Study Objectives Insomnia is common among adults with chronic heart failure (HF) and associated with daytime symptoms and decrements in function. The purpose of this randomized controlled trial (RCT) was to evaluate the sustained effects over one year of CBT-I (Healthy Sleep: HS) compared with HF self-management education (Healthy Hearts; attention control: HH) on insomnia severity, sleep characteristics, symptoms, and function among people with stable HF. The primary outcomes were insomnia severity, actigraph-recorded sleep efficiency, and fatigue. Methods We randomized adults with stable HF with preserved or reduced ejection fraction who had at least mild insomnia (Insomnia severity index >7) in groups to HS or HH (4 sessions/8 weeks). We obtained wrist actigraphy and measured insomnia severity, self-reported sleep characteristics, symptoms (fatigue, excessive daytime sleepiness, anxiety, depression), and six-minute walk distance at baseline, within one month of treatment, and at 6 and 12 months. We used general linear mixed models (GLMM) and generalized estimating equations (GEE) to evaluate the effects. Results The sample included 175 participants (M age = 63 +12.9 years; 43% women; 18% Black; 68% New York Heart Association Class II or II; 33%; LVEF < 45%) randomized to HS (n = 91) or HH (N = 84). HS had sustained effects on insomnia severity, sleep quality, self-reported sleep latency and efficiency, fatigue, excessive daytime sleepiness, and six-minute walk distance at 12 months. Conclusions CBT-I produced sustained improvements in insomnia, fatigue, daytime sleepiness, and objectively measured physical function among adults with chronic HF, compared with a robust HF self-management program that included sleep hygiene education.

Clinicians should revisit conversations about cancer stage and care options to ensure patients' understanding and support self-management.

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Self- and family management (SFM) refers to patients’ and family caregivers’ activities to co-manage illness. Two barriers to SFM are low palliative care literacy and lack of goals of care communication, which potentially result in SFM activities that are unsupportive of patients’ goals. Managing Cancer Care: A Caregiver’s Guide (MCC-CG) aims to improve palliative care literacy and communication within a SFM training program. In this pilot randomized trial, we enrolled breast cancer family caregivers and collected data at 0, 1, and 3 months on palliative care literacy, SFM engagement, communication, transitions management, uncertainty, caregiver burden, and caregiver competence/personal gain. Participants ( n = 35) had a mean age of 54 (range: 18–81) and were 66% white and 34% racial/ethnic minorities. Intervention participants improved their palliative care literacy and SFM engagement, reduced uncertainty and caregiver burden, increased competence/personal gain, and had more goals of care conversations over time. MCC-CG has preliminary efficacy, warranting further study.

Recruiting participants with chronic medical conditions is time-consuming and expensive. Electronic medical record databases and patient portals may enable outreach to larger numbers of patients in comparison to face-to-face methods. We aimed to describe the yields, benefits, and limitations of recruitment strategies used for a randomized clinical trial of cognitive behavioral therapy for insomnia among patients with chronic stable heart failure (NCT02660385). We used multiple recruitment strategies including clinic-based recruitment, letters to patients identified from electronic databases, the patient portal, brochures and posters placed in clinics, presentations to heart failure support groups, and online advertising. We screened 10,291 medical records, enrolled 231 participants, and 195 participants completed baseline data collection. We enrolled 92 (23%) participants using clinic-based recruitment, 24 and 29 (6% and 10%) using letters to patients from two electronic databases, and 42 (55%) via the patient portal. Multiple recruitment strategies and flexibility are needed to achieve recruitment goals.