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

Abstract

BackgroundThe 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.ObjectiveThis 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.MethodsA 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.ResultsData 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.ConclusionsThe 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 RegistrationClinicalTrials.gov NCT00922376; http://clinicaltrials.gov/ct2/show/NCT00922376 (Archived by WebCite at http://www.webcitation.org/6Vu4nhLI6).

The impact of E-diaries and accelerometers on young adults' perceived and objectively assessed physical activity

“…It is possible that prolonged use with the accelerometers or e-diaries would cause a change in behavior not observed after only one week and this possibility should be tested in future studies. However, research would predict that the greatest reactance would occur while the device was still novel and the influence of the device would actually reduce over time (Baron, Hirani, & Newman, 2015). Overall, the fact that neither the e-diaries nor the accelerometers increased self-reports of vigorous intentional PA or frequency of discrete exercise sessions is a promising result for researchers who want to use these methods to observe exercise, at least in healthy young adults.…”

A randomized wait-list control trial to evaluate the impact of a mobile application to improve self-management of individuals with type 2 diabetes: a study protocol

“…All outcomes will be assessed again at 6 months. Intervention usability is an additional secondary outcome which will be evaluated at the end of study as measured by an adapted version of the Mobile App Rating Scale [28] (refer to Fig. 3 for adapted version) and application utilization data collected routinely collected through the application.…”

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

“…The 9-month RCT during which data were collected was conducted in a diabetes clinic in the London borough of Newham, United Kingdom (UK). Details of the study protocol are described elsewhere (19).…”

“…Eligibility criteria are listed in Box 1, and the target sample size was 248 (19). An electronic database was used to record the number of potentially eligible patients identified, number of patients invited to the study, number of patients approached, number of exclusions and refusals, and reasons reported, and number of patients enrolled to the study.…”

“…Although implementation can refer to both intervention delivery and receipt (Linnan and Steckler et al, 2002), the current paper focuses on the former since the latter (i.e. MTH usage) is described in another paper (19).…”