Testing solutions for improvement of primary care for people with diabetes

Testing co-produced solutions for service delivery redesign of primary care for people with diabetes

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN63277390

Enrollment

396

Registered

2025-02-19

Start date

2025-09-01

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Nutritional, Metabolic, Endocrine

Interventions

As this is a cluster RCT, the intervention package targets a group of primary health centres located in 6 randomly selected departments, and it will be implemented for 15 months. The intervention pac

Eligibility

Sex/Gender

All

Age

18 Years to 120 Years

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 20/08/2025: 1. Adults residing in Mendoza who have been diagnosed with type 2 diabetes for at least 1 year 2. 18 years of age or older 3. Diagnosis of type 2 diabetes for at least 1 year 4. Residents of Mendoza Province 5. Assisting selected public PHC centres Previous inclusion criteria: 1. Adults residing in Mendoza with exclusive public insurance coverage who have been diagnosed with type 2 diabetes for at least 1 year 2. 18 years of age or older with exclusive public insurance coverage 3. Diagnosis of type 2 diabetes for at least 1 year 4. Residents of Mendoza Province 5. Assisting selected PHC centres

Exclusion criteria

Exclusion criteria: Less than 18 years old

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 20/08/2025: 1. Composite outcome measured using routine clinical records. It will be measured at least once during the baseline period and at least once during the intervention period: 1.1. Glycaemic control (HbA1c <8%) 1.2. Blood pressure control (<140/90 mmHg) 1.3. Use of statins (statin prescription) -limited to patients =40 years Previous primary outcome measures: 1. Composite outcome measured using routine clinical records. It will be measured at least once during the baseline period and at least once during the intervention period: 1.1. Glycaemic control (HbA1c <8%) 1.2. Blood pressure control (<140/90 mmHg) 1.3. Use of statins (statin prescription) -limited to patients =40 years 2. User-reported Quality of Care (QoC) measured at least once during the baseline period and every 2 or 3 months during the intervention period	—

Measure

Time frame

Current primary outcome measures as of 20/08/2025: 1. Composite outcome measured using routine clinical records. It will be measured at least once during the baseline period and at least once during the intervention period: 1.1. Glycaemic control (HbA1c <8%) 1.2. Blood pressure control (<140/90 mmHg) 1.3. Use of statins (statin prescription) -limited to patients =40 years Previous primary outcome measures: 1. Composite outcome measured using routine clinical records. It will be measured at least once during the baseline period and at least once during the intervention period: 1.1. Glycaemic control (HbA1c <8%) 1.2. Blood pressure control (<140/90 mmHg) 1.3. Use of statins (statin prescription) -limited to patients =40 years 2. User-reported Quality of Care (QoC) measured at least once during the baseline period and every 2 or 3 months during the intervention period

—

Secondary

Measure	Time frame
Measured using E-Cohort Survey at least once during the baseline period and every 2 or 3 months during the intervention period (unless noted otherwise): 1. User-reported Quality of Care (QoC) (added 26/01/2026) 2. Primary care engagement is measured by the percentage of visits conducted at the primary healthcare level reported by participants 3. System competence is measured by the compliance with the full set of selected diabetes prevention recommendations from national guidelines 4. Patient confidence in the health system is measured by the combination of health security, endorsement of the current system, and trajectory 5. Inequities assessment is measured by exploring gender, migration status, education, and income as potential variables related to underperformance in primary outcomes 6. Patient empowerment is measured using the Diabetes Empowerment Scale 7. Direct costs related to diabetes care are estimated from the costs assessed including medications, diagnostic tests, procedures, medical supplies, and visits to health professionals using data from the Accounting Department, Ministry of Health at least once during the baseline period and at least once during the intervention period	—

Measure

Time frame

Measured using E-Cohort Survey at least once during the baseline period and every 2 or 3 months during the intervention period (unless noted otherwise): 1. User-reported Quality of Care (QoC) (added 26/01/2026) 2. Primary care engagement is measured by the percentage of visits conducted at the primary healthcare level reported by participants 3. System competence is measured by the compliance with the full set of selected diabetes prevention recommendations from national guidelines 4. Patient confidence in the health system is measured by the combination of health security, endorsement of the current system, and trajectory 5. Inequities assessment is measured by exploring gender, migration status, education, and income as potential variables related to underperformance in primary outcomes 6. Patient empowerment is measured using the Diabetes Empowerment Scale 7. Direct costs related to diabetes care are estimated from the costs assessed including medications, diagnostic tests, procedures, medical supplies, and visits to health professionals using data from the Accounting Department, Ministry of Health at least once during the baseline period and at least once during the intervention period

—

Countries

Argentina

Contacts

Public ContactEzequiel Garcia-Elorrio

egarciaelorrio@iecs.org.ar+54 111558570687

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026