1. Quality of Life and Depression as Determinants of Treatment Adherence in Hypertensive Leonelo E. Bautista 1 ; Paul Smith 2 ; Cynthia Colombo 2 ; Dennis G. Fryback 1 ; Lyn Y. Abramson 2 ; Lina M. Vera 1 1 Department of Population Health Sciences 2 Department of Family Medicine

2. Outline Background Background Objective Objective Study design Study design Data analysis Data analysis Preliminary Results Preliminary Results Conclusions Conclusions

3. Background Hypertension affects almost one third of the adults in the US. 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. 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. The chance of developing these diseases decreases significantly if hypertension is detected and treated.

4. Background Only 53% of known hypertensives receiving pharmacologic treatment have their blood pressure controlled. 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. 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. Current adherence-enhancing interventions are complex and labor- intensive and have had little success.

5. 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.

6. Objective To evaluate whether health-related quality of life (QOL) and depression symptoms severity (DSS) are 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. Long-term goal: to identify predictors of treatment adherence useful to identify high risk groups and to design effective adherence-enhancing interventions.

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

8. Study Design Sample size: 280 newly-diagnosed hypertensive men (n=140) and women (n=140); 21% (n=60) from minority groups Sample size: 280 newly-diagnosed hypertensive men (n=140) and women (n=140); 21% (n=60) from minority groups Eligibility criteria: 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. This cohort is being recruited and followed at the UW-Department of Family Medicine and WREN Clinics.

9. Study Design Exposure measurements (QOL and DSS): 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.

10. Study Design Outcome measurements (treatment adherence): Outcome measurements (treatment adherence):  Pill count  Primary outcome Non-complier: <80% of prescribed pills Non-complier: <80% of prescribed pills  Self-reported adherence  Secondary outcome  Blood pressure level  Secondary outcome Trained study personnel measure the participant’s blood pressure three times in each visit, with a 2- minute wait between measurements, using an automated device. Trained study personnel measure the participant’s blood pressure three times in each visit, with a 2- minute wait between measurements, using an automated device.

11. Study Design Recruitment: 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.

12. Study Design Recruitment 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.

13. Study Desing Follow-up 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 Participant stops taking his/her medication Drop out Drop out Completion of the follow-up period (4th follow-up visit). Completion of the follow-up period (4th follow-up visit).

14. Data Analysis Descriptive statistics Descriptive statistics Survival analysis: 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. Cox regression for cluster data with a robust estimate of the variance to account for the presence of repeated observations.

15. Preliminary Results Baseline data from 159 subjects Baseline 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 years Average age: 49.1, Range: 23-69 years Follow-up Follow-up  BaselineF1F2F3F4Total FU 159114674729416 159114674729416 Person time: 807.1 person-months Person time: 807.1 person-months

16. Characteristics of the population Characteristics% 95% CI Married73.6 66.0, 80.3 White91.8 86.4, 95.6 High school or less 26.4 19.8, 34.0 Full time employee 68.6 60.7, 75.7 Income <$50,000 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

17. Preliminary Results: Well-being Self-reported health status: Self-reported health status:  Excellent/Very good60.0%  Good33.5%  Fair/Poor 6.5% Psychological General Well-Being Index (PGWB) : Psychological General Well-Being Index (PGWB) :  Average: 81.2, Range: 19-105

18. Preliminary Results: Depression Beck Depression Inventory-II (BDI-II) : Beck Depression Inventory-II (BDI-II) : Minimal (<14)88.6% Minimal (<14)88.6% Mild (14-19) 5.6% Mild (14-19) 5.6% Moderate (20-28) 3.2% Moderate (20-28) 3.2% Severe (29-63) 2.7% Severe (29-63) 2.7%  Average 5.4, Range: 0-59 Depression: 11.4% (95%CI: 8.5, 14.8) Depression: 11.4% (95%CI: 8.5, 14.8)

19. Preliminary Results: Compliance _________________________________________________________ Follow-Person-FailuresRate95% Conf. Cumulative up visittime(100 pm) Intervalrisk (%) _________________________________________________________ 1354.04512.79.5, 17.032.9 2214.0115.12.9, 9.314.7 3146.9117.54.2, 13.520.9 492.244.3 1.6, 11.612.6 Overall807.1718.86.9, 11.060.4 _________________________________________________________

20. Factors associated with non-compliance (adjusted analysis) VariablesHazard Ratio95%Confidence Interval P-Value Gender: Male vs. Female0.990.58, 1.670.957 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/No0.430.20, 0.930.032 Number of pills per day1.331.12, 1.580.001 Well-being score: 85+/<850.480.28, 0.800.005 Depression: Yes/No0.850.45, 1.620.624

21. Conclusions These are preliminary results. These are preliminary results. The risk of non-adherence (60% in 12 months) was slightly higher than that reported in other cohort studies. 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. Copayment for medication seemed to improve while an increased number of pills per day seemed to decrease adherence.

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

23. Questions?

24. THANK YOU