Investigating Digital Patient-Reported Outcome Measures in Patient-Centered Diabetes Specialist Outpatient Care (DigiDiaS): Protocol for a Multimethod Prospective Observational Study.

BACKGROUND: Living with type 1 diabetes is challenging, and to support self-management, repeated consultations in specialist outpatient care are often required. The emergence of new digital solutions has revolutionized how health care services can be patient centered, providing unprecedented opportunities for flexible, high-quality care. However, there is a lack of studies exploring how the use of digital patient-reported outcome measures (PROMs) for flexible specialist care affects diabetes self-management. To provide new knowledge on the relevance of using PROMs in standard care, we have designed a multimethod prospective study. OBJECTIVE: The overall aim of this protocol is to describe our prospective multimethod observational study designed to investigate digital PROMs in a routine specialist outpatient setting for flexible patient-centered diabetes care (DigiDiaS). METHODS: This protocol outlines the design of a multimethod prospective observational cohort study that includes data from electronic health records, self-reported questionnaires, clinical consultation field observations, and individual in-depth interviews with patients and diabetes health care personnel. All patients with type 1 diabetes at a designated outpatient clinic were invited to participate and use the digital PROM implemented in clinical care. Both users and nonusers of the digital PROM were eligible for the prospective study, allowing for a comparison of the two groups. Data were collected at baseline and after 12 months, including self-management as the primary outcome assessed using the Patient Activation Measure, along with the secondary outcomes of digital health literacy, quality of life, health economy, and clinical variables such as glycated hemoglobin. RESULTS: The digital solution was implemented for routine clinical care in the department in November 2021, and data collection for the prospective study started in October 2022. As of September 6, 2023, 84.6% (186/220) of patients among those in the digital PROM and 15.5% (34/220) of patients among the nonusers have consented to participate. We expect the study to have enough participants by the autumn of 2023. With 1 year of follow-up, the results are expected by spring 2025. CONCLUSIONS: In conclusion, a multimethod prospective observational cohort study can offer valuable insights into the relevance, effectiveness, and acceptability of digital tools using PROMs in diabetes specialist care. Such knowledge is crucial for achieving broad and successful implementation and use of these tools in a large diabetes outpatient clinic. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52766.

Adapting a Patient-Reported Outcome Measure to Digital Outpatient Specialist Health Care Services for Type 1 Diabetes: User Involvement Study.

BACKGROUND: Diabetes self-management is crucial for patients with type 1 diabetes, and digital services can support their self-management and facilitate flexible follow-up. The potential of using digital patient-reported outcome (PRO) measures in routine outpatient care is not fully used owing to a lack of adapted PRO measures. OBJECTIVE: This study presents the process of identifying and adapting a digital PRO measure for use in clinical diabetes practice and describes the preferred item topics of the adapted PRO measure, as reported by patients and diabetes specialist nurses. METHODS: With the involvement of patients, diabetes specialist nurses, management, and researchers, we hosted a series of workshops and 2 dialogue conferences. Scoping searches to identify relevant PRO measures formed the foundation for the process. An in-person dialogue conference was conducted with diabetes specialist nurses as participants, and a digital dialogue conference was conducted with patients with type 1 diabetes as participants. A diabetes-specific PRO measure was translated and adapted to our digital platform. Notes and summaries from the dialogue conferences were imported into NVivo (QSR International) and thematically analyzed as a single combined data set. RESULTS: The thematic analysis of the 2 dialogue conferences aimed to explore the views of patients with type 1 diabetes and diabetes specialist nurses on the outcomes necessary to measure. An overarching theme, Ensuring that the PRO measure captures the patients' needs precisely and accurately, in a way that facilitates care and communication with health care personnel, was identified and supported with data from both the patients and diabetes specialist nurses. This theme contained four categories: The need for explanatory text after questions to ensure understanding and accurate response, Capturing individual needs in standardized questions, getting to the heart of the patient's problem, and The questions increase patient reflection. CONCLUSIONS: We successfully conducted an iterative process that identified a PRO measure aligned with the topics raised by the diabetes specialist nurses. Similarly, the patients found the PRO measure to be relevant and one that was addressing their needs. Only minor adjustments were necessary when programming the PRO measure in the digital platform. Our management, patients, and diabetes specialist nurses had a valuable impact on the results. User involvement facilitated a specific focus on the clinical requests to be met by PRO measures and how they must be adapted to local and digital platforms. Overall, this has facilitated the current implementation of the adapted digital PRO measure.

Reduced Endothelial Function in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome-Results From Open-Label Cyclophosphamide Intervention Study.

Introduction: Patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) present with a range of symptoms including post-exertional malaise (PEM), orthostatic intolerance, and autonomic dysfunction. Dysfunction of the blood vessel endothelium could be an underlying biological mechanism, resulting in inability to fine-tune regulation of blood flow according to the metabolic demands of tissues. The objectives of the present study were to investigate endothelial function in ME/CFS patients compared to healthy individuals, and assess possible changes in endothelial function after intervention with IV cyclophosphamide. Methods: This substudy to the open-label phase II trial "Cyclophosphamide in ME/CFS" included 40 patients with mild-moderate to severe ME/CFS according to Canadian consensus criteria, aged 18-65 years. Endothelial function was measured by Flow-mediated dilation (FMD) and Post-occlusive reactive hyperemia (PORH) at baseline and repeated after 12 months. Endothelial function at baseline was compared with two cohorts of healthy controls (N = 66 and N = 30) from previous studies. Changes in endothelial function after 12 months were assessed and correlated with clinical response to cyclophosphamide. Biological markers for endothelial function were measured in serum at baseline and compared with healthy controls (N = 30). Results: Baseline FMD was significantly reduced in patients (median FMD 5.9%, range 0.5-13.1, n = 35) compared to healthy individuals (median FMD 7.7%, range 0.7-21, n = 66) (p = 0.005), as was PORH with patient score median 1,331 p.u. (range 343-4,334) vs. healthy individuals 1,886 p.u. (range 808-8,158) (p = 0.003). No significant associations were found between clinical response to cyclophosphamide intervention (reported in 55% of patients) and changes in FMD/PORH from baseline to 12 months. Serum levels of metabolites associated with endothelial dysfunction showed no significant differences between ME/CFS patients and healthy controls. Conclusions: Patients with ME/CFS had reduced endothelial function affecting both large and small vessels compared to healthy controls. Changes in endothelial function did not follow clinical responses during follow-up after cyclophosphamide IV intervention.

Students' top 10 priorities of research uncertainties on students' sleep: a pragmatic James Lind Alliance approach.

OBJECTIVES: Inspired by the James Lind Alliance (JLA) user involvement approach, the aim of the present study was to identify the top 10 uncertainties for sleep research raised by students in higher education, and to discuss our experiences with adapting the JLA method to a student population. DESIGN: The study design is a pragmatic JLA approach, including a priority setting partnership within the field of sleep, collection of sleep-related research uncertainties as reported by students in higher education, sorting of the uncertainties and a final identification of the top 10 uncertainties through collaborative work between researchers, students, stakeholders and experts in the field. Uncertainties were collected using a one-question online survey: 'as a student, which question(s) do you consider to be important with regards to sleep?'. A variety of approaches were applied to promote the survey to the students, including social media, radio, the university website, stands in university cafeterias and a sleep stunt. NVivo V.12 was used to code and sort the questions. SETTING: A higher education institution in Norway. PARTICIPANTS: 555 students. RESULTS: The data collection provided 608 uncertainties, and the following prioritised top 10: (1) screen time, (2) stress, (3) educational achievements, (4) social relations, (5) mental health, (6) physical activity, (7) indoor environment, (8) substance abuse, (9) shift work and (10) sleep quality. Despite successful data collection, we found sleep to be a broad topic, and defining specific questions throughout the sorting and verification process proved difficult. CONCLUSIONS: We identified the prioritised top 10 research uncertainties as reported by students in higher education, ranking screen time first. However, the process was time and resource consuming. The research uncertainties addressed by the students showed great diversity, characterised by heterogeneity and a lack of specificity, making verification of the uncertainties challenging.

Associations between menopausal hormone therapy and sleep disturbance in women during the menopausal transition and post-menopause: data from the Norwegian prescription database and the HUNT study.

BACKGROUND: Impaired sleep is common in menopausal women. The aim was to examine associations between uses of systemic menopausal hormone therapy (MHT) and sleep disturbance in a large population sample. METHODS: Female participants aged 45 to 75 years were selected from the Norwegian Health Study in Nord-Trøndelag (HUNT3, 2006-2008) (N = 13,060). Data were linked to the Norwegian Prescription Database, identifying use of prescribed MHT and use of sleep medication. Data were analyzed using multiple linear regression. RESULTS: In total, 996 women used systemic MHT (7.6%), with the highest prevalence of 10.3% among women 55 to 64 years of age. Despite high reports of frequent nocturnal awakening (24.7%) and high reports of hot flashes, use of MHT was low in this large population based survey. Although MHT use was associated with more sleep disturbance in unadjusted analyses, the association was not significant after adjusting for relevant covariates. Using sleep medication, reporting poor health, tobacco and alcohol use, doing daily exercise, having higher levels of anxiety, and being less satisfied with life were factors showing the strongest associations with sleep disturbance. CONCLUSION: The lack of association between MHT and sleep disturbance suggests that other factors, such as self-perceived good health, a healthy lifestyle and anxiety/depression, are more relevant to sleep than MHT.

Users' acceptability of a mobile application for persons with type 2 diabetes: a qualitative study.

BACKGROUND: The use of mobile health apps is now common in diabetes self-management and acceptability of such tools could help predict further use. There is limited research on the acceptability of such apps: use over time, the factors and features that influence self-management, how to overcome barriers, and how to use an app in relation to health-care personnel. In this study, we aimed to obtain an in-depth understanding of users' acceptability of a mobile app for diabetes self-management, and to explore their communication with health-care personnel concerning the app. METHODS: The study had a qualitative descriptive design. Two researchers conducted 24 semi-structured in-depth interviews with adults with type 2 diabetes who had used a digital diabetes diary app for 1 year, during participation in the Norwegian Study in the EU project RENEWING HeALTH. We recruited the participants in a primary health-care setting. The transcripts of the interviews were analyzed using qualitative content analysis on developing themes, which we interpreted according to a theory of acceptability. We used NVivo 11 Pro during the process. RESULTS: The users' acceptability of the app diverged. Overall, the responses indicated that the use of a digital diabetes diary requires hard work, but could also ease the effort involved in following a healthy lifestyle and better-controlled levels of blood glucose. Crucial to the acceptability was that a routine use could give an overview of diabetes registration and give new insights into self-management. In addition, support from health-care personnel with diabetes knowledge was described as necessary, either to confirm the decisions made based on use of the app, or to get additional self-management support. There were gradual transitions between practical and social acceptability, where utility of the app seems to be necessary for both practical and social acceptability. Lack of acceptability could cause both digital and clinical distress. CONCLUSIONS: Both practical and social acceptability were important at different levels. If the users found the utility of the app to be acceptable, they could tolerate some lack of usability. We need to be aware of both digital and clinical distress when diabetes apps form a part of relevant health-care. TRIAL REGISTRATIONS: Self-management in Type 2 Diabetes Patients Using the Few Touch Application, NCT01315756, https://clinicaltrials.gov/show/NCT01315756 March 15, 2011.

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

AIM: To develop a theoretical explanation for the daily life problems and challenges perceived by those living with type 2 diabetes. DESIGN AND METHODS: We used a grounded theory approach with a constant comparative method to discover a framework with the core concept of struggling between "ought to do" and "want to do" and related concepts. RESULTS: The struggle to self-manage and maintain new habits can be more or less difficult depending on the patient's perceived conditions. We identified three situations illustrated in a diagram: one where there is less struggle to let go of old habits, a second where there is more of a struggle to balance between what individuals want to do and what they ought to do and a third where they are giving up struggling. Study findings show that healthcare personnel must consciously seek to understand how patients perceive their own situation.

The Service User Technology Acceptability Questionnaire: Psychometric Evaluation of the Norwegian Version.

BACKGROUND: When developing a mobile health app, users' perception of the technology should preferably be evaluated. However, few standardized and validated questionnaires measuring acceptability are available. OBJECTIVE: The aim of this study was to assess the validity of the Norwegian version of the Service User Technology Acceptability Questionnaire (SUTAQ). METHODS: Persons with type 2 diabetes randomized to the intervention groups of the RENEWING HEALTH study used a diabetes diary app. At the one-year follow-up, participants in the intervention groups (n=75) completed the self-reported instrument SUTAQ to measure the acceptability of the equipment. We conducted confirmatory factor analysis for evaluating the fit of the original five-factor structure of the SUTAQ. RESULTS: We confirmed only 2 of the original 5 factors of the SUTAQ, perceived benefit and care personnel concerns. CONCLUSIONS: The original five-factor structure of the SUTAQ was not confirmed in the Norwegian study, indicating that more research is needed to tailor the questionnaire to better reflect the Norwegian setting. However, a small sample size prevented us from drawing firm conclusions about the translated questionnaire.

Analysing mHealth usage logs in RCTs: Explaining participants' interactions with type 2 diabetes self-management tools.

BACKGROUND: The Introduction of mobile health (mHealth) devices to health intervention studies challenges us as researchers to adapt how we analyse the impact of these technologies. For interventions involving chronic illness self-management, we must consider changes in behaviour in addition to changes in health. Fortunately, these mHealth technologies can record participants' interactions via usage-logs during research interventions. OBJECTIVE: The objective of this paper is to demonstrate the potential of analysing mHealth usage-logs by presenting an in-depth analysis as a preliminary study for using behavioural theories to contextualize the user-recorded results of mHealth intervention studies. We use the logs collected by persons with type 2 diabetes during a randomized controlled trial (RCT) as a use-case. METHODS: The Few Touch Application was tested in a year-long intervention, which allowed participants to register and review their blood glucose, diet and physical activity, goals, and access general disease information. Usage-logs, i.e. logged interactions with the mHealth devices, were collected from participants (n = 101) in the intervention groups. HbA1c was collected (baseline, 4- and 12-months). Usage logs were categorized into registrations or navigations. RESULTS: There were n = 29 non-mHealth users, n = 11 short-term users and n = 61 long-term users. Non-mHealth users increased (+0.33%) while Long-term users reduced their HbA1c (-0.86%), which was significantly different (P = .021). Long-term users significantly decreased their usage over the year (P < .001). K-means clustering revealed two clusters: one dominated by diet/exercise interactions (n = 16), and one dominated by BG interactions and navigations in general (n = 40). The only significant difference between these two clusters was that the first cluster spent more time on the goals functionalities than the second (P < .001). CONCLUSION: By comparing participants based upon their usage-logs, we were able to discern differences in HbA1c as well as usage patterns. This approach demonstrates the potential of analysing usage-logs to better understand how participants engage during mHealth intervention studies.

Acceptability of an mHealth App Intervention for Persons With Type 2 Diabetes and its Associations With Initial Self-Management: Randomized Controlled Trial.

BACKGROUND: Mobile health interventions are increasingly used in health care. The level of acceptability may indicate whether and how such digital solutions will be used. OBJECTIVE: This 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. METHODS: Participants 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. RESULTS: We 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. CONCLUSIONS: Our 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 REGISTRATION: ClinicalTrials.gov NCT01315756; https://clinicaltrials.gov/show/NCT01315756 (Archived by WebCite at http://www.webcitation.org/6z46qPhWl).

Tailored Communication Within Mobile Apps for Diabetes Self-Management: A Systematic Review.

BACKGROUND: The prevalence of diabetes is increasing and with the requirements for self-management and risk of late complications, it remains a challenge for the individual and society. Patients can benefit from support from health care personnel in their self-management, and the traditional communication between patients and health care personnel is changing. Smartphones and apps offer a unique platform for communication, but apps with integrated health care personnel communication based on patient data are yet to be investigated to provide evidence of possible effects. OBJECTIVE: Our goal was to systematically review studies that aimed to evaluate integrated communication within mobile apps for tailored feedback between patients with diabetes and health care personnel in terms of (1) study characteristics, (2) functions, (3) study outcomes, (4) effects, and (5) methodological quality. METHODS: A systematic literature search was conducted following our International Prospective Register of Systematic Reviews (PROSPERO) protocol, searching for apps with integrated communication for persons with diabetes tested in a controlled trial in the period 2008 to 2016. We searched the databases PubMed, Medical Literature Analysis and Retrieval System Online (MEDLINE), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Central, Excerpta Medica database (EMBASE), ClinicalTrials.gov, and the World Health Organization (WHO) International Clinical Trials Registry Platform. The search was closed in September 2016. Reference lists of primary articles and review papers were assessed. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed, and we applied the Cochrane risk of bias tool to assess methodological quality. RESULTS: We identified 2822 citations and after duplicate removal, we assessed 1128 citations. A total of 6 papers were included in this systematic review, reporting on data from 431 persons participating in small trials of short duration. The integrated communication features were mostly individualized as written non-real-time feedback. The number of functions varied from 2 to 9, and blood glucose tracking was the most common. HbA1c was the most common primary outcome, but the remaining reported outcomes were not standardized and comparable. Because of both the heterogeneity of the included trials and the poor methodological quality of the studies, a meta-analysis was not possible. A statistically significant improvement in the primary measure of outcome was found in 3 of the 6 included studies, of which 2 were HbA1c and 1 was mean daytime ambulatory blood pressure. Participants in the included trials reported positive usability or feasibility postintervention in 5 out of 6 trials. The overall methodological quality of the trials was, however, scored as an uncertain risk of bias. CONCLUSIONS: This systematic review highlights the need for more trials of higher methodological quality. Few studies offer an integrated function for communication and feedback from health care personnel, and the research field represents an area of heterogeneity with few studies of highly rigorous methodological quality. This, in combination with a low number of participants and a short follow-up, is making it difficult to provide reliable evidence of effects for stakeholders.

Telemonitoring and Health Counseling for Self-Management Support of Patients With Type 2 Diabetes: A Randomized Controlled Trial.

BACKGROUND: The prevalence of diabetes is increasing among adults globally, and there is a need for new models of health care delivery. Research has shown that self-management approaches encourage persons with chronic conditions to take a primary role in managing their daily care. OBJECTIVE: The objective of this study was to investigate whether the introduction of a health technology-supported self-management program involving telemonitoring and health counseling had beneficial effects on glycated hemoglobin (HbA1c), other clinical variables (height, weight, body mass index, blood pressure, blood lipid profile), and health-related quality of life (HRQoL), as measured using the Short Form Health Survey (SF-36) version 2 in patients with type 2 diabetes. METHODS: This was a pragmatic randomized controlled trial of patients with type 2 diabetes. Both the control and intervention groups received usual care. The intervention group also participated in additional health promotion activities with the use of the Prescribed Healthcare Web application for self-monitoring of blood glucose and blood pressure. About every second month or when needed, the general practitioner or the diabetes nurse reviewed the results and the health care activity plan. RESULTS: A total of 166 patients with type 2 diabetes were randomly assigned to the intervention (n=87) or control (n=79) groups. From the baseline to follow-up, 36 patients in the intervention group and 5 patients in the control group were lost to follow-up, and 2 patients died. Additionally, HbA1c was not available at baseline in one patient in the intervention group. A total of 122 patients were included in the final analysis after 19 months. There were no significant differences between the groups in the primary outcome HbA1c level (P=.33), and in the secondary outcome HRQoL as measured using SF-36. A total of 80% (67/87) of the patients in the intervention group at the baseline, and 98% (47/50) of the responders after 19-month intervention were familiar with using a personal computer (P=.001). After 19 months, nonresponders (ie, data from baseline) reported significantly poorer mental health in social functioning and role emotional subscales on the SF-36 (P=.03, and P=.01, respectively). CONCLUSIONS: The primary outcome HbA1c level and the secondary outcome HRQoL did not differ between groups after the 19-month follow-up. Those lost to follow-up reported significantly poorer mental health than did the responders in the intervention group. TRIAL REGISTRATION: Clinicaltrials.gov NCT01478672; https://clinicaltrials.gov/ct2/show/NCT01478672 (Archived by WebCite at http://www.webcitation.org/6r4eILeyu).

Psychosocial factors are strongly associated with insomnia in users and nonusers of prescribed sleep medication: evidence from the HUNT3 study.

OBJECTIVE: The aim of this study was to examine how neuroticism, stressful life events, self-rated health, life satisfaction, and selected lifestyle factors were related to insomnia both by sex and among users and nonusers of prescribed sleep medication (PSM). DESIGN: Cross-sectional data from the Norwegian Nord-Trøndelag Health Study (HUNT3, 2006-2008), a population-based health survey, were linked to individual data from the Norwegian Prescription Database. METHODS: Logistic regression analyses were used to investigate the associations between the selected variables and insomnia in both males and females and among subjects using and not using PSM. Individuals were considered to have a presumptive diagnosis of insomnia disorder if they reported difficulty with sleep initiation, sleep maintenance, or early morning awakening several days per week for the last 3 months. PSMs were categorized as anxiolytics or hypnotics; the dose was estimated according to defined daily dose (DDD). RESULTS: Of the total 50,805 participants, 6,701 (13.2%) used PSM. The proportions of PSM users were larger among elderly participants. Increased risk of insomnia was strongly associated with poor self-rated health and higher level of neuroticism. These associations were evident for both sexes and were similar among both users and nonusers of PSM. Low satisfaction with life was strongly related to insomnia, but only among nonusers of PSM. Increased doses of PSM were not associated with reduced likelihood of insomnia. CONCLUSION: Insomnia is a problem among both users and nonusers of PSM and is associated with psychosocial factors. Our findings suggest that successful treatment for sleep problems should take individual variation into account, such as age, sex, personality traits, satisfaction with life, and health perception.

Stages of change for physical activity and dietary habits in persons with type 2 diabetes included in a mobile health intervention: the Norwegian study in RENEWING HEALTH.

OBJECTIVE: The aim of this study was to investigate stages of change for physical activity and dietary habits using baseline data from persons with type 2 diabetes included in a mobile health intervention. We examined the associations between stages of change for physical activity change and dietary change, and between stages of change for each behavior and individual characteristics, health-related quality of life, self-management, depressive symptoms, and lifestyle. RESEARCH DESIGN AND METHODS: We examined 151 persons with type 2 diabetes with an glycated hemoglobin (HbA1c) level ≥7.1%, aged ≥18 years at baseline of a randomized controlled trial, before testing a mobile app with or without health counseling. Stages of change were dichotomized into 'pre-action' and 'action'. Self-management was measured using the Health Education Impact Questionnaire (heiQ) where a higher score reflects increased self-management, and health-related quality of life was measured with the Short-Form-36 (SF-36). Logistic regression modeling was performed. RESULTS: The median HbA1c level was 7.9% (7.1-12.4), 90% were overweight or obese, and 20% had ≥3 comorbidities. 58% were in the preaction stage for physical activity change and 79% in the preaction stage for dietary change. Higher scores of self-management were associated with an increased chance of being in the action stage for both dietary change and physical activity change. Higher body mass index was associated with an 8% reduced chance of being in the action stage for physical activity change (OR 0.92, 95% CI 0.86 to 0.99). CONCLUSIONS: Being in the action stage was associated with higher scores of self-management, crucial for type 2 diabetes. Over half of the participants were in the preaction stage for physical activity and dietary change, and many had a high disease burden with comorbidities and overweight. TRIAL REGISTRATION NUMBER: NCT01315756.

Making robust decisions about the impact of health education programs: Psychometric evaluation of the Health Education Impact Questionnaire (heiQ) in diverse patient groups in Norway.

OBJECTIVE: To undertake a rigorous psychometric evaluation of the widely used eight-scale heiQ version 2.0 (evaluating immediate effects of self-management interventions) in diverse patient groups in Norway. METHODS: Cross-sectional survey data were collected from 1019 Norwegians. Data were extracted from studies among people with musculoskeletal disorders (n=516), psoriasis (n=254), heart disease (n=97), and Type 2 diabetes (n=152). To investigate the factorial validity of the Norwegian heiQ, confirmatory factor analyses (CFA) were carried out using Mplus. RESULTS: One-factor model fit, without modifications, was acceptable for the Emotional distress scale. Only one correlated residual was required to be fitted in each of the other scales to achieve satisfactory model fit. The postulated highly restricted full eight-factor model (no cross-loadings, no correlated residuals) showed good fit to the data. Internal consistency was acceptable for most scales (0.72-0.90) but low for Self-monitoring and insight. CONCLUSION: This study of the Norwegian heiQ replicates the factor structure of the original Australian heiQ, using robust and highly restricted CFA procedures, demonstrating a clean independent clusters model structure. PRACTICE IMPLICATIONS: Researchers, program implementers and policymakers could use the Norwegian heiQ with confidence to generate reliable information on program outcomes and support quality improvement activities.

A pilot study testing the feasibility of skin temperature monitoring to reduce recurrent foot ulcers in patients with diabetes--a randomized controlled trial.

BACKGROUND: Although monitoring foot skin temperatures has been associated with diabetic foot ulcer recurrence, no studies have been carried out to test the feasibility among European Caucasians. Moreover, the educational and/or motivational models that promote cognitive or psychosocial processes in these studies are lacking. Thus, we conducted a pilot randomized controlled trial to test the feasibility of monitoring foot skin temperatures in combination with theory-based counselling to standard foot care to reduce diabetic foot ulcer recurrence. METHODS: In a single-blinded nurse-led 1-year controlled trial, conducted at a hospital setting in Norway, 41 patients with diabetic neuropathy and previous foot ulcer were randomized to the intervention (n = 21) or control groups (n = 20). All participants were instructed in foot care and recording observations daily. Additionally, the intervention group was taught how to monitor and record skin temperature at baseline, and received counselling every third month supporting them to use the new treatment. Subjects observing temperature differences > 2.0 °C between corresponding sites on the left and right foot on two consecutive days were asked to contact the study nurse and reduce physical activity. Fisher exact test was used to evaluate the effect of the intervention on the proportion of subjects with a foot ulcer. Kaplan-Meier survival analysis was performed to compare the two groups in regard to the time to development of a foot ulcer. RESULTS: In the intervention group, 67 % (n = 14/21) monitored and recorded skin temperatures ≥ 80 % of the time while 70 % (n = 14/20) of the controls recorded foot inspections. Foot ulcer incidence was 39 % (7/21) vs. 50 % (10/20) in the intervention and control groups, respectively (ns). CONCLUSIONS: This feasibility study showed that the addition of counselling to promote self-monitoring of skin temperature to standard care to prevent recurrence of foot ulcer is feasible in patients with diabetes in Norway. Home skin temperature monitoring was performed as frequently by the intervention group as usual foot observations in the controls despite the extra effort required. We did not detect a difference in foot ulcer recurrence between groups, but our study may inform future full scale studies. TRIAL REGISTRATION: Clinicaltrials.gov NCT01269502.

A Low-Intensity Mobile Health Intervention With and Without Health Counseling for Persons With Type 2 Diabetes, Part 1: Baseline and Short-Term Results From a Randomized Controlled Trial in the Norwegian Part of RENEWING HEALTH.

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.

A Mobile Health Intervention for Self-Management and Lifestyle Change for Persons With Type 2 Diabetes, Part 2: One-Year Results From the Norwegian Randomized Controlled Trial RENEWING HEALTH.

BACKGROUND: Self-management is crucial in the daily management of type 2 diabetes. It has been suggested that mHealth may be an important method for enhancing self-management when delivered in combination with health counseling. OBJECTIVE: The objective of this study was to test whether the use of a mobile phone-based self-management system used for 1 year, with or without telephone health counseling by a diabetes specialist nurse for the first 4 months, could improve glycated hemoglobin A1c (HbA1c) level, self-management, and health-related quality of life compared with usual care. METHODS: We conducted a 3-arm prospective randomized controlled trial involving 2 intervention groups and 1 control group. Eligible participants were persons with type 2 diabetes with an HbA1c level ≥7.1% (≥54.1 mmol/mol) and aged ≥18 years. Both intervention groups received the mobile phone-based self-management system Few Touch Application (FTA). The FTA consisted of a blood glucose-measuring system with automatic wireless data transfer, diet manual, physical activity registration, and management of personal goals, all recorded and operated using a diabetes diary app on the mobile phone. In addition, one intervention group received health counseling based on behavior change theory and delivered by a diabetes specialist nurse for the first 4 months after randomization. All groups received usual care by their general practitioner. The primary outcome was HbA1c level. Secondary outcomes were self-management (heiQ), health-related quality of life (SF-36), depressive symptoms (CES-D), and lifestyle changes (dietary habits and physical activity). Data were analyzed using univariate methods (t test, ANOVA) and multivariate linear and logistic regression. RESULTS: A total of 151 participants were randomized: 51 to the FTA group, 50 to the FTA-health counseling (FTA-HC) group, and 50 to the control group. Follow-up data after 1 year were available for 120 participants (79%). HbA1c level decreased in all groups, but did not differ between groups after 1 year. The mean change in the heiQ domain skills and technique acquisition was significantly greater in the FTA-HC group after adjusting for age, gender, and education (P=.04). Other secondary outcomes did not differ between groups after 1 year. In the FTA group, 39% were substantial users of the app; 34% of the FTA-HC group were substantial users. Those aged ≥63 years used the app more than their younger counterparts did (OR 2.7; 95% CI 1.02-7.12; P=.045). CONCLUSIONS: The change in HbA1c level did not differ between groups after the 1-year intervention. Secondary outcomes did not differ between groups except for an increase in the self-management domain of skill and technique acquisition in the FTA-HC group. Older participants used the app more than the younger participants did.

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.

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).

Triage in Norwegian emergency departments.

BACKGROUND: An increasing number of patients and stricter requirements for quality and efficiency in the management of emergency patients have spurred several Norwegian emergency departments (EDs) to introduce triage as one of several measures. This introduction has taken place without any accompanying research. We therefore wanted to investigate the use and organisation of triage, as well as the use of triage scales in the emergency departments. MATERIAL AND METHOD: In the spring of 2010, a cross-sectional survey was undertaken among EDs with the aid of a questionnaire and telephone interviews. RESULTS: Altogether 45 of a total of 56 Norwegian emergency hospitals (80%) participated. All our respondents reported that emergency patients underwent assessment for level of urgency. 34 (76%) reported to use triage scales, and 17 (50%) of these used self-composed scales. 21 (68%) of a total of 31 EDs that had goals for triage reported to evaluate these goals. 14 and 15 EDs respectively reported to have designated triage personnel and triage area. 24 EDs required internal triage training for nurses and assistant nurses. INTERPRETATION: Our study reveals varying practices for use and organisation of triage in Norwegian EDs. This may be an effect of the absence of guidelines from the health authorities and reflect the insufficient priority which is given to ED work.