BACKGROUND: Heart failure (HF) is a progressive disease associated with a high burden of symptoms, high morbidity and mortality, and low quality of life (QoL). This study aimed to evaluate the feasibility and potential outcomes of a novel multicomponent complex intervention, to inform a future full-scale randomized controlled trial (RCT) in Switzerland.
METHODS: We conducted a pilot RCT at a secondary care hospital for people with HF hospitalized due to decompensated HF or with a history of HF decompensation over the past 6 months. We randomized 1:1; usual care for the control (CG) and intervention group (IG) who received the intervention as well as usual care. Feasibility measures included patient recruitment rate, study nurse time, study attrition, the number and duration of consultations, intervention acceptability and intervention fidelity. Patient-reported outcomes included HF-specific self-care and HF-related health status (KCCQ-12) at 3 months follow-up. Clinical outcomes were all-cause mortality, hospitalization and days spent in hospital.
RESULTS: We recruited 60 persons with HF (age mean = 75.7 years, ± 8.9) over a 62-week period, requiring 1011 h of study nurse time. Recruitment rate was 46.15%; study attrition rate was 31.7%. Follow-up included 2.14 (mean, ± 0.97) visits per patient lasting a total of 166.96 min (mean, ± 72.55), and 3.1 (mean, ± 1.7) additional telephone contacts. Intervention acceptability was high. Mean intervention fidelity was 0.71. We found a 20-point difference in mean self-care management change from baseline to 3 months in favour of the IG (Cohens\' d = 0.59). Small effect sizes for KCCQ-12 variables; less IG participants worsened in health status compared to CG participants. Five deaths occurred (IG = 3, CG = 2). There were 13 (IG) and 18 (CG) all-cause hospital admissions; participants spent 8.90 (median, IQR = 9.70, IG) and 15.38 (median, IQR = 18.41, CG) days in hospital. A subsequent full-scale effectiveness trial would require 304 (for a mono-centric trial) and 751 participants (for a ten-centre trial) for HF-related QoL (effect size = 0.3; power = 0.80, alpha = 0.05).
CONCLUSIONS: We found the intervention, research methods and outcomes were feasible and acceptable. We propose increasing intervention fidelity strategies for a full-scale trial.
BACKGROUND: ISRCTN10151805 , retrospectively registered 04/10/2019.

OBJECTIVE: To compare the effectiveness of a structured goal-setting and tailored follow-up rehabilitation intervention with existing rehabilitation in patients with rheumatic and musculoskeletal diseases.
METHODS: A pragmatic stepped-wedge cluster randomized trial.
METHODS: Eight rehabilitation centers in secondary healthcare, Norway.
METHODS: A total of 374 adults with rheumatic and musculoskeletal diseases were included in either the experimental (168) or the control group (206).
METHODS: A new rehabilitation intervention which comprised structured goal setting, action planning, motivational interviewing, digital self-monitoring of goal progress, and individual follow-up support after discharge according to patients\' needs and available resources in primary healthcare (the BRIDGE-intervention), was compared to usual care.
METHODS: Patient-reported outcomes were collected electronically on admission and discharge from rehabilitation, and after 2, 7, and 12 months. The primary outcome was patients\' goal attainment measured by the Patient Specific Functional Scale (0-10, 10 best) at 7 months. Secondary outcome measures included physical function (30-s Sit-To-Stand test), health-related quality of life (EQ-5D-5L-index), and self-assessed health (EQ-VAS). The main statistical analyses were performed on an intention-to-treat basis using linear mixed models.
RESULTS: No significant treatment effects of the BRIDGE-intervention were found for either primary (Patient Specific Functional Scale mean difference 0.1 [95% CI: -0.5, 0.8], p = 0.70), or secondary outcomes 7 months after rehabilitation.
CONCLUSIONS: The BRIDGE-intervention was not shown to be more effective than existing rehabilitation for patients with rheumatic and musculoskeletal diseases. There is still a need for more knowledge about factors that can improve the quality, continuity, and long-term health effects of rehabilitation for this patient group.