Methods	RCT, single centre Recruitment: December 1991 to October 1993. Duration of follow up: 12 months.
Participants	Country: Sweden Participants: 110 patients (57 males, 52%) in comparison group, 80 (44 males, 55%) in intervention group. Actual age of study subjects: mean 75.6 years (SD 5.3) Male sex: 53% Ethnicity: not given Actual severity of heart failure in study subjects at baseline: NYHA class, mean: controls 2.6 (SD 0.7), intervention group 2.6 (SD 0.7) LVEF: control group mean 35.7% (SD 12.3), intervention group 31.6% (SD 8.4). (75% LVEF <40%) Study inclusion criteria: Patients hospitalised primarily because of heart failure. Heart failure diagnosed on symptoms and signs with “at least one objective sign present on admission such as pulmonary rales, peripheral oedema, congestion on CXR, or a 3rd heart sound”. Aged 65-84 years. Study exclusion criteria: The presence of other serious disease that either prevented participation or was expected to significantly influence quality of life, morbidity or mortality in the following year. Forseeable follow up problems including residence outside the hospital catchment area. Serious alcohol or drug abuse. Psychiatric disease. Inability to understand or answer study questionnaire. Participation in another clinical trial. Discretion of treating physician.
Interventions	Duration of intervention: 12 months Intervention Group: “Management programme for heart failure” During index hospitalisation: Patients received an education programme from HF nurse consisting of two 30 minute visits After discharge: Two weeks after discharge patients and their families were invited to a one hour group education session led by the HF nurse which included an oral presentation by the nurse, and educational video and a question and answer session. Patients were also offered a seven day medication dispenser if deemed appropriate. Patients were followed up at a nurse directed o/p clinic and there was a single prescheduled visit by the nurse at 8 months after discharge. The HF nurse was available for phone contact during office hours. Patients encouraged to contact the study nurse at their discretion, if unsure, if diuretic adjustments did not ameliorate symptoms in 2-3 days, or if there were “profound changes in self management variables”. Patients were offered cardiology outpatient visits one and four months after discharge The inpatient and outpatient education programme covered: HF pathophysiology, pharmacological and non-pharmacological treatment. Patients were also given guidelines for self-management of diuretics in the event of fluid overload or fluid depletion. Patients were given a “heart failure diary” containing information on HF, list of HF medications, names and contact phone numbers for the HF clinic and in which to regularly record bodyweight, ankle circumference and HF symptoms Comparison Group: usual care These patients were “followed up at the outpatient clinic in the department of cardiology by either cardiologists in private practice or by primary care physicians as considered appropriate by the discharging consultant.”
Outcomes	Primary endpoint: Not specified, abstract states that main outcome measures were: time to re-admission, days in hospital and health care costs during one year Other endpoints: Quality of life using The Quality of Life in Heart Failure Questionnaire, Nottingham Health Profile and patients’ global self assessment (all self-administered) Also looked at: Deaths at 90 days Event free (i.e. death or re-admission) survival at 90 days Analysis done on intention to treat basis?: unclear
Notes	Data source: published data only Generalisability: no information supplied on number of patients screened for entry to the study or on the number of patients excluded. 206 eligible patients were randomised before consenting, 16 patients (8%) randomised to the intervention group withheld their consent, no patient randomised to the control group withheld consent Consort flow chart: not supplied Rationale for sample size: not given Other points: Reasons for exclusions: proportions of patients with different reasons for exclusion not given Generation of randomisation sequence: computer generated random allocation. Allocation concealment: “Patients were invited to participate and informed consent was given on the basis of information relevant to the allocated study group. This procedure avoided bias arising from control patients being informed of the intervention strategy.” Risk of care giver performance bias: possible that some of the control patients were also seen by cardiologists involved in the study. Risk of attrition bias: low “all patients were accounted for”. Risk of detection bias: possible, not clear who collected data on patients and not clear if this data collection was masked
Risk of bias
Item	Authors’ judgement	Description
Allocation concealment?	Unclear	B - Unclear