Developing Accessible Telehealth Programs for Hypertensive Patients in Latin America

NCT01484782 | Completed

• 1 other identifier: UM-00047263
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Hypertension

Keywords

Hypertension; Telephone Care Management; Blood pressure; Medication adherence; Interactive Voice Response (IVR); Cloud computing

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure

  6 weeks

Secondary Outcomes (2)

• Self-reported health status

  6 weeks

• Medication adherence

  6 weeks

Study Arms (2)

Interactive Voice Response (IVR) calls

EXPERIMENTAL

Weekly automated telephone assessment and behavior change calls focused on blood pressure management. The experimental group 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.

Behavioral: Interactive Voice Response (IVR) automated calls

Usual care

NO INTERVENTION

This group received results of blood pressure readings. PCP referrals. Educational materials about hypertension and self-management. At follow-up, patients received home blood pressure monitoring cuffs.

Interventions

Interactive Voice Response (IVR) automated calls BEHAVIORAL

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.

Interactive Voice Response (IVR) calls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertension (for diabetic patients: systolic blood pressure 130 or greater; for non-diabetic patients: systolic blood pressure 140 or greater)
• Access to a functional telephone
• Able to respond to automated telephone calls

You may not qualify if:

• No access to a functional telephone
• Diagnosis of cancer with less than a six month life expectancy
• Severe mental illness as reported by their clinical team

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (2)

Yojoa International Medical Center

Santa Cruz de Yojoa, Cortés Department, Honduras

Location

Remedi Diabetes Clinic

Pachuca, Hidalgo, Mexico

Location

MeSH Terms

Conditions

Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• John D Piette, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, University of Michigan

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 2, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: January 1, 2012
• Last Updated: April 28, 2015

Record last verified: 2015-04

Locations

ME (1); HO (1)