Enhanced hypertension care through private clinics in Pakistan: a cluster randomised trial

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Table 1. Baseline characteristics

Characteristics	Intervention, n (%)	Control, n (%)
Clusters
Total	13 (50.0)	13 (50.0)
Doctors
Male	13 (100.0)	13 (100.0)
Female	0 (0.0)	0 (0.0)
Paramedics
Male	13 (100.0)	13 (100.0)
Female	0 (0.0)	0 (0.0)
Participants
Total	574 (50.4)	564 (49.6)
Mean cluster size (SD)	44.15 (33.22)	43.38 (27.96)
Sex
Male	290 (50.5)	268 (47.5)
Female	284 (49.5)	296 (52.5)
Mean age, years (SD)	45.69 (11.72)	44.60 (12.40)
Mean education, years (SD)	6.5 (4.8)	6.1 (4.4)
Mean BMI, kg/m² (SD)	27.52 (5.85)	26.49 (5.67)
Hypertensive	574 (100)	564 (100)
Smoker	71 (12.4)	90 (16.0)
Mean fasting blood sugar, mg/dL (SD)	134.69 (56.06)	141.88 (55.81)
Mean random blood sugar, mg/dL (SD)	151.99 (70.73)	140.78 (62.43)
Mean HbA1c (%)	8.28 (2.51)	8.026 (2.58)
Mean systolic blood pressure, mmHg (SD)	161.25 (13.28)	161.42 (16.38)
Mean diastolic blood pressure, mmHg (SD)	103.60 (8.91)	103.48 (9.02)
Mean serum cholesterol, mg/dL (SD)	195.06 (45.38)	185.95 (44.03)

Table 2. Primary and secondary outcomes

	Intervention, mean outcome (95% CI) (clusters n = 13)	Control, mean outcome (95% CI) (clusters n = 13)	Crude control-intervention difference (95% CI); P value^b	Adjusted control-intervention difference (95% CI); P value^b
Change in SBP, mmHg^c	-25.23 (-29.86 to -20.61)	-9.41 (-21.24 to 2.24)	15.82 (3.60 to 28.04); 0.01	12.63 (0.68 to 24.57); 0.04
Change in DBP, mmHg^c	-18.18 (-22.12 to -14.25)	-8.62 (-15.00 to -2.24)	9.57 (2.39 to 16.74); 0.01	7.58 (0.61 to 14.55); 0.04
Hypertension control, %^d	69.56 (57.09 to 82.03)	35.79 (15.44 to 56.13)	-34pp (-56 to -11); 0.01	-30pp (-53 to -6); 0.02
Change in HbA1c, %^c	-0.70pp (-2.02 to 0.61)	-1.71pp (-2.63 to -0.79)	1.01pp (-2.53 to 0.52); 0.18	0.59pp (-0.29 to 0.17); 0.60
Glycaemic control, %^e	33.03 (10.11 to 55.94%)	42.79 (27.22 to 58.36%)	10pp (-17 to 36); 0.45	3pp (-2 to 87); 0.19
Change in total serum cholesterol (mg/dL)^c	-27.69 (-31.69 to -23.69)	0.52 (-9.85 to 10.89)	28.21 (17.37 to 39.06); 0.001	22.52 (15.89 to 29.16); 0.001
Treatment adherence^f	73.11 (56.34 to 89.88)	18.60 (6.63 to 30.57)	-54.51 (-74.13 to -34.88); 0. 00	-53.57 (-77.68 to -29.46); 0.00
Smoking cessation	3.08 (0.78 to 5.38)	4.17 (1.74 to 6.62)	1.10 (-2.08 to 4.28); 0.48	0.03 (-1.37 to 1.43); 0.97

DBP = diastolic blood pressure. pp = percentage points. SBP = systolic blood pressure. ^aArm-specific mean outcomes and their 95% confidence intervals are themselves based on cluster-level summary (mean/proportion) outcomes. ^bAll control minus intervention differences (that is, intervention effect estimates) are based on analysis of crude/covariate-adjusted cluster-level summary (mean/proportion) outcomes. ^cAll change outcomes are calculated as outcome at endpoint minus outcome at baseline. ^dHypertension control defined as endpoint systolic BP ≤140 mmHg; ^eGlycaemic control defined as endpoint HbA1c ≤7%. ^fTreatment adherence was defined as patient having attended ≥5 treatment visits. All differences for percentage outcomes are on the absolute scale as percentage points. All analyses use only complete cases.

Table 3. Effect modification by sex for the primary outcome (change in SBP)

	Mean outcome (95% CI)^a
	Intervention (clusters n = 13)	Control (clusters n = 13)	Crude effect (95% CI); P value^b	Adjusted effect (95% CI); P value
Female change in SBP	-25.62 (-30.49 to -20.75)	-10.42 (-21.92 to 1.09)	15.20 (3.06 to 27.34); 0.02	13.32 (0.74 to 25.89); 0.04
Male change in SBP	-24.64 (-29.33 to -19.95)	-7.52 (-23.42 to 8.39)	17.13 (0.81 to 33.44); 0.04	17.51 (3.69 to 31.34); 0.02
Female–male difference for change in SBP	-	-	-1.93 (-12.38 to 8.53); 0.70	-0.50 (-9.27 to 8.27); 0.90

SBP = systolic blood pressure. ^aArm-specific mean outcomes and their 95% confidence intervals are themselves based on cluster-level summary mean outcomes for females/males/female–male differences. ^bAll control minus intervention differences (intervention effect estimates) are based on analysis of crude/covariate-adjusted cluster-level summary (mean/proportion) female–male difference outcomes. Change in SBP is calculated as outcome at endpoint minus outcome at baseline.