| Variables | Treatment (n = 61) | Control (n = 61) | Percentage difference‡ | p Value | ||
| Baseline (n = 61) (% (n)) | Year 2 (n = 55) (% (n)) | Baseline (n = 61) (% (n)) | Year 2 (n = 49) (% (n)) | |||
| Males (%) | 49.2 (30/61) | 49.2 (30/61) | 0 | NS | ||
| Age (y) (mean (SD)) | 69.9 (9.6) | 69.68 (10.4) | 0.22 | 0.474† | ||
| BMI (median (range)) | 25.0 (14–38) | 24 (16–40) | 1 | |||
| Smoking status | ||||||
| Current smoker | 29.5 (18/61) | 29.1 (16/55) | 19.7 (12/61) | 22.4 (11/49) | 6.7 | 0.426 |
| MRC dyspnoea score (median (range)) | 3 (1–5) | 4 (1–5) | 3 (1–5) | 4 (1–5) | ||
| Home O2 | ||||||
| Yes (%) | 19.7 (12/61) | 25.4 (14/55) | 21.3 (13/61) | 26.5 (13/49) | −1.1 | 0.901 |
| Cylinder | 33.3 (4/12) | 28.6 (4/14) | 46.1 (6/13) | 46.1 (6/13) | −17.5 | |
| Concentrator | 66.6 (8/12) | 71.4 (10/14) | 53.8 (7/13) | 53.8 (7/13) | 17.6 | |
| FEV1 (mean (SD)) | 1.04 (0.44) | 0.95 (0.42) | 1.17 (0.49) | 1.06 (0.44) | −0.16 | 0.186* |
| FVC (mean (SD)) | 2.12 (0.74) | 1.98 (0.65) | 2.2 (0.77) | 2.1 (0.79) | −0.12 | 0.387* |
| FEV1% pred (mean (SD)) | 42.9 (15.5) | 41.1 (17.1) | 48.9 (18.69) | 45.7 (17.48) | −4.6 | 0.201* |
| Change in FEV1 ml (mean (SD)) | −94.9 (162.1) | −162.7 (249.9) | 0.111* | |||
| Prior hospital admissions (before randomisation) | ||||||
| Total No of admissions | 73 | 64 | 9 | 0.186* | ||
| Admission in the 2 y prior to recruitment (% (n)) | 80.3 (49/61) | 68.8 (42/61) | 11.5 | 0.145 | ||
| No of admissions/patient/2 y (median (range)) | 1.0 (0–6) | 1.0 (0–6) | ||||
| LABA prescription | ||||||
| Yes (%) | 67.2 (41/61) | 92.7 (51/55) | 63.9 (39/61) | 71.4 (35/49) | 21.3 | 0.004 |
| LABA inhaler alone | 29.3 (12/41) | 0.00 (0/51) | 33.3 (13/39) | 8.6 (3/35) | 8.6 | |
| LABA and ICS combination inhaler | 70.7 (29/41) | 100 (51/51) | 66.7 (26/39) | 91.4 (32/35) | 8.6 | |
| ICS prescription | ||||||
| Yes (%) | 88.5 (54/61) | 94.5 (52/55) | 80.3 (49/61) | 100.0 (49/49) | −5.5 | 0.097 |
| Inhaled ICS alone | 46.3 (25/54) | 1.9 (1/52) | 46.9 (23/49) | 24.5 (12/49) | −22.6 | |
| ICS and LABA combination inhaler | 53.7 (29/54) | 98.0 (51/52) | 53.1 (26/49) | 65.3 (32/49) | 32.7 | |
| Anticholinergic prescription | ||||||
| Yes (%) | 73.7 (45/61) | 89.1 (49/55) | 63.9 (39/61) | 65.3 (32/49) | 23.8 | 0.004 |
| Short acting | 53.3 (24/45) | 6.1 (3/49) | 58.9 (23/39) | 31.2 (10/32) | −25.1 | |
| Long acting | 46.6 (21/45) | 93.9 (46/49) | 41.0 (16/39) | 68.7 (22/32) | 25.2 | |
| Deaths in 2 y study period | ||||||
| Total (%) | 9.8 (6/61) | 19.7 (12/61) | −13.1 | 0.126 | ||
| COPD | 16.7 (1/6) | 66.6 (8/12) | −41.6 | 0.015 | ||
| Non-COPD | 83.3 (5/6) | 33.3 (4/12) | 41.7 | |||
| Hospital admissions | ||||||
| Total No of admissions in study period | 70 | 52 | 3.8 | 0.421* | ||
| Admission in study period ((% (n)) | 52.7 (29/55) | 48.9 (24/49) | 0.361 | |||
| No of admissions per patient (median (range)) | 0 (0–13) | 0 (0–5) | ||||
| Days alive and out of hospital/2 y | 41400/44530 | 39 578/44 530 | 0.705* | |||
| Total | (93.0%) | (88.9%) | ||||
| Median (range) | 724 (244–730) | 730 (19–730) | ||||
| Self-management of COPD | ||||||
| Reserve oral antibiotics prescribed | 4.9 (3/61) | 92.7 (51/55) | 11.5 (7/61) | 24.5 (12/49) | 68.2 | <0.001 |
| Reserve oral steroids prescribed | 4.9 (3/61) | 92.7 (51/55) | 6.5 (4/61) | 16.3 (8/49) | 76.4 | <0.001 |
| No of patients who reported an exacerbation | 86.9 (53/61) | 86.9 (53/61) | 0 | |||
| Treated with oral antibiotics only | 36.2 (161/445) | 63.8 (233/364) | −27.6 | <0.001 | ||
| Treated with oral steroids only | 19.8 (88/445) | 7.7 (28/364) | 12.1 | <0.001 | ||
| Treated with oral antibiotics and steroids | 44.0 (196/445) | 28.3 (103/364) | 15.7 | <0.001 | ||
| Who initiated treatment for exacerbation? | ||||||
| Self | 43.1 (192/445) | 10.4 (38/364) | 32.7 | <0.001 | ||
| Research nurse | 6.3 (28/445) | 0 (0/364) | 6.3 | <0.001 | ||
| GP | 31.5 (140/445) | 68.7 (250/364) | −37.2 | <0.001 | ||
| A&E doctor | 0.9 (4/445) | 2.5 (9/364) | −1.6 | 0.077 | ||
| Outpatients clinic doctor | 2.9 (13/445) | 5.2 (19/364) | −2.3 | 0.095 | ||
| Inpatient hospital doctor | 15.3 (68/445) | 13.5 (49/364) | 1.8 | 0.464 | ||
| Total No of unscheduled GP visits/contact | 171 | 280 | −109 | <0.05* | ||
| Telephonic consultation | 9.9 (17/171) | 3.5 (10/280) | 6.4 | 0.006 | ||
| Practice attendance | 67.8 (116/171) | 88.2 (247/280) | −20.4 | <0.001 | ||
| Home visit | 22.3 (38/171) | 8.2 (23/280) | 14.1 | <0.001 | ||
| Disease Specific QoL Questionnaire: CRQ | 47 (fully completed) | 47 (fully completed) | 40 (fully completed) | 40 (fully completed) | ||
| Dyspnoea | 3.55 (1.12) | 2.83 (1.21)¶ | 3.49 (1.26) | 2.65 (1.23)¶ | ¶p<0.05 (paired t-test) between baseline and 2 y | |
| Fatigue | 3.62 (1.26) | 3.68 (1.35) | 3.59 (1.51) | 3.24 (1.11) | ||
| Physical domain | ||||||
| Emotional function | 4.58 (1.22) | 4.74 (1.43) | 4.39 (1.37) | 4.03 (1.30) | ||
| Mastery | 4.71 (1.26) | 5.14 (1.33)¶ | 4.71 (1.46) | 4.44 (1.45) | ||
| Emotional domain | ||||||
| Total score | 16.46 (4.05) | 16.41 (3.94) | 16.18 (4.56) | 14.37 (3.97)¶ | ||
*Mann Whitney, †Student t test.
‡Percentage difference at 2 years between intervention and control (treatment – control).
§Control versus treatment end of year 2, all χ2 statistical analysis except where stated.
BMI, body mass index; COPD, chronic obstructive pulmonary disease; CRQ, Chronic Respiratory Questionnaire; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; GP, general practitioner; ICS, inhaled corticosteroids; LABA, long acting beta-2 agonist.