Stepped Intervention for Meds Adherence and Blood Pressure Control
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Interventional

Summary: 
      To test the effectiveness of a stepped-care intervention involving 2 stages: (1)
      Self-Telemonitoring (STM) of blood pressure (BP) which uses a telephone transmission system
      (2) Telephone-Based Nurse Case Management (NCM), provided by a commercially available
      service.
    

Detailed description: 
      DESIGN NARRATIVE:

      The Medication Adherence and Blood Pressure Control Trial (ABC Trial) is a randomized
      controlled trial in a multicultural population of uncontrolled, hypertensive patients to test
      the effectiveness of a stepped-care intervention involving 2 stages: (1) Self-Telemonitoring
      (STM) of blood pressure (BP) which uses a telephone transmission system by which an
      easy-to-use modem, contained in the BP monitor, sends the BP measurements to a commercial
      service (Lifelink Monitoring) who then sends the measurements to the patient's health care
      provider; and (2) Telephone-Based Nurse Case Management (NCM), provided by a commercially
      available service (U-Med). The nurse case managers will call patients once/month, and provide
      counseling regarding BP control, and adherence to medication regimens. All patients in the
      intervention condition will begin with STM; after 3 months, patients whose BP has come under
      control remain in the STM condition; patients whose BP remain uncontrolled are then
      randomized, half to NCM + Self-Telemonitoring; the other half to continue in STM only (the
      design allows us to evaluate the effects of each arm of the intervention separately, and the
      combination; in addition, there will be a Usual Care condition). The focus is on an
      intervention strategy which readily transfers to a variety of usual health care situations.
      Both interventions are commercially available, and therefore are accessible to a wide range
      of health care providers, including smaller community-based clinics. An innovative aspect of
      the intervention is that the 2 commercial services will work together; the nurse case
      managers will receive BP reports from Lifelink, which the nurse will then use as a basis for
      counseling. The effectiveness of the interventions will be tested in 12 community-based
      clinics, which serve an economically disadvantaged, largely African American and Hispanic
      population, in New York City. The main outcome measures are medication adherence, determined
      by electronic drug event monitoring (MEMS), and pharmacy refill records, as well as BP
      control. Study duration is 1 year. The multilevel focus of the interventions is on provider
      as well as patient behavior. Reviews will be conducted for each patient at study discharge,
      recording data on clinic BP measurements during the previous 12 months, if any, doctor
      appointments, ER visits, medication changes, and evidence that the physician has responded to
      the interventions. The long-term goals of the research are to assess the medical and cost
      effectiveness of the interventions separately, and combined.
    

Intervention name(s): self-medication monitoring
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Treatment