A Randomized Trial of Changing Medication Adherence In Hypertensive African-American Patients

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Intervention Group

Study type: Interventional

Funder types: Other

Identifiers

NCT00248872

N01-HC-25196 (0203-704)

Details and patient eligibility

About

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.

Full 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

3. To determine, among African American patients with poorly controlled hypertension, the extent to which positive affect induction and self-affirmation influence patients' self-efficacy.

4. 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).

5. To determine, among African-American patients with poorly controlled hypertension, the extent to which positive affect induction and self-affirmation influence blood pressure control.

6. 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.

Enrollment: 278 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must be self-identified as African-Americans.
2. All patients must be aged 18 years and older.
3. All patients must be diagnosed as having hypertension: For this project, hypertension will be defined according to the widely accepted criteria of the 6th Joint National Committee (JNC VI) Guidelines on Prevention, Detection, Evaluation and Treatment of Hypertension, which is a systolic blood pressure > 140 mm hg or a diastolic blood pressure > 90 mm hg or if participants are taking any prescribed antihypertensive medication.
4. Patients must be able to provide informed consent in English.

Exclusion criteria

1. Patients who are unable to walk several blocks for any reason.
2. Patients who refused to participate
3. Patients who are unable to provide informed consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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278 participants in 2 patient groups

control group

No Intervention group

Description:

This group received follow-up every 2-months for one year. Follow-up included questions about their blood pressure and how well they had been able to adhere to their medication goal.

Intervention Group

Experimental group

Description:

This group received follow-up every 2-months for one year. Follow-up included questions about their blood pressure and how well they had been able to engage adhere to their medication goal. 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 physical activity level.

Treatment:

Behavioral: Intervention Group