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BackgroundMobile health interventions are increasingly used in health care. The level of acceptability may indicate whether and how such digital solutions will be used. ObjectiveThis study aimed to explore associations between the level of acceptability of a mobile diabetes app and initial ability of self-management for patients with type 2 diabetes. MethodsParticipants with type 2 diabetes were recruited from primary health care settings to a 3-armed randomized controlled trial in the Norwegian study in the RENEWING HEALTH project. At the 1-year follow-up, 75 out of 101 participants from the intervention groups completed an acceptability questionnaire (The Service User Technology Acceptability Questionnaire). In the randomized controlled trial, the 2 intervention groups (n=101 in total) received a mobile phone with a diabetes diary app, and one of the groups received additional health counseling given by telephone calls from a diabetes specialist nurse (n=50). At baseline, we collected clinical variables from medical records, whereas demographic data and self-management (The Health Education Impact Questionnaire) measures were self-reported. Log data from the use of the app by self-monitoring were registered continuously. Associations between initial ability to self-manage at baseline and acceptability of the diabetes diary app after 1 year were analyzed using linear regression. ResultsWe found statistically significant associations between 5 of the 8 self-management domains and perceived benefit, one of the acceptability factors. However, when adjusting for age, gender, and frequency of use, only 1 domain, skill and technique acquisition, remained independently associated with perceived benefit. Frequency of use of the app was the factor that revealed the strongest association with the acceptability domain perceived benefit. ConclusionsOur findings indicate that persons with diabetes may accept the app, despite its perceived benefit being associated with only one of the 8 domains of their initial level of self-management. Trial RegistrationClinicalTrials.gov NCT01315756; https://clinicaltrials.gov/show/NCT01315756 (Archived by WebCite at http://www.webcitation.org/6z46qPhWl)

BackgroundSelf-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. ObjectivesThe 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. MethodsA 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. ResultsData 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. ConclusionsThe 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.

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).

BackgroundModerate/severe pain after total knee arthroplasty (TKA) is a poor surgical outcome. Many studies have identified preoperative risk factors of pain after TKA, but studies of the joint contributions of co-occurring symptoms are lacking.MethodsPatients undergoing primary TKA (n = 202) were enrolled in a longitudinal cohort study. Preoperatively, patients completed questionnaires measuring demographics and symptoms (pain, fatigue, sleep problems and depression). Pain was re-assessed 12 months after TKA. Logistic regression analysis was used to compute the probabilities of moderate-severe pain at 12 months based on preoperative symptom levels, and results were combined into a risk matrix.ResultsMore than one-third (40%) of patients (n = 187) reported moderate-severe pain after TKA. Among preoperative risk factors included in the logistic regression analyses were age, sex, pain, fatigue, sleep problems and depression. Adjusting for possible confounders, fatigue (p = 0.02) and pain (p = 0.01) were significant risk factors for moderate-severe pain at 12-months follow-up and were retained in the final risk matrix. The co-occurrence of high-preoperative fatigue and pain scores resulted in 57% estimated probability of moderate-severe pain at 12 months. Similarly, the co-occurrence of low-preoperative fatigue and pain scores resulted in 14% estimated probability of moderate-severe pain 12 months after TKA.ConclusionThe combination of high fatigue and pain scores prior to surgery was a key risk factor for moderate-severe pain 12 months after TKA. Mapping of these factors could be used preoperatively to identify patients who are at risk to experience a poor outcome of TKA.