Shively 2013.

Study characteristics
Methods	Aim of study: to determine the efficacy of a patient activation (Heart PACT) intervention compared with usual care on activation, self‐care management, hospitalisations, and emergency department visits in patients at high risk of re‐admission/hospitalisation for HF Study design: RCT (repeated measure design; unit of allocation: individual) Number of arms/groups: 2
Participants	Description: patient/consumer Geographic location: USA Setting: Veterans Affairs Healthcare System (single site) Inclusion criteria: document clinical HF stage C, incident hospitalisation or ED visit for HF treatment within previous 12 months, ≥ 18 years, live in San Diego County, read and speak English, telephone access, has a primary care provider Exclusion criteria: inability to provide written consent, acute medical problems within previous month, considered by investigators to be medically unstable, enrolled in speciality HF programme or telehealth or had long‐term follow‐up by cardiology after hospital admission, severe medical problems, life expectancy < 1 year, acute substance abuse, psychiatric problems, homelessness Number of participants randomised: 84 (43 vs 41) Number of participants included in analysis: 6 months: 68 (34 vs 34) Age: grouped: mean ± SD 66.1 ± 10.76, range 42 to 89 (intervention: 63.4 ± 9.10, control: 68.9 ± 11.73) Gender: 1 female (1.2%) (0 vs 1) Ethnicity: white: 76.7% vs 78.0% (other races not extracted) Number of medications: trial author reported all > 4 medications (unpublished) Frailty/Functional impairment: not specified Cognitive impairment: not specified Comorbidities: 71% reported ≥ 3 comorbidities
Interventions	Group 1 ‐ Patient activation (Heart PACT): 6‐month activation/Heart PACT programme developed to enhance self‐management. Intervention used activation theory and was tailored to each participant's activation level. At each meeting/telephone call, goals and progress toward attaining these were discussed (Figure 2). Also received a self‐management tool kit (BP cuff, weight scale, pedometer, HF self‐management DVD, and educational booklet) Group 2‐ Usual care ‐ general medical care and any HF‐specific clinical care from primary care provider. Received self‐management toolkit after final assessment (6 months) Co‐intervention: 2‐hour baseline outcome assessment Provider: nurse (advanced practice nurse) Where: telephone and F2F. Unclear location ‐ assume at clinic When and how often: 6 sessions over 6 months Intervention personalised: yes ‐ personalised based on activation level
Outcomes	Timing of outcome assessment: baseline and 6 months Medication adherence (subjective) : self‐reported medication adherence: medication adherence (as part of MOS‐specific adherence scale). "Took medications as prescribed (on time without skipping dose) in the past 4 weeks". Responses from 0 to 5, transformed to a 0 to 100 scale Adverse clinical health outcomes (subjective): self‐reported hospitalisations: patients asked to report any hospitalisations, ED visits, and other unscheduled visits including reason for visit and treatment. Results reported as mean (SD)
Notes	Trial registration: N/A Consumer involvement: not specified Funding source: Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service, project 04‐252 Dropout: no details provided Unpublished data: trial author reported that participants were on > 4 medications; most had minimum of 12 medications and 3 comorbid conditions
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Stratified block randomisation approach, based on baseline activation, was used to ensure patients were equally distributed. No other details regarding randomisation were provided
Allocation concealment (selection bias)	Unclear risk	Randomly assigned after baseline assessment ‐ unclear who was allocated or if concealed
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not clear if outcome assessors were blinded
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Missing completely at random (MCAR) analysis completed but not reported. Attrition rate 19%
Selective reporting (reporting bias)	Low risk	As per methods
Other bias	Unclear risk	Participants received $10 at baseline and at 3 months, $20 at 6 months