Background: The present study protocol is designed to cover the Norwegian part of the European Union Collaborative Project—REgioNs of Europe WorkINg together for HEALTH (RENEWING HEALTH). Self-management support is an important element of care for persons with type 2 diabetes (T2D) for achieving metabolic control and positive lifestyle changes. Telemedicine (TM) with or without health counseling may become an important technological aid for self-management and may provide a user-centered model of care. In spite of many earlier studies on TM, there remains a lack of consensus in research findings about the effect of TM interventions. Objective: The aim of RENEWING HEALTH is to validate and evaluate innovative TM tools on a large scale through a common evaluation, making it easier for decision makers to choose the most efficient and cost-effective technological interventions. The Norwegian pilot study evaluates whether the introduction of a mobile phone with a diabetes diary application together with health counseling intervention produces benefits in terms of the desired outcomes, as reflected in the hemoglobin A1c level, health-related quality of life, behavior change, and cost-effectiveness. Methods: The present study has a mixed-method design comprising a three-armed prospective randomized controlled trial and qualitative interviews with study data collected at three time points: baseline, after 4 months, and after 1 year. The patients’ registrations on the application are recorded continuously and are sent securely to a server. Results: The inclusion of patients started in March 2011, and 100% of the planned sample size is included (N=151). Of all the participants, 26/151 patients (17.2%) are lost to follow-up by now, and 11/151 patients (7.3%) are still in the trial. Results of the study protocol will be presented in 2014. Conclusions: The key goals of this trial are to investigate the effect of an electronic diabetes diary app with and without health counseling, and to determine whether health counseling is important to the continued use of the application and the patients’ health competence and acceptability. Research within this area is needed because few studies have investigated the effectiveness of apps used in long-term interventions with this degree of self-management. Trial Registration: Clinicaltrials.gov NCT01315756; http://clinicaltrials.gov/ct2/show/NCT01315756 (Archived by WebCite at http://www.webcitation/6BTyuRMpH).
Background: Self-management support for people with type 2 diabetes is essential in diabetes care. Thus, mobile health technology with or without low-intensity theory-based health counseling could become an important tool for promoting self-management. Objectives: The aim was to evaluate whether the introduction of technology-supported self-management using the Few Touch Application (FTA) diabetes diary with or without health counseling improved glycated hemoglobin (HbA1c) levels, self-management, behavioral change, and health-related quality of life, and to describe the sociodemographic, clinical, and lifestyle characteristics of the participants after 4 months. Methods: A 3-armed randomized controlled trial was conducted in Norway during 2011-2013. In the 2 intervention groups, participants were given a mobile phone for 1 year, which provided access to the FTA diary, a self-help tool that recorded 5 elements: blood glucose, food habits, physical activity, personal goal setting, and a look-up system for diabetes information. One of the intervention groups was also offered theory-based health counseling with a specialist diabetes nurse by telephone for 4 months from baseline. Both intervention groups and the control group were provided usual care according to the national guidelines. Adults with type 2 diabetes and HbA1c ≥7.1% were included (N=151). There were 3 assessment points: baseline, 4 months, and 1 year. We report the short-term findings after 4 months. HbA1c was the primary outcome and the secondary outcomes were self-management (Health Education Impact Questionnaire, heiQ), behavioral change (diet and physical activity), and health-related quality of life (SF-36 questionnaire). The data were analyzed using univariate methods (ANOVA), multivariate linear, and logistic regression. Results: Data were analyzed from 124 individuals (attrition rate was 18%). The groups were well balanced at baseline. There were no differences in HbA1c between groups after 4 months, but there was a decline in all groups. There were changes in self-management measured using the health service navigation item in the heiQ, with improvements in the FTA group compared to the control group (P=.01) and in the FTA with health counseling group compared with both other groups (P=.04). This may indicate an improvement in the ability of patients to communicate health needs to their health care providers. Furthermore, the FTA group reported higher scores for skill and technique acquisition at relieving symptoms compared to the control group (P=.02). There were no significant changes in any of the domains of the SF-36. Conclusions: The primary outcome, HbA1c, did not differ between groups after 4 months. Both of the intervention groups had significantly better scores than the control group for health service navigation and the FTA group also exhibited improved skill and technique acquisition.