Chronic DiseaseNCT02384356
A Longitudinal Survey of Health in Bolivia
An observational study of Chronic Disease, run by University of Michigan at 2 sites in Bolivia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- How many people
- 2,000 participants
- Where
- 2 sitesBolivia
- Study dates
- Jun 2014to Jun 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 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
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
2 sites in 1 country.
Bolivia2 sites
Universidad Católica Boliviana associated clinics, including SEDES La Paz and Universidad Mayor San Andres
El Alto
Universidad Católica Boliviana associated clinics, including SEDES La Paz and Universidad Mayor San Andres
La Paz
About this study
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.
Read the detailed description
Within Latin America, there is a significant lack of data about the medical management and self-care for patients with non-communicable diseases (NCDs), such as diabetes and hypertension. In an effort to improve availability of such data in the Latin American region, the World Health Organization (WHO) created and tailored a survey tool that has been used in various countries throughout Central and South America. Our own research team has extensive experience surveying clinic-based populations in Latin America regarding their chronic disease burden and the potential effectiveness of novel approaches to self-care support via mobile phones. The objective of the planned project is to gather baseline surveillance data for non-communicable diseases in urban and peri-urban Bolivian communities, using the WHO instrument as a foundation with modifications to reflect local public health priorities and the goal of developing mobile health services that improve self-management support.
This project will be conducted by investigators and students of the University of Michigan Schools of Medicine, Public Health, and Information, in partnership with the Catholic University of Bolivia, San Pablo (UCB-San Pablo). The over-arching aim is to conduct a longitudinal survey of health indicators in a variety of primary and ambulatory care sites within clinics associated with Universidad Católica Boliviana, including SEDES La Paz and Universidad Mayor San Andres, in La Paz and El Alto, Bolivia. The survey is based on: a) the World Health Organizations' Division of Disease Prevention and Control's Program on Non-Communicable Diseases' (NCD) Surveillance Toolkit: Risk Factors for Non-Communicable Diseases, with the addition of b) the 8 Item Patient Health Questionnaire (PHQ-8) to screen for Depression, c) the Alcohol Use Disorders Identification Test (AUDIT), d) the Patient Assessment of Chronic Illness Care (PACIC) Questionnaire, e) questions developed by our research team regarding the feasibility and desirability of mobile health monitoring and self-care support and f) 8 item Morisky Medication use questions. By using validated survey instruments, the investigators will be able to compare health indicators across countries and provide the participating Bolivian government agencies and universities information crucial to understanding the factors contributing to the development and maintenance of NCD services in Bolivia. Specifically, this study will provide baseline data, which does not exist to date, identifying the prevalent risk factors for NCDs and the barriers to those patients' care. More generally, the investigators will gain invaluable experience regarding the feasibility of enrolling large representative samples in various outpatient sites for use in subsequent observational studies of NCD management and in randomized trials.
- Conditions
- Chronic Disease
- Keywords
- Non-communicable diseases, Chronic disease, Mobile health, Diabetes Mellitus, Hypertension, Bolivia, Longitudinal survey, Health indicators, Primary care, Ambulatory care
- Medical subject headings
- Chronic Disease, Noncommunicable Diseases, Diabetes Mellitus, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Information will be gathered at baseline and follow-up to assess changes in status.
Measured: Baseline and then annually for up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Piette, University of Michigan
- Investigators
- John D Piette, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384356
- Sponsor's protocol ID
- HUM00071766
- Status last verified
- Jul 2018
- First submitted
- 4 Mar 2015
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Survey of Health in Bolivia
- ClinicalTrials.gov ID
- NCT02384356
- Acronym / sponsor ID
- HUM00071766
- Conditions
- Chronic Disease
- Keywords
- Non-communicable diseases, Chronic disease, Mobile health, Diabetes Mellitus, Hypertension, Bolivia, Longitudinal survey, Health indicators
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Within Latin America, there is a significant lack of data about the medical management and self-care for patients with non-communicable diseases (NCDs), such as diabetes and hypertension. In an effort to improve availability of such data in the Latin American region, the World Health Organization (WHO) created and tailored a survey tool that has been used in various countries throughout Central and South America. Our own research team has extensive experience surveying clinic-based populations in Latin America regarding their chronic disease burden and the potential effectiveness of novel approaches to self-care support via mobile phones. The objective of the planned project is to gather baseline surveillance data for non-communicable diseases in urban and peri-urban Bolivian communities, using the WHO instrument as a foundation with modifications to reflect local public health priorities and the goal of developing mobile health services that improve self-management support.
This project will be conducted by investigators and students of the University of Michigan Schools of Medicine, Public Health, and Information, in partnership with the Catholic University of Bolivia, San Pablo (UCB-San Pablo). The over-arching aim is to conduct a longitudinal survey of health indicators in a variety of primary and ambulatory care sites within clinics associated with Universidad Católica Boliviana, including SEDES La Paz and Universidad Mayor San Andres, in La Paz and El Alto, Bolivia. The survey is based on: a) the World Health Organizations' Division of Disease Prevention and Control's Program on Non-Communicable Diseases' (NCD) Surveillance Toolkit: Risk Factors for Non-Communicable Diseases, with the addition of b) the 8 Item Patient Health Questionnaire (PHQ-8) to screen for Depression, c) the Alcohol Use Disorders Identification Test (AUDIT), d) the Patient Assessment of Chronic Illness Care (PACIC) Questionnaire, e) questions developed by our research team regarding the feasibility and desirability of mobile health monitoring and self-care support and f) 8 item Morisky Medication use questions. By using validated survey instruments, the investigators will be able to compare health indicators across countries and provide the participating Bolivian government agencies and universities information crucial to understanding the factors contributing to the development and maintenance of NCD services in Bolivia. Specifically, this study will provide baseline data, which does not exist to date, identifying the prevalent risk factors for NCDs and the barriers to those patients' care. More generally, the investigators will gain invaluable experience regarding the feasibility of enrolling large representative samples in various outpatient sites for use in subsequent observational studies of NCD management and in randomized trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 18 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health Status using general health-related quality of life, perceived health, and PHQ8
Time frame: Baseline and then annually for up to 7 years
Outcomes will be assessed at baseline and follow-up if follow-up is possible.
1 secondary outcome
Demographics, use of formal care and access, substance use, NCD diagnoses, self-care behavior, knowledge/perceptions, and anthropometric measures
Time frame: Baseline and then annually for up to 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D Piette, PhD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by University of Michigan at 2 sites 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 3 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 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Health Status using general health-related quality of life, perceived health, and PHQ8 (time frame: Baseline and then annually for up to 7 years). 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 19 Jul 2018.