Type 2 DiabetesNCT05979142
Community-based Primary Care Program Effects on Pharmacotherapy of Type 2 Diabetes and Hypertension in Peru
An observational study of Type 2 Diabetes and Hypertension, run by Asociación Siempre Salud.
Trial summary
The goal of this observational study is to compare usual care to a community-based primary care program (having components of treatment decisions based on clinical guidelines, self-management education, community health workers, and free health care visits and medications) in low-income Peruvians with type 2 diabetes… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Type 2 Diabetes, Hypertension
- What is being tested?
- community-based primary care program
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to May 2014
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Three neighborhoods ("the community") in Pueblo Nuevo, Chincha District, Ica, Peru participated in the study. Peru is a middle-income country, but most people in the study community live below the poverty line. Door-to-door surveys identified all persons residing in the study community. Patients 35 years and older were eligible to participate in diabetes and hypertension screening. 83% of all eligible persons participated in mass screenings between September and December 2011. Others participated in later ad hoc screenings. Those with confirmed diagnoses of type 2 diabetes and/or hypertension were eligible to participate in the program.
Who may be able to join
- 35 years or older with confirmed diagnosis of type 2 diabetes and/or hypertension
Who cannot join
- None
About this study
Official title: A Prospective Cohort Study of a Community-based Primary Care Program's Effects on Pharmacotherapy Quality in Low-income Peruvians With Type 2 Diabetes and Hypertension
The goal of this observational study is to compare usual care to a community-based primary care program (having components of treatment decisions based on clinical guidelines, self-management education, community health workers, and free health care visits and medications) in low-income Peruvians with type 2 diabetes and/or hypertension.
The main question[s] it aims to answer are:
Read more
- Compared to pre-program usual care, does the program result in greater benefits, measured as greater proportions of patients with glucose and blood pressure control or maximal quantities and doses of medications?
- Are there greater benefits when the program was provided at home compared to when the program was provided in a clinic?
- Does longer participation in the program result in greater benefits?
Participants will participate in:
- Self-management education provided by community health workers.
- Monitoring of healthy behaviors and glucose, blood pressure, and weight.
- Receipt of free medications for blood pressure, glucose, and heart disease prevention.
Read the detailed description
A pre-post study of visit-level data gathered prospectively during a community-based primary care program evaluated its effects on pharmacotherapy of type 2 diabetes and hypertension. The program was conducted by Asociación Siempre Salud, a Peruvian non-profit organization, in three neighborhoods ("the community") in Pueblo Nuevo, Chincha District, Peru. Door-to-door surveys identified all persons residing in the study community. Persons > 35 years old were eligible, without exclusions, to participate in type 2 diabetes and hypertension screening and diagnosis. Most participated in mass screenings between September and December 2011, others in later ad hoc screenings. Patients with negative screening results on medications were re-screened following medication withdrawal. Those with confirmed diagnoses were eligible to participate in the program.
Three binary exposures were evaluated for their effects on adherence to four treatment standards and one composite standard: 1) 'program exposure' (post- vs. pre-exposure); 2) 'program retention in care' (>50% of allowable time in both home and clinic care periods, compared to <50% in either care period (but not both)), and 3) 'care period', (clinic compared to home care). 'Care period treatment time' (>50% of allowable time versus less) was evaluated as an independent variable in the study of the care period exposure.
During the pre-exposure period, usual care was provided by two public hospitals, several Ministry of Health clinics, private clinics and pharmacies, and Siempre Salud. The program, to which patients were then exposed, had components of four CCM elements (delivery system design, self-management, decision support, and community resources), CHWs, and no out-of-pocket costs for visits and medications. Self-management was based on national standards and utilized educational materials from professional societies and government agencies in the USA. Decision support consisted of guidelines-based standards adapted to our low-resource setting and simplified medication treatment protocols for diabetes, hypertension, and primary prevention of CVD. The delivery system consisted of two care models employed sequentially: first home care, then clinic care (see care period exposure).
During the home care period, the physician made an initial visit, after which CHWs made weekly visits to patients' homes. CHWs monitored clinical parameters, provided self-management education and support, tracked self-care behaviors, documented visits, acted on clinical alerts, and delivered medications. They entered encounter data into a spreadsheet and filled prescriptions under physician supervision. The physician made treatment decisions reliant on home visit data and patient care conferences. During the subsequent clinic period, patients made monthly visits to the clinic physician who provided all care.
- Conditions
- Type 2 Diabetes, Hypertension
- Being tested
- community-based primary care program
- Keywords
- low and middle income countries, primary care, chronic care model, community health workers, cohort study, pharmacotherapy
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
community-based primary care programOther
See group description
| Study group | Role | What they receive |
|---|---|---|
| program (pre-exposure) | During the pre-exposure period, usual care was provided by two public hospitals, several Ministry of Health clinics, private clinics and pharmacies, and Siempre Salud. | |
| program (post-exposure) | The program had components of four Chronic Care Model (CCM) elements (delivery system design, self-management, decision support, and community resources), community health workers (CHWs), and no out-of-pocket costs for visits and medications. Receives: Other: community-based primary care program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemic agent standard
Standard was defined as glycemic control or maximum doses of two hypoglycemic agents (metformin and glibenclamide) in eligible patients with type 2 diabetes.
Measured: 27 months
Antihypertensive agent standard
Standard was defined blood pressure control or maximum doses of three or more antihypertensive agents in eligible patients with elevated blood pressure (>130/80 mm Hg in diabetics, >140/90 mm Hg in non-diabetics)
Measured: 27 months
Angiotensin-converting enzyme inhibitor (ACEi) standard
Standard was defined as any ACEi in eligible patients with diabetes and elevated BP (>130/80 mm Hg).
Measured: 27 months
Low-dose aspirin standard
Standard was defined as any low-dose aspirin in eligible patients with 10-year cardiovascular disease (CVD) risk >10%.
Measured: 27 months
Composite standard
Coded 'yes' if all treatment standards for which eligible were achieved.
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study startSep 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación Siempre Salud
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona
- Responsible party
- Sponsor
- Investigators
- John E Deaver, MD, Principal investigator, Asociación Siempre Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979142
- Sponsor's protocol ID
- 1912252903
- Status last verified
- Jul 2023
- First submitted
- 30 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study data in the following formats: Stata (\*.dta) and comma-delimited text (\*.csv) files and a data dictionary will be shared with Dryad data repository.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of a Community-based Primary Care Program's Effects on Pharmacotherapy Quality in Low-income Peruvians With Type 2 Diabetes and Hypertension
- ClinicalTrials.gov ID
- NCT05979142
- Acronym / sponsor ID
- 1912252903
- Conditions
- Type 2 Diabetes, Hypertension
- Keywords
- low and middle income countries, primary care, chronic care model, community health workers, cohort study, pharmacotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Asociación Siempre SaludUniversity, hospital or other
- Collaborators
- University of Arizona
- Study start
- Sep 2011 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 7 Aug 2023 (actual)
- 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 goal of this observational study is to compare usual care to a community-based primary care program (having components of treatment decisions based on clinical guidelines, self-management education, community health workers, and free health care visits and medications) in low-income Peruvians with type 2 diabetes and/or hypertension.
The main question[s] it aims to answer are:
- Compared to pre-program usual care, does the program result in greater benefits, measured as greater proportions of patients with glucose and blood pressure control or maximal quantities and doses of medications?
- Are there greater benefits when the program was provided at home compared to when the program was provided in a clinic?
- Does longer participation in the program result in greater benefits?
Participants will participate in:
- Self-management education provided by community health workers.
- Monitoring of healthy behaviors and glucose, blood pressure, and weight.
- Receipt of free medications for blood pressure, glucose, and heart disease prevention.
Detailed description
A pre-post study of visit-level data gathered prospectively during a community-based primary care program evaluated its effects on pharmacotherapy of type 2 diabetes and hypertension. The program was conducted by Asociación Siempre Salud, a Peruvian non-profit organization, in three neighborhoods ("the community") in Pueblo Nuevo, Chincha District, Peru. Door-to-door surveys identified all persons residing in the study community. Persons > 35 years old were eligible, without exclusions, to participate in type 2 diabetes and hypertension screening and diagnosis. Most participated in mass screenings between September and December 2011, others in later ad hoc screenings. Patients with negative screening results on medications were re-screened following medication withdrawal. Those with confirmed diagnoses were eligible to participate in the program.
Three binary exposures were evaluated for their effects on adherence to four treatment standards and one composite standard: 1) 'program exposure' (post- vs. pre-exposure); 2) 'program retention in care' (>50% of allowable time in both home and clinic care periods, compared to <50% in either care period (but not both)), and 3) 'care period', (clinic compared to home care). 'Care period treatment time' (>50% of allowable time versus less) was evaluated as an independent variable in the study of the care period exposure.
During the pre-exposure period, usual care was provided by two public hospitals, several Ministry of Health clinics, private clinics and pharmacies, and Siempre Salud. The program, to which patients were then exposed, had components of four CCM elements (delivery system design, self-management, decision support, and community resources), CHWs, and no out-of-pocket costs for visits and medications. Self-management was based on national standards and utilized educational materials from professional societies and government agencies in the USA. Decision support consisted of guidelines-based standards adapted to our low-resource setting and simplified medication treatment protocols for diabetes, hypertension, and primary prevention of CVD. The delivery system consisted of two care models employed sequentially: first home care, then clinic care (see care period exposure).
During the home care period, the physician made an initial visit, after which CHWs made weekly visits to patients' homes. CHWs monitored clinical parameters, provided self-management education and support, tracked self-care behaviors, documented visits, acted on clinical alerts, and delivered medications. They entered encounter data into a spreadsheet and filled prescriptions under physician supervision. The physician made treatment decisions reliant on home visit data and patient care conferences. During the subsequent clinic period, patients made monthly visits to the clinic physician who provided all care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| program (pre-exposure) | – | –During the pre-exposure period, usual care was provided by two public hospitals, several Ministry of Health clinics, private clinics and pharmacies, and Siempre Salud. |
| program (post-exposure) | – | Other: community-based primary care programThe program had components of four Chronic Care Model (CCM) elements (delivery system design, self-management, decision support, and community resources), community health workers (CHWs), and no out-of-pocket costs for visits and medications. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Three neighborhoods ("the community") in Pueblo Nuevo, Chincha District, Ica, Peru participated in the study. Peru is a middle-income country, but most people in the study community live below the poverty line. Door-to-door surveys identified all persons residing in the study community. Patients 35 years and older were eligible to participate in diabetes and hypertension screening. 83% of all eligible persons participated in mass screenings between September and December 2011. Others participated in later ad hoc screenings. Those with confirmed diagnoses of type 2 diabetes and/or hypertension were eligible to participate in the program.
Key inclusion criteria (1 listed)
- 35 years or older with confirmed diagnosis of type 2 diabetes and/or hypertension
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| community-based primary care programSee group description | Other | program (post-exposure) |
Primary outcome
Hypoglycemic agent standard
Time frame: 27 months
Standard was defined as glycemic control or maximum doses of two hypoglycemic agents (metformin and glibenclamide) in eligible patients with type 2 diabetes.
Antihypertensive agent standard
Time frame: 27 months
Standard was defined blood pressure control or maximum doses of three or more antihypertensive agents in eligible patients with elevated blood pressure (>130/80 mm Hg in diabetics, >140/90 mm Hg in non-diabetics)
Angiotensin-converting enzyme inhibitor (ACEi) standard
Time frame: 27 months
Standard was defined as any ACEi in eligible patients with diabetes and elevated BP (>130/80 mm Hg).
Low-dose aspirin standard
Time frame: 27 months
Standard was defined as any low-dose aspirin in eligible patients with 10-year cardiovascular disease (CVD) risk >10%.
Composite standard
Time frame: 27 months
Coded 'yes' if all treatment standards for which eligible were achieved.
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 7 Aug 2023.
- Individual participant dataSharing planned: Yes. De-identified study data in the following formats: Stata (*.dta) and comma-delimited text (*.csv) files and a data dictionary will be shared with Dryad data repository.
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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 E Deaver, MD principal investigator
Asociación Siempre Salud
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Hypertension, run by Asociación Siempre Salud.
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 1 inclusion and 1 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 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Hypoglycemic agent standard (time frame: 27 months). The study lists 5 primary outcomes in all. 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 7 Aug 2023.