Justine Baron

The Impact of Mobile Monitoring Technologies on Glycosylated Hemoglobin in Diabetes: A Systematic Review

Background: A new development in the field of telehealth is the use of mobile health technologies (mhealth) to help patients record and track medical information. Mhealth appears particularly advantageous for conditions that require intense and ongoing monitoring, such as diabetes, and where people are of working age and not disabled. This review aims to evaluate the evidence for the effectiveness of mhealth interventions in diabetes management on glycosylated hemoglobin. Method: A comprehensive search strategy was developed and applied to eight electronic databases to identify studies that investigated the clinical effectiveness of mobile-based applications that allowed patients to record and send their blood glucose readings to a central server. The eligibility of 8543 papers was assessed against the selection criteria, and 24 papers were reviewed. All studies reviewed were assessed for quality using a standardized quality assessment tool. Results: Results for patients with type 1 and type 2 diabetes were examined separately. Study variability and poor reporting made comparison difficult, and most studies had important methodological weaknesses. Evidence on the effectiveness of mhealth interventions for diabetes was inconsistent for both types of diabetes and remains weak.

A randomised, controlled trial of the effects of a mobile telehealth intervention on clinical and patient-reported outcomes in people with poorly controlled diabetes.

Objective The objective of this research is to determine the effects of mobile telehealth (MTH) on glycosylated haemoglobin (HbA1c) and other clinical and patient-reported outcomes in insulin-requiring people with diabetes. Methods A nine-month randomised, controlled trial compared standard care to standard care supplemented with MTH (self-monitoring, mobile-phone data transmissions, graphical and nurse-initiated feedback, and educational calls). Clinical (HbA1c, blood pressure, daily insulin dose, diabetes outpatient appointments (DOAs)) and questionnaire data (health-related quality of life, depression, anxiety) were collected. Mean group changes over time were compared using hierarchical linear models and Mann-Whitney tests. Results Eighty-one participants with a baseline HbA1c of 8.98% ± 1.82 were randomised to the intervention (n = 45) and standard care (n = 36). The Group by Time effect revealed MTH did not significantly influence HbA1c (p = 0.228), but p values were borderline significant for blood pressure (p = 0.054) and mental-health related quality of life (p = 0.057). Examination of effect sizes and 95% confidence intervals for mean group differences at nine months supported the existence of a protective effect of MTH on mental health-related quality of life as well as depression. None of the other measured outcomes were found to be affected by the MTH intervention. Conclusions Findings from this study must be interpreted with caution given the small sample size, but they do not support the widespread adoption of MTH to achieve clinically significant changes in HbA1c. MTH may, however, have positive effects on blood pressure and protective effects on some aspects of mental health.

A Mobile Telehealth Intervention for Adults With Insulin-Requiring Diabetes: Early Results of a Mixed-Methods Randomized Controlled Trial

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).

Methods used to address fidelity of receipt in health intervention research: a citation analysis and systematic review

BackgroundThe American Behaviour Change Consortium (BCC) framework acknowledges patients as active participants and supports the need to investigate the fidelity with which they receive interventions, i.e. receipt. According to this framework, addressing receipt consists in using strategies to assess or enhance participants’ understanding and/or performance of intervention skills. This systematic review aims to establish the frequency with which receipt is addressed as defined in the BCC framework in health research, and to describe the methods used in papers informed by the BCC framework and in the wider literature.MethodsA forward citation search on papers presenting the BCC framework was performed to determine the frequency with which receipt as defined in this framework was addressed. A second electronic database search, including search terms pertaining to fidelity, receipt, health and process evaluations was performed to identify papers reporting on receipt in the wider literature and irrespective of the framework used. These results were combined with forward citation search results to review methods to assess receipt. Eligibility criteria and data extraction forms were developed and applied to papers. Results are described in a narrative synthesis.Results19.6% of 33 studies identified from the forward citation search to report on fidelity were found to address receipt. In 60.6% of these, receipt was assessed in relation to understanding and in 42.4% in relation to performance of skill. Strategies to enhance these were present in 12.1% and 21.1% of studies, respectively. Fifty-five studies were included in the review of the wider literature. Several frameworks and operationalisations of receipt were reported, but the latter were not always consistent with the guiding framework. Receipt was most frequently operationalised in relation to intervention content (16.4%), satisfaction (14.5%), engagement (14.5%), and attendance (14.5%). The majority of studies (90.0%) included subjective assessments of receipt. These relied on quantitative (76.0%) rather than qualitative (42.0%) methods and studies collected data on intervention recipients (50.0%), intervention deliverers (28.0%), or both (22.0%). Few studies (26.0%) reported on the reliability or validity of methods used.ConclusionsReceipt is infrequently addressed in health research and improvements to methods of assessment and reporting are required.

Challenges in Patient Recruitment, Implementation, and Fidelity in a Mobile Telehealth Study

INTRODUCTION Mobile telehealth (MTH) evaluations in diabetes have been conducted, but few report details and issues related to recruitment, implementation (intervention delivery), fidelity, and context. These have important implications on the interpretation of the findings and effectiveness of the intervention. This article reports these data from an MTH study and describes the challenges experienced in running an intervention such as this in an active clinical environment. MATERIALS AND METHODS We conducted a mixed-methods MTH study that included a 9-month randomized controlled trial in people with poorly controlled diabetes. Detailed recruitment data were recorded during the study. Data on contacts between MTH participants and the MTH team were collected and used to report on intervention delivery and fidelity. Meeting and field notes, as well as communications between research team members during the study, were used to report on the contextual factors that affected recruitment, implementation, and fidelity. RESULTS The recruited sample size represented 6% of the total clinic population (n = 1,360) and 10.7% of the number of potentially eligible people at the clinic (n = 802) identified at the beginning of the study. Contextual factors related to patients, healthcare providers, the institution, or the recruitment protocol contributed to influence access to study participants and the number of participants randomized (n = 81). Technical and device-related aspects of the MTH intervention were delivered successfully, but the expected education and clinical feedback by the MTH nurse were not delivered according to the protocol. Although 92.5% of introductory calls were made by the MTH nurses, only 13.3% of expected educational calls were performed. Changes to the MTH nursing staff affected intervention participants differently and contributed to the low fidelity of intervention delivery. CONCLUSIONS The current article presents data on the influence of contextual factors on the conduct of this MTH study and underlines the need for these processes to be assessed and reported adequately in future MTH research.

Investigating the behavioural effects of a mobile-phone based home telehealth intervention in people with insulin-requiring diabetes: Results of a randomized controlled trial with patient interviews.

Introduction Evidence supporting home telehealth effects on clinical outcomes in diabetes is available, yet mechanisms of action for these improvements remain poorly understood. Behavioural change is one plausible explanation. This study investigated the behavioural effects of a mobile-phone based home telehealth (MTH) intervention in people with diabetes. It was hypothesized that MTH would improve self-efficacy, illness beliefs, and diabetes self-care. Methods A randomized controlled trial compared standard care to standard care supplemented with MTH (self-monitoring, data transmission, graphical and nurse-initiated feedback, educational calls). Self-report measures of self-efficacy, illness beliefs, and self-care were repeated at baseline, three months, and nine months. MTH effects were based on the group by time interactions in hierarchical linear models and effect sizes with 95% confidence intervals (CIs). Interviews with MTH participants explored the perceived effects of MTH on diabetes self-management. Results Eighty-one participants were randomized to the intervention (n = 45) and standard care (n = 36). Significant group by time effects were observed for five out of seven self-efficacy subscales. Effect sizes were large, particularly at nine months. Interaction effects for illness beliefs and self-care were non-significant, but effect sizes and confidence intervals suggested MTH may positively affect diet and exercise. In interviews, MTH was associated with increased awareness, motivation, and a greater sense of security. Improved self-monitoring and diet were reported by some participants. Discussion MTH empowers people with diabetes to manage their condition and may influence self-care. Future MTH research would benefit from investigating behavioural mechanisms and determining patient profiles predictive of greater behavioural effectiveness.

Self-management interventions for skin care in people with a spinal cord injury: part 2—a systematic review of use of theory and quality of intervention reporting

Study designSystematic review.ObjectivesTo examine use of theory and quality of reporting in skin care self-management interventions for people with SCI.SettingInternational.MethodsThe Theory Coding Scheme (TCS) and the Template for Intervention Description and Replication (TIDieR) checklist were applied by two independent researchers to 17 interventions identified in a systematic review of self-management interventions for skin care in people with SCI.ResultsSix (35%) of the 17 interventions reviewed were reported to have a theoretical basis. Theories used included three of the most commonly featured in health behavior research (the Health Belief Model, Social Cognitive Theory, and the Transtheoretical Model). In these six interventions, theory was used to design content but not to select participants or tailor strategies. None of the interventions were used to test theories in the SCI population, or to propose theoretical refinements. Reporting quality was found to vary by TIDieR item, with 6–100% of interventions including recommended information. Information on two intervention fidelity items was missing in 53 and 82% of descriptions.ConclusionsUse of theory and reporting quality in SCI self-management research remains suboptimal, potentially slowing down advancements in this area of research. Rehabilitation researchers should direct their efforts toward improving these practices to help build a science of SCI self-management that is cumulative and reproducible by clinicians, scientists, and policy makers.SponsorshipThis work was funded through a postdoctoral fellowship awarded to the first author by the Rick Hansen Institute.

Self-management interventions for skin care in people with a spinal cord injury: part 1—a systematic review of intervention content and effectiveness

Study designSystematic review.ObjectivesTo review the content and effectiveness of skin care self-management interventions for people with SCI.SettingInternational.MethodsWe searched electronic bibliographic databases, trial registers, and relevant reference lists. Eligibility criteria for the reviews of intervention content and effectiveness were identical with the exception of study design. The review of intervention content included non-randomized and randomized controlled trials (RCTs). The review of effectiveness included RCTs. A Behavior Change Technique (BCT) taxonomy of 93 BCTs was used to code intervention content. Intervention effects on outcomes of interest are summarized descriptively. Effect sizes were calculated, and the Cochrane risk of bias tool applied.ResultsIn all, 15 studies testing 17 interventions were included in the review of intervention content. Interventions in these studies included 28 BCTs. The most common were “instructions on how to perform behavior” (16 interventions), “credible source” (12 interventions), and “social support (unspecified)” (9 interventions). Ten RCTs were included in the review of intervention effectiveness and they measured knowledge, self-efficacy, and skills relating to skin care/pressure ulcer (PU) prevention, skin care behaviors, skin status (PU prevalence, severity, and time to PU), and health-care utilization for skin problems. Evidence to support intervention effects on these outcomes was limited, particularly for clinical outcomes. Risk of bias assessments was often inconclusive due to poor reporting.ConclusionsThere is potential to design SCI skin care interventions that include currently untested BCTs. Further research and better consistency in outcome measurements and reporting are required to synthesize evidence on effectiveness.