NCT02429297

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

March 4, 2015

Last Update Submit

May 4, 2016

Conditions

HypertensionDiabetes

Keywords

HypertensionDiabetesmHealthInteractive Voice ResponseBoliviaChronic disease

Outcome Measures

Primary Outcomes (1)

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

    Up to 16 weeks

Secondary Outcomes (2)

  • Patient satisfaction (satisfaction questionnaire)

    Up to 16 weeks

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

    Up to 16 weeks

Study Arms (3)

Patient Only - HITCM-only

EXPERIMENTAL

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

Patient & CarePartner - HITCM-only

EXPERIMENTAL

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

Patient & CarePartner - HITCM+CP

EXPERIMENTAL

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

Interventions

HITCM-onlyOTHER

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

Patient & CarePartner - HITCM-onlyPatient Only - HITCM-only
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.

Patient & CarePartner - HITCM+CP

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El Servicio Departmental de Salud (SEDES) affiliated clinics

La Paz, Bolivia

Location

MeSH Terms

Conditions

HypertensionDiabetes MellitusChronic Disease

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John D Piette, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
VA Senior Research Career Scientist, Professor of Health Behavior and Health Education and of Internal Medicine

Study Record Dates

First Submitted

March 4, 2015

First Posted

April 29, 2015

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

May 5, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

BO(1)