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British Journal of General Practice

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Original Papers

A cluster randomised controlled trial of the effect of a treatment algorithm for hypertension in patients with type 2 diabetes

Charlotte Bebb, Denise Kendrick, Carol Coupland, Richard Madeley, Jane Stewart, Ken Brown, Richard Burden and Nigel Sturrock
British Journal of General Practice 2007; 57 (535): 136-143.
Charlotte Bebb
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Denise Kendrick
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Carol Coupland
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Richard Madeley
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Jane Stewart
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Ken Brown
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Richard Burden
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Nigel Sturrock
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Article Figures & Data

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    Figure 1

    Algorithm for the management of hypertension

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    Figure 2

    Flow of participants through the study

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    Table 1

    Baseline characteristics of participants: n (%) unless otherwise stated.

    Participant characteristicsIntervention arm n = 797Control arm n = 737
    Mean age (SD)64.3 (9.9)64.3 (10.0)
    Males464 (58.2)443 (60.1)
    Ethnic group: non-white61 (7.7)83 (11.3)
    Years since diagnosis of diabetes
     0–5437 (54.8)395 (53.6)
     6–10184 (23.1)190 (25.8)
     11–15107 (13.4)85 (11.5)
     >1569 (8.7)67 (9.1)
    Diabetes controlled by
     Diet191 (24.0)150 (20.4)
     Oral medication504 (63.2)497 (67.4)
     Insulin102 (12.8)90 (12.2)
    Mean systolic blood pressure (SD) [3]146 (21)146 (19)
    Mean diastolic blood pressure (SD) [3]80 (10)80 (10)
    Controlled blood pressure [3]264 (33.3)228 (30.9)
    Receiving treatment for hypertension540 (67.8)505 (68.5)
    Number of antihypertensive medications:
     0257 (32.3)232 (31.5)
     1199 (25.0)191 (25.9)
     2204 (25.6)185 (25.1)
     3103 (12.9)89 (12.1)
     430 (3.8)36 (4.9)
     53 (0.4)3 (0.4)
     61 (0.1)1 (0.1)
     Median (IQR)1 (0,2)1(0,2)
    Prescribed >50% of maximum dose of antihypertensivesa269 (50.6)260 (52.6)
    Mean body mass index (SD)[2]30.0 (5.3)30.2 (3.4)
    Current smoker [1]119 (14.9)104 (14.1)
    Macrovascular complicationsb263 (33.0)228 (30.9)
    Microvascular complicationsc[173]314 (44.6)292 (44.4)
    Mean glycosylated haemoglobin (SD) [10]7.7 (1.4)7.7 (1.5)
    • ↵a Calculated by summing percentage of maximum recommended dose prescribed for each antihypertensive drug and dividing by number of prescribed antihypertensive drugs. Loop diuretics have been excluded from this analysis.

    • ↵b Defined as a history of ischaemic heart disease, cerebrovascular disease, or peripheral vascular disease.

    • ↵c Defined as the presence of retinopathy, abnormal albumin creatinine ratio or peripheral neuropathy. IQR = interquartile range. [] = missing values. SD = standard deviation.

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    Table 2

    Baseline characteristics of practices.

    Practice characteristicsIntervention arm n = 20Control arm n = 22
    Median (IQR)Median (IQR)
    List size4615 (2969–7056)5593 (2475–6834)
    Number of WTE GPs3.0 (1.4–3.7)2.8 (1.0–3.3)
    Number of WTE nurses1.5 (1.1–2.0)1.5 (1.0–2.0)
    Number of patients with diabetes134 (68–196)127 (73–183)
    Practice Townsend score [1]0.06 (−0.73–2.85)−0.19 (−1.49–2.87)
    Percentage of practice population from non-white ethnic group [1]6.3 (3.1–8.2)6.8 (2.7–10.2)
    n (%)n (%)
    Practice has agreed BP target14 (70.0)21 (95.5)
    BP target agreed by practice, mmHg
     <140/8013 (92.9)17 (81.0)
      140/80–160/951 (7.1)4 (19.1)
    Practice negotiates targets with
     Almost all or many patients12 (60.0)11 (50.0)
     A few or hardly any patients8 (40.0)11 (50.0)
    • [] = missing values. BP = blood pressure. IQR = interquartile range. WTE = whole time equivalent.

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    Table 3

    Primary and secondary outcome measures comparing intervention arm to control arm: n (%) unless stated otherwise.

    Intervention arm n = 743Control arm n = 677ICCOR (95% CI)P-value
    Primary outcome measure
    Controlled blood pressure272 (36.6)232 (34.3)0.0351.23 (0.85 to 1.78)0.27
    Secondary outcome measures
    Categorical outcome measuresOR (95% CI)
    BP <140/80mmHg245 (33.0)202 (29.8)0.0411.27 (0.86 to 1.89)0.23
    Prescribed antihypertensives526 (70.8)471 (69.6)0.0501.30 (0.85 to 1.97)0.23
    Prescribed >50% of max dose of antihypertensives301 (58.2)248 (53.1)0.0331.50 (1.03 to 2.17)0.03
    Satisfied with care (versus neither/dissatisfied) [161]560 (83.7)504 (85.4)0.0070.84 (0.59 to 1.19)0.32
    Continuous outcome measuresDifference between means (95% CI)
    Mean systolic BP (SD)143.3 (19.5)143.1 (17.7)0.034−1.30 (−4.43 to 1.83)0.42
    Mean diastolic BP (SD)78.2 (10.2)77.9 (10.4)0.039−0.11 (−1.78 to 1.56)0.90
    Count outcome measuresRR (95% CI)
    Number of antihypertensive drugs prescribed0.0541.07 (0.91 to 1.26)0.42
     0217 (29.2)206 (30.4)
     1180 (24.2)157 (23.2)
     2181 (24.4)165 (24.4)
     3115 (15.5)111 (16.4)
     441 (5.5)27 (4.0)
     56 (0.8)9 (1.3)
     63 (0.4)2 (0.3)
     Median (IQR)1(0,2)1(0,2)
    Number of BP consultations [17]0.1741.50 (1.25 to 1.80)<0.001
     024 (3.3)54 (8.1)
     173 (10.0)122 (18.2)
     2108 (14.7)114 (17.0)
     3117 (16.0)99 (14.8)
     491 (12.4)89 (13.3)
     582 (11.2)63 (9.4)
     ≥6238 (32.5)129 (19.3)
     Rate/year4.93.7
    • [] = missing values. BP = blood pressure. ICC = intraccluster correlation coefficient. OR = odds ratio. RR = rate ratio.

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British Journal of General Practice: 57 (535)
British Journal of General Practice
Vol. 57, Issue 535
February 2007
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A cluster randomised controlled trial of the effect of a treatment algorithm for hypertension in patients with type 2 diabetes
Charlotte Bebb, Denise Kendrick, Carol Coupland, Richard Madeley, Jane Stewart, Ken Brown, Richard Burden, Nigel Sturrock
British Journal of General Practice 2007; 57 (535): 136-143.

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A cluster randomised controlled trial of the effect of a treatment algorithm for hypertension in patients with type 2 diabetes
Charlotte Bebb, Denise Kendrick, Carol Coupland, Richard Madeley, Jane Stewart, Ken Brown, Richard Burden, Nigel Sturrock
British Journal of General Practice 2007; 57 (535): 136-143.
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Keywords

  • hypertension
  • primary care
  • type 2 diabetes mellitus

More in this TOC Section

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Print ISSN: 0960-1643
Online ISSN: 1478-5242