Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini
NCT ID: NCT04183413
Last Updated: 2024-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
3500 participants
INTERVENTIONAL
2021-11-01
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Community-based, eHealth Supported Type 2 Diabetes Care by Lay Village Health Workers in Rural Lesotho
NCT05743387
The Diabetes Specialist Nurse as Delegated Main Care Provider for Patients With Type 2 Diabetes
NCT00394875
The Efficacy of Specialist Collaboration and Mobile Screening for Improving the Management of Diabetes
NCT01275040
Diabetes Management for Primary Healthcare Centers.
NCT06907472
The Effect of a Diabetes Self-management Coaching Program for Type 2 Diabetes Patients in the Ethiopian PC.
NCT05336019
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard of Care
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.
No interventions assigned to this group
DSD
Clients are invited to participate in one of three Differentiated Service Delivery models tailored to their needs.
DSD
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.
CDP
Health services for diabetes and hypertension are provided in the scope of outreach activities set up on a monthly basis in communities.
CDP
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DSD
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.
CDP
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥40 years
Exclusion Criteria
* Inability to provide written informed consent
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amsterdam Institute for Global Health and Development
OTHER
Swiss Tropical & Public Health Institute
OTHER
Clinton Health Access Initiative, Eswatini
UNKNOWN
University of Göttingen
OTHER
University of Eswatini
UNKNOWN
SWABCHA, Eswatini
UNKNOWN
Diabetes Swaziland
UNKNOWN
University Hospital Heidelberg
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Till Bärnighausen
Prof. Dr. Dr. Till Bärnighausen
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pascal Geldsetzer, MD ScD MPH
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Jan-Walter De Neve, MD ScD MPH
Role: PRINCIPAL_INVESTIGATOR
Heidelberg Institute of Global Health, Heidelberg University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinton Health Access Initiative
Mbabane, , Eswatini
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Harkare HV, Osetinsky B, Ginindza N, Cindzi BT, Mncina N, Akomolafe B, Marowa LR, Ntshalintshali N, Tediosi F. Human and financial resource needs for universal access to WHO-PEN interventions for diabetes and hypertension care in Eswatini: results from a time-and-motion and bottom-up costing study. Hum Resour Health. 2024 May 27;22(1):32. doi: 10.1186/s12960-024-00913-0.
Theilmann M, Ginindza N, Myeni J, Dlamini S, Cindzi BT, Dlamini D, Dlamini TL, Greve M, Harkare HV, Hleta M, Khumalo P, Kolbe LM, Lewin S, Marowa LR, Masuku S, Mavuso D, Molemans M, Ntshalintshali N, Nxumalo N, Osetinsky B, Pell C, Reis R, Shabalala F, Simelane BR, Stehr L, Tediosi F, van Leth F, De Neve JW, Barnighausen T, Geldsetzer P. Strengthening primary care for diabetes and hypertension in Eswatini: study protocol for a nationwide cluster-randomized controlled trial. Trials. 2023 Mar 22;24(1):210. doi: 10.1186/s13063-023-07096-4.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WHO-PEN@Scale
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.