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.

What characterizes the use of digital technology in bachelor-level practice placements in health programs?

AIM: The study aimed to investigate what characterizes the use of digital technology in bachelor-level practice placements in health programs. BACKGROUND: Practice placement for health students in higher education is complex and suffers from a lack of personnel and scant resources. However, the requirements and expectations of the students in managing an evidence-based practice are increasing. This decade, digital transformation in society and higher education can potentially improve students learning in higher education and practice placement due to increased availability for closer communication and collaboration. DESIGN: A systematic review of reviews was conducted based on Joanna Briggs Institute Framework. METHODS: Bibliographical databases were searched for studies published between 2010-2022. Out of 4891 screened articles, 15 met eligibility criteria and were included in this review. RESULTS: The analysis revealed three main topics that elucidate what characterises the use of digital technology in placements: Leveraging digital solutions for enhanced practical learning; Empowering student learning and confidence in practice placement; and The value of interactive collaboration. CONCLUSIONS: The findings show that digital technology used in a structured pedagogical framework may support and enhance students learning in practice placement. However, further work needs to be done to keep up with the rapid development of digital technology in practice placement in health work environments.

Patient-reported outcome measures in diabetes outpatient care: a scoping review.

BACKGROUND: Patient-reported outcome (PRO) measures are increasingly used in clinical diabetes care to increase patient involvement and improve healthcare services. The objectives were to identify instruments used to measure PROs in outpatient diabetes clinics and to investigate the use of these PRO measures alongside the experiences of patients and healthcare personnel in a clinical setting. RESEARCH DESIGN AND METHODS: A scoping review was conducted according to the framework of Arksey and O'Malley with scoping searches of Cinahl, EMBASE, Medline and Health and Psychosocial Instruments. Studies reporting on adults with diabetes in a clinical setting where the PRO measure response directly affected patient care were eligible for inclusion. RESULTS: In total, 35 197 citations were identified, of which 7 reports presenting 4 different PRO measures were included in the review. All four of the included items measured psychosocial aspects of diabetes, and three included elements of the Problem Areas in Diabetes scale. All the patients were satisfied with the use of PRO measures in clinical care, whereas the level of satisfaction among healthcare personnel with PRO measures varied within and among studies. CONCLUSIONS: The limited number of eligible studies in this review suggests that research on PRO measures for diabetes outpatient care is scarce. Patients welcome the opportunity to express their concerns through the systematic collection of PRO measures, and some healthcare personnel value the broader insight that PRO measures provide into the impact of diabetes on patients' lives. However, the heterogeneity among services and among patients challenges the implementation of PRO measures. Research is needed to explore how PRO measures in clinical outpatient care affect healthcare personnel workflow. REVIEW REGISTRATION: https://doi.org/10.17605/OSF.IO/46AHC.

Long-term social assistance recipients' experiences with an increased monthly payment: a qualitative pilot study.

AIMS: Ten long-term social assistance recipients in a Norwegian municipality received a greater-than-average fixed monthly payment for 12 months. This study aimed to explore whether these recipients with reduced administrative requirements and a fixed monthly payment that was greater than the average social assistance experienced reduced poverty, increased feelings of independence, better daily living, and an improved quality of life. METHODS: The study's explorative design included 20 qualitative, in-depth, semi-structured interviews and a longitudinal electronic survey for 12 months. The 10 participants had been selected by the local labour and welfare agency based on stringent criteria and are therefore not representative of social assistance recipients in general. Individual interviews were conducted during autumn 2021 and spring 2022. The interview data were analysed using systematic text condensation, and the survey results are presented using descriptive statistics. RESULTS: The participants included in the project described a reduced experience of poverty. They could buy additional items and set aside money, something they had not been able to do in the past, and meant a great deal to them. They expressed experiencing freedom, gaining a stronger sense of independence, and having lessened feelings of shame. Many of the participants described health issues that were incompatible with working. CONCLUSIONS: Being given this opportunity led to a feeling of increased dignity and greater inclusion in society among this selected group of participants. They appreciated the simplified conditions and reduced requirements for administrative matters. All expressed that spending 8 months without contact with the social welfare office was a liberation.

Integrating research in health professions education: a scoping review.

BACKGROUND: Integrating teaching and research may boost students' learning and improve future clinical practice when incorporated into education. Explorations of health professions students' involvement in the research processes and their learning outcomes are sparse. Thus, the purpose of this scoping review is to explore the existing scientific literature on courses involving students from health professions education in research activities. The research questions are: Which parts of the research process are the health professions students involved in, and what are the students' main learning outcomes related to the research process reported to be? METHODS: A scoping review following the six-step approach of Arksey and O'Malley was undertaken. We searched four electronic databases to identify studies focusing on research-based teaching in health professions education. Inspired by content analysis, we identified key concepts relating to the research process and learning outcomes. RESULTS: We screened 1084 abstracts, reviewed 95 full-text reports, and included 24 for analysis. Overall, the students were more involved in conducting and disseminating research than in the planning phases. Learning outcomes were most frequently reported as specific research skills, such as conducting literature reviews, writing academically, and presenting results, but also as improved understanding of research in general as well as improved motivation and confidence in conducting research. CONCLUSIONS: The heterogeneity of educational programs, study designs, and measures makes it difficult to draw conclusions across the studies included in the review. More research is needed to conclude whether health professions students who actively engage in research gain a better understanding of the research process, become more likely to pursue research in their practice, or are more motivated to choose an academic career.

Unpacking the Public Health Triad of Social Inequality in Health, Health Literacy, and Quality of Life-A Scoping Review of Research Characteristics.

Social inequalities in health, health literacy, and quality of life serve as distinct public health indicators, but it remains unclear how and to what extent they are applied and combined in the literature. Thus, the characteristics of the research have yet to be established, and we aim to identify and describe the characteristics of research that intersects social inequality in health, health literacy, and quality of life. We conducted a scoping review with systematic searches in ten databases. Studies applying any design in any population were eligible if social inequality in health, health literacy, and quality of life were combined. Citations were independently screened using Covidence. The search yielded 4111 citations, with 73 eligible reports. The reviewed research was mostly quantitative and aimed at patient populations in a community setting, with a scarcity of reports specifically defining and assessing social inequality in health, health literacy, and quality of life, and with only 2/73 citations providing a definition for all three. The published research combining social inequality in health, health literacy, and quality of life is heterogeneous regarding research designs, populations, contexts, and geography, where social inequality appears as a contextualizing variable.

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.

"It's hard to keep a distance when you're with someone you really care about"-A qualitative study of adolescents' pandemic-related health literacy and how Covid-19 affects their lives.

PURPOSE: The aim of this study was to explore how adolescents accessed, understood, appraised, and applied information on pandemic preventive measures, how their lives were impacted by long-lasting regulations and how they described their quality of life. METHODS: A qualitative design with focus group interviews was used to elaborate on the quantitative survey results obtained and analyzed in a previous survey study from the first phase of the Covid-19 pandemic. Five focus groups with seventeen adolescents were conducted digitally during the second pandemic phase in November and December 2020. The interview data were analyzed with directed content analysis. RESULTS: The adolescents reported using traditional media and official websites as sources for Covid-19 information. They engaged in preventive behavior, and washing hands and keeping a distance from strangers had become a habit. However, not being physically close to friends felt strange and unpleasant. The measure most frequently discussed was limiting social contact, which was a constant struggle. No one disputed the authorities' guidelines and rules, but the social restrictions caused boredom and despair, particularly due to interrupted schooling and missed opportunities to engage in life events, and freely socialize with friends. CONCLUSION: The adolescents gave an overall impression of being health literate, which corresponds well with the results from our previous survey study. Their descriptions of how they translated protective measures into their everyday lives demonstrate that they took responsibility and accepted personal costs for the collective good. However, life with social restrictions decreased their quality of life.

Enhancing students learning experiences in nursing programmes: An integrated review.

Nursing as a profession is both fragmented and complex. The education setting is demanding, and prepared students are more clinically and academically robust. Therefore, nursing programmes should implement high-quality teaching based on the best available scientific evidence to improve learning quality and students' experience. This study aimed to identify the teaching tools used to enhance students' perceived experiences in undergraduate nursing programmes. Nine databases were systematically searched to identify quantitative and qualitative studies regarding the teaching tools utilised across nursing education programmes. Results were summarised following a systematic integrated review framework. The searches identified 15,886 citations, and after title/abstract/full-text screening, 66 primary research studies were included comprising data from 4,411 participants with a mean sample size of 66 (range 6-447). Educators utilising a student-centred wrapping approach exploiting knowledge building and self-development were found to improve students' experiences; however, consensus on success factors was lacking. The findings indicate that educators' knowledge and pedagogical skills used in a flexible way, tailored and sensible to students and the learning context, enhance student experiences. Nursing educators should identify learning situations that make students vulnerable and pay particular attention to the students' learning experiences. We identified several tools accommodating the students' experience.

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.

Adolescents' health literacy, health protective measures, and health-related quality of life during the Covid-19 pandemic.

PURPOSE: First, to describe adolescents' health information sources and knowledge, health literacy (HL), health protective measures, and health-related quality of life (HRQoL) during the initial phase of the Covid-19 pandemic in Norway. Second, to investigate the association between HL and the knowledge and behavior relevant for preventing spread of the virus. Third, to explore variables associated with HRQoL in a pandemic environment. METHODS: This cross-sectional study includes survey data from 2,205 Norwegian adolescents 16-19 years of age. The participants reported on their health information sources, HL, handwashing knowledge and behavior, number of social interactions, and HRQoL. Associations between study variables and specified outcomes were explored using multiple linear and logistic regression analyses. RESULTS: Television (TV) and family were indicated to be the main sources for pandemic-related health information. Handwashing, physical distancing, and limiting the number of social contacts were the most frequently reported measures. HL and handwashing knowledge and HL and handwashing behavior were significantly associated. For each unit increase on the HL scale, the participants were 5% more likely to socialize less with friends in comparison to normal. The mean HRQoL was very poor compared to European norms. Being quarantined or isolated and having confirmed or suspected Covid-19 were significantly negatively associated with HRQoL, but seeing less friends than normal was not associated. HL was significantly positively associated with HRQoL, albeit of minor clinical importance. CONCLUSION: Adolescents follow the health authorities' guidelines and appear highly literate. However, high fidelity requires great sacrifice because the required measures seem to collide with certain aspects that are important for the adolescents' HRQoL.

Using the RE-AIM framework to evaluate internal and external validity of mobile phone-based interventions in diabetes self-management education and support.

OBJECTIVE: We evaluated the extent to which studies that tested short message service (SMS)- and application (app)-based interventions for diabetes self-management education and support (DSMES) report on factors that inform both internal and external validity as measured by the RE-AIM (Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance) framework. MATERIALS AND METHODS: We systematically searched PubMed, Embase, Web of Science, CINAHL (Cumulative Index of Nursing and Allied Health Literature), and IEEE Xplore Digital Library for articles from January 1, 2009, to February 28, 2019. We carried out a multistage screening process followed by email communications with study authors for missing or discrepant information. Two independent coders coded eligible articles using a 23-item validated data extraction tool based on the RE-AIM framework. RESULTS: Twenty studies (21 articles) were included in the analysis. The comprehensiveness of reporting on the RE-AIM criteria across the SMS- and app-based DSMES studies was low. With respect to internal validity, most interventions were well described and primary clinical or behavioral outcomes were measured and reported. However, gaps exist in areas of attrition, measures of potential negative outcomes, the extent to which the protocol was delivered as intended, and description on delivery agents. Likewise, we found limited information on external validity indicators across adoption, implementation, and maintenance domains. CONCLUSIONS: Reporting gaps were found in internal validity but more so in external validity in the current SMS- and app-based DSMES literature. Because most studies in this review were efficacy studies, the generalizability of these interventions cannot be determined. Future research should adopt the RE-AIM dimensions to improve the quality of reporting and enhance the likelihood of translating research to practice.

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.

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.

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).

A review of self-rated generic quality of life instruments used among older patients receiving home care nursing.

In the last two decades, quality of life and health-related quality of life have become commonly used outcome measures in the large number of studies evaluating healthcare and home care nursing. The objective of this systematic search and review was to evaluate studies that include self-rated generic quality of life instrument used among elderly patients receiving home care nursing. Searches were conducted in Medline, Embase, PsycINFO and Cinahl for articles published between January 2005 and June 2016, with 17 studies in eight countries meeting the inclusion criteria and assessed for quality. Overall, the review shows great variations in the included studies regarding characteristics of the participants and place of origin, the generic quality of life instruments applied and their dimensions. In this review, we raise the question of whether the generic questionnaires used to measure quality of life do in fact measure what is essential for quality of life in elderly users of home care nursing. The psychological and physical dimensions of quality of life were assessed in almost all included studies, while older-specific dimensions like autonomy, control and sensation were less frequently assessed. There is reason to believe that generic quality of life instruments frequently do not capture the dimensions that are most important for elderly people with health problems in need of home care nursing.

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).

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.

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.