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- Figure 1. CONSORT trial flow chart
Tables
A B C Inputs Intervention arm facilities Control arm facilities Contextualised care protocols and tools Case management desk guide and counselling tool None Training of doctors and allied staff (jointly by the programme staff and research team) Full care tasks: screen on the first visit, diagnose, and maintain patient records; use provided desk guide on how to prescribe, educate, follow-up, and retrieve patients Limited care tasks: screen on the first visit, diagnose, and maintain patient records only Material inputs Peak flow meter, recording tools; also salbutamol and ipratropium inhalers, mobile reminders for patient retrieval Peak flow meter, and recording tools only Access to spirometry at baseline (that is within 2 weeks of registration) and endline (that is completed 6 months after registration) was offered as a research measurement activity (that is not to inform clinical decisions) for all patients in the two trial arms.
Clinical feature BODE index score points 0 1 2 3 mMRC scale 0–1 2 3 4 6MWD, m ≥350 250–349 150–249 ≤149 FEV1% pred ≥65 50–64 36–49 ≤35 BMI, kg/m2 >21 ≤21 mMRC dyspnoea scale ranges from 0–4: Score 0–1 indicates breathlessness on exercise only, or on brisk walking
Score 2 indicates person walks slowly or stops for breath (due to breathlessness)
Score 3 indicates person stops for breath in less than 100 m walking
Score 4 indicates person is breathless even while dressing
Distance walked in 6 minutes, contributes 0–3 in the BODE index score. Patient is asked to walk for 6 minutes and his/her score is calculated as below:Score 0 indicates ≥350 m walking
Score 1 indicates 250–349 m walking
Score 2 indicates 150–249 m walking
Score 3 indicates ≤149 m walking
The spirometry (FEV1% pred.) contributes 0–3 in the BODE index score:Score 0 ≥65 FEV1% pred. (FEV1 is 65% or more of the predicted amount)
Score 1 ≥50-64 FEV1% pred. (FEV1 is 50–64% of the predicted amount)
Score 2 ≥36-49 FEV1% pred. (FEV1 is 36–49% of the predicted amount)
Score 3 ≤35 FEV1% pred. (FEV1 is 35% or less of the predicted amount)
Body mass index (relates height with weight), contributes 0–1 in the BODE index scoreScore 0 indicates BMI >21
Score 1 indicates BMI ≤21
Extracted from the doctors’ training module, developed as part of intervention.
6MWD = six-minute walk distance. BODE = Body mass index, airway Obstruction, Dyspnoea, Exercise capacity. BMI = body mass index. mMRC = modified Medical Research Council.
Characteristics Intervention, n (%) Control, n (%) Clusters Total 15 15 Doctors Male 15 (100.0) 15 (100.0) Female 0 (0.0) 0 (0.0) Paramedics Male 15 (100.0) 15 (100.0) Female 0 (0.0) 0 (0.0) Participants Total 159 (50.8) 154 (49.2) Mean cluster size, ±SD 10.60 ± 3.85 10.27 ± 3.90 Male 122 (76.7) 111 (72.1) Female 37 (23.3) 43 (27.9) Mean age, years, ±SD 48.11 ± 13.89 48.47 ± 12.86 Not educated 104 (70.7) 102 (72.3) Primary (grade 1–5) 16 (10.9) 15 (10.6) Secondary (grade 6–12) 24 (16.3) 22 (15.6) Above secondary (grade >12) 3 (2.0) 2 (1.4) Mean BMI, kg/m2, ±SD 22.47 ± 4.79 22.45 ± 5.93 Diagnosed with COPD 159 (100.0) 154 (100.0) Smoker 59 (37.11) 54 (35.06) Mean BODE index score, ±SDa 3.85 ± 1.94 3.78 ± 1.88 Mean PEFR value, ±SD 232.97 ± 100.88 246.81 ± 108.73 Mean weight, kg, ±SD 58.69 ± 13.18 58.24 ± 14.09 Mean height, inches, ±SD 63.68 ± 3.83 63.63 ± 3.85 aSpirometry was done by an external assessor within 15 days of diagnosis and/or registration.
BODE = Body mass index, airway Obstruction, Dyspnoea, Exercise capacity. BMI = body mass index. COPD = chronic obstructive pulmonary disease. PEFR = peak expiratory flow rate. SD = standard deviation.
Mean outcome
(95% CI)aCrude intervention-
control difference
(95% CI);
P valuebAdjusted intervention-
control difference
(95% CI);
P valuebIntervention
(clusters = 15)Control
(clusters = 15)Primary outcomes BODE index
score changec-1.67
(-2.18 to -1.16)-0.66
(-1.09 to -0.22)-1.01
(-1.65 to -0.37);
0.003-0.96
(-1.49 to -0.44);
0.001COPD controld 66.88%
(54.99 to 78.77)38.20%
(22.35 to 54.06)28.68%
(9.68 to 47.67);
0.00529.03%
(12.41 to 45.64);
0.001Secondary outcome Quit rate
among smokerse53.90%
(34.98 to 72.82)17.52%
(7.36 to 27.69)36.38%
(15.66 to 57.10);
0.00231.98%
(15.42 to 48.54);
0.001Follow-up
adherencef65.54%
(52.64 to 78.44)25.17%
(14.86 to 35.47)40.38%
(24.57 to 56.18);
<0.00140.40%
(24.15 to 56.67);
<0.001aArm-specific mean outcomes and their 95% confidence intervals are calculated from cluster-level mean and/or proportion summary values of outcomes. bAll intervention minus control differences (that is, intervention effect estimates) are based on crude and/or covariate-adjusted analysis of cluster-level mean and/or proportion summary values of outcomes. cBODE index score change calculated as outcome at 6-month follow-up minus outcome at baseline. dCOPD control defined as BODE index ≤ 2 at 6-month follow-up. eQuit rate among smokers calculated as smokers who had quit smoking at 6-month follow-up. fFollow-up adherence defined as attending ≥4 follow-up visits. All analyses use only complete cases.
BODE = Body mass index, airway Obstruction, Dyspnoea, Exercise capacity. CI = confidence intervals. COPD = chronic obstructive pulmonary disease.
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