Powell 2010.

Methods	Randomized controlled trial
Participants	The study location was 10 recruiting hospitals, Chicago metropolitan area, Illinois, USA 451 participants were randomized to the intervention group and 451 participants were randomized to the control group The inclusion criteria were HF for not less than the prior 3 months defined as either: (1) left ventricular ejection fraction = 40% by echocardiography, radiographic ventriculography, or radionuclide ventriculography; or (2) diuretic therapy for at least 3 months and 1 previous hospitalization for HF The exclusion criteria were (1) New York Heart Association (NYHA) class IV, owing to low likelihood of benefiting from behavioral treatment; (2) NYHA class I, owing to low likelihood of having a primary endpoint; (3) heart failure symptoms that may be eliminated by surgery (e.g. severe aortic stenosis); (4) uncertain 12‐month prognosis; (5) severe medical or psychiatric comorbid condition; (6) patient unwillingness to make lifestyle changes; (7) logistical barriers; (8) physician refusal; and (9) patient refusal
Interventions	Intervention: SELF MANAGEMENT PLUS EDUCATION In the self management plus education treatment, patients received group base heart failure education plus counseling to help patients develop mastery in problem‐solving skills and in 5 self management skills. 18 2‐hour group meetings of approximately 10 patients were spread over the course of 1 year. At each meeting, education in the form of 18 heart failure tip sheets summarized basic elements of patient management. A problem‐solving format was used. Groups were led by health professionals Control: EDUCATION ONLY Patients randomized to receive education received the same 18 Heart Failure Tip Sheets, on the same schedule as the self management group meetings but delivered by mail. To ensure receipt and check comprehension, a study co‐ordinator contacted the patient by telephone within 2 to 3 days of each mailing. If the tip sheet had not been read, the call was rescheduled. All questions about the tip sheets were answered. For concerns unrelated to the tip sheets, the patient was referred to his or her primary care clinician
Outcomes	The adherence measure was assessed using MEMS for 1 month after a patient's annual exam. At the conclusion of each exam, the patient was asked to put a month's supply of an ACE inhibitor (or beta‐blocker if the patient was not taking an ACE inhibitor) into a MEMS container and was taught to use it for the ensuing month. The patient outcomes were 1) death or heart failure hospitalization during follow‐up, 2) quality of life, and 3) psychosocial function. Death or heart failure was assessed in blinded fashion by a team of cardiologists. All patients, or in the case of death, their family members, were contacted every 3 months by telephone to ascertain occurrence of a death or hospitalization. Reports of death were confirmed by medical record, death certificate, emergency medical services record, or queries from the Social Security Death Index. Heart failure admissions were adjudicated by the presence of shortness of breath, peripheral edema, or chest radiographic evidence of pulmonary edema without evidence of another disease process accounting for symptoms or signs. Heart failure admissions were confirmed if the patient responded to heart failure therapy or had a documented decrease in left ventricular function. Quality of life was assessed as (1) physical function, using the 10‐item subscale from the RAND 36‐Item Short‐Form Health Survey (> = 0.93); (2) vitality, using the 4‐item subscale from the RAND survey (> = 0.86); (3) satisfaction with health and function, using the 11‐item subscale from the Quality of Life Index–Cardiac (> = 0.93); and (4) satisfaction with psychological/spiritual function, using the 11‐item subscale from the Quality of Life Index–Cardiac (> = 0.89). Psychosocial function was assessed as (1) major depressive symptoms, using the Geriatric Depression Scale (for which a score greater than 10 is a sensitive and specific screen for major depressive symptoms); (2) social support–emotional, using the 8‐item subscale of the Medical Outcomes Study Social Support Scale (> = 0.90); and (3) purpose in life, using the 14‐item subscale of the Psychological Well‐Being Scale. Quality of life and psychosocial function were assessed at the patient's annual follow‐up
Notes	Re. cluster question: HART featured a cluster design within the self management group only, in which patients were treated in 42 groups of approximately 10 patients each. The effect of group assignment and group leader on the primary outcome was found to be non‐significant, therefore clustering was not considered further
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Automated randomization method was used. "At the conclusion of the baseline examination, the nurse coordinator called the automated randomization service (Moffitt Cancer Center, University of South Florida)" (pg 1333)
Allocation concealment (selection bias)	Unclear risk	"At the conclusion of the baseline examination, the nurse coordinator called the automated randomization service (Moffitt Cancer Center, University of South Florida) and treatment assignment was sent to an unblinded staff member, who mailed a letter of notification to the patient." (pg 1333)
Selective reporting (reporting bias)	Low risk	The study protocol is available and all of the study's pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way
Other bias	Low risk	The study seems to be free of other types of bias
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) MEMS ‐ "All investigators and staff, except for 2 biostatisticians and the recruiting nurses, were blinded to the randomization status of the participant. Treatment teams within each trial arm had no contact with patients in the other arm." (pg 3s)
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) SURVIVAL AND HOSPITALIZATION ‐ "All investigators and staff, except for the data management team, were blinded to the randomization status of the patient." (pg 3s)
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) MEMS ‐ Although patients were not blinded to group, they were blinded to the purpose of the study. However, the blinding could have been broken due to the nature of the intervention
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) SURVIVAL AND HOSPITALIZATION ‐ Patients were blinded. "All participants were blinded to trial hypotheses by providing neutral names for the randomized treatment arms."
Blinding of personnel (performance bias) Adherence measure	Low risk	(PRIMARY) MEMS ‐ Although there is insufficient information about who the key personnel are, "All investigators and staff, except for 2 biostatisticians and the recruiting nurses, were blinded to the randomization status of the participant. Treatment teams within each trial arm had no contact with patients in the other arm." (pg 3s)
Blinding of personnel (performance bias) Patient outcome	Unclear risk	(PRIMARY) SURVIVAL AND HOSPITALIZATION ‐ The study seems to be free of other types of bias
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) MEMS ‐ Dropouts appear balanced across the 2 conditions with similar reasons for data missing
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) SURVIVAL AND HOSPITALIZATION ‐ incomplete data were balanced across groups