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HypertensionNCT02429297

Developing Accessible Telehealth Programs for Diabetes and Hypertension Management in Bolivia

A study testing HITCM-only and HITCM+CP in people with Hypertension and Diabetes, run by University of Michigan at 1 site in Bolivia.

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 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. Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Hypertension, Diabetes
What is being tested?
HITCM-only and HITCM+CP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteBolivia
Study dates
Jun 2014to Dec 2015
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 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Bolivia1 site
  • El Servicio Departmental de Salud (SEDES) affiliated clinics

    La Paz

Other trials in Bolivia

About this study

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.

Read the 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.

Being tested
HITCM-only, HITCM+CP
Keywords
Hypertension, Diabetes, mHealth, Interactive Voice Response, Bolivia, Chronic disease
Medical subject headings
Hypertension, Diabetes Mellitus, Chronic Disease

What participants receive

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

  • HITCM-onlyOther

    HITCM-only group: patients receive weekly automated calls with feedback to the clinical team.

  • HITCM+CPOther

    HITCM + CP group: patients receive weekly automated calls with feedback to the clinical team and their CarePartner receives updates via phone or email.

Study groups in NCT02429297
Study groupRoleWhat they receive
Patient Only - HITCM-onlyExperimentalPatients 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.
Receives: Other: HITCM-only
Patient & CarePartner - HITCM-onlyExperimentalPatients 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.
Receives: Other: HITCM-only
Patient & CarePartner - HITCM+CPExperimentalPatients 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.
Receives: Other: HITCM+CP

What is being measured

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

  1. Change from baseline on self-care behaviors and health at 16 weeks (questionnaire)

    Measured: Up to 16 weeks

Secondary outcomes (2)
  1. Patient satisfaction (satisfaction questionnaire)

    Measured: Up to 16 weeks

  2. Evaluate program feasibility (questionnaire, satisfaction, and usage rates)

    Measured: Up to 16 weeks

Timeline

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

  1. First posted29 Apr 2015 (estimated)
  2. Study startJun 2014
  3. Primary completionDec 2014
  4. Study completionDec 2015

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02429297
Sponsor's protocol ID
HUM00081734
Status last verified
May 2016
First submitted
4 Mar 2015
Last updated
5 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing HITCM-only and HITCM+CP in people with Hypertension and Diabetes, run by University of Michigan at 1 site in Bolivia.

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 4 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 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bolivia. 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?

Change from baseline on self-care behaviors and health at 16 weeks (questionnaire) (time frame: Up to 16 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 5 May 2016.

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