1. CAN ADHERENCE BE IMPROVED?

2. Status of Adherence Intervention Studies t To Medication t To Exercise t To Diet

3. 19 Adherence Intervention Studies  Randomized  Control Group  Assessment of Adherence  Assessment of Outcome  6 month Follow Up Haynes, R. B., Montague, P., Oliver, T., McKibbon, K. A., Brouwers, M. C., & Kanani, R. (2001). Interventions for helping patients to follow prescriptions for medications. [Systematic Review] Cochrane Consumers & Communication Group Cochrane Database of Systematic Reviews.

4. 19 Adherence Intervention Studies  All Use Self - Report  1 Study addresses Remediation  Education/Counseling/Behavioral Strategies  All Address Single Regimen/Disease

5. Characteristics of Successful Interventions t Educational/Behavioral t Multicomponent t Long-Term (from Haynes, 1996)

6. Adherence Monitoring as Intervention t Use of Electronically Monitored Data as Feedback t Improved Blood Pressure Control 1 Improved Blood Pressure Management t Reduction in Seizures 2 Improved Adherence 1 Bertholet et al, 2000 2 Schneider et al, 2000

7. Summary of Interventions tSelf-Monitoring tCounseling tPositive Reinforcement tCuing tVerbal Persuasion tEducation tSocial Support tSelf-Efficacy Enhancement tBehavioral Intervention tElectronic Monitoring/Feedback

8. Interventions to Promote Adherence to Exercise t Self-Monitoring 1,6,8 t Counseling 2,6,7 t Positive Reinforcement 1,5 1 Atkins et al, 1984 2 Belise et al, 1987 3 Daltroy, 1985 4 Jakicic et al, 1995 5 Keefe & Blumenthal, 1980 t Cuing 1,5 t Verbal Persuasion 3 t Education 4,9 6 King et al, 1988 7 King & Frederikson, 1984 8 Rogers et al, 1987 9 Schneiders et al, 1998

9. Interventions to Promote Adherence to Dietary Regimen t Counseling 3,4,8 t Social Support 1,2,6 t Self-Efficacy Enhancement 6 1 Barnard et al, 1992 2 Borbjerb et al, 1995 3 Dolecek et al, 1986 4 Glueck et al, 1986 5 Karvetti, 1981 t Education 5,7 t Behavioral Intervention 9 6 McCann et al, 1988 7 Mojonnier et al, 1980 8 Simkin-Silverman et al, 1995 9 Wing & Anglen, 1996

10. Summary t Interventions are not targeted to patient adherence patterns or to patient-reported reasons for poor adherence t Outcome measures are not reliable or accurate t Very few RCT’s have been reported

11. Study 1. An intervention study designed to improve poor adherers - asymptomatic condition Study 2. An intervention study with poor compliers - symptomatic condition Study 3. Adherence in clinical trials - an induction study 3 Randomized Controlled Studies Designed to Examine Strategies to Improve Compliance

12. Purpose:To evaluate a multicomponent behavioral strategy designed to improve compliance among poor compliers Setting:Multi-center randomized controlled clinical trial designed to test the cholesterol hypothesis * Coronary Primary Prevention Trial An Intervention Study Designed to Improve Poor Compliers

13. Proportion of Subjects > 75% Compliance Pre-intervention Post-Intervention* Experimental09 Attention Control01 Usual Care03 *  2 = 10.21, 2dƒ, p =.006

14. Change in Cholesterol Levels

15. Variability in Adherence and Treatment Response t Greater response to monitoring/attention overestimated compliance (r =.75) greater variability(r =.50) t Relationship between variability and overestimation (r =.54)

16. Purpose: To evaluate a series of behavioral/problem solving interventions to improve poor adherence Setting: Specialty practice sites An Intervention Study Designed to Improve Poor Adherers RAC-1

17. Group Differences Baseline To End Of Treatment t Average Change In Adherence x sd Intervention 4.30+ 24.7 Usual Care-7.99+ 27.1 t = -2.02, p =.023 t Proportion Greater Than 80% Adherence Intervention + Maintenance= 29.7% Usual Care= 15.6% X 2 = 2.25, df = 1, p =.065 RESULTS

18. Relationship of Change in Adherence and Functional Status TxF/U Adherence: Painr s =.02 r s = -.22* (n = 96)(n = 98) Adherence: Difficulty r s =.04 r s = -.11 (n = 95) (n = 97) Adherence: Assistance r s =.03 r s = -.12 (n = 96) (n = 97) *p<.01 Changes in adherence were associated with changes in pain in carrying out activities of daily living, but no level of difficulty or assistance required

19. Predictors of Change t Baseline Correlates With Change Score End of Treatmentr s = -.20 p =.036 Follow-upr s = -.32 p =.001 t Session Attendance and Change Score Follow-upf = 9.07, df = 2, p =.0007

20. Compliance in Clinical Trials - An Induction Study t Purpose:To evaluate a minimal strategy designed to promote initial compliance t Setting:Single center randomized, clinical trial designed to study the psychological and behavioral effects of cholesterol lowering* * M. Muldoon, the CARE Study

21. Group Differences in Adherence ACT at 6 Months n = 180 MEMSMEMSPill Count (% days compliant)(% pills taken) Usual Care (Mdn) 62.5%85.7%93.5% Habit Training (Mdn) 67.9%92.8%96.1% Habit Training (Mdn) 61.6%90.2%93.8% + Problem Solving p =NSNSNS

22. Summary t Poor Adherence is: Wide Spread Costly Hard to Identify Difficult to Predict Who Does Not Adhere t Few Studies Point to Interventions

23. Summary t Individuals vary in dosing adherence t Measures to identify poor adherence need to be sensitive to dosing patterns t Minimal intervention does not appear to improve long-term adherence t Adherence can be improved with intensive interventions t Improving adherence positively impacts clinical outcomes

24. Recommendations t Address individual adherence patterns in clinical and research setting t Take careful account of method of assessment in interpretation of adherence data t Design/evaluate adherence interventions

25. Any Questions? Thank You!