Browsing by Author "Kitsiou, Spyros"

Now showing 1 - 2 of 2
  • Thumbnail Image
    Item
    Patient-Centered mHealth Intervention to Improve Self-Care in Patients With Chronic Heart Failure: Phase 1 Randomized Controlled Trial
    (JMIR, 2025-01-15) Kitsiou, Spyros; Gerber, Ben S.; Buchholz, Susan W.; Kansal, Mayank M.; Sun, Jiehuan; Pressler, Susan J.; School of Nursing
    Background: Heart failure (HF) is one of the most common causes of hospital readmission in the United States. These hospitalizations are often driven by insufficient self-care. Commercial mobile health (mHealth) technologies, such as consumer-grade apps and wearable devices, offer opportunities for improving HF self-care, but their efficacy remains largely underexplored. Objective: The objective of this study was to examine the feasibility, acceptability, safety, and preliminary efficacy of a patient-centered mHealth intervention (iCardia4HF) that integrates 3 consumer mHealth apps and devices (Heart Failure Health Storylines, Fitbit, and Withings) with a program of individually tailored SMS text messages to improve HF self-care. Methods: We conducted a phase 1 randomized controlled trial. Eligible patients had stage C HF, were aged ≥40 years, and had New York Heart Association (NYHA) class I, II, or III HF. Patients were randomly assigned to either iCardia4HF plus usual care or to usual care only and were observed for 8 weeks. Key feasibility measures were recruitment and retention rates. The primary efficacy outcome was change in HF self-care subscale scores (maintenance, symptom perception, and self-care management) at 8 weeks, assessed with the Self-Care Heart Failure Index (SCHFI; version 7.2). Key secondary outcomes were modifiable behaviors targeted by the intervention (health beliefs, self-efficacy, and HF knowledge), health status, and adherence to daily self-monitoring of 2 core vital signs (body weight and blood pressure). Results: A total of 27 patients were enrolled in the study and randomly assigned to iCardia4HF (n=13, 48%) or usual care (n=14, 52%). Of these 27 patients, 11 (41%) in the intervention group (iCardia4HF) and 14 (52%) in the usual care group started their assigned care and were included in the full analysis. Patients' mean age was 56 (SD 8.3) years, 44% (11/25) were female, 92% (23/25) self-reported race as Black, 76% (19/25) had NYHA class II or III HF, and 60% (15/25) had HF with reduced left ventricular ejection fraction. Participant retention, completion of study visits, and adherence to using the mHealth apps and devices for daily self-monitoring were high (>80%). At 8 weeks, the mean group differences in changes in the SCHFI subscale scores favored the intervention over the control group: maintenance (Cohen d=0.19, 95% CI -0.65 to 1.02), symptom perception (Cohen d=0.33, 95% CI -0.51 to 1.17), and self-care management (Cohen d=0.25, 95% CI -0.55 to 1.04). The greatest improvements in terms of effect size were observed in self-efficacy (Cohen d=0.68) and health beliefs about medication adherence (Cohen d=0.63) and self-monitoring adherence (Cohen d=0.94). There were no adverse events due to the intervention. Conclusions: iCardia4HF was found to be feasible, acceptable, and safe. A larger trial with a longer follow-up duration is warranted to examine its efficacy among patients with HF.
  • Thumbnail Image
    Item
    Patient-centered mobile health technology intervention to improve self-care in patients with chronic heart failure: Protocol for a feasibility randomized controlled trial
    (Elsevier, 2021) Kitsiou, Spyros; Gerber, Ben S.; Kansal, Mayank M.; Buchholz, Susan W.; Chen, Jinsong; Ruppar, Todd; Arrington, Jasmine; Owoyemi, Ayomide; Leigh, Jonathan; Pressler, Susan J.; School of Nursing
    This randomized controlled trial aims to determine the feasibility and preliminary efficacy of a patient-centered, mobile health technology intervention (iCardia4HF) in patients with chronic Heart Failure (HF). Participants (n = 92) are recruited and randomized 1:1 to the intervention or control group. The intervention group receives a commercial HF self-care app (Heart Failure Storylines), three connected health devices that interface with the app (Withings weight scale and blood pressure monitor, and Fitbit activity tracker), and a program of individually tailored text-messages targeting health beliefs, self-care self-efficacy, HF-knowledge, and physical activity. The control group receives the same connected health devices, but without the HF self-care app and text messages. Follow-up assessments occur at 30 days and 12 weeks. The main outcome of interest is adherence to HF self-care assessed objectively through time-stamped data from the electronic devices and also via patient self-reports. Primary measures of HF self-care include medication adherence and adherence to daily weight monitoring. Secondary measures of HF self-care include adherence to daily self-monitoring of HF symptoms and blood pressure, adherence to low-sodium diet, and engagement in physical activity. Self-reported HF self-care and health-related quality of life are assessed with the Self-care Heart Failure Index and the Kansas City Cardiomyopathy Questionnaire, respectively. Hospitalizations and emergency room visits are tracked in both groups over 12 weeks as part of our safety protocol. This study represents an important step in testing a scalable mHealth solution that has the potential to bring about a new paradigm in self-management of HF.