Trial Without Borders IMPLEMENT-CKD: IMPLEMENTation of Evidence-Based SGLT2i to Reduce Global Burden of Cardiovascular and Chronic Kidney Disease

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe University of Queensland

About this trial

Chronic kidney disease (CKD) affects millions, especially in low- and middle-income countries, where many die early due to lack of treatment. One group of medicines, called SGLT2 inhibitors (SGLT2i), have been shown to slow down kidney damage and reduce the risk of heart-related deaths. The IMPLEMENT-CKD project will work with communities in Thailand, Fiji and Samoa to make it easier for people with CKD or type 2 diabetes to get these life-saving medicines as part of their regular care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

chronic kidney disease (CKD) with eGFR > 20 mL/min/1.73m²;

type 2 diabetes mellitus (T2DM).

Disqualifiers

Nil

Trial population

Participants will be recruited from Thailand, Fiji and Samoa.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Implementation of recommendations

    Other intervention

    The study will be organised into three periods: * A pre-implementation phase - co-design implementation strategies development in each region; * An implementation phase - initiation of SGT2i and evaluation; * A post-implementation phase - consolidate learnings and dissemination for scaling up

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

A Reach of 50% of eligible patients initiated on SGLT2i therapy

Proportion of eligible patients initiated on SGLT2i therapy, calculated as number of patients who were prescribed SGLT2i therapy during the intervention period/ number of patients meeting predefined eligibility criteria.

Time frame
24 months

Secondary outcomes

1

Adherence to SGLT2i therapy

Patient reported uptake

Time frame
24 months
2

Effectiveness

Rates of CKD detection

Time frame
24 months
3

Adoption

% of participating centres that initiate implementation strategies.

Time frame
24 months
4

Implementation

Acceptability and feasibility of implementation strategies. Fidelity to protocol

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: