Low-Intensity Self-Management Intervention for Persons With Type 2 Diabetes Using a Mobile Phone-Based Diabetes Diary, With and Without Health Counseling and Motivational Interviewing: Protocol for a Randomized Controlled Trial

Abstract

BackgroundThe 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.ObjectiveThe 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.MethodsThe 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.ResultsThe 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.ConclusionsThe 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 RegistrationClinicaltrials.gov NCT01315756; http://clinicaltrials.gov/ct2/show/NCT01315756 (Archived by WebCite at http://www.webcitation/6BTyuRMpH).

Medical apps in endocrine diseases – hide and seek

“…According to various sources [Golden et al 2009;National Center for Health Statistics, 2014b], about 10% of adults aged 18+ in the US have diabetes. Many of these patients suffer from obesity as well, explaining the relatively large This trend is also mirrored by the growing number of recent publications dealing with such apps [Arnhold et al 2014;Årsand et al 2012;García-Gómez et al 2014;Goyal and Cafazzo, 2013;Holtz and Lauckner, 2012;Klonoff, 2013;Markowitz et al 2013;Ribu et al 2013]. Another large proportion of the apps indicated an educational or reference purpose (37% or 69/189).…”

People with type 2 diabetes struggling for self‐management: A part study from the randomized controlled trial in RENEWING HEALTH

“…Participants were recruited from the two intervention groups in the Norwegian three-armed RCT of the EU project RENEWING HEALTH (RH) (N = 79). The details of the Norwegian study have been previously described (Ribu et al, 2013;Torbjørnsen et al, 2014;Holmen et al, 2014).…”

“…This qualitative study was part of a larger randomized controlled trial (RCT) that aimed to evaluate telemedicine self‐management tools, the details of which have been previously described (Holmen et al, ; Ribu et al, ; Torbjørnsen et al, ). In this study, we attained more in‐depth knowledge about the persons voluntarily participated in this study, according to their self‐management and daily living with type 2 diabetes.…”

Quality-of-Life Technologies

“…This was either because of the domain being impacted [12], or the fragility context of the subject population [13]. Other domains and contexts still need to be systematically investigated.…”