mHealth Interventions for Lifestyle and Risk Factor Modification in Coronary Heart Disease: Randomized Controlled Trial

Background Self-management of lifestyle and cardiovascular disease risk factors is challenging in older patients with coronary heart disease (CHD). SMS text messaging could be a potential support tool for self-management and the most affordable and accessible method through a mobile phone. High-quality evidence had been lacking, and previous studies evaluated the effects of SMS text messaging on the subjective measures of short-term outcomes. Recently, a large-sized randomized controlled trial in Australia reported promising findings on the objective measures upon 6-month follow-up. However, an examination of the effectiveness of such interventions in an Asian population with unique demographic characteristics would be worthwhile. Objective This study examined the effectiveness of a 1-way SMS text messaging program to modify the lifestyle and cardiovascular disease risk factors of patients who underwent the first percutaneous coronary intervention (PCI). Methods A parallel, single-blinded, 1:1 random allocation clinical trial was conducted with 879 patients treated through PCI. They were recruited during hospital admission from April 2017 to May 2020 at 2 university hospitals in the Republic of Korea. In addition to standard care, the intervention group received access to a supporting website and 4 SMS text messages per week for 6 months regarding a healthy diet, physical activity, smoking cessation, and cardiovascular health. Random allocation upon study enrollment and SMS text messaging after hospital discharge were performed automatically using a computer program. The coprimary outcomes were low-density-lipoprotein cholesterol (LDL-C), systolic blood pressure (SBP), and BMI. The secondary outcomes were change in lifestyle and adherence to the recommended health behaviors. Results Of the eligible population, 440 and 439 patients who underwent PCI were assigned to the intervention and control groups, respectively. The 1-way SMS text messaging program significantly enhanced physical activity (P=.02), healthy diet (P<.01), and medication adherence (P<.04) among patients with CHD. Hence, more people were likely to control their cardiovascular disease risk factors per the recommendations. The intervention group was more likely to control all 5 risk factors by 62% (relative risk 1.62, 95% CI 1.05-2.50) per the recommendations. On the other hand, physiological measures of the primary outcomes, including LDL-C levels, SBP, and BMI, were not significant. Most participants found the SMS text messaging program useful and helpful in motivating lifestyle changes. Conclusions Lifestyle-focused SMS text messages were effective in the self-management of a healthy diet, exercise, and medication adherence, but their influence on the physiological measures was not significant. One-way SMS text messages can be used as an affordable adjuvant method for lifestyle modification to help prevent the recurrence of cardiovascular disease. Trial Registration Clinical Research Information Service (CRiS) KCT0005087; https://cris.nih.go.kr/cris/search/detailSearch.do/19282

mHealth Interventions to Support Prescription Opioid Tapering in Patients With Chronic Pain: Qualitative Study of Patients’ Perspectives

Background Patients with chronic pain who are tapering prescription opioids report a need for greater support for coping with symptoms of pain and withdrawal. Mobile health (mHealth) technologies (SMS text messaging– or app-based) have the potential to provide patients with educational, emotional, and motivational support for opioid tapering beyond what is offered by their health care provider. However, it is not known whether patients with chronic pain who are tapering opioids would be willing or able to engage with technology-based support. Objective This study aims to examine patients’ use of mobile technologies in health care, interest in using mHealth support, preferences for the form and content of mHealth support, and potential barriers to and facilitators of engagement with mHealth support for opioid tapering. Methods A total of 21 patients (11 women and 10 men; age range 29-83 years) with chronic noncancer pain on long-term opioid therapy who had recently initiated a voluntary opioid taper were recruited from primary and tertiary care clinics in metropolitan and regional Australia for a larger study of patients’ experiences of opioid tapering. Participants had been taking prescription opioids for a mean duration of 13 (SD 9.6; range 0.25-30) years at the time of the study. Survey items characterized participants’ typical mobile phone use and level of interest in mobile technology–based support for opioid tapering. Semistructured interviews further explored patients’ use of mobile technologies and their interest in, preferences for, and perspectives on potential barriers to and facilitators of engagement with mHealth support for opioid tapering. Two researchers collaborated to conduct a thematic analysis of the interview data. Results All participants reported owning and using a mobile phone, and most (17/21, 81%) participants reported using mobile apps. The majority of participants expressed interest in SMS text messaging–based (17/21, 81%) and app-based (15/21, 71%) support for opioid tapering. Participants expected that messages delivering both informational and socioemotional support would be helpful. Participants expected that access to technology, mobile reception, internet connectivity, vision impairment, and low self-efficacy for using apps may be barriers to user engagement. Patients expected that continuity of care from their health care provider, flexible message dosing, responsivity, and familiarity with pain self-management strategies would increase user engagement. Conclusions The results of this study indicate that patients with chronic noncancer pain may be willing to engage with SMS text messaging–based and app-based mHealth interventions to support opioid tapering. However, the feasibility and acceptability of these interventions may depend on how patients’ preferences for functionality, content, and design are addressed.

mHealth Interventions for Lifestyle and Risk Factor Modification in Coronary Heart Disease: Randomized Controlled Trial (Preprint)

BACKGROUND Self-management of lifestyle and cardiovascular disease risk factors is challenging in older patients with coronary heart disease (CHD). SMS text messaging could be a potential support tool for self-management and the most affordable and accessible method through a mobile phone. High-quality evidence had been lacking, and previous studies evaluated the effects of SMS text messaging on the subjective measures of short-term outcomes. Recently, a large-sized randomized controlled trial in Australia reported promising findings on the objective measures upon 6-month follow-up. However, an examination of the effectiveness of such interventions in an Asian population with unique demographic characteristics would be worthwhile. OBJECTIVE This study examined the effectiveness of a 1-way SMS text messaging program to modify the lifestyle and cardiovascular disease risk factors of patients who underwent the first percutaneous coronary intervention (PCI). METHODS A parallel, single-blinded, 1:1 random allocation clinical trial was conducted with 879 patients treated through PCI. They were recruited during hospital admission from April 2017 to May 2020 at 2 university hospitals in the Republic of Korea. In addition to standard care, the intervention group received access to a supporting website and 4 SMS text messages per week for 6 months regarding a healthy diet, physical activity, smoking cessation, and cardiovascular health. Random allocation upon study enrollment and SMS text messaging after hospital discharge were performed automatically using a computer program. The coprimary outcomes were low-density-lipoprotein cholesterol (LDL-C), systolic blood pressure (SBP), and BMI. The secondary outcomes were change in lifestyle and adherence to the recommended health behaviors. RESULTS Of the eligible population, 440 and 439 patients who underwent PCI were assigned to the intervention and control groups, respectively. The 1-way SMS text messaging program significantly enhanced physical activity (<i>P</i>=.02), healthy diet (<i>P</i>&lt;.01), and medication adherence (<i>P</i>&lt;.04) among patients with CHD. Hence, more people were likely to control their cardiovascular disease risk factors per the recommendations. The intervention group was more likely to control all 5 risk factors by 62% (relative risk 1.62, 95% CI 1.05-2.50) per the recommendations. On the other hand, physiological measures of the primary outcomes, including LDL-C levels, SBP, and BMI, were not significant. Most participants found the SMS text messaging program useful and helpful in motivating lifestyle changes. CONCLUSIONS Lifestyle-focused SMS text messages were effective in the self-management of a healthy diet, exercise, and medication adherence, but their influence on the physiological measures was not significant. One-way SMS text messages can be used as an affordable adjuvant method for lifestyle modification to help prevent the recurrence of cardiovascular disease. CLINICALTRIAL Clinical Research Information Service (CRiS) KCT0005087; https://cris.nih.go.kr/cris/search/detailSearch.do/19282

Feasibility of Using Text Messaging to Gather Qualitative Diary Data from COPD Sufferers: An Ecological Momentary Assessment and BYOD Approach (Preprint)

BACKGROUND The ubiquitous use of SMS text messaging offers a viable data collection method that aligns well with ecological momentary assessment (EMA) coupled with a bring-your-own-device (BYOD) approach. This unique conceptual model may extend to qualitative data collection through diary entries, which promises novel, in-the-moment insights for researchers interested in subjective patient-reported outcome measures (PROMS). OBJECTIVE This study aims to investigate the feasibility of using SMS text messaging to gather qualitative diary data from COPD sufferers, using EMA and participants’ mobile phones. It compares data gathered through this method with similar qualitative data gathered through email and with responses to quantitative, closed-ended categorical questions. METHODS This study involved 93 COPD-affected Alpha-1 sufferers who participated in a two-month long pilot intervention that used push messaging to respondents 2-to-3 times a day, either via SMS text messaging or email. In the first month of the study, respondents received 2 push messages a day urging them to answer closed-ended questions. The second month of the study integrated push messages which encouraged participants to engage in completion of daily, qualitative diary entries, in addition to the closed-ended questions. This research tracked and compared speed to answer and depth of responses between 69 (74%) individuals completing the push message requests through email and 24 (26%) who completed them through text messaging. It also compared completion rates of the diary entries to those of the closed-ended categorical questions. RESULTS Analysis of speed to answer, or the quickness in which respondents replied to the push messages, indicated that those answering by SMS text messaging were faster than those answering by email, both for categorical closed-ended questions and for diary questions. For the diary questions, specifically, those answering by SMS text messaging responded 6 hours and 29 minutes faster than those responding by email. We deemed this difference to be statistically significant. Depth of response, as measured by word count, varied between the two delivery methods as well, with those answering by email using, on average, 5.3 more words per entry than those answering by SMS text messaging (24.9 words per entry compared to 19.6 words per entry). Average compliance to the closed-ended questions over the study period was 94.4% (12,642/13,392) compared to 90.8% (2365/2604) for diary entries. This difference was also statistically significant. CONCLUSIONS SMS text messaging is a viable option for qualitative diary data collection among chronically ill individuals using an EMA and BYOD methodology. However, researchers must weigh considerations of time versus response rate and depth of response when employing SMS text messaging for this methodological approach. Benefits include quick response times, which matches the EMA method of responding as near to a trigger or intervention as possible. Weaknesses include the fact that qualitative diary data collected by SMS text messaging have inherent limits regarding depth of response. This study also recognized a lower compliance rate for those participating by SMS text messaging than by email, even though rates for both were quite high.

Text Message Interventions in Adolescent Mental Health and Addiction Services: Scoping Review

Background The vast majority of adolescent mental health and substance use disorders go undiagnosed and undertreated. SMS text messaging is increasingly used as a method to deliver adolescent health services that promote psychological well-being and aim to protect adolescents from adverse experiences and risk factors critical for their current and future mental health. To date, there has been no comprehensive synthesis of the existing literature on the extent, range, and implementation contexts of these SMS text message interventions. Objective The objective of this scoping review was to map and categorize gaps in the current body of peer-reviewed research around the use of SMS text messaging–based interventions for mental health and addiction services among adolescents. Methods A scoping review was conducted according to Levac’s adaptation of Arksey and O’Malley’s methodological framework for scoping reviews in six iterative stages. A search strategy was cocreated and adapted for five unique databases. Studies were screened using Covidence software. The PICO (patient, intervention, comparator, outcome) framework and input from multiple stakeholder groups were used to structure and pilot a data extraction codebook. Data were extracted on study methodology and measures, intervention design, and implementation characteristics, as well as policy, practice, and research implications. Results We screened 1142 abstracts. Of these, 31 articles published between 2013 and 2020 were eligible for inclusion. Intervention engagement was the most common type of outcome measured (18/31), followed by changes in cognitions (16/31; eg, disease knowledge, self-awareness) and acceptability (16/31). Interventions were typically delivered in less than 12 weeks, and adolescents received 1-3 messages per week. Bidirectional messaging was involved in 65% (20/31) of the studies. Limited descriptions of implementation features (eg, cost, policy implications, technology performance) were reported. Conclusions The use of SMS text messaging interventions is a rapidly expanding area of research. However, lack of large-scale controlled trials and theoretically driven intervention designs limits generalizability. Significant gaps in the literature were observed in relation to implementation considerations, cost, clinical workflow, bidirectionality of texting, and level of personalization and tailoring of the interventions. Given the growth of mobile phone–based interventions for this population, a rigorous program of large-scale, well-designed trials is urgently required.

A Culturally Adapted SMS Text Messaging Intervention to Promote Antiretroviral Therapy Adherence Among African Americans: Protocol for a Single-Arm Trial

Background African Americans are disproportionally affected by HIV and have poorer rates of antiretroviral therapy (ART) adherence compared to other racial or ethnic groups in the United States. Factors associated with poor HIV disease outcomes are commonly associated with sociostructural barriers that prevent engagement with and retention in HIV care. SMS text messaging interventions to promote ART adherence among predominantly non-Hispanic White persons with HIV (PWH) have been shown to be efficacious; however, limited research has been devoted to culturally tailoring interventions for underrepresented racial/ethnic groups. Considering African Americans show poorer engagement along the HIV care continuum, we developed an individualized and culturally tailored two-way SMS text messaging intervention to improve ART adherence and associated virologic suppression among African American PWH. Objective In this paper we describe the protocol of a culturally tailored individualized Texting for Adherence Building (iTAB) intervention in a 24- to 48-week, single-arm study. Methods We developed a culturally tailored iTAB intervention, which we are implementing in a 24- to 48-week, single-arm study. Participants were recruited from the Family Health Centers of San Diego (FHCSD), a federally qualified health center. Patient inclusion criteria were (1) receiving care at the FHCSD, (2) living with HIV, (3) self-identification as Black, African American, or of African ancestry, (4) English speaking, (5) age 18 or older, (6) currently on ART, and (7) able to provide informed consent. Study enrollment began in November 2017 and closed in July 2019. A total of 90 participants from the FHCSD enrolled in the iTAB intervention, and we anticipate completing data collection in July 2020. Participants were assisted in individualizing and customizing their SMS text message preferences at the baseline study visit. Self-assessment measures are collected at baseline, interim, and final study visits. Problems related to sending/receiving SMS text messages and barriers to ART adherence are assessed at each interim study visit. The FHCSD staff monitors and tracks participants’ daily SMS text message responses to ART adherence reminders using a clinical dashboard. Results We hypothesize that the proportion of individuals achieving HIV virologic suppression (viral load <40 copies/mL) will be greater at the end of the intervention period compared to the proportion prior to study implementation. Additionally, we anticipate that rates of virologic suppression at the end of the intervention among participants receiving iTAB will be comparable to those among the general FHCSD non-African American population who did not receive iTAB. Finally, we anticipate a high response rate to iTAB SMS text messages as well as positive participant feedback at the end of the intervention with regard to the acceptability of, satisfaction with, and perceived efficacy of iTAB. Conclusions The iTAB intervention is a novel individualized two-way SMS text messaging intervention that has been culturally tailored for use among African Americans with HIV. We anticipate that iTAB will demonstrate efficacy in future randomized control trials and will be supportive of medication adherence among other populations facing health disparities. International Registered Report Identifier (IRRID) DERR1-10.2196/21592

Awareness Development and Usage of Mobile Health Technology Among Individuals With Hypertension in a Rural Community of Bangladesh: Randomized Controlled Trial

Background Hypertension (HTN) is a major modifiable risk factor and the leading cause of premature deaths globally. The lack of awareness and knowledge have been identified as risk factors in low- and middle-income countries including Bangladesh. Recently, the use of mobile phone SMS text messaging is found to have an important positive impact on HTN management. Objective The study aimed to develop awareness and knowledge in order to enhance lifestyle behavior changes among individuals with HTN in a rural community of Bangladesh by using health education and mobile health (mHealth) technology (SMS text messaging). Methods A prospective randomized 5-month intervention, open-label (1:1), parallel-group trial was implemented among the individuals with HTN aged 35 years or older. Both men and women were included. Between August 2018 and July 2019, we enrolled 420 participants, selected from a tertiary level health facility and through door-to-door visits by community health workers. After block randomization, they were assigned to either the intervention group (received SMS text messaging and health education; n=209) or the control group (received only health education; n=211). The primary outcome was the evaluation of self-reported behavior changes (salt intake, fruits and vegetables intake, physical activity, and blood pressure [BP], and body weight monitoring behaviors). The secondary outcomes were measurements of actual salt intake and dietary salt excretion, blood glucose level, BP values, and quality of life (QOL). Results During the study period, a total of 8 participants were dropped, and the completion rate was 98.0% (412/420). The adherence rates were significantly higher (9%) among the control group regarding salt intake (P=.04) and physical activity behaviors (P<.03), and little differences were observed in other behaviors. In primary outcome, the focused behavior, salt intake less than 6 g/day, showed significant chronological improvement in both groups (P<.001). The fruits intake behavior steadily improved in both groups (P<.001). Participants in both groups had a custom of vegetables intake everyday/week. Physical activity suddenly increased and continued until the study end (P<.001 in both groups). Both BP and body weight monitoring status increased from baseline to 1 month but decreased afterward (P<.001). In case of secondary outcomes, significant chronological changes were observed in food salt concentration and urinary salinity between the groups (P=.01). The mean systolic BP and diastolic BP significantly chronologically decreased in both groups (systolic BP, P=.04; diastolic BP, P=.02.P<.05). All of these supported self-reported behavior changes. For the QOL, both groups showed significant improvement over the study periods (P<.001). Conclusions Based on these results, we suggest that face-to-face health education requires integration of home health care provision and more relevant and timely interactive SMS text messages to increase the effectiveness of the intervention. Besides, community awareness can be created to encourage “low-salt culture” and educate family members. Trial Registration Bangladesh Medical Research Council (BMRC) 06025072017; ClinicalTrials.gov NCT03614104; https://clinicaltrials.gov/ct2/show/NCT03614104 and UMIN-CTR R000033736; https://tinyurl.com/y48yfcoo International Registered Report Identifier (IRRID) RR2-10.2196/15523

mHealth Interventions to Support Prescription Opioid Tapering in Patients With Chronic Pain: Qualitative Study of Patients’ Perspectives (Preprint)

BACKGROUND Patients with chronic pain who are tapering prescription opioids report a need for greater support for coping with symptoms of pain and withdrawal. Mobile health (mHealth) technologies (SMS text messaging– or app-based) have the potential to provide patients with educational, emotional, and motivational support for opioid tapering beyond what is offered by their health care provider. However, it is not known whether patients with chronic pain who are tapering opioids would be willing or able to engage with technology-based support. OBJECTIVE This study aims to examine patients’ use of mobile technologies in health care, interest in using mHealth support, preferences for the form and content of mHealth support, and potential barriers to and facilitators of engagement with mHealth support for opioid tapering. METHODS A total of 21 patients (11 women and 10 men; age range 29-83 years) with chronic noncancer pain on long-term opioid therapy who had recently initiated a voluntary opioid taper were recruited from primary and tertiary care clinics in metropolitan and regional Australia for a larger study of patients’ experiences of opioid tapering. Participants had been taking prescription opioids for a mean duration of 13 (SD 9.6; range 0.25-30) years at the time of the study. Survey items characterized participants’ typical mobile phone use and level of interest in mobile technology–based support for opioid tapering. Semistructured interviews further explored patients’ use of mobile technologies and their interest in, preferences for, and perspectives on potential barriers to and facilitators of engagement with mHealth support for opioid tapering. Two researchers collaborated to conduct a thematic analysis of the interview data. RESULTS All participants reported owning and using a mobile phone, and most (17/21, 81%) participants reported using mobile apps. The majority of participants expressed interest in SMS text messaging–based (17/21, 81%) and app-based (15/21, 71%) support for opioid tapering. Participants expected that messages delivering both informational and socioemotional support would be helpful. Participants expected that access to technology, mobile reception, internet connectivity, vision impairment, and low self-efficacy for using apps may be barriers to user engagement. Patients expected that continuity of care from their health care provider, flexible message <i>dosing</i>, responsivity, and familiarity with pain self-management strategies would increase user engagement. CONCLUSIONS The results of this study indicate that patients with chronic noncancer pain may be willing to engage with SMS text messaging–based and app-based mHealth interventions to support opioid tapering. However, the feasibility and acceptability of these interventions may depend on how patients’ preferences for functionality, content, and design are addressed.

The Feasibility of using Web-Based Methods to Capture Quality of Recovery in the Perioperative Period: Comparing Email, SMS Text, and Concurrent Mixed Modes Approaches (Preprint)

BACKGROUND As patients are being discharged from the hospital earlier, the ability to monitor patient recovery between hospital discharge and the first follow-up clinic visit is becoming increasingly important. Despite substantial increases in both internet use and smartphone ownership over the past 5 years, clinicians have been slow to embrace the use of these devices to capture patient recovery information in the period between hospital discharge and the first clinical follow-up appointment. OBJECTIVE To investigate the generalizability of using a web-based platform to capture patient recovery in a broad surgical patient population, and compare response rates for three different web-based strategies for delivering recovery surveys over the perioperative time-period: email, short message service (SMS) text messaging, and a concurrent mixed approach of using both email and SMS text messaging. METHODS Patients undergoing surgeries managed with an Enhanced Recovery After Surgery (ERAS) pathway program were asked to participate in the web-based quality assurance monitoring program at the time of their pre-operative surgery appointment. Different follow-up methods were implemented over three sequential phases. Patients received HIPAA compliant web-based survey links by either email (phase 1), SMS text (phase 2), or concurrently using both email and SMS text (phase 3) using RedCap® and Twillio® software. Recovery assessments using the established Quality of Recovery-9 (QOR-9) tool were measured 4 days prior to surgery, and at 7 and 30 days postoperatively. Generalizability of the web-based system was examined by comparing demographic and clinical characteristics of those who participated vs. those that did not. Differences in response rates by web-based collection method were analyzed in adjusted models. RESULTS A total of 615 patients asked to participate, with 526 (85.53%) opting in to the follow-up program. Those who opted in were younger, slightly healthier, and more likely to be in a partnership. The concurrent mixed modes (CMM) was the most successful method for obtaining responses at every time point compared to text or email alone (pre: 74% vs. 67% vs 43%, P <.001; 7 day: 67% vs. 50% vs. 47%, P = .001; 30 day: 65% vs. 50% vs. 43%, P = .001, respectively). In the adjusted model, the CMM method of contact significantly predicted response compared to using email alone (Odds Ratio (OR) =3.4, P <.0001), and SMS text alone (OR=1.9, P =.0003). Additional significant predictors of response were race, partnership and time. CONCLUSIONS For internet users and smartphone owners, electronic capture of recovery surveys appears to be possible through this HIPAA compliant resource friendly mechanism. Discrepancies in both inclusion and response rates still exist among certain subgroups of patients, but the concurrent approach of using both email and text messages was the most effective approach to reach the largest number of patients across all subgroups.