Developing Accessible Telehealth Programs for Diabetes and Hypertension Management in Bolivia

May 4, 2016 updated by: John Piette, University of Michigan
The purpose of the study is to evaluate the feasibility and impact of an automated phone system in monitoring and improving self-care and health outcomes among patients with diabetes and/or hypertension in Bolivia, in addition to assessing the additional benefit of support from a family member or friend.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All patients will receive weekly automated calls with feedback to the clinical team. Blood pressures will be taken for all patients by researchers and finger-stick blood glucose readings will be taken at baseline for diabetic patients only and if possible, at follow-up. Fingersticks will use the patient's own glucometer or standard home glucometers donated by the project to the clinic. Patients will be informed about their blood pressure results; and, the clinic will be alerted if the systolic BP exceeds 150.

If participants enroll with a CarePartner, they will be randomized to have their CarePartner receive weekly automated updates focused on symptom monitoring and patient self-care (HITCM+CP) versus usual care (no updates to CarePartner), HITCM-only. All participants will receive a weekly 10-15 minute automated phone call to their cell phone for disease assessment and self-care support for up to 16 weeks. Some patients with hypertension may be provided with in-home cuffs for measurement of blood pressure throughout the study. During enrollment, the research team will explain how the cuffs are used, as well as how to work the automated phone system. During patients' automated calls, they will be asked questions about their self-care relevant to their diagnosis, blood pressure regimen and readings (hypertension only), diet, glucose monitoring and symptoms of high/low blood sugar (diabetes only) and medication adherence. Based on the patient's self-report, they will receive targeted suggestions for how to improve their self-management. No identifying information is included in the automated call sent to the patient's phone other than the patient's first name. At the end of each automated call, patients will hear the phone number of their clinic, which they can call for a health problem or to disenroll from the program. At the time of recruitment, an initial automated call will be sent to the patient's phone so that they can learn what to expect and have the chance to ask questions of the research associate.

In the event that the patient reports a health or self-care problem during their call (i.e., the patient reports rarely or never taking their medication), a report will automatically be generated and sent by email to the research team plus the patient's designated clinician so that follow-up can take place. The secure email address will be verified with each clinician, and be password protected.

The intervention will last up to 16 weeks, after which the patient will have a follow-up meeting with the research team and will complete a survey about the program. All follow-ups will take place either in person or over the phone. Patients will receive an incentive at follow-up at no more than $10 USD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bolivia
      • La Paz, Bolivia
        • El Servicio Departmental de Salud (SEDES) affiliated clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 21-80 years of age
  • Diagnosis of hypertension, a systolic blood pressure > 140mmHg, and/or diagnosis of diabetes
  • Access to a functional cell phone
  • Able to respond to automated telephone calls

Exclusion Criteria:

  • Life-threatening health problem such as cancer with less than a six month life expectancy
  • Are visiting the clinic for an urgent health problem (for themselves)
  • If they have severe mental illness as reported by their clinical team

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patient Only - HITCM-only
Patients enrolling without a CarePartner receive weekly Health Information Technology/Care Manager (HITCM) automated assessment and self-care support calls with feedback to the clinical team.
Other: HITCM-only
HITCM-only group: patients receive weekly automated calls with feedback to the clinical team.
Experimental: Patient & CarePartner - HITCM-only
Patients enrolling with a CarePartner receive weekly Health Information Technology/Care Manager (HITCM) automated assessment and self-care support calls with feedback to the clinical team.
Other: HITCM-only
HITCM-only group: patients receive weekly automated calls with feedback to the clinical team.
Experimental: Patient & CarePartner - HITCM+CP
Patients enrolling with a CarePartner receive weekly Health Information Technology/Care Manager (HITCM) automated assessment and self-care support calls with feedback to the clinical team plus updates to their CarePartner via phone or email.
Other: HITCM+CP
HITCM + CP group: patients receive weekly automated calls with feedback to the clinical team and their CarePartner receives updates via phone or email.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline on self-care behaviors and health at 16 weeks (questionnaire)
Time Frame: Up to 16 weeks
Up to 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Patient satisfaction (satisfaction questionnaire)
Time Frame: Up to 16 weeks
Up to 16 weeks
Evaluate program feasibility (questionnaire, satisfaction, and usage rates)
Time Frame: Up to 16 weeks
Up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John D Piette, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00081734

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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