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HypertensionNCT01484782

Developing Accessible Telehealth Programs for Hypertensive Patients in Latin America

A study testing Interactive Voice Response (IVR) automated calls in people with Hypertension, run by University of Michigan at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hypertension
What is being tested?
Interactive Voice Response (IVR) automated calls
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesin 2 countries
Study dates
May 2011to Jan 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Honduras1 site
  • Yojoa International Medical Center

    Santa Cruz de Yojoa, Cortés Department

Other trials in Honduras

Mexico1 site
  • Remedi Diabetes Clinic

    Pachuca, Hidalgo

Other trials in Mexico

About this study

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.

Read the 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.

Conditions
Hypertension
Being tested
Interactive Voice Response (IVR) automated calls
Keywords
Hypertension, Telephone Care Management, Blood pressure, Medication adherence, Interactive Voice Response (IVR), Cloud computing
Medical subject headings
Hypertension, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interactive Voice Response (IVR) automated callsBehavioural

    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.

Study groups in NCT01484782
Study groupRoleWhat they receive
Interactive Voice Response (IVR) callsExperimentalWeekly 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.
Receives: Behavioral: Interactive Voice Response (IVR) automated calls
Usual careNo interventionThis 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Systolic blood pressure

    Measured: 6 weeks

Secondary outcomes (2)
  1. Self-reported health status

    Measured: 6 weeks

  2. Medication adherence

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionNov 2011
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01484782
Sponsor's protocol ID
UM-00047263
Status last verified
Apr 2015
First submitted
30 Nov 2011
Last updated
28 Apr 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Interactive Voice Response (IVR) automated calls in people with Hypertension, run by University of Michigan at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Honduras, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic blood pressure (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.

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