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Research

Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan

Muhammad Amir Khan, John D Walley, Nida Khan, Joseph Hicks, Maqsood Ahmed, Shaheer Ellahi Khan, Muhammad Ahmar Khan, Haroon Jehangir Khan and Anthony D Harries
BJGP Open 2018; 2 (4): bjgpopen18X101618. DOI: https://doi.org/10.3399/bjgpopen18X101618
Muhammad Amir Khan
1 Chief Coordinating Professional, Association for Social Development, , Pakistan
DHA, MPH, PhD, FFPH
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John D Walley
2 Professor of International Public Health, Nuffield Centre for International Health and Development, Leeds Institute of Health Sciences, , UK
MComH, FFPH, MRCGP
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Nida Khan
3 Project Coordinator, Association for Social Development, , Pakistan
MSc, MS
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  • For correspondence: nidakhan{at}asd.com.pk
Joseph Hicks
4 Senior Medical Statistician, Nuffield Centre for International Health and Development, Leeds Institute of Health Sciences, , UK
MSc, PhD
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Maqsood Ahmed
5 Senior Professional, Association for Social Development, , Pakistan
MBBS, MPhil (Public Health)
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Shaheer Ellahi Khan
6 Assistant Professor, Humanities and Social Sciences Department, Bahria University, , Pakistan
MSc, MPhil
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Muhammad Ahmar Khan
7 Research Coordinator, Association for Social Development, , Pakistan
MBBS
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Haroon Jehangir Khan
8 Director, NCD & Mental Health, Directorate General of Health Services, , Pakistan
BSc, MA HMPP, MPH, FRIPH
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Anthony D Harries
9 Senior Advisor, Department of Research, International Union Against Tuberculosis and Lung Disease, , UK
MD
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Article Figures & Data

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  • Figure 1.
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    Figure 1. Diabetes intervention (ACM) and control (TTR-only) care package details. ACM = additional case management. BP = blood pressure. FBG = fasting blood glucose. RBG = random blood glucose. TTR = testing, treating, and recording.
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    Figure 2. CONSORT trial flow chart

    ACM = additional case management. TTR = testing, treating, and recording.

Tables

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    Table 1. Baseline characteristics of clusters and patients
    CharacteristicsACM, n (%)TTR-only, n (%)
    Clusters
    Total7 (100.0)7 (100.0)
    Doctors
    Male7 (100.0)7 (100.0)
    Female0 (0.0)0 (0.0)
    Paramedics
    Male5 (71.4)3 (42.9)
    Female2 (28.6)4 (57.1)
    Participants in clusters
    Total250 (50.5)245 (49.5)
    Mean cluster size (SD)35.7 (± 10.4)35 (± 15.4)
    Sex
    Male92 (36.8)97 (39.6)
    Female158 (63.2)148 (60.4)
    Mean age, years (SD)46.1 (± 10.4)46.1 (± 9.7)
    Mean education ,years (SD)3.5 (± 4.4)4.9 (± 4.8)
    Mean BMI, kg/m2 (SD)31.9 (± 7.8)32.8 (± 8.1)
    Hypertensive60 (24.0)68 (27.8)
    Mean fasting blood sugar, mg/dL (SD)216.3 (± 56.5)203.8 (± 52.7)
    Mean random blood sugar, mg/dL (SD)303.3 (± 81.6)292.7 (± 69.5)
    Mean HbA1c% (SD)10.4 (± 2.4)10.0 (± 2.4)
    Mean systolic blood pressure, mmHg (SD)129.9 (± 16.6)130.1 (± 17.6)
    Mean diastolic blood pressure, mmHg (SD)84.7 (± 9.4)87.0 (± 13.3)
    Mean total serum cholesterol, mg/dL (SD)192.6 (± 51.8)193.0 (± 46.6)
    • 'Hypertensive' defined as baseline systolic blood pressure >140 mmHg.

    • ACM = additional case management. BMI = body mass index. TTR = testing, treating, and recording

    • View popup
    Table 2. Primary and secondary outcome results
    ACM arm
    (clusters, n = 7)
    TTR-only arm
    (clusters, n = 7)
    Crude ACM-TTR difference
    (95% CI); P valuea
    Adjusted ACM-TTR
    difference (95% CI); P valuea
    Mean outcome (95% CI)b
    Primary outcome
    Change in HbA1c (pp)c -2.26pp (-2.99 to -1.53)-1.44pp (-2.34 to -0.54)-0.82pp (-1.86 to 0.21); 0.11-0.57pp (-1.44 to 0.29); 0.17
    Secondary outcomes
    Adherenced 75.64% (45.56 to 105.71%)36.29% (3.9 to 68.67%)39.35pp (-0.02 to 78.73); 0.050136.06pp (-0.78 to 72.9); 0.054
    Glycaemic controle 45.04% (32.48 to 57.6%)34.86% (16.15 to 53.57%)10.18pp (-10.21 to 30.57); 0.2910.87pp (-7.92 to 29.67); 0.23
    Change in SBP (mmHg)c 2.33 (-0.1 to 4.76)1.47 (-4.32 to 7.26)0.86 (-5.05 to 6.77); 0.751.3 (-3.41 to 6.01); 0.56
    Change in DBP (mm Hg)c 2.81 (-1.04 to 6.66)0.68 (-4.34 to 5.69)2.13 (-3.54 to 7.81); 0.430.29 (-1.93 to 2.51); 0.78
    Hypertension controlf 73.2% (61.92 to 84.49%)72.47% (59.36 to 85.58%)0.73pp (-14.71 to 16.17); 0.920.0pp (-12 to 12.95); 0.93
    Change in total serum
    cholesterol (mg/dL)c
    -5.24 (-19.82 to 9.34)2.75 (-5.73 to 11.22)-7.99 (-23.43 to 7.45); 0.27-5.79 (-20.22 to 8.65); 0.4
    • ACM = additional case management. CI = confidence intervals. TTR = test, treat, and record. PP = percentage points.

    • aAll ACM–TTR differences (that is, ACM effect size measures) are based on analysis of cluster-level (mean/proportion) outcomes. bMean outcomes and their 95% confidence intervals are based on cluster-level (mean/proportion) raw outcome data. cAll change outcomes are calculated as outcome at 9 months minus outcome at baseline. dAdherence defined as attendance of ≥4 follow-up appointments within 9 months. eGlycaemic control defined as 9-month HbA1c (%) <7%. fHypertension control defined as 9-month systolic blood pressure ≤140 mmHg.

    • All analyses exclude patients’ missing outcome and/or covariate data as required by the relevant analysis.

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Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan
Muhammad Amir Khan, John D Walley, Nida Khan, Joseph Hicks, Maqsood Ahmed, Shaheer Ellahi Khan, Muhammad Ahmar Khan, Haroon Jehangir Khan, Anthony D Harries
BJGP Open 2018; 2 (4): bjgpopen18X101618. DOI: 10.3399/bjgpopen18X101618

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Effectiveness of an integrated diabetes care package at primary healthcare facilities: a cluster randomised trial in Pakistan
Muhammad Amir Khan, John D Walley, Nida Khan, Joseph Hicks, Maqsood Ahmed, Shaheer Ellahi Khan, Muhammad Ahmar Khan, Haroon Jehangir Khan, Anthony D Harries
BJGP Open 2018; 2 (4): bjgpopen18X101618. DOI: 10.3399/bjgpopen18X101618
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