CONSORT-EHEALTH Checklist V1.6.2 Report

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT "Methods. 331 HF patients identified a “CarePartner” outside their household and received weekly interactive voice response (IVR) calls, i.e., “standard mHealth.” CarePartners of patients randomized to “mHealth+CP” received emails based on patients’ IVR responses." 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT CarePartners of patients randomized to “mHealth+CP” received "automated emails" based on patients’ IVR responses. 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Self-care and symptoms were measured via 6and 12-month surveys "with a research associate", and were measured weekly "via IVR." 1b-iv) RESULTS section in abstract must contain use data "331 HF patients" identified a “CarePartner” outside their household and received weekly interactive voice response (IVR) calls, i.e., “standard mHealth.” CarePartners of patients randomized to “mHealth+CP” "(N=166)" received automated emails based on patients’ IVR responses. 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials The trial was not negative. INTRODUCTION 2a-i) Problem and the type of system/solution Research has demonstrated the utility of informal caregivers in helping chronically-ill patients follow self-management recommendations by providing support that is unavailable through professional care management [17-20]. However, in-home caregivers are often elderly, ill, and overwhelmed [21, 22]. Most in-home caregivers lack the training and resources needed to systematically monitor HF patients and provide self-management assistance. Moreover, chronically-ill patients increasingly have caregivers outside of the household, making health and self-care monitoring much more difficult [23, 24]. The CarePartner program was developed to address these challenges by enabling structured support by informal caregivers (CarePartners) who reside outside the patient’s home. Through this program, patients receive regular monitoring and tailored self-management education via IVR calls with feedback to their clinician. Prior studies demonstrated that chronically-ill patients are able and willing to regularly complete IVR calls and report clinically meaningful information [25, 26]. While one large trail of HF patients found no impact of IVR telemonitoring on rehospitalization or death post-discharge [27], meta-analyses have shown that remote patient monitoring with clinician feedback and self-management assistance can improve the quality and outcomes of HF care [28, 29]. It remains unclear, however, whether feedback to CarePartners is helpful over-and-above the support provided directly to patients and clinicians. 2a-ii) Scientific background, rationale: What is known about the (type of) system Telephone care management can improve HF patients’ prognosis [6-10]. However, telephone follow-up is inadequately reimbursed and competes with in-person care for clinicians’ time [11]. Mobile health (mHealth) interventions, including interactive voice response (IVR) calls, can improve self-care behaviors and physiologic risk factors [12-15]. But without systems to follow-up on identified problems, increased monitoring may be insufficient to fill the gap between what HF patients need and what health systems can provide [15, 16]. METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio The current study reports the results of a randomized comparative effectiveness trial testing the impact of systematic feedback to patients’ CarePartners, compared to patients receiving standard mHealth monitoring and self-management education. Analyses focused on changes in patients’ HF-related quality of life, self-care, and patient-CarePartner communication reported via 6and 12-month surveys, as well as on patients’ medication adherence and symptoms reported via weekly IVR calls. 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons Not applicable. 3b-i) Bug fixes, Downtimes, Content Changes Not applicable. 4a) CONSORT: Eligibility criteria for participants Patients were recruited from VA Cleveland Medical Center outpatient clinics between June 2009 and January 2012 and were followed for 12 months. To be eligible, patients had to: have a HF diagnosis, New York Heart Association classification of II or III, and a documented ejection fraction <40% (see Electronic Supplementary Material 1 for details). Patients also had to have attended at least one VA outpatient visit within the previous 12 months, have a VA primary care provider, and be able to participate in automated telephone calls in English. Patients also needed to nominate an eligible CarePartner, i.e., a relative or friend living outside their home. Patients were excluded if they: lived in a skilled nursing facility; were prescribed oxygen supplementation; were receiving palliative care; had a life-threating condition such as lung cancer; or had ICD-9 coded diagnoses indicating dementia, bipolar disorder, or schizophrenia. 4a-i) Computer / Internet literacy Computer literacy was not a criterion for eligibility. 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Potentially eligible patients identified from electronic medical records were sent an invitation letter, followed by a screening and recruitment call. Eligible and interested patients were mailed informed consent forms and were assisted in identifying potential CarePartners using the Norbeck Social Support Questionnaire (NSSQ) [30]. 4a-iii) Information giving during recruitment