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Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini

Primary Purpose

Diabetes Mellitus, Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Swaziland
Study Type
Interventional
Intervention
DSD
CDP
Sponsored by
University Hospital Heidelberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus focused on measuring 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

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinton Health Access InitiativeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Standard of Care

DSD

CDP

Arm Description

Health services for diabetes and hypertension are provided as was the standard of care prior to the healthcare reform after the emergency decentralization motivated by the COVID-19 outbreak. Healthcare for diabetes and hypertension for complicated cases is provided through physician-led teams at hospitals and health centers. Healthcare for diabetes and hypertension for uncomplicated cases is provided at primary care clinics through nurses.

Clients are invited to participate in one of three Differentiated Service Delivery models tailored to their needs.

Health services for diabetes and hypertension are provided in the scope of outreach activities set up on a monthly basis in communities.

Outcomes

Primary Outcome Measures

Glycemic control (continuous) among adults with diabetes
Mean glycated haemoglobin (HbA1c) among adults aged 40 years and older with diabetes
Systolic blood pressure among adults with hypertension
Mean systolic blood pressure among adults aged 40 years and older with hypertension

Secondary Outcome Measures

HbA1c among adults with diabetes or prediabetes
Mean glycated haemoglobin (HbA1c) among adults aged 40 years and older with diabetes or prediabetes
Glycemic control (binary) among adults with diabetes
The proportion of adults aged 40 years and older with diabetes who have an HbA1c less than 7.0%
Glycemic control (binary) among adults with diabetes or prediabetes
The proportion of adults aged 40 years and older with diabetes or prediabetes who have an HbA1c less than 7.0%
Awareness of one's diabetes diagnosis
The proportion of adults aged 40 years and older with diabetes who report to have been diagnosed with diabetes prior to the household survey
Awareness of one's diabetes or prediabetes diagnosis
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
Probability of being treated for diabetes among adults with diabetes
The proportion of adults aged 40 years and older with diabetes who report to be taking medication for their diabetes
Probability of having been tested for diabetes among adults with diabetes
The proportion of adults aged 40 years and older with diabetes who report to have ever been tested for diabetes
Probability of having been tested for diabetes among adults with diabetes or prediabetes
The proportion of adults aged 40 years and older with diabetes or prediabetes who report to have ever been tested for diabetes
Probability of smoking among adults with diabetes, prediabetes, or hypertension
The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who report to be a current smoker
Time spent doing moderate- or vigorous-intensity exercise among adults with diabetes, prediabetes, or hypertension
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
Systolic blood pressure among adults with diabetes
Mean systolic blood pressure among adults aged 40 years and older with diabetes
Systolic blood pressure among adults with diabetes or prediabetes
Mean systolic blood pressure among adults aged 40 years and older with diabetes or prediabetes
Diastolic blood pressure among adults with diabetes
Mean diastolic blood pressure among adults aged 40 years and older with diabetes
Diastolic blood pressure among adults with diabetes or prediabetes
Mean diastolic blood pressure among adults aged 40 years and older with diabetes or prediabetes
Hypertension control (binary) among adults with hypertension
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
Diastolic blood pressure among adults with hypertension
Mean diastolic blood pressure among adults aged 40 years and older with hypertension
Awareness of one's hypertension diagnosis
The proportion of adults aged 40 years and older with hypertension who report to have been diagnosed with hypertension prior to the household survey
Probability of being treated for hypertension among adults with hypertension
The proportion of adults aged 40 years and older with hypertension who report to be taking blood-pressure-lowering medication
Probability of having been tested for hypertension among adults with hypertension
The proportion of adults aged 40 years and older with hypertension who report to have ever had their blood pressure measured
Frequency of drinking alcohol in the past 12 months among adults with diabetes, prediabetes, or hypertension
The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who report to having drunk daily, 5-6 days per week, 3-4 days per week, 1-2 days per week, 1-3 days per month, less than once a month, or never over the past 12 months.
21. Knowledge on diabetes and hypertension among adults with diabetes, prediabetes, or hypertension
The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who correctly responded to each individual question on diabetes and hypertension related knowledge.

Full Information

First Posted
November 22, 2019
Last Updated
December 12, 2022
Sponsor
University Hospital Heidelberg
Collaborators
Amsterdam Institute for Global Health and Development, Swiss Tropical & Public Health Institute, Clinton Health Access Initiative, Eswatini, University of Göttingen, University of Eswatini, SWABCHA, Eswatini, Diabetes Swaziland
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1. Study Identification

Unique Protocol Identification Number
NCT04183413
Brief Title
Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini
Official Title
Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini: A Cluster-randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 16, 2022 (Anticipated)
Study Completion Date
December 16, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Heidelberg
Collaborators
Amsterdam Institute for Global Health and Development, Swiss Tropical & Public Health Institute, Clinton Health Access Initiative, Eswatini, University of Göttingen, University of Eswatini, SWABCHA, Eswatini, Diabetes Swaziland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Hypertension
Keywords
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a parallel three-arm cluster-randomized trial without a baseline assessment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Health services for diabetes and hypertension are provided as was the standard of care prior to the healthcare reform after the emergency decentralization motivated by the COVID-19 outbreak. Healthcare for diabetes and hypertension for complicated cases is provided through physician-led teams at hospitals and health centers. Healthcare for diabetes and hypertension for uncomplicated cases is provided at primary care clinics through nurses.
Arm Title
DSD
Arm Type
Experimental
Arm Description
Clients are invited to participate in one of three Differentiated Service Delivery models tailored to their needs.
Arm Title
CDP
Arm Type
Experimental
Arm Description
Health services for diabetes and hypertension are provided in the scope of outreach activities set up on a monthly basis in communities.
Intervention Type
Other
Intervention Name(s)
DSD
Intervention Description
This intervention consist of three Differentiated Service Delivery Models in which stable clients can be enrolled. The fast-track model gives preferential treatment to enrolled clients. Clients arrive at clinics, usually early in the morning, and can see the nurse as well as collect their medication without queuing. This model mainly targets the working population. The facility-based treatment clubs consist of bimonthly meetings where clients meet in groups of approximately 20 members. They receive health counselling, risk factor screening and medication prescription. This model mainly targets clients living close to the facility. The community advisory groups consist of groups of up to six clients. Groups are equipped with a point of care blood pressure and blood glucose measurement devices. They take turns in collecting the medication for the entire group and meet on a monthly basis. This model targets clients in hard-to-reach areas.
Intervention Type
Other
Intervention Name(s)
CDP
Intervention Description
Community Distribution Points are set up on a monthly basis in communities linked to the clinic. Healthcare staff sets up a temporary point of contact where clients can obtain screening for diabetes and hypertension, health counselling, referral to primary or tertiary facilities, and medication.
Primary Outcome Measure Information:
Title
Glycemic control (continuous) among adults with diabetes
Description
Mean glycated haemoglobin (HbA1c) among adults aged 40 years and older with diabetes
Time Frame
12 months
Title
Systolic blood pressure among adults with hypertension
Description
Mean systolic blood pressure among adults aged 40 years and older with hypertension
Time Frame
12 months
Secondary Outcome Measure Information:
Title
HbA1c among adults with diabetes or prediabetes
Description
Mean glycated haemoglobin (HbA1c) among adults aged 40 years and older with diabetes or prediabetes
Time Frame
12 months
Title
Glycemic control (binary) among adults with diabetes
Description
The proportion of adults aged 40 years and older with diabetes who have an HbA1c less than 7.0%
Time Frame
12 months
Title
Glycemic control (binary) among adults with diabetes or prediabetes
Description
The proportion of adults aged 40 years and older with diabetes or prediabetes who have an HbA1c less than 7.0%
Time Frame
12 months
Title
Awareness of one's diabetes diagnosis
Description
The proportion of adults aged 40 years and older with diabetes who report to have been diagnosed with diabetes prior to the household survey
Time Frame
12 months
Title
Awareness of one's diabetes or prediabetes diagnosis
Description
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
Time Frame
12 months
Title
Probability of being treated for diabetes among adults with diabetes
Description
The proportion of adults aged 40 years and older with diabetes who report to be taking medication for their diabetes
Time Frame
12 months
Title
Probability of having been tested for diabetes among adults with diabetes
Description
The proportion of adults aged 40 years and older with diabetes who report to have ever been tested for diabetes
Time Frame
12 months
Title
Probability of having been tested for diabetes among adults with diabetes or prediabetes
Description
The proportion of adults aged 40 years and older with diabetes or prediabetes who report to have ever been tested for diabetes
Time Frame
12 months
Title
Probability of smoking among adults with diabetes, prediabetes, or hypertension
Description
The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who report to be a current smoker
Time Frame
12 months
Title
Time spent doing moderate- or vigorous-intensity exercise among adults with diabetes, prediabetes, or hypertension
Description
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
Time Frame
12 months
Title
Systolic blood pressure among adults with diabetes
Description
Mean systolic blood pressure among adults aged 40 years and older with diabetes
Time Frame
12 months
Title
Systolic blood pressure among adults with diabetes or prediabetes
Description
Mean systolic blood pressure among adults aged 40 years and older with diabetes or prediabetes
Time Frame
12 months
Title
Diastolic blood pressure among adults with diabetes
Description
Mean diastolic blood pressure among adults aged 40 years and older with diabetes
Time Frame
12 months
Title
Diastolic blood pressure among adults with diabetes or prediabetes
Description
Mean diastolic blood pressure among adults aged 40 years and older with diabetes or prediabetes
Time Frame
12 months
Title
Hypertension control (binary) among adults with hypertension
Description
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
Time Frame
12 months
Title
Diastolic blood pressure among adults with hypertension
Description
Mean diastolic blood pressure among adults aged 40 years and older with hypertension
Time Frame
12 months
Title
Awareness of one's hypertension diagnosis
Description
The proportion of adults aged 40 years and older with hypertension who report to have been diagnosed with hypertension prior to the household survey
Time Frame
12 months
Title
Probability of being treated for hypertension among adults with hypertension
Description
The proportion of adults aged 40 years and older with hypertension who report to be taking blood-pressure-lowering medication
Time Frame
12 months
Title
Probability of having been tested for hypertension among adults with hypertension
Description
The proportion of adults aged 40 years and older with hypertension who report to have ever had their blood pressure measured
Time Frame
12 months
Title
Frequency of drinking alcohol in the past 12 months among adults with diabetes, prediabetes, or hypertension
Description
The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who report to having drunk daily, 5-6 days per week, 3-4 days per week, 1-2 days per week, 1-3 days per month, less than once a month, or never over the past 12 months.
Time Frame
12 months
Title
21. Knowledge on diabetes and hypertension among adults with diabetes, prediabetes, or hypertension
Description
The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who correctly responded to each individual question on diabetes and hypertension related knowledge.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Till Bärnighausen, MD ScD
Phone
+49 6221 56 5637
Email
till.baernighausen@uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Geldsetzer, MD ScD MPH
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan-Walter De Neve, MD ScD MPH
Organizational Affiliation
Heidelberg Institute of Global Health, Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinton Health Access Initiative
City
Mbabane
Country
Swaziland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nyasatu Ntshalishali, PhD
Email
nntshalintshali@clintonhealthaccess.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
No detailed IPD sharing plan has been developed yet.

Learn more about this trial

Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini

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