A Randomized Controlled Trial of Positive-Affect Intervention and Medication Adherence in Hypertensive African Americans

ORIGINAL INVESTIGATION ONLINE FIRST A Randomized Controlled Trial of Positive-Affect Intervention and Medication Adherence in Hypertensive African Americans Gbenga O. Ogedegbe, MD; Carla Boutin-Foster, MD, MS; Martin T. Wells, PhD; John P. Allegrante, PhD; Alice M. Isen, PhD; Jared B. Jobe, PhD; Mary E. Charlson, MD Background: Poor adherence explains poor blood pres- tients had diabetes; 11% had stroke; and 3% had chronic sure (BP) control; however African Americans suffer worse kidney disease. Based on the intention-to-treat prin- hypertension-related outcomes. ciple, medication adherence at 12 months was higher in Methods: This randomized controlled trial evaluated the PA group than in the PE group (42% vs 36%, respec- whether a patient education intervention enhanced with tively; P =.049). The within-group reduction in systolic positive-affect induction and self-affirmation (PA) was more BP (2.14 mm Hg vs 2.18 mm Hg; P =.98) and diastolic effective than patient education (PE) alone in improving BP (−1.59 mm Hg vs −0.78 mm Hg; P=.45) for the PA medication adherence and BP reduction among 256 hy- group and PE group, respectively, was not significant. pertensive African Americans followed up in 2 primary care practices. Patients in both groups received a culturally tai- Conclusions: A PE intervention enhanced with PA led to lored hypertension self-management workbook, a behav- significantly higher medication adherence compared with ioral contract, and bimonthly telephone calls designed to PE alone in hypertensive African Americans. Future stud- help them overcome barriers to medication adherence. Also, ies should assess the cost-effectiveness of integrating such patients in the PA group received small gifts and bi- interventions into primary care. monthly telephone calls to help them incorporate positive thoughts into their daily routine and foster self- Trial Registration: clinicaltrials.gov Identifier: affirmation. The main outcome measures were medication NCT00227175 adherence (assessed with electronic pill monitors) and within-patient change in BP from baseline to 12 months. Arch Intern Med. 2012;172(4):322-326. Results: The baseline characteristics were similar in both Published online January 23, 2012. groups: the mean BP was 137/82 mm Hg; 36% of the pa- doi:10.1001/archinternmed.2011.1307 YPERTENSION DISPROPOR- come barriers to adherence have demon- tionately affects African strated substantial improvements in patients’ Americans compared with adherence behaviors.7 The theoretical foun- whites,1 and it explains dation of previous interventions are largely most of the racial gap in based on the social cognitive theory of hu- mortality.2 Poor medication adherence may man behavior, with a particular emphasis H 8 explain poor blood pressure (BP) control in on self-efficacy. However, despite the avail- hypertensive patients, especially African ability of effective adherence interventions Americans.3,4 The adverse effect of poor ad- in patients with cardiovascular dis- herence on cardiovascular mortality and eases,7,9,10 their effectiveness in primary care morbidity is well established.5,6 Therefore, settings remains largely untested, espe- interventions targeted at improving medi- cially among minority patients. cation adherence are necessary to reduce the racial gap in hypertension-related out- See Invited Commentary comes. Evidence suggests that successful in- at end of article terventions designed to improve medication adherence in patients with chronic diseases use a combined strategy, with the For editorial comment behavioral-education combination being the see page 309 one most frequently used.7 Similarly, interventions that involve patient activation, ad- Among hypertensive African Ameri- dress their concerns about medications, are cans evaluated in a primary care practice, Author Affiliations are listed at emotively supportive, and enhance pa- we examined whether a patient educa- the end of this article. tients’ confidence in their abilities to over- tion (PE) intervention enhanced with posi- ARCH INTERN MED/ VOL 172 (NO. 4), FEB 27, 2012 WWW.ARCHINTERNMED.COM 322 ©2012 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ by a Columbia University Libraries User on 10/28/2019 tive-affect induction and self-affirmation (PA) was more study staff. Reminders were sent via telephone calls to all pa- effective than PE alone in improving medication adher- tients about returning their pill monitors. ence and BP reduction. We hypothesized a greater effect of the PA intervention on medication adherence and RANDOMIZATION BP reduction compared with PE alone over 12 months. Positive affect is a state of pleasurable engagement with On completion of the baseline assessments, the study biostat- the environment and reflects feelings of mild everyday istician randomly assigned patients to either the PE control group happiness, joy, contentment, and enthusiasm.11 It can be or the PA intervention group in a 1:1 ratio. Patient assign- induced in several ways, including the receipt of unex- ments were placed in sealed opaque envelopes. As is typical for most behavioral interventions, neither the patients nor the RAs pected compliments and gifts, a focus on positive 12 were blinded to the intervention. The primary care providers thoughts, and the successful completion of small tasks. did not know their patients’ group assignments. The combination of positive-affect induction and self- affirmation is defined as one’s motivation to preserve a TREATMENT GROUPS positive image and self-integrity when one’s self- 13 identify is threatened. It enhances the ability to over- PE Control Group come negative expectations by drawing on previous ex- 14 periences of success. It can be produced through the Patients in the PE control group received a culturally tailored use of positive statements or memories about one’s ac- educational workbook designed (1) to enhance patients’ knowl- 14 complishments or successes to build self-confidence. edge about hypertension, (2) to improve self-management behaviors, and (3) to support goal-setting.21 On receipt of the work- METHODS book, trained RAs reviewed each chapter with the patients and then asked them to sign a behavioral contract that asked them to make a commitment to taking their medications as pre- STUDY POPULATION scribed. Subsequent to this session, each patient received bimonthly telephone calls, during which the RAs assessed the pa- Adult patients were recruited from a primary-care practice tient’s behavioral contract and confidence to take their within the ambulatory care network of New York Presbyte- medications as prescribed. These assessments served as the ba- rian Hospital, New York, New York, during routine office sis for reviewing and counseling the patient on perceived bar- visits. Eligibility included self-identification as African riers to medication adherence.15 American or black, fluency in the English language, a diag- nosis of hypertension, and the use of at least 1 antihyperten- sive medication. Eligible patients were identified via elec- PA Intervention Group tronic medical records (EMRs) and review of clinic appointment schedules. The institutional review board of Patients randomized to the PA intervention group were given Weill Cornell Medical College, New York, New York, the same workbook as those in the PE group but with an ad- approved the study, and all patients provided written ditional chapter that addresses the benefits of positive mo- informed consent. Greater detail of the study methods has ments in overcoming obstacles to medication adherence. Also, been provided elsewhere.15 these patients received 2 forms of PA during bimonthly telephone calls. First, they were asked to identify small things in STUDY DESIGN their lives that invoke positive feelings in them and were then instructed to incorporate these positive thoughts into their daily routine. The positive thoughts were further reinforced during The study was a 2-arm randomized controlled trial with a 12- subsequent bimonthly telephone calls. Second, the patients month follow-up.15 After enrollment and baseline assessment, received unexpected small gifts mailed to them before each patients were followed up by individual telephone interviews telephone call.22 This strategy was based on the potential of the bimonthly for 12 months. receipt of unexpected gifts to induce positive feelings.23,24 For self- affirmation induction, the patients were asked to remember their BASELINE ASSESSMENTS core values and proud moments in their lives whenever they encounter situations that make it difficult for them to take their At baseline, research assistants (RAs) confirmed each patient’s medications.13,14 eligibility, assessed their demographic status, and reviewed the EMRs for office BP readings, medication list, and comorbidity using the Charlson comorbidity index.16 Also, patients were ad- FOLLOW-UP ASSESSMENTS ministered validated self-report measures to assess depressive symptoms,17 social support,18 medication adherence,19 and posi- The RAs conducted bimonthly follow-up telephone inter- tive and negative affect.20 Each patient was then given an elec- views with each patient for 12 months. Data collection at the tronic pill monitor (Medic-eCap; Information Mediary Corp), final study visit was similar to that at the baseline visit. which was used to assess adherence to prescribed antihyper- tensive medication. The electronic pill monitor consists of a OUTCOMES AND MEASUREMENTS

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