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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: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.

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: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:BackgroundDiabetes mellitus is a major health problem among people with physical disabilities. Health coaching has been proven to be an effective approach in terms of behavioral changes, patient self-efficacy, adherence to treatment, health service use, and health outcomes. Telehealth systems combined with health coaching have the potential to improve the quality of health care by increasing access to services. Treatment fidelity is particularly important for behavior change studies; however, fidelity protocols are inadequately administered and reported in the literature.ObjectiveThe aim of this study is to outline all the intervention fidelity strategies and procedures of a telecoaching intervention-artificial intelligence for diabetes management (AI4DM)-which is a randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of a telehealth platform in adults with type 2 diabetes and permanent impaired mobility. AI4DM aims to create a web-based disability-inclusive diabetes self-management program. We selected the National Institutes of Health Behavior Change Consortium (NIH BCC) fidelity framework to describe strategies to ensure intervention fidelity in our research.MethodsWe have developed fidelity strategies based on the five fidelity domains outlined by the NIH BCC-focusing on study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. The design of the study is grounded in the social cognitive theory and is intended to ensure that both arms would receive the same amount of attention from the intervention. All providers will receive standardized training to deliver consistent health coaching to the participants. The intervention will be delivered through various controlling and monitoring strategies to reduce differences within and between treatment groups. The content and structure of the study are delivered to ensure comprehension and participation among individuals with low health literacy. By constantly reviewing and monitoring participant progress and protocol adherence, we intend to ensure that participants use cognitive and behavioral skills in real-world settings to engage in health behavior.ResultsEnrollment for AI4DM will begin in October 2021 and end in October 2022. The results of this study will be reported in late 2022.ConclusionsDeveloping and using fidelity protocols in behavior change studies is essential to ensure the internal and external validity of interventions. This study incorporates NIH BCC recommendations into an artificial intelligence embedded telecoaching platform for diabetes management designed for people with physical disabilities. The developed fidelity protocol can provide guidance for other researchers conducting telehealth interventions within behavioral health settings to present more consistent and reproducible research.Trial registrationClinicalTrials.gov NCT04927377; http://clinicaltrials.gov/ct2/show/NCT04927377.International registered report identifier (irrid)PRR1-10.2196/31695.

Project description:BackgroundAlthough healthy aging can be stimulated by the reduction of sedentary behavior, few interventions are available for older adults. Previous studies suggest that self-monitoring might be a promising behavior change technique to reduce older adults' sedentary behavior. However, little is known about older adults' experiences with a self-monitoring-based intervention aimed at the reduction of sedentary behavior.ObjectiveThe aim of this study is to evaluate engagement, acceptability, usability, and preliminary efficacy of a self-monitoring-based mHealth intervention developed to reduce older adults' sedentary behavior.MethodsA mixed methods study was performed among 28 community-dwelling older adults living in Flanders, Belgium. The 3-week intervention consisted of general sedentary behavior information as well as visual and tactile feedback on participants' sedentary behavior. Semistructured interviews were conducted to explore engagement with, and acceptability and usability of, the intervention. Sitting time was measured using the thigh-worn activPAL (PAL Technologies) accelerometer before and after the intervention. System usage data of the app were recorded. Quantitative data were analyzed using descriptive statistics and paired-samples t tests; qualitative data were thematically analyzed and presented using pen profiles.ResultsParticipants mainly reported positive feelings regarding the intervention, referring to it as motivating, surprising, and interesting. They commonly reported that the intervention changed their thinking (ie, they became more aware of their sedentary behavior) but not their actual behavior. There were mixed opinions on the kind of feedback (ie, tactile vs visual) that they preferred. The intervention was considered easy to use, and the design was described as clear. Some problems were noticed regarding attaching and wearing the self-monitoring device. System usage data showed that the median frequency of consulting the app widely differed among participants, ranging from 0 to 20 times a day. No significant reductions were found in objectively measured sitting time.ConclusionsAlthough the intervention was well perceived by the majority of older adults, no reductions in sitting time were found. Possible explanations for the lack of reductions might be the short intervention duration or the fact that only bringing the habitual sedentary behavior into conscious awareness might not be sufficient to achieve behavior change.Trial registrationClinicalTrials.gov NCT04003324; https://tinyurl.com/y2p4g8hx.

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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