Moertl 2009.
Study characteristics | ||
Methods | Prospective, randomised study design Study duration: 2 years The major limitation of the study was selection bias because only participants who responded to a letter of invitation had the opportunity to take part in the study. |
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Participants | 96 participants took part in the study; 48 were randomised to the nurse group and 48 to the non‐nurse group. Setting: outpatient heart failure clinic Diagnostic criteria: participants who survived index hospitalisation were invited by letter to a visit for treatment optimisation at the outpatient heart failure unit. Among the participants who appeared at the ambulatory visit, those with a verified heart failure diagnosis and residing < 50 km from Vienna were eligible for the nurse intervention and therefore offered to participate in the present study. Baseline evaluation was performed by a cardiologist specialising in the management of heart failure. The ambulatory visit comprised a patient history, physical examination, electrocardiogram, a routine blood analysis, and, if necessary, an echocardiography. Furthermore, blood samples were taken for later analysis of natriuretic peptides. The participants were thoroughly informed about the disease of CHF and recommendations were made regarding medication, self‐assessment of weight, blood pressure and pulse, and diet and exercise management. The baseline demographic, clinical, and therapeutic characteristics were not statistically different between the nurse group and the non‐nurse group. Age (years) (mean ± SD): non‐nurse, control (66 ± 13); nurse, intervention 70 ± 12 Country: Vienna, Austria Comorbidity: hypertension, diabetes, respiratory diseases Sociodemographics: not reported Ethnicity: Austrian (unclear if they were all white) |
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Interventions | 1 intervention and 1 control. There were 48 participants in each group. Intervention: home‐based nurse care Participants in the nurse group were visited by a nurse specialised in caring for people with heart failure on the initial visit at the outpatient heart failure unit and then at their home 3, 6, 9, and 12 months after randomisation. At home visits, the nurse checked and recorded weight, symptoms and signs of heart failure, heart rate and blood pressure, and organised and reviewed blood analyses on demand, especially of electrolytes and renal parameters. Furthermore, the nurse had to check for and, in co‐ordination with the treating physician, implement guideline‐based medication. Moreover, the nurse was in charge of individualised participant and caregiver education and enhancement of self‐management. If the nurse noted any deterioration in the participant's status, she reported to the treating physician or advised the participant to visit the treating physician. Control group received the usual care provided |
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Outcomes | Admission for heart failure at 12 months and 24 months Mortality at 12 months and 24 months |
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Notes | The major limitation of the study is selection bias because only participants who responded to a letter of invitation had the opportunity to take part in the study. See notes to other relevant studies |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | It is unclear how the sequence generation was done. |
Allocation concealment (selection bias) | High risk | The major limitation of the study was selection bias because only participants who responded to a letter of invitation had the opportunity to take part in the study. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | It is unclear if participants were blinded to the intervention. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There is no incomplete outcome data. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Independent data collector |
Selective reporting (reporting bias) | Low risk | All outcomes were reported as mentioned at the start of the trial. |
Protection against contamination bias | Unclear risk | Unclear |
Other bias | High risk | Small sample size |