-diagnosed Sample size: 280 newly-diagnosed hypertensive men (n=140) and women hypertensive men (n=140) and women (n=140); 21% (n=60) from minority groups(n=140); 21% (n=60) from minority groups

Eligibility criteria:Eligibility criteria:20-69 years old.20-69 years old.Not taking mood-modifying drugsNot taking mood-modifying drugs

This cohort is being recruited and followed This cohort is being recruited and followed at the UW-Department of Family Medicine at the UW-Department of Family Medicine and WREN Clinics.and WREN Clinics.

Study DesignStudy Design Exposure measurements (QOL and DSS):Exposure measurements (QOL and DSS):

A short version of the Physical Symptoms A short version of the Physical Symptoms Distress Index (PSDI).Distress Index (PSDI).

The Sexual Symptoms Distress Index (SSDI)The Sexual Symptoms Distress Index (SSDI) The Psychological General Well-Being Index The Psychological General Well-Being Index

(PGWB)(PGWB)..The Sleep Dysfunction Scale (SDS)The Sleep Dysfunction Scale (SDS)..The Beck Depression Inventory-II (BDI-II)The Beck Depression Inventory-II (BDI-II)..Self-administration of the PSDI, SSDI, PGWB Self-administration of the PSDI, SSDI, PGWB

and SDS takes about 30-40 minutes.and SDS takes about 30-40 minutes.

Study DesignStudy Design Outcome measurements (treatment Outcome measurements (treatment

adherence):adherence):

Pill count Pill count Primary outcome Primary outcome Non-complier: <80% of prescribed pillsNon-complier: <80% of prescribed pills

Self-reported adherence Self-reported adherence Secondary outcome Secondary outcomeBlood pressure level Blood pressure level Secondary outcome Secondary outcome

Trained study personnel measure the participant’s Trained study personnel measure the participant’s blood pressure three times in each visit, with a 2-blood pressure three times in each visit, with a 2-minute wait between measurements, using an minute wait between measurements, using an automated device.automated device.

Study DesignStudy Design

Recruitment:Recruitment:WREN Clinics WREN Clinics Hypertensive patients who Hypertensive patients who

are about to start or have recently started are about to start or have recently started antihypertensive medication are identified and antihypertensive medication are identified and referred by their physicians or by clinic nursesreferred by their physicians or by clinic nurses

Study personnel administer screening form to Study personnel administer screening form to verify eligibility.verify eligibility.

Eligible patients then are invited to participate.Eligible patients then are invited to participate.

Study DesignStudy Design

RecruitmentRecruitmentUW-DFM Clinics UW-DFM Clinics Potentially eligible patients Potentially eligible patients

are identified through the DFM Clinical Data are identified through the DFM Clinical Data Warehouse (CDW). Warehouse (CDW).

A DFM Research Specialist sends a letter to A DFM Research Specialist sends a letter to potentially eligible patients informing them about potentially eligible patients informing them about the study and asking whether they may be the study and asking whether they may be interested in participating in the study.interested in participating in the study.

Informed consent and data collection are Informed consent and data collection are conducted at DFM clinics.conducted at DFM clinics.

Study DesingStudy Desing Follow-upFollow-up

Participants are evaluated at baseline and at 3, Participants are evaluated at baseline and at 3, 6, 9, and 12 months after the start of treatment.6, 9, and 12 months after the start of treatment.

If a participant misses a clinic visit he/she is If a participant misses a clinic visit he/she is contacted and invited to come in for a study contacted and invited to come in for a study visit at the DFM or WREN Clinic.visit at the DFM or WREN Clinic.

Follow-up ends:Follow-up ends: Participant stops taking his/her medicationParticipant stops taking his/her medication Drop outDrop out Completion of the follow-up period (4th follow-up Completion of the follow-up period (4th follow-up

visit). visit).

Data AnalysisData Analysis

Descriptive statisticsDescriptive statistics Survival analysis: Survival analysis:

Rate of non-adherence in each quarter.Rate of non-adherence in each quarter. Cumulative risk is calculated using the Cumulative risk is calculated using the

estimated rates (risk=1-exp(-rate*time))estimated rates (risk=1-exp(-rate*time)) Multivariate analysisMultivariate analysis

Cox regression for cluster data with a robust Cox regression for cluster data with a robust estimate of the variance to account for the estimate of the variance to account for the presence of repeated observationspresence of repeated observations..

Preliminary ResultsPreliminary Results

Baseline data from 159 subjectsBaseline data from 159 subjects Male 59.5% (95%CI: 51.8, 67.2)Male 59.5% (95%CI: 51.8, 67.2) Average age: 49.1, Range: 23-69 yearsAverage age: 49.1, Range: 23-69 years

Follow-upFollow-upBaselineBaseline F1F1 F2F2 F3F3 F4F4 Total FUTotal FU 159159 114114 6767 4747 2929 416416

Person time: 807.1 person-monthsPerson time: 807.1 person-months

Characteristics of the populationCharacteristics of the populationCharacteristicsCharacteristics %% 95% CI95% CI

MarriedMarried 73.673.6 66.0, 80.366.0, 80.3

WhiteWhite 91.891.8 86.4, 95.686.4, 95.6

High school or lessHigh school or less 26.426.4 19.8, 34.019.8, 34.0

Full time employeeFull time employee 68.668.6 60.7, 75.760.7, 75.7

IncomeIncome <$50,000 <$50,000 34.034.0 26.7, 41.926.7, 41.9

HMO/Other privateHMO/Other private 78.678.6 71.4, 84.771.4, 84.7

Copay for drugsCopay for drugs 80.580.5 73.5, 86.473.5, 86.4

House tenency (House tenency (own/mortgageown/mortgage)) 78.078.0 70.7, 84.270.7, 84.2

Current smokingCurrent smoking 17.017.0 11.5, 23.711.5, 23.7

Preliminary Results: Well-beingPreliminary Results: Well-being

Self-reported health status:Self-reported health status:Excellent/Very goodExcellent/Very good 60.0% 60.0% GoodGood 33.5% 33.5% Fair/PoorFair/Poor 6.5% 6.5%

Psychological General Well-Being Index Psychological General Well-Being Index (PGWB) :(PGWB) :Average: 81.2, Range: 19-105Average: 81.2, Range: 19-105

Preliminary Results: DepressionPreliminary Results: Depression

Beck Depression Inventory-II (BDI-II) :Beck Depression Inventory-II (BDI-II) :

Minimal (<14)Minimal (<14) 88.6%88.6% Mild (14-19)Mild (14-19) 5.6% 5.6% Moderate (20-28)Moderate (20-28) 3.2% 3.2% Severe (29-63)Severe (29-63) 2.7% 2.7%

AverageAverage 5.4, Range: 0-59 5.4, Range: 0-59

Depression: 11.4% (95%CI: 8.5, 14.8)Depression: 11.4% (95%CI: 8.5, 14.8)

Preliminary Results: CompliancePreliminary Results: Compliance

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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 Factors associated with non-compliance (adjusted analysis)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

1.001.250.801.640.83

0.61, 2.550.39, 1.630.61, 4.400.26, 2.69

0.5470.5400.3220.757

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

ConclusionsConclusions

These are preliminary results.These are preliminary results. The risk of non-adherence (60% in 12 The risk of non-adherence (60% in 12

months) was slightly higher than that months) was slightly higher than that reported in other cohort studies.reported in other cohort studies.

Copayment for medication seemed to Copayment for medication seemed to improve while an increased number of pills improve while an increased number of pills per day seemed to decrease adherence.per day seemed to decrease adherence.

ConclusionsConclusions

Better overall quality of life improved Better overall quality of life improved adherence. adherence.

Depression symptoms were not Depression symptoms were not associated to adherence.associated to adherence.

Age was not associated with adherence.Age was not associated with adherence.

Questions?Questions?

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