NCT02384356

Brief Summary

The purpose of the study is to gather baseline surveillance data about the current health status of adults with chronic health conditions in La Paz and El Alto, Bolivia and identify barriers to the management of NCDs during face-to-face outpatient encounters as well as via novel mobile health services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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
9 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

4 years

First QC Date

March 4, 2015

Last Update Submit

July 17, 2018

Conditions

Keywords

Non-communicable diseasesChronic diseaseMobile healthDiabetes MellitusHypertensionBoliviaLongitudinal surveyHealth indicatorsPrimary careAmbulatory care

Outcome Measures

Primary Outcomes (1)

  • Health Status using general health-related quality of life, perceived health, and PHQ8

    Outcomes will be assessed at baseline and follow-up if follow-up is possible.

    Baseline and then annually for up to 7 years

Secondary Outcomes (1)

  • Demographics, use of formal care and access, substance use, NCD diagnoses, self-care behavior, knowledge/perceptions, and anthropometric measures

    Baseline and then annually for up to 7 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients visiting clinics associated with Universidad Católica Boliviana, including SEDES La Paz and Universidad Mayor San Andres, in La Paz and El Alto, Bolivia for a non-urgent health problem.

You may qualify if:

  • years of age or older
  • Existing diagnosis (per medical record) of at least 1 chronic health issue: diabetes, hypertension, cardiac issues, angina, high cholesterol, depression, cancer, stroke, arthritis, chronic bronchitis, emphysema, COPD, migraine headaches, heartburn, acid reflux or irritable bowel syndrome, stomach or duodenal ulcers, chronic back pain or sciatica, asthma, history of gestational diabetes (female), history of polycystic ovary syndrome (female)
  • If no existing diagnosis of at least 1 chronic health issue, then clinical indicator patient may be at risk of diabetes (has a close relative with diabetes, female patient who delivered a baby weighing more than 9 pounds); PHQ-2 score between 3-6, BMI \>25; or, Systolic BP over 140

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 (2)

Universidad Católica Boliviana associated clinics, including SEDES La Paz and Universidad Mayor San Andres

El Alto, Bolivia

Location

Universidad Católica Boliviana associated clinics, including SEDES La Paz and Universidad Mayor San Andres

La Paz, Bolivia

Location

MeSH Terms

Conditions

Chronic DiseaseNoncommunicable DiseasesDiabetes MellitusHypertension

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • John D Piette, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
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

March 10, 2015

Study Start

June 1, 2014

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

July 19, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations