A Randomized Trial of Changing Medication Adherence In Hypertensive African-American Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The long-term objective is to determine whether better adherence to prescribed medications
      can be achieved through positive affect induction and self-affirmation leading to reduction
      in hypertension-related outcomes such as end-stage renal disease, stroke, and cardiovascular
      mortality among African American patients with poorly controlled hypertension.
    

Detailed description: 
      The objective of this randomized trial is to evaluate, among African American patients with
      poorly controlled hypertension, whether a novel intervention of positive affect induction and
      self-affirmation is more effective than usual care in increasing adherence to prescribed
      antihypertensive medications. The main outcome will be the change in medication adherence
      rate from enrollment to 12 months, which is defined as percentage (%) of prescribed doses
      taken by the patient during the interval of observation as measured by electronic medication
      event monitoring system (MEMS).

      2. Secondary objectives

        1. To determine, among African American patients with poorly controlled hypertension, the
           extent to which positive affect induction and self-affirmation influence patients'
           self-efficacy.

        2. To determine, among African American patients with poorly controlled hypertension, the
           extent to which positive affect induction and self-affirmation influence medication
           adherence in those with significant depressive symptomatology (CES-D score > 16).

        3. To determine, among African-American patients with poorly controlled hypertension, the
           extent to which positive affect induction and self-affirmation influence blood pressure
           control.

        4. To explore the health beliefs of hypertensive African-American patients, regarding the
           meaning, causes and treatment of hypertension. In addition, the factors that facilitate
           and prevent adherence to prescribed antihypertensive medications will also be explored
           using a qualitative approach.
    

Intervention name(s): Intervention Group
Intervention type(s): Behavioral
Intervention description(s): During the physical activity goal setting process, subjects were randomly assigned to either the control or the intervention group. The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their medication adherence. Patient also received small token gifts to remind them of their participation in the study and to induce positive affect. The control group also set a physical activity goal and received the same follow-up, but did not participate in the positive affect and self-affirmation portion.
Other intervention name(s): Positive affect and self-affirmation induction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: African-American; Hypertension; Medication adherence; Risk reduction