Methods	RCT Recruitment: May 1994 to March 1997. Duration of follow up: 9 months.
Participants	Country: the Netherlands Participants (patients enrolled and surviving to discharge): 95 patients in comparison group, 84 in intervention group* Actual age of study subjects: not given for original group, those who remained at 9 months were mean age 72 years (SD 9) at baseline. Male sex: of those who remained at 9 months, 60% Ethnicity: not given Actual severity of heart failure in study subjects at recruitment: not known Study inclusion criteria: Patients admitted to the cardiology unit of one hospital with HF symptoms and diagnosis verified with Boston score. NYHA III or IV. HF diagnosis for longer than 3 months. Age 50 years or older. Dutch literate. Study exclusion criteria: Coexisting, severe, chronic debilitating disease. Discharge to a nursing home. Psychiatric diagnosis. CABG, angioplasty or valve replacement in past 6 months or expected to have such treatment in next 3 months
Interventions	Duration of intervention: up to 10 days after discharge from index admission, on average one week* Intervention Group: ‘Supportive educational intervention’ During index admission: Intensive education by study nurse using standard nursing care plan After discharge: Study nurse phoned patient within one week of discharge to assess potential problems and made appointment for home visit. Home visit on average one week after discharge*. At home visit education continued If required, study nurse wrote to patient’s home care nurse about patient’s specific needs. Between discharge and home visit patient could contact study nurse if they encountered problems. After home visit patient encouraged to contact their cardiologist, GP or emergency heart centre with any problems. Educational component covered: symptoms of worsening failure, sodium restriction, fluid balance and compliance and individuals’ problems, and included education and support to patients’ family Comparison Group: usual care. “A nurse or physician, depending on his or her individual insight into the patients’ questions, provided these patients with education about medication and lifestyle”. Usual care patients did not receive structured education
Outcomes	Primary endpoints: none specified Measures of QOL: Heart Failure Functional Status Inventory (to assess functional capabilities at baseline, 3 and 9 months). Symptom occurrence (at baseline, 1, 3 and 9 months), severity and distress questionnaire, designed for this study (at 3 and 9 months). Psychosocial Adjustment to Illness Scale (at baseline, 3 and 9 months). Cantril’s Ladder of Life (to measure overall well being at baseline, 1, 3 and 9 months) Measures of self-agency and self-care behaviour: The patients’ ability to care for themselves using the Appraisal of Self-care Agency Scale (ASE) (at baseline, 3 and 9 months). The patients’ self care behaviour using a Heart Failure Self-care Behaviour Scale, designed for this study (at baseline, 1, 3 and 9 months) Healthcare resource use: Patients’ report of number and reason for contact with GP, cardiologist, medical specialists, physical therapists, social care providers and alternative health specialists. Hospital readmissions and out patient visits from hospital database. Reasons for readmission form patient charts. Also reported: Deaths at 9 months. Analysis done on intention to treat basis? No, some adjustments for attrition made
Notes	Data source: published data and author contacted for clarification (indicated by *) Generalisability: * Of 828 admissions to the ward with heart failure; 184 (22%) were re-admissions; 66 patients were not screened and 14 died during screening. 564 (68%) patients met inclusion criteria; 352 of these (62%) were excluded; 40 (7% of 564) did not give informed consent, 186 (33% of 564, 22% of the 828 admissions) were randomised of whom 7 died before discharge Consort flow chart: not supplied Rationale for sample size: Power was calculated for psychosocial adjustment to illness as measured by the PAIS and based on data from a HF sample in the USA. It was calculated that two groups of 58 patients would be required to show an 8 point difference in the PAIS with an a of 0.005 and a ß of 0.9* Other points: Reason for exclusions (352 patients): *history < 3 months 171 (49%); psychiatric disturbance, dementia or cancer 31 (9%); NYHA class <III or cardiac intervention 22 (6%); Boston score <6 12 (3%); age <50 years 12 (3%); discharged to a nursing home 9 (3%); language 5 (1%); >1 exclusion criteria 76 (22%) *The symptom occurrence, severity and distress questionnaire was designed for this study but was derived from pre-existing literature. The data were based on patient self report. Experts in the field assessed content validity, but otherwise the validity and reliability of the questionnaire had not been formally examined The Heart failure Self-care Behavior Scale was designed for this study and validated by a panel of experts Generation of randomisation sequence and allocation concealment: “By drawing from an envelope patients were randomly assigned to receive either care-as-usual or the supportive-education intervention”. Risk of care giver performance bias: low; “Health care personnel (cardiologists or staff) involved in the care for the patients did not know if the patient was in the intervention or control group.” Risk of attrition bias: possible, 186 patients enrolled in to the study and 132 (71%) remained at 9 months. 58/84 (69%) remained in the intervention group whilst 74/95 (78%) in the control group, NS, there was a trend towards more patients with NYHA IV dropping out. Analyses on self-care abilities and behaviour were adjusted in an attempt to compensate for the influence of attrition - this adjustment assumed that those who dropped out did not improve their self-care and self-agency from baseline this assumption may not have adequately adjusted for attrition. Risk of detection bias: high; the two study nurses who delivered the intervention were also involved in the study as data collectors and were aware of the allocation status of the patients
Risk of bias
Item	Authors’ judgement	Description
Allocation concealment?	Unclear	B - Unclear