The effectiveness, reproducibility, and durability of tailored mobile coaching on diabetes management in policyholders: A randomized, controlled, open-label study.
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SUBMITTER: Lee DY
PROVIDER: S-EPMC5827660 | biostudies-literature | 2018 Feb
REPOSITORIES: biostudies-literature
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The effectiveness, reproducibility, and durability of tailored mobile coaching on diabetes management in policyholders: A randomized, controlled, open-label study.
Lee Da Young DY Park Jeongwoon J Choi Dooah D Ahn Hong-Yup HY Park Sung-Woo SW Park Cheol-Young CY
Scientific reports 20180226 1
This randomized, controlled, open-label study conducted in Kangbuk Samsung Hospital evaluated the effectiveness, reproducibility, and durability of tailored mobile coaching (TMC) on diabetes management. The participants included 148 Korean adult policyholders with type 2 diabetes divided into the Intervention-Maintenance (I-M) group (n = 74) and Control-Intervention (C-I) group (n = 74). Intervention was the addition of TMC to typical diabetes care. In the 6-month phase 1, the I-M group received ...[more]
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Project description:BackgroundMobile health applications have been developed to support diabetes self-management, but their effectiveness could depend on patient engagement. Therefore, patient engagement must be examined through multifactorial tailored behavioral interventions from an individual perspective.ObjectiveThis study aims to evaluate the usefulness of a novel user utility score (UUS) as a tool to measure patient engagement by using a mobile health application for diabetes management.MethodsWe conducted a subanalysis of results from a 12-month randomized controlled trial of a tailored mobile coaching (TMC) system among insurance policyholders with type 2 diabetes. UUS was calculated as the sum of the scores for 4 major core components (range 0-8): frequency of self-monitoring blood glucose testing, dietary and exercise records, and message reading rate. We explored the association between UUS for the first 3 months and glycemic control over 12 months. In addition, we investigated the relationship of UUS with blood pressure, lipid profile, and self-report scales assessing diabetes self-management.ResultsWe divided 72 participants into 2 groups based on UUS for the first 3 months: UUS:0-4 (n=38) and UUS:5-8 (n=34). There was a significant between-group difference in glycated hemoglobin test (HbA1c) levels for the 12-months study period (P=.011). The HbA1c decrement at 12 months in the UUS:5-8 group was greater than that of the UUS:0-4 group [-0.92 (SD 1.24%) vs -0.33 (SD 0.80%); P=.049]. After adjusting for confounding factors, UUS was significantly associated with changes in HbA1c at 3, 6, and 12 months; the regression coefficients were -0.113 (SD 0.040; P=.006), -0.143 (SD 0.045; P=.002), and -0.136 (SD 0.052; P=.011), respectively. Change differences in other health outcomes between the 2 groups were not observed throughout a 12-month follow-up.ConclusionsUUS as a measure of patient engagement was associated with changes in HbA1c over the study period of the TMC system and could be used to predict improved glycemic control in diabetes self-management through mobile health interventions.Trial registrationClinicalTrial.gov NCT03033407; https://clinicaltrials.gov/ct2/show/NCT03033407.
| S-EPMC7946585 | biostudies-literature
Project description:BackgroundThe role of mobile health care (mHealth) in glycemic control has been investigated, but its impact on self-management skills and its psychological aspects have not been studied.ObjectiveWe evaluated the efficacy of mHealth-based diabetes self-management education and the effect of voluntary participation on its effects.MethodsThis study was a randomized controlled open-label trial conducted for 6 months at Kangbuk Samsung Hospital. Participants in the control group (n=31) maintained their previous diabetes management strategies. Participants in the intervention group (n=41) additionally received mHealth-based diabetes self-management education through a mobile app and regular individualized feedback from health care professionals. The primary outcome was change in glycated hemoglobin (HbA1c) level over 6 months between the 2 groups (intervention versus control) and within each group (at 6 months versus baseline). The secondary outcomes were changes in body mass index, blood pressure, lipid profile, and questionnaire scores (the Korean version of the Summary of Diabetes Self-Care Activities Questionnaire, an Audit of Diabetes Dependent Quality of Life, the Appraisal of Diabetes Scale, and Problem Areas in Diabetes) over 6 months between groups and within each group.ResultsA total of 66 participants completed this study. HbA1c (P=.04), total cholesterol level (P=.04), and Problem Areas in Diabetes scores (P=.02) significantly decreased; total diet (P=.03) and self-monitoring of blood glucose level scores (P=.01), based on the Summary of Diabetes Self-Care Activities Questionnaire, markedly increased within the intervention group. These significant changes were observed in self-motivated participants who were recruited voluntarily via advertisements.ConclusionsmHealth-based diabetes self-management education was effective at improving glycemic control and diabetes self-management skills and lowering diabetes-related distress in voluntary participants.Trial registrationClinicalTrials.gov NCT03468283; http://clinicaltrials.gov/ct2/show/NCT03468283.
| S-EPMC7532462 | biostudies-literature
Project description:IntroductionThe widespread prevalence of type 2 diabetes (T2D) not only influences patients' daily lives but also has an economic impact on society. Increasing physical activity and a healthy diet can delay the progression of T2D. Although there are evidence-based recommendations on diet and physical activity, patients with T2D have difficulties implementing them. An appropriate lifestyle intervention can address this problem.Methods and analysisThis study is based on the need to develop an intervention that helps patients to establish behavioural changes in order to achieve glycaemic control. The intervention will be evaluated in a monocentric, open-label, pragmatic, two-arm randomised controlled trial with a sample ratio of 1:1 and a parallel design. This superiority study will be conducted in Switzerland. All enrolled patients (n=90) will receive the standard medical treatment for T2D. The intervention group will receive personal health coaching by telephone and access to a smartphone and web application for 1 year. The control group will receive access to the application for 1 year and a one-time written diet and exercise recommendation. The primary outcomes are objectively measured physical activity and glycated haemoglobin. Secondary outcomes are self-reported physical activity, nutrition, cognitive mediators of changes in sport-related behaviour, blood values, medication and nutritional supplements, anthropometric data, quality of life, neuropathy and cost-effectiveness. All outcomes will be measured at baseline, at 27 weeks after inclusion and at 54 weeks after inclusion. The recruitment of participants and the measurements will be completed after 2 years. Linear mixed-effects models will be applied for each outcome variable to analyse the intervention effects.Ethics and disseminationThis study was approved by the Ethics Committee North-western and Central Switzerland in February 2021 (ref: 2020-02755). All participants will be required to provide written informed consent. The results will be published in international peer-reviewed journals.Trial registration numberISRCTN79457541.
| S-EPMC9161069 | biostudies-literature
Project description:This study aims to determine the effectiveness of a phosphate mobile app (PMA), MyKidneyDiet-Phosphate Tracker ©2019, on hemodialysis (HD) patients with hyperphosphatemia. A multicenter, open-label, randomized controlled trial design allowed randomization of patients with hyperphosphatemia to either the usual care group (UG; receiving a single dietitian-led session with an education booklet) or the PMA group (PG). Thirty-three patients in each intervention group completed the 12-week study. Post-intervention, serum phosphorus levels were reduced in both groups (PG: −0.25 ± 0.42 mmol/L, p = 0.001; UG: −0.23 ± 0.33 mmol/L, p < 0.001) without any treatment difference (p > 0.05). Patients in both groups increased their phosphate knowledge (PG: 2.18 ± 3.40, p = 0.001; UG: 2.50 ± 4.50, p = 0.003), without any treatment difference (p > 0.05). Dietary phosphorus intake of both groups was reduced (PG: −188.1 ± 161.3 mg/d, p < 0.001; UG: −266.0 ± 193.3 mg/d, p < 0.001), without any treatment difference (p > 0.05). The serum calcium levels of patients in the UG group increased significantly (0.09 ± 0.20 mmol/L, p = 0.013) but not for the PG group (−0.03 ± 0.13 mmol/L, p = 0.386), and the treatment difference was significant (p = 0.007). As per phosphate binder adherence, both groups reported a significant increase in Morisky Medication Adherence Scale scores (PG: 1.1 ± 1.2, p < 0.001; UGa: 0.8 ± 1.5, p = 0.007), without any treatment difference (p > 0.05). HD patients with hyperphosphatemia using the PMA achieved reductions in serum phosphorus levels and dietary phosphorus intakes along with improved phosphate knowledge and phosphate binder adherence that were not significantly different from a one-off dietitian intervention. However, binder dose adjustment with meal phosphate content facilitated by the PMA allowed stability of corrected calcium levels, which was not attained by UC patients whose binder dose was fixed.
| S-EPMC9224811 | biostudies-literature
Project description:ObjectivesThis study aimed to identify, assess and summarize available scienti?c evidence on tailored text messaging interventions focused on type 2 diabetes self-management. The systematic review concentrated on message design and delivery features, and tailoring strategies. The meta-analysis assessed the moderators of the effectiveness of tailored text messaging interventions.MethodsA comprehensive search strategy included major electronic databases, key journal searches and reference list searching for related studies. PRISMA and Cochrane Collaboration's guidelines and recommended tools for data extraction, quality appraisal and data analysis were followed. Data were extracted on participant characteristics (age, gender, ethnicity), and interventional and methodological characteristics (study design, study setting, study length, choice of modality, comparison group, message type, format, content, use of interactivity, message frequency, message timing, message delivery, tailoring strategies and theory use). Outcome measures included diet, physical activity, medication adherence and glycated hemoglobin data (HbA1C). Where possible, a random effects meta-analysis was performed to pool data on the effectiveness of the tailored text messaging interventions and moderator variables.ResultsThe search returned 13 eligible trials for the systematic review and 11 eligible trials for the meta-analysis. The majority of the studies were randomized controlled trials, conducted in high-income settings, used multi-modalities, and mostly delivered informative, educational messages through an automated message delivery system. Tailored text messaging interventions produced a substantial effect (g?=?0.54, 95% CI?=?0.08-0.99, p?<?0.001) on HbA1C values for a total of 949 patients. Subgroup analyses revealed the importance of some moderators such as message delivery (Q B?=?18.72, df?=?1, p?=?0.001), message direction (Q B?=?5.26, df?=?1, p?=?0.022), message frequency (Q B?=?18.72, df?=?1, p?=?0.000) and using multi-modalities (Q B?=?6.18, df?=?1, p?=?0.013).ConclusionsTailored mobile text messaging interventions can improve glycemic control in type 2 diabetes patients. However, more rigorous interventions with larger samples and longer follow-ups are required to confirm these findings and explore the effects of tailored text messaging on other self-management outcomes.
| S-EPMC6481002 | biostudies-literature
Project description:INTRODUCTION:Carbohydrate restriction markedly improves glycemic control in patients with type 2 diabetes (T2D) but necessitates prompt medication changes. Therefore, we assessed the effectiveness and safety of a novel care model providing continuous remote care with medication management based on biometric feedback combined with the metabolic approach of nutritional ketosis for T2D management. METHODS:We conducted an open-label, non-randomized, controlled, before-and-after 1-year study of this continuous care intervention (CCI) and usual care (UC). Primary outcomes were glycosylated hemoglobin (HbA1c), weight, and medication use. Secondary outcomes included fasting serum glucose and insulin, HOMA-IR, blood lipids and lipoproteins, liver and kidney function markers, and high-sensitivity C-reactive protein (hsCRP). RESULTS:349 adults with T2D enrolled: CCI: n = 262 [mean (SD); 54 (8) years, 116.5 (25.9) kg, 40.4 (8.8) kg m2, 92% obese, 88% prescribed T2D medication]; UC: n = 87 (52 (10) years, 105.6 (22.15) kg, 36.72 (7.26) kg m2, 82% obese, 87% prescribed T2D medication]. 218 participants (83%) remained enrolled in the CCI at 1 year. Intention-to-treat analysis of the CCI (mean ± SE) revealed HbA1c declined from 59.6 ± 1.0 to 45.2 ± 0.8 mmol mol-1 (7.6 ± 0.09% to 6.3 ± 0.07%, P < 1.0 × 10-16), weight declined 13.8 ± 0.71 kg (P < 1.0 × 10-16), and T2D medication prescription other than metformin declined from 56.9 ± 3.1% to 29.7 ± 3.0% (P < 1.0 × 10-16). Insulin therapy was reduced or eliminated in 94% of users; sulfonylureas were entirely eliminated in the CCI. No adverse events were attributed to the CCI. Additional CCI 1-year effects were HOMA-IR - 55% (P = 3.2 × 10-5), hsCRP - 39% (P < 1.0 × 10-16), triglycerides - 24% (P < 1.0 × 10-16), HDL-cholesterol + 18% (P < 1.0 × 10-16), and LDL-cholesterol + 10% (P = 5.1 × 10-5); serum creatinine and liver enzymes (ALT, AST, and ALP) declined (P ≤ 0.0001), and apolipoprotein B was unchanged (P = 0.37). UC participants had no significant changes in biomarkers or T2D medication prescription at 1 year. CONCLUSIONS:These results demonstrate that a novel metabolic and continuous remote care model can support adults with T2D to safely improve HbA1c, weight, and other biomarkers while reducing diabetes medication use. CLINICALTRIALS. GOV IDENTIFIER:NCT02519309. FUNDING:Virta Health Corp.
| S-EPMC6104272 | biostudies-literature
Project description:BackgroundDespite decreasing prevalence over the last several decades, cigarette smoking remains the leading cause of preventable death and disease, underscoring the need for innovative, effective solutions. Pivot is a novel, inclusive smoking cessation program designed for smokers along the entire spectrum of readiness to quit. Pivot leverages proven methods and technological advancements, including a personal portable breath carbon monoxide sensor, smartphone app, and in-app text-based coaching. We previously reported outcomes from the end of active Pivot program participation in 319 adult smokers. Herein, we report longer-term follow up in this cohort.ObjectiveThe aim of this study was to assess and report participant outcomes 3 months after completion of Pivot, including smoking behavior, quit rates, continuous abstinence rates and durability, and predictors of abstinence.MethodsThis prospective remote cohort study included US-based cigarette smokers aged 18 to 65 years who smoked ?5 cigarettes per day (CPD). Three months after completion of active participation in Pivot, final follow-up data were collected via an online questionnaire. Outcomes included smoking behavior (CPD and quit attempts), self-reported quit rates (7- and 30-day point prevalence abstinence [PPA]), and continuous abstinence rates (proportion who achieved uninterrupted abstinence) and duration. Exploratory regression analyses were performed to identify baseline characteristics associated with achievement of 7-day PPA, 30-day PPA, and continuous abstinence.ResultsA total of 319 participants completed onboarding (intention-to-treat [ITT]); 288/319 participants (90.3%) completed follow up (completers) at a mean of 7.2 (SD 1.2) months after onboarding. At final follow up, CPD were reduced by 52.6% (SE 2.1; P<.001) among all 319 participants, and most completers (152/288, 52.8%) reduced their CPD by at least 50%. Overall, most completers (232/288, 80.6%) made at least one quit attempt. Quit rates increased after the end of Pivot; using ITT analyses, 35.4% (113/319) achieved 7-day PPA and 31.3% (100/319) achieved 30-day PPA at final follow up compared with 32.0% (102/319) and 27.6% (88/319), respectively, at the end of the Pivot program. Continuous abstinence was achieved in about a quarter of those who onboarded (76/319, 23.8%) and in most who reported 30-day PPA at the end of Pivot (76/88, 86.4%), with a mean abstinence duration of 5.8 (SD 0.6) months. In exploratory regression analyses, lower baseline CPD, more positive baseline attitudes reflecting higher self-efficacy (higher confidence to quit and lower perceived difficulty of quitting), and higher education were associated with achieving abstinence.ConclusionsThis study provides the first longer-term outcomes of the Pivot smoking cessation program. At final follow up, quit rates increased and continuous abstinence was favorable; the majority who achieved abstinence at the end of Pivot sustained abstinence throughout follow up. Decreases in CPD persisted and most participants made a quit attempt. Overall, final follow-up outcomes were stable or improved when compared to previous outcomes from the end of the program. These findings validate earlier results, and suggest that Pivot is an effective and durable solution for smoking cessation.Trial registrationClinicalTrials.gov NCT03295643; https://clinicaltrials.gov/ct2/show/NCT03295643.
| S-EPMC7920755 | biostudies-literature
Project description:BackgroundMobile health (mHealth) is increasingly advocated for diabetes management. It is unclear if mobile applications are effective in improving glycaemic control, clinical outcomes, quality of life and overall patient satisfaction in patients with type 2 diabetes (T2DM). A new mobile application was specifically built for people with T2DM with the help of the local expertise. The objective of the study was to evaluate the effectiveness of the mobile app.MethodsThe planned study is an ongoing open-label randomised controlled trial in which adults living with T2DM treated with insulin will be randomised 1:1 to the use of this diabetes application versus current standard care. The primary outcome will be the difference in mean HbA1c from baseline to 6 months. Other outcome measures include anthropometric measures, hypoglycaemic events, medication adjustments, number of clinical interactions and missed appointments and patient perceptions of their disease and diabetes self-management. The study will randomise 180 subjects for assessment of the primary outcome.DiscussionWe hypothesise that the diabetes-specific mobile application will improve glycaemic control, increase patient empowerment for self-management of diabetes and improve interaction between patients and healthcare providers. If the Qatar Diabetes Mobile Application Trial (QDMAT) demonstrates this, it will inform clinical services for the future self-management of T2DM.Trial registrationClinicalTrials.gov Identifier: NCT03998267 . Registered on 26 June 2019.
| S-EPMC9205079 | biostudies-literature
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| S-EPMC6104276 | biostudies-literature
Project description:BACKGROUND:Diabetes and obesity have become epidemics and costly chronic diseases. The impact of mobile health (mHealth) interventions on diabetes and obesity management is promising; however, studies showed varied results in the efficacy of mHealth interventions. OBJECTIVE:This review aimed to evaluate the effectiveness of mHealth interventions for diabetes and obesity treatment and management on the basis of evidence reported in reviews and meta-analyses and to provide recommendations for future interventions and research. METHODS:We systematically searched the PubMed, IEEE Xplore Digital Library, and Cochrane databases for systematic reviews published between January 1, 2005, and October 1, 2019. We analyzed 17 reviews, which assessed 55,604 original intervention studies, that met the inclusion criteria. Of those, 6 reviews were included in our meta-analysis. RESULTS:The reviews primarily focused on the use of mobile apps and text messaging and the self-monitoring and management function of mHealth programs in patients with diabetes and obesity. All reviews examined changes in biomarkers, and some reviews assessed treatment adherence (n=7) and health behaviors (n=9). Although the effectiveness of mHealth interventions varied widely by study, all reviews concluded that mHealth was a feasible option and had the potential for improving patient health when compared with standard care, especially for glycemic control (-0.3% to -0.5% greater reduction in hemoglobin A1c) and weight reduction (-1.0 kg to -2.4 kg body weight). Overall, the existing 6 meta-analysis studies showed pooled favorable effects of these mHealth interventions (-0.79, 95% CI -1.17 to -0.42; I2=90.5). CONCLUSIONS:mHealth interventions are promising, but there is limited evidence about their effectiveness in glycemic control and weight reduction. Future research to develop evidence-based mHealth strategies should use valid measures and rigorous study designs. To enhance the effectiveness of mHealth interventions, future studies are warranted for the optimal formats and the frequency of contacting patients, better tailoring of messages, and enhancing usability, which places a greater emphasis on maintaining effectiveness over time.
| S-EPMC7218595 | biostudies-literature