Developing Accessible Telehealth Programs for Hypertensive Patients in Latin America
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the feasibility of utilizing an interactive voice
      response (IVR) system to supplement hypertension self-management for patients in
      underdeveloped regions in Mexico and Honduras. Weekly disease assessment calls included
      hypertension self-management suggestions and support to patients. The impact on patients'
      blood pressure levels and other secondary outcomes were evaluated.
    

Detailed description: 
      Background: Three quarters of all cardiovascular disease-related deaths occur in low- to
      middle- income countries. In addition, there are more than 1 billion people worldwide at risk
      of a serious cardiovascular event due to high blood pressure, high serum cholesterol levels
      and/or diabetes. In Latin America, hypertensive-related heart disease is among the top ten
      causes of death. Inadequacies in health care service access and treatment quality along with
      high rates of poverty, only work to exacerbate the problem.

      Objectives/Aims: Based on prior study and other previous projects conducted in Santa Cruz de
      Yojoa, the purpose of the study is to evaluate the short-term feasibility and impact of an
      automated phone system in monitoring and improving hypertension among patients from
      semi-rural communities in Mexico and Honduras. The specific aims are: (1) to evaluate the
      feasibility (acceptability and usage rates) of a program including weekly disease assessment
      calls that include self-management suggestions and support among patients with hypertension;
      (2) to evaluate the program's impact on patients' blood pressure levels and other secondary
      outcomes; and (3) to discuss with local clinical, community, and health policy leaders the
      potential for expansion of this telemedicine program to other underdeveloped regions
      throughout the world and as well as its possible efficacy for other chronic diseases beyond
      cardiovascular diseases.

      Methods: Adult hypertensive patients who receive care from participating clinics affiliated
      with Yojoa International Medical Center in Santa Cruz de Yojoa, Honduras and the Diabetes
      Center clinics in Pachuca and Real del Monte, Mexico, will be recruited for this study. 200
      patients (100 from each clinic site), including adult men and women (up to 100 from each
      clinic) between the ages of 18 and 80 who have high blood pressure and who see their primary
      care doctor at one of the participating clinics will be screened and enrolled in this
      program. The patient may choose to enroll with a family member or friend (a "Care Partner")
      for disease management support throughout the study. Blood pressure will be taken by
      researchers at baseline, and at the six-week follow-up.

      Participants will be randomized to receive written information about blood pressure control
      versus weekly automated telephone assessment and behavior change calls focused on blood
      pressure management. The intervention group will receive a weekly 10-minute automated phone
      call to their cell phone for disease assessment and self-care support for 6 weeks.
      Intervention patients also will be provided with in-home cuffs for measurement of blood
      pressure throughout the study. During patients' automated calls, they will be asked questions
      about their hypertension, medication, and self-care. Based on the patient's self-report, they
      will receive targeted suggestions for how to improve their hypertension self- care. The
      intervention patient's CarePartner (if applicable) will receive a weekly update via automated
      phone call or email, which will give that informal caregiver a summary of the enrolled
      patient's health and provide him/her with suggestions for addressing the needs of the patient
      and supporting the patient's self-care.

      Urgent alerts for patients with critical health problems will be provided, via email, to the
      research team plus the clinic so that follow-up with a clinician can take place. The
      intervention will last six weeks, after which the patient will have a follow-up visit with
      the research team and will complete a survey about the program. The control group will be
      enrolled just as the intervention group; however, the control group will not receive
      automated phone calls or a blood pressure monitor over the six-week study period.
    

Intervention name(s): Interactive Voice Response (IVR) automated calls
Intervention type(s): Behavioral
Intervention description(s): Interactive Voice Response (IVR) is a type of automated telephone call. Weekly automated telephone assessment and behavior change calls focused on blood pressure management will be sent to the experimental group. They will receive a weekly 10-minute automated phone call to their telephone for disease assessment and self-care support for 6 weeks. In-home blood pressure cuffs were provided for measurement of blood pressure throughout the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypertension; Telephone Care Management; Blood pressure; Medication adherence; Interactive Voice Response (IVR); Cloud computing