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Developing Accessible Telehealth Programs for Diabetes and Hypertension Management in Bolivia

Primary Purpose

Hypertension, Diabetes

Status
Completed
Phase
Not Applicable
Locations
Bolivia
Study Type
Interventional
Intervention
HITCM-only
HITCM+CP
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring Hypertension, Diabetes, mHealth, Interactive Voice Response, Bolivia, Chronic disease

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • El Servicio Departmental de Salud (SEDES) affiliated clinics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Patient Only - HITCM-only

Patient & CarePartner - HITCM-only

Patient & CarePartner - HITCM+CP

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient satisfaction (satisfaction questionnaire)
Evaluate program feasibility (questionnaire, satisfaction, and usage rates)

Full Information

First Posted
March 4, 2015
Last Updated
May 4, 2016
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02429297
Brief Title
Developing Accessible Telehealth Programs for Diabetes and Hypertension Management in Bolivia
Official Title
Developing Accessible Telehealth Programs for Diabetes and Hypertension Management in Bolivia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes
Keywords
Hypertension, Diabetes, mHealth, Interactive Voice Response, Bolivia, Chronic disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient Only - HITCM-only
Arm Type
Experimental
Arm Description
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.
Arm Title
Patient & CarePartner - HITCM-only
Arm Type
Experimental
Arm Description
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.
Arm Title
Patient & CarePartner - HITCM+CP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
HITCM-only
Intervention Description
HITCM-only group: patients receive weekly automated calls with feedback to the clinical team.
Intervention Type
Other
Intervention Name(s)
HITCM+CP
Intervention Description
HITCM + CP group: patients receive weekly automated calls with feedback to the clinical team and their CarePartner receives updates via phone or email.
Primary Outcome Measure Information:
Title
Change from baseline on self-care behaviors and health at 16 weeks (questionnaire)
Time Frame
Up to 16 weeks
Secondary Outcome Measure Information:
Title
Patient satisfaction (satisfaction questionnaire)
Time Frame
Up to 16 weeks
Title
Evaluate program feasibility (questionnaire, satisfaction, and usage rates)
Time Frame
Up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Piette, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
El Servicio Departmental de Salud (SEDES) affiliated clinics
City
La Paz
Country
Bolivia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Developing Accessible Telehealth Programs for Diabetes and Hypertension Management in Bolivia

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