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Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini

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ClinicalTrials.gov Identifier: NCT04183413
Recruitment Status : Not yet recruiting
First Posted : December 3, 2019
Last Update Posted : December 3, 2019
Sponsor:
Collaborators:
Amsterdam Institute for Global Health and Development
Swiss Tropical & Public Health Institute
Clinton Health Access Initiative, Nigeria
University of Göttingen
University of Eswatini
SWABCHA, Eswatini
Diabetes Swaziland
Information provided by (Responsible Party):
Till Bärnighausen, University Hospital Heidelberg

Brief Summary:
The WHO-PEN@Scale project is a three-arm cluster-randomized trial that is investigating the population-level effects of a healthcare reform in Eswatini, which aims to strengthen primary care for diabetes and hypertension. Prior to the reform, healthcare for diabetes and hypertension was mostly provided through physician-led teams in hospital outpatient departments. The healthcare reform aims to strengthen the provision of nurse-led care for diabetes and hypertension in primary healthcare facilities and community health worker-led care for these conditions in the facilities' catchment areas. The reform will broadly be guided by the World Health Organization's "Package of Essential Noncommunicable Disease Interventions for Primary Health Care in Low-Resource Settings" (WHO-PEN). The trial will take place at 84 clusters (a primary healthcare facility and its catchment area) across the country.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Hypertension Other: PEN Other: ePEN Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a parallel three-arm cluster-randomized trial without a baseline assessment.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini: A Cluster-randomized Trial
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard of Care
Health services for diabetes and hypertension are provided as was the standard of care prior to the healthcare reform. Healthcare for diabetes and hypertension is provided only through physician-led teams at hospitals and health centers.
Experimental: PEN
Screening for diabetes and hypertension, as well as all care for uncomplicated cases of diabetes and hypertension, will be provided through nurse-lead teams at primary healthcare facilities.
Other: PEN
This intervention consists of the strengthening of primary healthcare facilities to screen for diabetes and hypertension, and to provide care for uncomplicated cases of these conditions. The intervention will broadly follow the disease screening, management, and referral protocols detailed in the WHO-PEN guidelines and adapted for the Eswatini context during a feasibility pilot.

Experimental: enhanced PEN (ePEN)
This arm consists of all activities of arm 2 (the "PEN arm") plus additional responsibilities for community health workers.
Other: ePEN
This arm consists of all activities of arm 2 (the "PEN arm") plus additional responsibilities for community health workers who are affiliated with the given healthcare facility through the public-sector health system structure. Specifically, community health workers will i) conduct household visits to refer adults aged 40 years and older who have not been screened for diabetes and hypertension in the past 12 months to the primary healthcare facility with which the community health worker is affiliated, ii) provide counseling on reducing one's risk of cardiovascular disease during these home visits, iii) follow up with individuals whom they referred to a healthcare facility at their home, and iv) provide information on primary and secondary prevention of cardiovascular disease at community meetings.




Primary Outcome Measures :
  1. Glycemic control (continuous) among adults with diabetes [ Time Frame: 17 months ]
    Mean glycated haemoglobin (HbA1c) among adults aged 40 years and older with diabetes

  2. Systolic blood pressure among adults with hypertension [ Time Frame: 17 months ]
    Mean systolic blood pressure among adults aged 40 years and older with hypertension


Secondary Outcome Measures :
  1. HbA1c among adults with diabetes or prediabetes [ Time Frame: 17 months ]
    Mean glycated haemoglobin (HbA1c) among adults aged 40 years and older with diabetes or prediabetes

  2. Glycemic control (binary) among adults with diabetes [ Time Frame: 17 months ]
    The proportion of adults aged 40 years and older with diabetes who have an HbA1c less than 7.0%

  3. Glycemic control (binary) among adults with diabetes or prediabetes [ Time Frame: 17 months ]
    The proportion of adults aged 40 years and older with diabetes or prediabetes who have an HbA1c less than 7.0%

  4. Awareness of one's diabetes diagnosis [ Time Frame: 17 months ]
    The proportion of adults aged 40 years and older with diabetes who report to have been diagnosed with diabetes prior to the household survey

  5. Awareness of one's diabetes or prediabetes diagnosis [ Time Frame: 17 months ]
    The proportion of adults aged 40 years and older with diabetes or prediabetes who report to have been diagnosed with diabetes or prediabetes prior to the household survey

  6. Probability of being treated for diabetes among adults with diabetes [ Time Frame: 17 months ]
    The proportion of adults aged 40 years and older with diabetes who report to be taking medication for their diabetes

  7. Probability of having been tested for diabetes among adults with diabetes [ Time Frame: 17 months ]
    The proportion of adults aged 40 years and older with diabetes who report to have been tested for diabetes in the past five years

  8. Probability of having been tested for diabetes among adults with diabetes or prediabetes [ Time Frame: 17 months ]
    The proportion of adults aged 40 years and older with diabetes or prediabetes who report to have been tested for diabetes in the past five years

  9. Probability of smoking among adults with diabetes, prediabetes, or hypertension [ Time Frame: 17 months ]
    The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who report to be a current smoker

  10. Time spent doing moderate- or vigorous-intensity exercise among adults with diabetes, prediabetes, or hypertension [ Time Frame: 17 months ]
    The mean number of minutes in a typical week spent doing moderate- or vigorous-intensity exercise among adults aged 40 years and older with diabetes

  11. Systolic blood pressure among adults with diabetes [ Time Frame: 17 months ]
    Mean systolic blood pressure among adults aged 40 years and older with diabetes

  12. Systolic blood pressure among adults with diabetes or prediabetes [ Time Frame: 17 months ]
    Mean systolic blood pressure among adults aged 40 years and older with diabetes or prediabetes

  13. Diastolic blood pressure among adults with diabetes [ Time Frame: 17 months ]
    Mean diastolic blood pressure among adults aged 40 years and older with diabetes

  14. Diastolic blood pressure among adults with diabetes or prediabetes [ Time Frame: 17 months ]
    Mean diastolic blood pressure among adults aged 40 years and older with diabetes or prediabetes

  15. Fruit and vegetable consumption among adults with diabetes, prediabetes, or hypertension [ Time Frame: 17 months ]
    The mean number of servings of fruit and vegetables in a typical week among adults aged 40 years and older with diabetes, prediabetes, or hypertension

  16. Hypertension control (binary) among adults with hypertension [ Time Frame: 17 months ]
    The proportion of adults aged 40 years and older with hypertension who have a systolic blood pressure <140 mm Hg and a diastolic blood pressure <90 mm Hg

  17. Diastolic blood pressure among adults with hypertension [ Time Frame: 17 months ]
    Mean diastolic blood pressure among adults aged 40 years and older with hypertension

  18. Awareness of one's hypertension diagnosis [ Time Frame: 17 months ]
    The proportion of adults aged 40 years and older with hypertension who report to have been diagnosed with hypertension prior to the household survey

  19. Probability of being treated for hypertension among adults with hypertension [ Time Frame: 17 months ]
    The proportion of adults aged 40 years and older with hypertension who report to be taking blood-pressure-lowering medication

  20. Probability of having been tested for hypertension among adults with hypertension [ Time Frame: 17 months ]
    The proportion of adults aged 40 years and older with hypertension who report to have had their blood pressure measured in the past five years

  21. Cervical cancer screening among women with diabetes, prediabetes, or hypertension [ Time Frame: 17 months ]
    The proportion of women aged 40 years and older with diabetes, prediabetes, or hypertension who report to have been screened for cervical cancer in the past two years

  22. Breast cancer screening among women with diabetes, prediabetes, or hypertension [ Time Frame: 17 months ]
    The proportion of women aged 40 years and older with diabetes, prediabetes, or hypertension who report to have been screened for breast cancer (by palpation) in the past two years

  23. Prostate cancer screening among men with diabetes, prediabetes, or hypertension [ Time Frame: 17 months ]
    The proportion of men aged 40 years and older with diabetes, prediabetes, or hypertension who report to have been screened for prostate cancer (by digital rectal examination) in the past two years

  24. HIV testing among adults with diabetes, prediabetes, or hypertension [ Time Frame: 17 months ]
    The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who report to have been screened for HIV in the past two years

  25. Tuberculosis testing among adults with diabetes, prediabetes, or hypertension [ Time Frame: 17 months ]
    The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who report to have been screened for tuberculosis in the past two years



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for the outcome assessment (household survey):

  • Residing in one of the selected households
  • Age ≥40 years

Exclusion criteria for the outcome assessment (household survey):

  • Pregnant
  • Inability to provide written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04183413


Contacts
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Contact: Till Bärnighausen, MD ScD +49 6221 56 5637 till.baernighausen@uni-heidelberg.de

Sponsors and Collaborators
University Hospital Heidelberg
Amsterdam Institute for Global Health and Development
Swiss Tropical & Public Health Institute
Clinton Health Access Initiative, Nigeria
University of Göttingen
University of Eswatini
SWABCHA, Eswatini
Diabetes Swaziland
Investigators
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Principal Investigator: Pascal Geldsetzer, MD ScD MPH Heidelberg Institute of Global Health, Heidelberg University
Principal Investigator: Jan-Walter De Neve, MD ScD MPH Heidelberg Institute of Global Health, Heidelberg University
  Study Documents (Full-Text)

Documents provided by Till Bärnighausen, University Hospital Heidelberg:
Statistical Analysis Plan  [PDF] November 10, 2019


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Responsible Party: Till Bärnighausen, Prof. Dr. Dr. Till Bärnighausen, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT04183413    
Other Study ID Numbers: WHO-PEN@Scale
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: No detailed IPD sharing plan has been developed yet.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Till Bärnighausen, University Hospital Heidelberg:
Diabetes Mellitus
Diabetes
Hypertension
WHO-PEN
Health service decentralization
Community Health Worker
Eswatini
Swaziland
Scale-up
Implementation research
Cost-effectiveness
Mixed methods
Comorbidity
Non-Communicable Disease
Cardiovascular disease risk factors
Additional relevant MeSH terms:
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Hypertension
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases