Table 3. Study outcome measures.
| Measure | Frequency | Notes and definition | |
|---|---|---|---|
| PRIMARY OUTCOMES | |||
| A. Disease control | |||
| 1. Hypertension
control |
Proportion of patients with controlled
blood pressure |
Routine (each visit) | Uncontrolled BP ≥140/≥90 (or ≥130/≥80 if DM or
chronic kidney disease) |
| 2. Diabetes control | Proportion of patients with controlled
diabetes |
0,6,12 months | Uncontrolled Diabetes if HbA1C < 7 or FBS
< 126 mg/dl |
| B. Supply chain/access to medicines | |||
| Number of stock-outs | Monthly | ||
| Ability to access GAAP medicines at
enrolled sites |
Monthly | ||
| Consumption rates of GAAP medicines
(uptake or prescription refills) |
Monthly | ||
| Number inventory checks, forecasting
reports, procurement events/cycles for GAAP medicines and other medicines in therapeutic classes |
Weekly | ||
| Assessment of prescriber patterns for
the GAAP medicines from patient files and prescriber |
0, 6, 12, 18 months | ||
| Source of supply | 0, 6, 12, 18 months | ||
| Delivery time from ordering | 0, 6, 12, 18 months | ||
| Frequency of orders | 0, 6, 12, 18 months | ||
| Mode of delivery to health facility | 0, 6, 12, 18 months | ||
| SECONDARY OUTCOMES | |||
| A. Adherence to medicine | |||
| Hypertension
medication adherence |
The Hills-Bone Compliance to Blood
Pressure Therapy Scale |
0,6,12, 18 months | 14 items assessing study participant’s self-reported
adherence (reduced sodium intake, appointment keeping and medication taking). Items are assumed to be additive, and, when summed, the total score ranges from 14 (minimum) to 56 (maximum) |
| Diabetes medication
adherence |
Morisky, Green and Levine (MGL)
Medication Adherence Questionnaire |
0,6,12, 18 months | 1 item used to determine adherence |
| B. Knowledge, Attitude and Practice | |||
| Questionnaire (qualitative) | 0,6,12, 18 months | Questionnaire assessing knowledge about
hypertension and diabetes |
|
| C. Cost of medicines | |||
| Out of pocket (OOP) cost | 0,6,12, 18 months | Computed by person months on treatment with the
same medication |
|
| Cost to Health System | 0,6,12, 18 months | Assessed both with and without the effects of price
differentials |
|
| D. Complications | |||
| Proportion of patients with renal failure
(proteinuria or GFR consistent with chronic renal failure) |
0,6,12, 18 months | Measurement of GFR, BUN/Cr, urine protein | |
| Proportion of patients with lower limb
amputations, peripheral neuropathy, retinopathy, stroke cardiovascular events, stroke |
0,6,12, 18 months | Self-report or medical records | |