Spyros Kitsiou

Background: Mobile health (mHealth) interventions are prevalent, yet people from marginalized communities are less likely to use digital health technologies to support self-management behaviors. Community engagement can inform health care design to enhance a hypertension self-management mHealth intervention. Objective: We applied human-centered design (HCD) to determine appropriate iterations of an existing hypertension intervention. Methods: Through an equity-focused, community-centered approach, we strove to optimize an mHealth app. We used validated theories and frameworks as well as an HCD methodology organized into three fundamental design skills: (1) methods to directly observe user experiences, (2) methods to analyze barriers to ideal intervention use, and (3) methods to design future iterations. Results: In October 2023, we conducted a series of HCD activities with a community advisory board (n=8) to refine an mHealth intervention for hypertension. Participants tested app prototypes with blood pressure monitors and suggested content modifications to enhance intervention fidelity. Among 6 participants, usability testing scored 67.5 (benchmark 68, “above average”), with all users finding the tool easy to use. Feedback identified critical needs, barriers, and work-arounds for future mHealth iterations. Conclusions: This study was a novel use case example of HCD as a patient-centered methodology to improve a hypertension management tool.

Background: Heart failure (HF) is a major public health problem associated with frequent hospitalizations, high mortality, and substantial health care costs. Self-care is fundamental to improving health outcomes; yet, self-care is commonly poor among patients with HF. SMS text messaging interventions may provide a simple, scalable, and accessible strategy to support HF self-care, particularly among older adults who may face barriers to using more complex digital health technologies. However, the efficacy of text messaging as a standalone intervention for patients with HF remains underexplored. Objective: This protocol paper describes the rationale and design of a pilot randomized controlled trial examining the feasibility, acceptability, and preliminary efficacy of an individually Tailored Text Messaging Intervention to Improve Self-Care in Adults with HF (Text4HF). Methods: This study is a single-site, stage I, parallel-group randomized controlled trial. Participants (n=30) are community-dwelling adults aged 50 years or older with stage C HF and suboptimal self-care, defined as a score of 3 or less on at least 2 items of the Self-Care of Heart Failure Index (SCHFI v7.2). Participants are randomized (1:1) to either a 12-week tailored text messaging intervention (Text4HF) plus usual care or usual care alone. Text messages are triggered based on patient responses to validated instruments assessing evidence-based, modifiable behavioral factors of HF self-care. Feasibility (recruitment and retention) and acceptability of the intervention are assessed as key process outcomes. The main exploratory patient-reported outcome is HF self-care (SCHFI v7.2). Other patient-reported outcomes include medication adherence, adherence to a heart-healthy diet, HF knowledge, health-related quality of life, self-efficacy, and health beliefs. Results: This study was funded in June 2022, and participant recruitment began in September 2024. A total of 26 participants have been enrolled and randomized to the intervention (n=13) and control (n=13) groups. Participants have a mean age of 60 (SD 6.6) years, 46% (12/26) are female, and 73% (19/26) identify as non-Hispanic Black. Half of the participants are individuals with reduced ejection fraction. Study completion is anticipated in June 2026. Conclusions: This protocol describes an important step toward evaluating a scalable, low-cost text messaging intervention designed to improve self-care in patients with HF. Study findings will provide critical data on feasibility and acceptability to guide a future fully powered efficacy trial of Text4HF.

BACKGROUND Heart failure (HF) is a serious chronic condition and is one of the most common hospital discharge diagnosis among adults in the United States. Self-care adherence is poor among middle aged and older adults with HF. Effective interventions targeting modifiable behavioral risk factors are critically needed given the increasing prevalence and worsened outcomes for patients with HF. Text4HF is a pilot study guided by the situation specific theory of HF self-care. The objective is to evaluate the feasibility and preliminary efficacy of an individually tailored text messaging intervention promoting self-care among middle aged and older adults with HF. OBJECTIVE This protocol aims to describe a randomized controlled trial designed to evaluate the feasibility and preliminary efficacy of individually tailored text messages on heart failure self-care. METHODS A single site, prospective, two-arm randomized controlled trial will be conducted. Participants (n= 30) will be recruited and randomized (1:1) to the intervention (Text4HF) or control group (usual care). The intervention group will receive 5 text messages per week for 12 weeks. Text message content reflects behavior consistent with adequate HF self-care such as medication adherence, heart healthy diet, HF symptoms self-monitoring, and self-efficacy in addition to usual care. The primary outcome is HF self-care, assessed with the Self-care Heart Failure Index (SCHFI v7.2). Feasibility (recruitment and retention) will be assessed over 12 weeks. Secondary outcomes include medication adherence, heart healthy diet adherence, HF knowledge, health related quality of life, self-efficacy, and health beliefs. RESULTS The trial was registered in June 2024. Recruitment is currently underway and began in September 2024 to the present, with 23 participants enrolled. Data collection will continue until early 2026. Results are expected to be published by the end of 2026. CONCLUSIONS This study represents a crucial step in testing a potentially scalable and low-cost intervention that can augment usual care to improve self-care among adults (≥50 years) with HF. CLINICALTRIAL NCT06473532

Background: Different interventions have shown efficacy in improving physical activity in women. This study aimed to determine the most effective adaptive intervention combining 4 efficacious treatments (Fitbit, text messages, personal calls, and group meetings) for improving physical activity. Methods: The Working Women Walking program used a Sequential Multiple Assignment Randomized Trial (SMART) design with 3 phases: initial (weeks 1–8), augmented (weeks 9–34), and maintenance (weeks 35–50). Low-active women aged 18–70 working at an academic medical center were recruited. In the initial phase, participants were randomized to Fitbit or Fitbit + text messages. After 8 weeks, nonresponders were rerandomized to an augmented treatment (personal calls or group meetings). The primary outcomes (steps/day and minutes of moderate/vigorous physical activity [MVPA]/day via ActiGraph) were assessed at baseline and 8, 34, and 50 weeks. Results: The study had 301 women (age: 45.1 [11.6] y). During the initial phase, there were no differences by initial treatment for change in steps (P = .78) or MVPA (P = .60). During the augmented phase, there were no differences by augmented treatment among nonresponders for change in steps (P = .95) or MVPA (P = .78). A significant overall increase was seen in steps (752/d; P < .001, d = 0.56) and MVPA at 8 weeks (4.1 min/d; P < .001, d = 0.48), and this was sustained at 34 and 50 weeks. Conclusions: Text messages, personal calls, and group meetings did not lead to increased physical activity. Using Fitbit and goal setting (a constant) appeared to have some benefit for many of the women in improving physical activity.

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. Trial Registration: ClinicalTrials.gov NCT03642275; https://clinicaltrials.gov/study/NCT03642275

Background: Exercise interventions often improve moderate to vigorous physical activity, but simultaneously increase sedentary time due to a compensatory resting response. A higher level of sedentary time is associated with a lower level of executive function, while increased moderate to vigorous physical activity is associated with improved global cognition and working memory among Latino adults. Latino adults are the fastest-growing minority group in the United States and are at high risk for cognitive decline, spend more time sedentary compared to non-Hispanic populations, and engage in low levels of physical activity. Interventions that are culturally appropriate for Latino adults to replace sedentary time with physical activity are critically needed. Objective: This study aims to develop and test the feasibility and acceptability of an ecological momentary intervention (EMI; delivered in real time) that is individually designed to replace sedentary time with physical activity in Latino adults. Methods: This pilot study randomized 39 (n=26, 67% female; mean age 61, SD 5.8 years) community-dwelling, Spanish-speaking Latino adults (1:1 allocation) to either a 6-week EMI program designed to replace sitting time with physical activity (20/39, 51%) or physical activity guidelines education (19/39, 49%). The program was conducted on the web and in Spanish. The intervention was individualized based on individual interview responses. The intervention included the use of a Fitbit activity monitor, weekly didactic phone meetings, interactive tools (SMS text messages), and coach-delivered feedback. Feasibility and acceptability were assessed via study satisfaction (Likert scales), motivation (ecological momentary assessment), retention, and compliance. Sedentary time and physical activity were assessed via 7-day actigraphy. Cognitive performance was assessed via the trail making test part A and B (part B=executive function) and via the National Institutes of Health Toolbox remote cognitive assessment. Statistical analysis included a linear model on change score from baseline, adjusting for age, sex, and education, emphasizing effect size. Results: Participant satisfaction with EMI was high (9.4/10), with a high degree of motivation to replace sitting time with physical activity (9.8/10). The intervention compliance rate was 79% with low difficulty using the Fitbit (1.7/10). Weekly step count increased in the intervention group by 5543 steps (group difference: d=0.54; P=.05) and sedentary time decreased by a mean 348 (SD 485) minutes (group difference: d=0.47; P=.24) compared to controls, with moderately strong effect sizes. The trail making test part B improved in the intervention group (mean –35.26, SD 60.35 seconds), compared to the control group (mean 7.19, SD 46 seconds; group difference: d=0.74; P=.01). No group differences were observed in other cognitive measures. Conclusions: An individualized EMI designed for midlife and older Latino adults has the potential to replace sitting time with physical activity and improve executive functioning. The intervention was feasible and well received with a high degree of satisfaction. Trial Registration: ClinicalTrials.gov NCT04507464; https://tinyurl.com/44c4thk5

Background: Black women experience a higher prevalence of poor asthma outcomes and physical inactivity than their White counterparts. Black women comprise a particularly vulnerable group of patients with asthma, with some of the highest rates of asthma in adults, high health care use (emergency department visits and hospitalizations), and the highest crude asthma mortality rate of all race or ethnicity groups. Despite recommendations to engage in regular physical activity, fewer than 15% of Black women meet the 2008 National Physical Activity Guidelines, the lowest of all racial subgroups of adults. Given the connection between physical inactivity and poor asthma outcomes, addressing physical activity among Black women with asthma is imperative. Objective: This 2-arm randomized controlled trial aims to (1) determine the efficacy of a lifestyle walking intervention on asthma control compared to an education (control) group over 24 weeks, (2) examine the maintenance effects of the lifestyle walking intervention on asthma control at 48 weeks, (3) explore the behavioral mediators (eg, self-efficacy, social support, self-regulation, and daily physical activity levels) and contextual moderators (eg, baseline asthma severity, neighborhood environment, comorbid conditions, and social determinants of health) that contribute to treatment responsiveness, and (4) assess the reach and implementation potential of the intervention. Methods: The proposed study (ACTION [A Lifestyle Physical Activity Intervention for Minority Women with Asthma]) delivers a 24-week lifestyle walking intervention designed for and by urban Black women with asthma. Participants (n=224) will be recruited through 2 urban health care systems that care for a diverse Black population. Patients will be randomized to one of two groups: (1) ACTION intervention (group sessions, physical activity self-monitoring—Fitbit, and text-based support for step goal setting) or (2) education control (an individual asthma education session and SMS text messages related to asthma education). Outcome assessments will take place at baseline, 12, 24, and 48 weeks. The primary outcome is a change in asthma control from baseline to week 24 as assessed by the asthma control questionnaire-6 (ACQ-6). Secondary outcomes include asthma-related quality of life, health care use, and asthma exacerbations and behavioral outcomes such as self-efficacy, self-regulation, social support, and physical activity. Results: This study was funded by the National Institute of Minority Health Disparities in August 2022. We pilot-tested our recruitment and intervention procedures and began recruitment in April 2023, with the enrollment of our first participant in May 2023. The anticipated completion of the study is April 2027. Conclusions: This study will deliver a new approach to physical activity interventions in Black women with asthma and help to provide guidance for addressing physical activity within this subgroup. This study will also provide a potential framework for future studies in minoritized populations with other disease conditions associated with low levels of physical activity. Trial Registration: ClinicalTrials.gov NCT05726487; https://clinicaltrials.gov/study/NCT05726487

BACKGROUND Black women experience a higher prevalence of poor asthma outcomes and physical inactivity than their White counterparts. Black women comprise a particularly vulnerable group of patients with asthma, with some of the highest rates of asthma in adults, high health care use (emergency department visits and hospitalizations), and the highest crude asthma mortality rate of all race or ethnicity groups. Despite recommendations to engage in regular physical activity, fewer than 15% of Black women meet the 2008 National Physical Activity Guidelines, the lowest of all racial subgroups of adults. Given the connection between physical inactivity and poor asthma outcomes, addressing physical activity among Black women with asthma is imperative. OBJECTIVE This 2-arm randomized controlled trial aims to (1) determine the efficacy of a lifestyle walking intervention on asthma control compared to an education (control) group over 24 weeks, (2) examine the maintenance effects of the lifestyle walking intervention on asthma control at 48 weeks, (3) explore the behavioral mediators (eg, self-efficacy, social support, self-regulation, and daily physical activity levels) and contextual moderators (eg, baseline asthma severity, neighborhood environment, comorbid conditions, and social determinants of health) that contribute to treatment responsiveness, and (4) assess the reach and implementation potential of the intervention. METHODS The proposed study (ACTION [A Lifestyle Physical Activity Intervention for Minority Women with Asthma]) delivers a 24-week lifestyle walking intervention designed for and by urban Black women with asthma. Participants (n=224) will be recruited through 2 urban health care systems that care for a diverse Black population. Patients will be randomized to one of two groups: (1) ACTION intervention (group sessions, physical activity self-monitoring—Fitbit, and text-based support for step goal setting) or (2) education control (an individual asthma education session and SMS text messages related to asthma education). Outcome assessments will take place at baseline, 12, 24, and 48 weeks. The primary outcome is a change in asthma control from baseline to week 24 as assessed by the asthma control questionnaire-6 (ACQ-6). Secondary outcomes include asthma-related quality of life, health care use, and asthma exacerbations and behavioral outcomes such as self-efficacy, self-regulation, social support, and physical activity. RESULTS This study was funded by the National Institute of Minority Health Disparities in August 2022. We pilot-tested our recruitment and intervention procedures and began recruitment in April 2023, with the enrollment of our first participant in May 2023. The anticipated completion of the study is April 2027. CONCLUSIONS This study will deliver a new approach to physical activity interventions in Black women with asthma and help to provide guidance for addressing physical activity within this subgroup. This study will also provide a potential framework for future studies in minoritized populations with other disease conditions associated with low levels of physical activity. CLINICALTRIAL ClinicalTrials.gov NCT05726487; https://clinicaltrials.gov/study/NCT05726487 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/55700