Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Bae JW

PROVIDER: S-EPMC8501404 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundThe treatment of many chronic illnesses involves long-term pharmaceutical therapy, but it is an ongoing challenge to find effective ways to improve medication adherence to promote good health outcomes. Cardioprotective medications can prevent the enlargement of harmful clots, cardiovascular symptoms, and poor therapeutic outcomes, such as uncontrolled high blood pressure and hyperlipidemia, for patients with coronary heart disease. Poor adherence to cardioprotective medications, however, has been reported as a global health concern among patients with coronary heart disease, and it is particularly a concern in China.ObjectiveThis study aimed to evaluate the efficacy of a mobile health (mHealth) intervention using 2 mobile apps to improve medication adherence and health outcomes.MethodsA randomized, placebo-controlled, 2-arm parallel study was conducted in a major university-affiliated medical center located in Chengdu, China. Participants were recruited by flyers and health care provider referrals. Each participant was observed for 90 days, including a 60-day period of mHealth intervention and a 30-day period of nonintervention follow-up. The study coordinator used WeChat and Message Express to send educational materials and reminders to take medication, respectively. Participants used WeChat to receive both the educational materials and reminders. Participants in the control group only received educational materials. This study received ethics approval from the Duke Health Institutional Review Board (Pro00073395) on May 5, 2018, and was approved by West China Hospital (20170331180037). Recruitment began on May 20, 2018. The pilot phase of this study was registered on June 8, 2016, and the current, larger-scale study was retrospectively registered on January 11, 2021 (ClinicalTrials.gov).ResultsWe recruited 230 patients with coronary heart disease. Of these patients, 196 completed the baseline survey and received the intervention. The majority of participants were married (181/196, 92.4%), male (157/196, 80.1%), and lived in urban China (161/196, 82.1%). Participants' average age was 61 years, and half were retired (103/191, 53.9%). More than half the participants (121/196, 61.7%) were prescribed at least 5 medications. The mean decrease in medication nonadherence score was statistically significant at both 60 days (t179=2.04, P=.04) and 90 days (t155=3.48, P<.001). Systolic blood pressure and diastolic blood pressure decreased in the experimental group but increased in the control group. The mean decrease in diastolic blood pressure was statistically significant at both 60 days (t160=2.07, P=.04) and 90 days (t164=2.21, P=.03). The mean decrease in systolic blood pressure was significantly different in the groups at 90 days (t165=3.12, P=.002).ConclusionsThe proposed mHealth intervention can improve medication adherence and health outcomes, including systolic blood pressure and diastolic blood pressure.Trial registrationClinicalTrials.gov NCT02793830; https://clinicaltrials.gov/ct2/show/NCT02793830 and ClinicalTrials.gov NCT04703439; https://clinicaltrials.gov/ct2/show/NCT04703439.

Project description:BackgroundCoronary heart disease (CHD) is the leading cause of death globally. In addition, 20% to 40% of the patients with CHD have comorbid mental health issues such as anxiety or depression, affecting the prognosis and quality of life (QoL). Mobile health (mHealth) interventions have been developed and are widely used; however, the evidence for the effects of mHealth interventions on QoL, anxiety, and depression in patients with CHD is currently ambiguous.ObjectiveIn this study, we aimed to assess the effects of mHealth interventions on QoL, anxiety, and depression in patients with CHD.MethodsWe searched the Cochrane Library, PubMed, Embase, CINAHL, Web of Science, China National Knowledge Infrastructure, and Wanfang databases from inception to August 12, 2023. Eligible studies were randomized controlled trials that involved patients with CHD who received mHealth interventions and that reported on QoL, anxiety, or depression outcomes. We used the Cochrane risk-of-bias tool for randomized trials to evaluate the risk of bias in the studies, ensuring a rigorous and methodologically sound analysis. Review Manager (desktop version 5.4; The Cochrane Collaboration) and Stata MP (version 17.0; StataCorp LLC) were used to conduct the meta-analysis. The effect size was calculated using the standardized mean difference (SMD) and its 95% CI.ResultsThe meta-analysis included 23 studies (5406 participants in total) and showed that mHealth interventions significantly improved QoL in patients with CHD (SMD 0.49, 95% CI 0.25-0.72; Z=4.07; P<.001) as well as relieved their anxiety (SMD -0.46, 95% CI -0.83 to -0.08; Z=2.38; P=.02) and depression (SMD -0.34, 95% CI -0.56 to -0.12; Z=3.00; P=.003) compared to usual care. The subgroup analyses indicated a significant effect favoring the mHealth intervention on reducing anxiety and depressive symptoms compared to usual care, especially when (1) the intervention duration was ≥6 months (P=.04 and P=.001), (2) the mHealth intervention was a simple one (only 1 mHealth intervention was used) (P=.01 and P<.001), (3) it was implemented during the COVID-19 pandemic (P=.04 and P=.01), (4) it was implemented in low- or middle-income countries (P=.01 and P=.02), (5) the intervention focused on mental health (P=.01 and P=.007), and (6) adherence rates were high (≥90%; P=.03 and P=.002). In addition, comparing mHealth interventions to usual care, there was an improvement in QoL when (1) the mHealth intervention was a simple one (P<.001), (2) it was implemented in low- or middle-income countries (P<.001), and (3) the intervention focused on mental health (P<.001).ConclusionsOn the basis of the existing evidence, mHealth interventions might be effective in improving QoL and reducing anxiety and depression in patients with CHD. However, large sample, high-quality, and rigorously designed randomized controlled trials are needed to provide further evidence.Trial registrationPROSPERO CRD42022383858; https://tinyurl.com/3ea2npxf.

Project description:BackgroundPostpartum women with overweight/obesity and a history of adverse pregnancy outcomes are at elevated risk for cardiometabolic disease. Postpartum weight loss and lifestyle changes can decrease these risks, yet traditional face-to-face interventions often fail. We adapted the Diabetes Prevention Program into a theory-based mobile health (mHealth) program called Fit After Baby (FAB) and tested FAB in a randomized controlled trial.MethodsThe FAB program provided 12 weeks of daily evidence-based content, facilitated tracking of weight, diet, and activity, and included weekly coaching and gamification with points and rewards. We randomized women at 6 weeks postpartum 2:1 to FAB or to the publicly available Text4baby (T4B) app (active control). We measured weight and administered behavioral questionnaires at 6 weeks, and 6 and 12 months postpartum, and collected app user data.Results81 eligible women participated (77% White, 2% Asian, 15% Black, with 23% Hispanic), mean baseline BMI 32±5 kg/m2 and age 31±5 years. FAB participants logged into the app a median of 51/84 (IQR 25,71) days, wore activity trackers 66/84 (IQR 43,84) days, logged weight 17 times (IQR 11,24), and did coach check-ins 5.5/12 (IQR 4,9) weeks. The COVID-19 pandemic interrupted data collection for the primary 12-month endpoint, and impacted diet, physical activity, and body weight for many participants. At 12 months postpartum women in the FAB group lost 2.8 kg [95% CI -4.2,-1.4] from baseline compared to a loss of 1.8 kg [95% CI -3.8,+0.3] in the T4B group (p = 0.42 for the difference between groups). In 60 women who reached 12 months postpartum before the onset of the COVID-19 pandemic, women randomized to FAB lost 4.3 kg [95% CI -6.0,-2.6] compared to loss in the control group of 1.3 kg [95% CI -3.7,+1.1] (p = 0.0451 for the difference between groups).ConclusionsThere were no significant differences between groups for postpartum weight loss for the entire study population. Among those unaffected by the COVID pandemic, women randomized to the FAB program lost significantly more weight than those randomized to the T4B program. The mHealth FAB program demonstrated a substantial level of engagement. Given the scalability and potential public health impact of the FAB program, the efficacy for decreasing cardiometabolic risk by increasing postpartum weight loss should be tested in a larger trial.

Project description:BackgroundLifestyle interventions, such as fasting, diet, and exercise, are increasingly used as a treatment option for patients with metabolic syndrome (MS). This study assesses the efficacy and safety of fasting followed by lifestyle modification in patients with MS compared to lifestyle modification only.MethodsSingle-blind, multicenter, parallel, randomized controlled trial in two German tertiary referral hospitals in metropolitan areas.Interventions(a) 5-day fasting followed by 10 weeks of lifestyle modification (modified DASH diet, exercise, mindfulness; n = 73); (b) 10 weeks of lifestyle modification only (n = 72).Main outcomes and measuresCo-primary outcomes were ambulatory systolic blood pressure and the homeostasis model assessment (HOMA) index at week 12. Further outcomes included anthropometric, laboratory parameters, and the PROCAM score at weeks 1, 12, and 24.ResultsA total of 145 patients with metabolic syndrome (62.8% women; 59.7 ± 9.3 years) were included. No significant group differences occurred for the co-primary outcomes at week 12. However, compared to lifestyle modification only, fasting significantly reduced HOMA index (Δ = -0.8; 95% confidence interval [CI] = -1.7, -0.1), diastolic blood pressure (Δ = -4.8; 95% CI = -5.5, -4.1), BMI (Δ = -1.7; 95% CI = -2.0, -1.4), weight (Δ = -1.7; 95% CI = -2.0, -1.4), waist circumference (Δ = -2.6; 95% CI = -5.0, -0.2), glucose (Δ = -10.3; 95% CI = -19.0, -1.6), insulin (Δ = -2.9; 95% CI = -5.3, -0.4), HbA1c (Δ = -0.2; 95% CI = -0.4, -0.05;), triglycerides (Δ = -48.9; 95% CI = -81.0, -16.9), IL-6 (Δ = -1.2; 95% CI = -2.5, -0.005), and the 10-year risk of acute coronary events (Δ = -4.9; 95% CI = -9.5, -0.4) after week 1. Fasting increased uric acid levels (Δ = 1.0; 95% CI = 0.1, 1.9) and slightly reduced eGRF (Δ = -11.9; 95% CI = -21.8, -2.0). Group differences at week 24 were found for weight (Δ = -2, 7; 95% CI = -4.8, -0.5), BMI (Δ = -1.0; 95% CI = -1.8, -0.3), glucose (Δ = -7.7; 95% CI = -13.5, -1.8), HDL (Δ = 5.1; 95% CI = 1.5, 8.8), and CRP (Δ = 0.2; 95% CI = 0.03, 0.4). No serious adverse events occurred.ConclusionsA beneficial effect at week 24 was found on weight; fasting also induced various positive short-term effects in patients with MS. Fasting can thus be considered a treatment for initializing lifestyle modification for this patient group; however, it remains to be investigated whether and how the multilayered effects of fasting can be maintained in the medium and longer term.

Project description:BackgroundPatients admitted with decompensated heart failure (HF) are at risk for hospital readmission and poor quality of life during the discharge period. Lifestyle behavior modifications that promote the self-management of chronic cardiac diseases have been associated with an improved quality of life. However, whether a mobile health (mHealth) program can assist patients in the self-management of HF during the acute posthospital discharge period is unknown.ObjectiveWe aimed to develop an mHealth program designed to enhance patients' self-management of HF by increasing knowledge, self-efficacy, and symptom detection. We hypothesized that patients hospitalized with HF would be willing to use a feasibly deployed mHealth program after their hospital discharge.MethodsWe employed a patient-centered outcomes research methodology to design a stakeholder-informed mHealth program. Adult patients with HF admitted to a large academic hospital were enrolled and randomized to receive the mHealth intervention versus usual care. Our feasibility outcomes included ease of program deployment, use of the clinical escalation process, duration of participant recruitment, and participant attrition. Surveys assessing the demographics and clinical characteristics of HF were measured at baseline and at 30 and 90 days after discharge.ResultsThe study period was between July 1, 2019, and April 7, 2020. The mean cohort (N=31) age was 60.4 (range 22-85) years. Over half of the participants were men (n=18, 58%) and 77% (n=24) were White. There were no significant differences in baseline measures. We determined that an educational mHealth program tailored for patients with HF is feasibly deployed and acceptable by patients. Though not significant, we found notable trends including a higher mean quality of life at 30 days posthospitalization among program users and a longer duration before rehospitalization, which are suggestive of better HF prognosis.ConclusionsOur mHealth tool should be further assessed in a larger comparative effectiveness trial. Our pilot intervention offers promise as an innovative means to help HF patients lead healthy, independent lives. These preliminary data suggest that patient-centered mHealth tools can enable high-risk patients to play a role in the management of their HF after discharge.Trial registrationClinicalTrials.gov NCT03982017; https://clinicaltrials.gov/ct2/show/NCT03982017.

Project description:BACKGROUND: Intensive lifestyle intervention significantly reduces the progression to diabetes in high-risk individuals. OBJECTIVE: It is not known whether a program of moderate intervention might effectively reduce metabolic abnormalities in the general population. DESIGN: Two-arm randomized controlled 1-year trial. PATIENTS: Three hundred and thirty-five patients participated from a dysmetabolic population-based cohort of 375 adults aged 45-64 years in northwestern Italy. MEASUREMENTS: We compared the effectiveness of a general recommendation-based program of lifestyle intervention carried out by trained professionals versus standard unstructured information given by family physicians at reducing the prevalence of multiple metabolic and inflammatory abnormalities. RESULTS: At baseline, clinical/anthropometric/laboratory and lifestyle characteristics of the intervention (n = 169) and control (n = 166) groups were not significantly different. The former significantly reduced total/saturated fat intake and increased polyunsaturated fat/fiber intake and exercise level compared to the controls. Weight, waist circumference, high-sensitivity C-reactive protein, and most of the metabolic syndrome components decreased in the intervention group and increased in the controls after 12 months. Lifestyle intervention significantly reduced metabolic syndrome (odds ratio [OR] = 0.28; 95% CI 0.18-0.44), with a 31% (21-41) absolute risk reduction, corresponding to 3.2 (2-5) patients needing to be treated to prevent 1 case after 12 months. The intervention significantly reduced the prevalence of central obesity (OR = 0.33; 0.20-0.56), and hypertriglyceridemia (OR = 0.48; 0.31-0.75) and the incidence of diabetes (OR = 0.23; 0.06-0.85). CONCLUSION: A lifestyle intervention based on general recommendations was effective in reducing multiple metabolic/inflammatory abnormalities. The usual care by family physicians was ineffective at modifying progressive metabolic deterioration in high-risk individuals.

Project description:Background Population-wide reduction in mean blood pressure is proposed as a key strategy for primary prevention of cardiovascular disease. We evaluated the effectiveness of a task-sharing strategy involving frontline health workers in the primary prevention of elevated blood pressure. Methods and Results We conducted DISHA (Diet and lifestyle Interventions for Hypertension Risk reduction through Anganwadi Workers and Accredited Social Health Activists) study, a cluster randomized controlled trial involving 12 villages each from 4 states in India. Frontline health workers delivered a custom-made and structured lifestyle modification intervention in the selected villages. A baseline survey was conducted in 23 and 24 clusters in the control (n=6663) and intervention (n=7150) groups, respectively. The baseline characteristics were similar between control and intervention clusters. In total 5616 participants from 23 clusters in the control area and 5699 participants from 24 clusters in the intervention area participated in a repeat cross-sectional survey conducted immediately after the intervention phase of 18-months. The mean (SD) systolic blood pressure increased from 125.7 (18.1) mm Hg to 126.1 (16.8) mm Hg in the control clusters, and it increased from 124.4 (17.8) mm Hg to 126.7 (17.5) mm Hg in the intervention clusters. The population average adjusted mean difference in difference in systolic blood pressure was 1.75 mm Hg (95% CI, -0.21 to 3.70). Conclusions Task-sharing interventions involving minimally trained nonphysician health workers are not effective in reducing population average blood pressure in India. Expanding the scope of task sharing and intensive training of health workers such as nurses, nutritionists, or health counselors in management of cardiovascular risk at the population level may be more effective in primary prevention of cardiovascular disease. Registration URL: https://www.ctri.nic.in; Unique identifier: CTRI/2013/10/004049.