- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02549495
Impact of Community Health Workers on Adherence to Therapy for Non-Communicable Chronic Disease in Chiapas, Mexico
Evaluation of a Community Health Worker Intervention on Adherence to Therapy for Non-Communicable Chronic Disease in Chiapas, Mexico
Studieoversikt
Status
Detaljert beskrivelse
Compañeros en Salud (CES), an affiliate project of Partners in Health, has been working in the rural Sierra of Chiapas, Mexico since February 2012. CES works in partnership with the local Ministry of Health to rehabilitate and staff existing government primary care clinics. Each community's clinic is staffed by one CES project physician year-round. CES activities span the range of allopathic medicine, but the focus of the project is in the prevention, detection, diagnosis and management of non-communicable diseases (NCDs) such as diabetes and hypertension. CES currently operates in several rural communities with catchment areas of approximately 1,500 - 2,500 people. Routine care for NCDs is based on national guidelines and consists of monthly in-clinic visits by primary care physicians.
Over 9 months in 2014 and again over 6 months in 2016, CES will introduce a community health worker program called "Acompañantes" to its project communities to augment care of patients with NCDs. Acompañantes are lay health workers and members of the community who bridge the gap between project clinics and patients, improving understanding of NCDs, their treatments, and adherence to therapy. The introduction of Acompañantes to communities is planned in a once-every-three-months fashion, the most rapid roll-out logistically feasible for CES. The investigators' project will document their experience over this time, and for one year after introduction of the Acompañantes program to all seven study communities, by documenting adherence to therapy, hemoglobin a1c, and blood pressure at every-three month intervals over this time frame.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02130
- Brigham and Women's Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Formal diagnosis of Type II Diabetes Mellitus, Stage I or II Hypertension or both
- Daily medications required for patient's condition
- Residence and receipt of therapy within the study catchment area
- Age greater than or equal to 18 years.
Exclusion Criteria:
- Known or suspected secondary hypertension
- Known or suspected Type 1 diabetes
- Pregnancy
- Chronic use of glucocorticoids.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Patients with Diabetes or Hypertension
All patients in the seven study communities will receive the community health worker intervention provided by CES, as it is incorporated into the standard of care.
However, they will receive the intervention at different points in time depending on which community they lived in, as community health worker programs can only be started at every-three-month intervals
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Hemoglobin A1c
Tidsramme: Every-three months, until one year after all communities receive intervention
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Percent glycated hemoglobin as measured by PTS diagnostics point-of-care assay
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Every-three months, until one year after all communities receive intervention
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Systolic blood pressure
Tidsramme: Every-three months, until one year after all communities receive intervention
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Systolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure monitor
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Every-three months, until one year after all communities receive intervention
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Adherence to daily medications
Tidsramme: Every-three months, until one year after all communities receive intervention
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Self-reported medication adherence as measured by 5-day recall, 30-day recall and response to Likert-style questions
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Every-three months, until one year after all communities receive intervention
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Diastolic blood pressure
Tidsramme: Every-three months, until one year after all communities receive intervention
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Diastolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure
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Every-three months, until one year after all communities receive intervention
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Disease control
Tidsramme: Every-three months, until one year after all communities receive intervention
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Diabetes and/or hypertension control.
Disease control among patients with hypertension was defined according to Mexican national guidelines: blood pressure <140/90 mm Hg for patients with hypertension and no diabetes; blood pressure <130/80 mm Hg for patients with hypertension and diabetes and blood pressure < 150/90 mm Hg for patients over the age of 80. Disease control for patients with diabetes defined as glycated hemoglobin (HbA1c) < 7% per national guidelines.
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Every-three months, until one year after all communities receive intervention
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Patrick M Newman, MD, Brigham and Women's Hospital
- Hovedetterforsker: Daniel Palazuelos, MD, MPH, Brigham and Women's Hospital
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Worster DT, Franke MF, Bazua R, Flores H, Garcia Z, Krupp J, Maza J, Palazuelos L, Rodriguez K, Newman PM, Palazuelos D. Observational stepped-wedge analysis of a community health worker-led intervention for diabetes and hypertension in rural Mexico. BMJ Open. 2020 Mar 8;10(3):e034749. doi: 10.1136/bmjopen-2019-034749.
- Newman PM, Franke MF, Arrieta J, Carrasco H, Elliott P, Flores H, Friedman A, Graham S, Martinez L, Palazuelos L, Savage K, Tymeson H, Palazuelos D. Community health workers improve disease control and medication adherence among patients with diabetes and/or hypertension in Chiapas, Mexico: an observational stepped-wedge study. BMJ Glob Health. 2018 Feb 15;3(1):e000566. doi: 10.1136/bmjgh-2017-000566. eCollection 2018.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2013P000711
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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