Lis Ribu

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.

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.

Health-related quality of life and all-cause mortality in patients with diabetes on dialysis

BackgroundThis study tests the hypotheses that health-related quality of life (HRQOL) in prevalent dialysis patients with diabetes is lower than in dialysis patients without diabetes, and is at least as poor as diabetic patients with another severe complication, i.e. foot ulcers. This study also explores the mortality risk associated with diabetes in dialysis patients.MethodsHRQOL was assessed using the Short Form-36 Health Survey (SF-36), in a cross-sectional study of 301 prevalent dialysis patients (26% with diabetes), and compared with diabetic patients not on dialysis (n = 221), diabetic patients with foot ulcers (n = 127), and a sample of the general population (n = 5903). Mortality risk was assessed using a Kaplan-Meier plot and Cox proportional hazards analysis.ResultsSelf-assessed vitality, general and mental health, and physical function were significantly lower in dialysis patients with diabetes than in those without. Vitality (p = 0.011) and general health (p <0.001) was impaired in diabetic patients receiving dialysis compared to diabetic patients with foot ulcers, but other subscales did not differ. Diabetes was a significant predictor for mortality in dialysis patients, with a hazard ratio (HR) of 1.6 (95% CI 1.0-2.5) after adjustment for age, dialysis vintage and coronary artery disease. Mental aspects of HRQOL were an independent predictor of mortality in diabetic patients receiving dialysis after adjusting for age and dialysis vintage (HR 2.2, 95% CI 1.0-5.0).ConclusionsPhysical aspects of HRQOL were perceived very low in dialysis patients with diabetes, and lower than in other dialysis patients and diabetic patients without dialysis. Mental aspects predicted mortality in dialysis patients with diabetes. Increased awareness and measures to assist physical function impairment may be particularly important in diabetes patients on dialysis.

Measuring health-related quality of life in non-complicated diabetes patients may be an effective parameter to assess patients at risk of a more serious disease course: a cross-sectional study of two diabetes outpatient groups

AIM To describe health-related quality of life in diabetes outpatients and investigate the impact of diabetic foot ulcers, by comparing a group of patients with and without diabetic foot ulcers complications. Secondary to study the impact of sociodemographic and clinical variables in the two groups. DESIGN Cross-sectional study. METHODS The study involved 130 diabetes outpatients and 127 diabetic foot ulcers patients. Health-related quality of life was measured with the generic questionnaire Short Form-36, consisting of eight dimensional scores. All scores were adjusted for differences in age and gender (estimated marginal means). Differences were compared with anova calculations, by the use of Predictive Analytics Software, PASW (version 17.0). RESULTS This study confirms that health-related quality of life differs significantly between disease subgroups when measured with Short Form-36. Diabetic foot ulcers had a major negative impact on 7/8 subscales on the Short Form-36 compared to the diabetes outpatients group. health-related quality of life decreased with increasing amount of complications and comorbidity in the diabetes outpatients group, with cardiovascular complications being the most pronounced predictor of lower health-related quality of life scores. CONCLUSION Patients who have developed diabetic foot ulcers reports much poorer health-related quality of life than compared to diabetes outpatients. Factors linked to the development of late complications were not detected in the diabetic foot ulcers group, such as cardiovascular comorbidity and neuropathy. RELEVANCE TO CLINICAL PRACTICE Health-related quality of life measurement in early stages of disease may detect patients at risk of a more serious disease course and who consequently are in need of a more intensive follow-up.

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.

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)

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.

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.