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Trial · NCT07589387

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryDose of quarterly supportive supervision visits measured by the proportion of observed/expected visits during the implementation period.36 monthsPrimary Implementation Outcome: Description: Dose of quarterly supportive supervision visits measured by the proportion of observed/expected visits during the implementation period.
Primary
Difference in 6-month rolling average of blood glucose control in patients with diabetes (random blood glucose ≤11.1 mmol/L while receiving treatment; or fasting plasma glucose/HbA1c within target, as available) per WHO HEARTS-D, pre- vs. implementation
36 months
Primary effectiveness outcome: The primary outcome will be the difference in the 6-month rolling average of blood glucose control among patients with diabetes, control defined as random blood glucose ≤ 11.1 mmol/L (or fasting plasma glucose/HbA1c within target, as available) while receiving treatment, in accordance with HEARTS-D, between the pre-implementation and implementation periods.
SecondaryDifference in 6-month rolling average diabetes treatment (proportion of eligible patients prescribed any glucose-lowering medication) between pre-implementation and implementation periods36 monthsSecondary Effectiveness Outcome (diabetes treatment): 6-month rolling average of diabetes treatment levels in the pre-implementation and implementation periods.
Secondary
Difference in 6-month rolling average blood sugar control (per WHO HEARTS-D: fasting plasma glucose <126 mg/dL, postprandial <160 mg/dL, or HbA1c <7%) between pre-implementation and implementation periods
36 months
Secondary Effectiveness Outcome (blood sugar control): 6-month rolling average of blood sugar control in the pre-implementation and implementation periods. Control will be defined according to the WHO HEARTS-D module2, specifically: fasting glucose \<126 mg/dl, postprandial glucose \<160 mg/dl, or HbA1c \<7%.
SecondaryDifference in 6-month rolling average mean fasting plasma glucose (mg/dL) between pre-implementation and implementation periods36 monthsSecondary Effectiveness Outcomes (mean fasting glucose levels): 6-month rolling average of mean fasting glucose levels in the pre-implementation and implementation periods.
SecondaryProportion of selected primary health centers (PHCs) that participated in baseline diabetes training (A ÷ B; A = PHCs that participated, B = total selected PHCs)36 monthsSecondary Implementation Outcome: A = Number of PHCs who participated in baseline diabetes training B = Total number of selected PHCs Calculation: A ÷ B
SecondaryProportion of selected PHCs that received at least one supportive supervision visit in the past 12 months (A ÷ B; B = total selected PHCs)36 monthsSecondary Implementation Outcome: A = Number of PHCs who received at least one supportive supervision visit in the past 12 months B = Total number of selected PHCs Calculation: A ÷ B
SecondaryProportion of eligible PHCs that received at least one audit-and-feedback report within the past 3 months (A ÷ B)36 monthsSecondary Implementation Outcome: A = Number of PHCs who received at least an audit and feedback report within the past 3-months B = Total number of selected PHCs Calculation: A ÷ B
SecondaryPercentage of PHCs with a working blood glucose monitor on-site on the day of assessment (last supervision visit) (A ÷ B)36 months
Secondary Implementation Outcome: A = Number of PHCs with a working blood glucose monitor at the site on the day of assessment (time point: last supervision visit) B = Total number of selected PHCs Calculation: A ÷ B
SecondaryPercentage of PHCs with diabetes medicines available on-site on the day of assessment (last supervision visit) (A ÷ B)36 months
Secondary Implementation Outcome: A = Number of PHCs with diabetes medicines available on the day of assessment (time point: last supervision visit) B = Total number of selected PHCs Calculation: A ÷ B
Secondary
6-monthly rolling average percentage of registered diabetes patients with clinically indicated step-up who received step-up treatment within 6 months (A = patients needing and receiving step-up; B = patients registered per month)
36 months
Secondary Implementation Outcome: A = Number of patients who need step up treatment and received it B = Total number of patients who are registered per month Calculation: A ÷ B, 6-monthly rolling average rate
Secondary6-monthly rolling average monthly proportion of registered diabetes patients receiving appropriate stepped care, out of total registered patients (A ÷ B)36 months
Secondary Implementation Outcome: A = Number of patients who need step up treatment and received it B = Total number of patients who are registered per month Calculation: A ÷ B, 6-monthly rolling average rate
OtherDifference in the proportion of patients with serious adverse events (SAEs) between pre-implementation and implementation periods36 monthsSafety Outcome: between-period (pre-implementation versus implementation) differences in proportions of serious adverse events
Other
Difference in the proportion of patients with adverse events of special interest (hypoglycemia, hyperglycemia, medication allergies, common medication side effects) between pre-implementation and implementation periods
36 monthsSafety Outcome: e.g., hypoglycemia, hyperglycemia, medication allergies, common medication side effects in pre-implementation and implementation periods.

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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