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A mobile telehealth intervention for adults with insulin-requiring diabetes: early results of a mixed-methods randomized controlled trial.

ABSTRACT: BACKGROUND:The role of technology in health care delivery has grown rapidly in the last decade. The potential of mobile telehealth (MTH) to support patient self-management is a key area of research. Providing patients with technological tools that allow for the recording and transmission of health parameters to health care professionals (HCPs) may promote behavior changes that result in improved health outcomes. Although for some conditions the evidence of the effectiveness of MTH is clear, to date the findings on the effects of MTH on diabetes management remain inconsistent. OBJECTIVE:This study aims to evaluate an MTH intervention among insulin-requiring adults with diabetes to establish whether supplementing standard care with MTH results in improved health outcomes-glycated hemoglobin (HbA1c), blood pressure (BP), health-related quality of life (HRQoL), diabetes self-management behaviors, diabetes health care utilization, and diabetes self-efficacy and illness beliefs. An additional objective was to explore the acceptability of MTH and patients' perceptions of, and experience, using it. METHODS:A mixed-method design consisting of a 9-month, two-arm, parallel randomized controlled trial (RCT) was used in combination with exit qualitative interviews. Quantitative data was collected at baseline, 3 months, and 9 months. Additional intervention fidelity data, such as participants' MTH transmissions and contacts with the MTH nurse during the study, were also recorded. RESULTS:Data collection for both the quantitative and qualitative components of this study has ended and data analysis is ongoing. A total of 86 participants were enrolled into the study. Out of 86 participants, 45 (52%) were randomized to the intervention group and 36 (42%) to the control group. Preliminary data on MTH training sessions and MTH usage by intervention participants are presented in this paper. We expect to publish complete study results in 2015. CONCLUSIONS:The range of data collected in this study will allow for a comprehensive evaluation of processes and outcomes. The early results presented suggest that MTH usage decreases over time and that MTH participants would benefit from attending more than one training session. TRIAL REGISTRATION:ClinicalTrials.gov NCT00922376; http://clinicaltrials.gov/ct2/show/NCT00922376 (Archived by WebCite at http://www.webcitation.org/6Vu4nhLI6).

SUBMITTER: Baron J

PROVIDER: S-EPMC4376177 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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A mobile telehealth intervention for adults with insulin-requiring diabetes: early results of a mixed-methods randomized controlled trial.

Baron Justine J Hirani Shashivadan S Newman Stanton S

JMIR research protocols 20150226 1

<h4>Background</h4>The role of technology in health care delivery has grown rapidly in the last decade. The potential of mobile telehealth (MTH) to support patient self-management is a key area of research. Providing patients with technological tools that allow for the recording and transmission of health parameters to health care professionals (HCPs) may promote behavior changes that result in improved health outcomes. Although for some conditions the evidence of the effectiveness of MTH is cle ...[more]

PMID: 25803226

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Project description:BACKGROUND:Successful treatment of diabetes includes patient self-management behaviors to prevent or delay complications and comorbid diseases. On the basis of findings from large clinical trials and professional guidelines, diabetes education programs and health providers prescribe daily regimens of glucose monitoring, healthy eating, stress management, medication adherence, and physical activity. Consistent, long-term commitment to regimens is challenging. Mobile health is increasingly being used to assist patients with lifestyle changes and self-management behaviors between provider visits. The effectiveness of mobile health to improve diabetes outcomes depends on patient engagement with a technology, content, or interactions with providers. OBJECTIVES:In the current analysis, we aimed to identify patient engagement themes in diabetes messaging with diabetes providers and determine if differences in engagement in the Mobile Diabetes Intervention Study (MDIS) influenced changes in glycated hemoglobin A1c (HbA1c) over a 1-year treatment period (1.9% absolute decrease in the parent study). METHODS:In the primary MDIS study, 163 patients were enrolled into 1 of 3 mobile intervention groups or a usual care control group based on their physician cluster randomization assignment. The control group received care from their physicians as usual. Participants in each intervention group had access to a patient portal where they could record monitoring values for blood glucose, blood pressure, medication changes, or other self-management information while also assigned to varying levels of physician access to patient data. Intervention participants could choose to send and receive messages to assigned certified diabetes educators with questions or updates through the secure Web portal. For this secondary analysis, patient engagement was measured using qualitative methods to identify self-care themes in 4109 patient messages. Mixed methods were used to determine the impact of patient engagement on change in HbA1c over 1 year. RESULTS:Self-care behavior themes that received the highest engagement for participants were glucose monitoring (75/107, 70.1%), medication management (71/107, 66.4%), and reducing risks (71/107, 66.4%). The average number of messages sent per patient were highest for glucose monitoring (9.2, SD 14.0) and healthy eating (6.9, SD 13.2). Compared to sending no messages, sending any messages about glucose monitoring (P=.03) or medication (P=.01) led to a decrease in HbA1c of 0.62 and 0.72 percentage points, respectively. Sending any messages about healthy eating, glucose monitoring, or medication combined led to a decrease in HbA1c of 0.54 percentage points compared to not sending messages in these themes (P=.045). CONCLUSIONS:The findings from this study help validate the efficacy of the mobile diabetes intervention. The next step is to determine differences between patients who engage in mobile interventions and those who do not engage and identify methods to enhance patient engagement. TRIAL REGISTRATION:ClinicalTrials.gov: NCT01107015; https://clinicaltrials.gov/ct2/show/NCT01107015 (Archived by WebCite at http://www.webcitation.org/6wh4ekP4R).

Project description:BackgroundDigital mental health interventions may help middle-aged and older adults with depression overcome barriers to accessing traditional care, but few studies have investigated their use in this population.ObjectiveThis pilot study examines the feasibility, acceptability, and potential efficacy of the Meru Health Program, an 8-week mobile app-delivered intervention.MethodsA total of 20 community-dwelling middle-aged and older adults (age: mean 61.7 years, SD 11.3) with elevated depressive symptoms participated in a single-arm pilot study investigating the Meru Health Program, an app-delivered intervention supported by remote therapists. The program primarily uses mindfulness and cognitive behavioral skills to target depressive symptoms. A semistructured interview was completed at the baseline to establish current psychiatric diagnoses. Depressive symptoms were measured using the Patient Health Questionnaire and Patient-Reported Outcomes Measurement Information System (PROMIS) depression measures. Anxiety symptoms were measured using the Generalized Anxiety Disorder Scale and the PROMIS Anxiety measure. User experience and acceptability were examined through surveys and qualitative interviews.ResultsIn total, 90% (18/20) of the participants completed the program, with 75% (15/20) completing at least 7 of the 8 introductory weekly lessons. On average, participants completed 60 minutes of practice and exchanged 5 messages with their therapists every week. The app was rated as helpful by 89% (17/19) participants. Significant decreases in depressive (P=.03) and anxiety symptom measures (P=.01) were found; 45% (9/20) of participants showed clinically significant improvement in either depressive symptoms or anxiety symptoms.ConclusionsThe findings suggest that the commercially available Meru Health Program may be feasible, acceptable, and potentially beneficial to middle-aged and older adults. Although larger controlled trials are needed to demonstrate efficacy, these findings suggest that digital health interventions may benefit adults of all ages.

Project description:BackgroundPeople of low socioeconomic position (SEP) are disproportionately affected by type 2 diabetes (T2D), partly due to unhealthy eating patterns that contribute to inadequate disease self-management and prognosis. Digital technologies have the potential to provide a suitable medium to facilitate diabetes education, support self-management, and address some of the barriers to healthy eating, such as lack of nutritional knowledge or shopping or cooking skills, in this target group.ObjectiveThis study aims to test the feasibility, appeal, and potential effectiveness of EatSmart, a 12-week, evidence-based, theoretically grounded, fully automated web-based and mobile-delivered healthy eating behavior change program to help disadvantaged people living with T2D to eat healthily on a budget and improve diabetes self-management.MethodsEatSmart is a mixed methods (quantitative and qualitative) pre-post design pilot study. Sixty socioeconomically disadvantaged people with T2D aged 18 to 75 years will be recruited. Participants will complete self-reported baseline assessments of their basic demographic and clinical data, dietary intake, dietary self-efficacy, and barriers to healthy eating. They will be provided with login access to the EatSmart web program, which includes six progressive skill-based modules covering healthy eating planning; smart food budgeting and shopping; time-saving meal strategies, healthy cooking methods, modifying recipes; and a final reinforcement and summary module. Over the 3-month intervention, participants will also receive 3 text messages weekly, encouraging them to review goals, continue to engage with different components of the EatSmart web program, and eat healthily. Participants will undertake follow-up assessments directly following the intervention 3 months post baseline and again after a 6-month postintervention follow-up period (9 months post baseline). Feasibility will be evaluated using the number of participants recruited and retained and objective indicators of engagement with the website. Program appeal and potential effects on primary and secondary outcomes will be assessed via the same surveys used at baseline, with additional questions asking about experience with and perceptions of the program. In-depth qualitative interviews will also be conducted 6 months post intervention to provide deeper insight into experiences with EatSmart and a more comprehensive description of the program's appeal.ResultsThe EatSmart website has been developed, and all participants have viewed the modules as of May 2020. Results are expected to be submitted for publication in December 2020.ConclusionsThis study will provide data to address the currently limited evidence regarding whether disadvantaged populations with T2D may benefit from digitally delivered behavior change programs that facilitate eating healthily on a budget.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12619001111167; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619001111167.International registered report identifier (irrid)DERR1-10.2196/19488.

Project description:BackgroundFathers make unique and central contributions to the health of their children. However, research in type 1 diabetes (T1D) education largely ignores the needs of fathers, including during the development of online and mobile educational materials.ObjectiveThe purpose of this study was to solicit and incorporate input from fathers of children with T1D into the design, content, and infrastructure of a suite of online diabetes self-management education and support (DSMES) resources.MethodsThe study took part in three phases: (1) exploratory research, (2) website and subdomain development, and (3) evaluation. Fathers of children with T1D (n=30) completed surveys and semistructured qualitative interviews. Thematic content analysis was used to identify fathers' content and design preferences. An online DSMES website (T1DToolkit.org) and a separate mobile subdomain targeting fathers (Mobile Diabetes Advice for Dads, or mDAD) were developed. A prototype of the site for fathers was evaluated by 33 additional father participants. End user feedback was elicited via survey.ResultsParticipants in the exploratory phase were enthusiastic about the online diabetes resources. Preferences included high-quality design, availability via mobile phone and tablet, brief text content supplemented with multimedia and interactive features, reminders via text or email, endorsement by medical professionals, and links to scientific evidence. The mDAD subdomain received high usability and acceptability ratings, with 100% of participants very likely or likely to use the site again.ConclusionsThe development of eHealth educational platforms for fathers of children with T1D remains an unmet need in optimizing diabetes management. This study incorporated fathers' feedback into the development of a suite of online diabetes education resources. The findings will serve as the basis for future research to assess the clinical efficacy of the website, its subdomain targeting fathers, and additional subdomains targeting unique populations.

Project description:BackgroundA healthy lifestyle may improve mental health. It is yet not known whether and how a mobile intervention can be of help in achieving this in adolescents. This study investigated the effectiveness and perceived underlying mechanisms of the mobile health (mHealth) intervention #LIFEGOALS to promote healthy lifestyles and mental health. #LIFEGOALS is an evidence-based app with activity tracker, including self-regulation techniques, gamification elements, a support chatbot, and health narrative videos.MethodsA quasi-randomized controlled trial (N = 279) with 12-week intervention period and process evaluation interviews (n = 13) took place during the COVID-19 pandemic. Adolescents (12-15y) from the general population were allocated at school-level to the intervention (n = 184) or to a no-intervention group (n = 95). Health-related quality of life (HRQoL), psychological well-being, mood, self-perception, peer support, resilience, depressed feelings, sleep quality and breakfast frequency were assessed via a web-based survey; physical activity, sedentary time, and sleep routine via Axivity accelerometers. Multilevel generalized linear models were fitted to investigate intervention effects and moderation by pandemic-related measures. Interviews were coded using thematic analysis.ResultsNon-usage attrition was high: 18% of the participants in the intervention group never used the app. An additional 30% stopped usage by the second week. Beneficial intervention effects were found for physical activity (χ21 = 4.36, P = .04), sedentary behavior (χ21 = 6.44, P = .01), sleep quality (χ21 = 6.11, P = .01), and mood (χ21 = 2.30, P = .02). However, effects on activity-related behavior were only present for adolescents having normal sports access, and effects on mood only for adolescents with full in-school education. HRQoL (χ22 = 14.72, P < .001), mood (χ21 = 6.03, P = .01), and peer support (χ21 = 13.69, P < .001) worsened in adolescents with pandemic-induced remote-education. Interviewees reported that the reward system, self-regulation guidance, and increased health awareness had contributed to their behavior change. They also pointed to the importance of social factors, quality of technology and autonomy for mHealth effectiveness.Conclusions#LIFEGOALS showed mixed results on health behaviors and mental health. The findings highlight the role of contextual factors for mHealth promotion in adolescence, and provide suggestions to optimize support by a chatbot and narrative episodes.Trial registrationClinicalTrials.gov [NCT04719858], registered on 22/01/2021.

Project description:BackgroundPatient engagement attrition in mobile health (mHealth) remote patient monitoring (RPM) programs decreases program benefits. Systemic disparities lead to inequities in RPM adoption and use. There is an urgent need to understand patients' experiences with RPM in the real world, especially for patients who have stopped using the programs, as addressing issues faced by patients can increase the value of mHealth for patients and subsequently decrease attrition.ObjectiveThis study sought to understand patient engagement and experiences in an RPM mHealth intervention in lung transplant recipients.MethodsBetween May 4, 2020, and November 1, 2022, a total of 601 lung transplant recipients were enrolled in an mHealth RPM intervention to monitor lung function. The predictors of patient engagement were evaluated using multivariable logistic and linear regression. Semistructured interviews were conducted with 6 of 39 patients who had engaged in the first month but stopped using the program, and common themes were identified.ResultsPatients who underwent transplant more than 1 year before enrollment in the program had 84% lower odds of engaging (odds ratio [OR] 0.16, 95% CI 0.07-0.35), 82% lower odds of submitting pulmonary function measurements (OR 0.18, 95% CI 0.09-0.33), and 78% lower odds of completing symptom checklists (OR 0.22, 95% CI 0.10-0.43). Patients whose primary language was not English had 78% lower odds of engaging compared to English speakers (OR 0.22, 95% CI 0.07-0.67). Interviews revealed 4 prominent themes: challenges with devices, communication breakdowns, a desire for more personal interactions and specific feedback with the care team about their results, understanding the purpose of the chat, and understanding how their data are used.ConclusionsCare delivery and patient experiences with RPM in lung transplant mHealth can be improved and made more equitable by tailoring outreach and enhancements toward non-English speakers and patients with a longer time between transplant and enrollment. Attention to designing programs to provide personalization through supplementary provider contact, education, and information transparency may decrease attrition rates.

Project description:IntroductionObesity and physical inactivity are major societal challenges and significant contributors to the global burden of disease and healthcare costs. Information and communication technologies are increasingly being used in interventions to promote behaviour change in diet and physical activity. In particular, social networking platforms seem promising for the delivery of weight control interventions.We intend to pilot test an intervention involving the use of a social networking mobile application and tracking devices (Fitbit Flex 2 and Fitbit Aria scale) to promote the social comparison of weight and physical activity, in order to evaluate whether mechanisms of social influence lead to changes in those outcomes over the course of the study.Methods and analysisMixed-methods study involving semi-structured interviews and a pre-post quasi-experimental pilot with one arm, where healthy participants in different body mass index (BMI) categories, aged between 19 and 35 years old, will be subjected to a social networking intervention over a 6-month period. The primary outcome is the average difference in weight before and after the intervention. Secondary outcomes include BMI, number of steps per day, engagement with the intervention, social support and system usability. Semi-structured interviews will assess participants' expectations and perceptions regarding the intervention.Ethics and disseminationEthics approval was granted by Macquarie University's Human Research Ethics Committee for Medical Sciences on 3 November 2016 (ethics reference number 5201600716).The social network will be moderated by a researcher with clinical expertise, who will monitor and respond to concerns raised by participants. Monitoring will involve daily observation of measures collected by the fitness tracker and the wireless scale, as well as continuous supervision of forum interactions and posts. Additionally, a protocol is in place to monitor for participant misbehaviour and direct participants-in-need to appropriate sources of help.

Project description:ObjectiveTo develop a conceptual model for effective use of telehealth in the management of chronic health conditions, and to use this to develop and evaluate an intervention for people with two exemplar conditions: raised cardiovascular disease risk and depression.DesignThe model was based on several strands of evidence: a metareview and realist synthesis of quantitative and qualitative evidence on telehealth for chronic conditions; a qualitative study of patients' and health professionals' experience of telehealth; a quantitative survey of patients' interest in using telehealth; and review of existing models of chronic condition management and evidence-based treatment guidelines. Based on these evidence strands, a model was developed and then refined at a stakeholder workshop. Then a telehealth intervention ('Healthlines') was designed by incorporating strategies to address each of the model components. The model also provided a framework for evaluation of this intervention within parallel randomised controlled trials in the two exemplar conditions, and the accompanying process evaluations and economic evaluations.SettingPrimary care.ResultsThe TElehealth in CHronic Disease (TECH) model proposes that attention to four components will offer interventions the best chance of success: (1) engagement of patients and health professionals, (2) effective chronic disease management (including subcomponents of self-management, optimisation of treatment, care coordination), (3) partnership between providers and (4) patient, social and health system context. Key intended outcomes are improved health, access to care, patient experience and cost-effective care.ConclusionsA conceptual model has been developed based on multiple sources of evidence which articulates how telehealth may best provide benefits for patients with chronic health conditions. It can be used to structure the design and evaluation of telehealth programmes which aim to be acceptable to patients and providers, and cost-effective.

Dataset Information

A mobile telehealth intervention for adults with insulin-requiring diabetes: early results of a mixed-methods randomized controlled trial.

Publications

A mobile telehealth intervention for adults with insulin-requiring diabetes: early results of a mixed-methods randomized controlled trial.

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