Smith 2005.
| Methods | RCT, patient recruitment: patients or clients of primary care clinic or pharmacy, patients or clients of respiratory care clinic Setting: hospital outpatient asthma clinics and general practices, Norfolk, Suffolk, UK |
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| Participants |
Control patients: n = 45, women: 84%, mean age: 34.7, smokers: 17.4%, moderate‐severe asthma (according to study self‐report), FEV1: not reported, ICS use: 100% Intervention patients: n = 47, women: 62%, mean age: 38.2, smokers: 19.4%, moderate‐severe asthma (according to study self‐report), FEV1: not reported, ICS use: 100% |
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| Interventions |
Name and duration of programme: The Coping with Asthma Study (a home‐based, nurse led psycho‐educational intervention for adults at risk of adverse asthma outcomes), during 6 months Intervention group components Organisational ‐ patients: structured follow‐up; advice and/or assistance as needed; involvement of family members; liaison with health and social care professionals; home visits Organisational ‐ healthcare professionals or system: teamwork and collaborative processes between providers (GP and health psychologist available to nurse as supervisors if needed; referral to specialist); manual to standardise delivery and general content of intervention Patient education: distribution of material and one on one education on asthma, management of the disease, prevention of exacerbations, smoking cessation, exercise Self‐management support: action plan; supervised reinforcement sessions; inhalation technique; use of peak flow device; collaborative problem solving approach; workbook with homework Frequency: visits every 2 weeks for 2 months (˜1 hour); phone calls every 2 weeks for 2 months then every month for 4 months Healthcare professionals involved: respiratory care nurse; GP; health psychologist Control group components Usual care Number of components and dominant component: 15, education and self‐management |
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| Outcomes |
Patient level Quality of life: LAQ score; SF‐36 physical function score; SF‐36 mental health score; HADS anxiety score; HADS depression score; GHQ‐12 psychiatric morbidity score Asthma symptoms and activity level: asthma symptom control score (primary) Self‐management: % patients monitoring their peak flow; % patients using reliever inhaler > 4 times/day; % patients currently smoking; % patients identifying additional triggers; perceived control of asthma score; medication compliance score Time of outcome measurement: at 12 months |
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| Notes | LAQ: Living with Asthma Questionnaire; SF‐36: general health status assessed by the Short Form 36; HADS: Hospital Anxiety and Depression Scale; GHQ‐12: General Health Questionnaire | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "randomisation by third party not involved in patient care using open computer generated block randomisation" |
| Allocation concealment (selection bias) | Low risk | By third party not involved in patient care |
| Blinding (performance bias and detection bias) All outcomes | High risk | "no attempts were made to blind assessment" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "small numbers of individual missing questionnaire items were replaced with ample medians to allow calculation of total scores for each scale"; 92 patients randomised ‐ 8 losses to follow‐up ("no clear differences between these and patients completing the study") = 84 in ITT |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available |
| Other bias | Low risk | Random‐effects model used to adjust for hierarchical structure of data |
| Outcomes at baseline similar? | Low risk | Baseline imbalance adjusted for in analyses |
| Characteristics at baseline similar? | Low risk | Imbalance for sex, education, hospitalisation or ED visit but adjusted for in analyses |
| Adequate protection against contamination? | Low risk | No risk of contamination (home visits) |