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A Tailored Cognitive-Behavioural Intervention Produces Comparable Reductions in Regimen-Related Distress in Adults With Type 2 Diabetes Regardless of Insulin Use: 12-Month Outcomes From the COMRADE Trial.
Lutes, LD, Cummings, DM, Littlewood, K, Le, MT, Kirian, K, Patil, S, Solar, C, Carraway, M, Hambidge, B
Canadian journal of diabetes. 2020;(6):530-536
Abstract
OBJECTIVES Our aim in this study was to determine whether a cognitive-behavioural therapy plus small changes lifestyle intervention can produce comparable improvements in insulin users vs patients not using insulin with uncontrolled type 2 diabetes (T2D) and comorbid depressive or regimen-related distress (RRD) symptoms. METHODS This study is a secondary analysis of Collaborative Care Management for Distress and Depression in Rural Diabetes Study, a randomized, controlled trial of a 16-session, severity-tailored cognitive-behavioural therapy plus small changes lifestyle intervention compared with usual care. Outcomes included glycated hemoglobin (A1C), regimen-related distress, depression, medication adherence and diabetes self-care. Our investigation provides 2 sets of contrasts: 1) insulin users in the intervention group compared with insulin users in the usual-care group and 2) insulin users compared with noninsulin users in the intervention group only. RESULTS Of the 139 participants, 72 (52%) were using insulin at baseline and had significantly higher levels of A1C (10.2±2.1% vs 8.9±1.6%) and RRD (3.3±1.4 vs 2.8±1.1), and significantly poorer medication adherence (5.2±2.1 days/wk vs 5.5±1.7 days/wk). Intervention patients using insulin exhibited significantly greater reductions in RRD and marginally significant improvements in medication adherence and A1C compared with insulin users in usual care. Within the intervention group, changes in RRD, medication adherence and A1C did not differ significantly by insulin use. CONCLUSIONS Tailored cognitive-behavioural therapy with a small-changes lifestyle intervention improved elevated RRD and A1C outcomes at least as effectively in insulin users as non‒insulin users. Future powered studies need to address the role of insulin use in uptake and treatment outcomes.
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Effects of self-guided e-counseling on health behaviors and blood pressure: Results of a randomized trial.
Liu, S, Tanaka, R, Barr, S, Nolan, RP
Patient education and counseling. 2020;(3):635-641
Abstract
OBJECTIVE 1) Evaluate the efficacy of e-Counseling vs. Control to promote lifestyle behaviors at 4 and 12-month follow-ups, 2) examine whether these behaviors changes were associated with lower blood pressure (BP), and Framingham Risk Index (FRI) at 12-month. METHODS Hypertensive patients (n = 264) were randomized to the e-Counseling or the Control group. Primary trial outcome was BP and secondary outcomes included exercise and diet behaviors. This study presented the results of secondary outcomes. Linear mixed models evaluated treatment effects at 4 and 12-month. Treatment-by-sex exploratory analyses were conducted if no main treatment effect was observed. RESULTS Daily steps significantly improved in e-Counseling vs. Controls at 12-month. Urinary sodium at 12-month did not significantly differ between the groups, but treatment-by-sex analysis showed that e-Counseling females lowered urinary sodium relative to Controls at 12 months. Improvements in steps and dietary sodium were significantly associated with improvements in BP and FRI at 12-month. CONCLUSION This hypertension e-Counseling protocol can promote long-term lifestyle behavior changes. Adherence to the lifestyle behavior change was associated with BP and FRI reduction at 12-month. PRACTICE IMPLICATIONS The hypertension e-counseling protocol has the potential to improve hypertension care and intervention reach.
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Multifactorial Intervention on Type 2 Diabetes (MIDiab) Study: A multicenter, open-label, randomized, parallel controlled, community trial.
Wang, Y, Guan, Q, Hou, X, Zhang, X, Zhang, H, Xu, C, Jing, F, Ma, S, Shao, S, Zhao, M, et al
Journal of diabetes. 2020;(11):862-864
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Users' acceptability of a mobile application for persons with type 2 diabetes: a qualitative study.
Torbjørnsen, A, Ribu, L, Rønnevig, M, Grøttland, A, Helseth, S
BMC health services research. 2019;(1):641
Abstract
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.
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A self-monitoring urinary salt excretion level measurement device for educating young women about salt reduction: A parallel randomized trial involving two groups.
Yasutake, K, Umeki, Y, Horita, N, Morita, R, Murata, Y, Ohe, K, Tsuchihashi, T, Enjoji, M
Journal of clinical hypertension (Greenwich, Conn.). 2019;(6):730-738
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Abstract
To prevent and treat hypertension, it is important to restrict salt in one's diet since adolescence. However, an effective salt-reduction education system has yet to be established. Besides accurate evaluation, we believe that the frequent usage of a measurement device may motivate individuals to avoid high salt intake. The present study evaluated the use of a urinary salt excretion measurement device for salt-reduction education in a parallel randomized trial of two groups. The sample comprised 100 university students who provided consent to participate. A survey with 24-hour home urine collection and blood pressure measurement was conducted. Participants in the self-monitoring group measured their own urinary salt excretion level for 4 weeks, using the self-measurement device. Analyses were conducted on 51 participants in the control group and 49 in the self-monitoring group. At baseline, there was no significant difference between the two groups in terms of their characteristics and 24-hour urinary salt excretion levels. After intervention, 24-hour urinary sodium/potassium ratio showed no change in the control group [baseline score: 4.1 ± 1.5; endline score: 4.2 ± 2.0; P = 0.723], but it decreased significantly in the self-monitoring group [baseline score: 4.0 ± 1.7; endline score: 3.5 ± 1.4; P = 0.044]. This change was significant even after adjusting for baseline and endline differences between groups using analysis of covariance (P = 0.045). The self-monitoring urinary salt excretion measurement device improved the 24-hour urinary sodium/potassium ratio. The device is a useful and practical tool for educating young individuals about dietary salt reduction.
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Home Management of Warfarin Treatment Through a Real-Time Supervised Telemedicine Solution: A Randomized Controlled Trial.
Brasen, CL, Madsen, JS, Parkner, T, Brandslund, I
Telemedicine journal and e-health : the official journal of the American Telemedicine Association. 2019;(2):109-115
Abstract
BACKGROUND Many patients are undergoing oral anticoagulation treatment with vitamin K antagonists, which necessitates measuring international normalized ratio (INR) several times each month. INTRODUCTION Patients can learn to measure their INR at home and choose their own dose for the next period with potential gains in treatment quality and reduced healthcare expenses. This is, however, connected to the potential problem of losing tight external control of the patient treatment. MATERIALS AND METHODS We performed a randomized controlled trial using the telemedicine software CSO/AC together with the INR point-of-care-test CoaguChek XS for 10 months to investigate the use of criteria-driven healthcare interactions. A total of 87 patients were divided into two groups. The patient self-management (PSM) group was surveilled using the criteria INR <1.8, INR >4.5, change in warfarin/week >1.25 mg, missing INR or dosage. The patient self-testing (PST) group was handled as routine care. RESULTS A total of 84 patients were followed for 10 months. No differences were seen in average INR or fraction of INR in therapeutic range (2-3) in the two groups or the start compared with the end. The PST group was handled using 4.2 interactions per month whereas the PSM group used 1.1 interactions per month. No adverse effects of PSM were observed. DISCUSSION Using criteria-driven interactions enabled a considerable reduction in interactions per month. The two groups were comparable in terms of treatment effect and safety. CONCLUSIONS Using criteria to guide PSM interactions maintains good treatment effect while reducing healthcare expenses.
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Knowledge and attitude about diabetes self-care of older adults in primary health care.
Borba, AKOT, Arruda, IKG, Marques, APO, Leal, MCC, Diniz, ADS
Ciencia & saude coletiva. 2019;(1):125-136
Abstract
This study aimed to assess the knowledge about diabetes, the attitude for self-care and associated factors through a cross-sectional study, the baseline of a randomized clinical trial with elderly diabetic in primary health care in Recife, Northeastern Brazil. We used the Diabetes Knowledge Scale (DKN-A) and Diabetes Attitudes Questionnaire (ATT-19). Of the 202 elderly, 77.7% had insufficient knowledge of the disease, especially for ketonuria, food replacement and were unaware of the causes and care of hypoglycemia. As for attitude, 85.6% had a negative psychological adjustment for diabetes. The logistic regression model showed that living alone was a protective factor (OR = 0.24; 95% CI 0.09-0.65; OR = 0.22; 95% CI 0.07 to 0.71), and low education, a risk factor (OR = 7.78; 95% CI 3.36-18.01; OR = 13.05; 95% CI 4.63-36.82) for the insufficient knowledge and the negative attitude for self-care, respectively. The findings reinforce the need for interdisciplinary educational actions that include socioeconomic, psycho-emotional and educational aspects in diabetes management to maintain elderly autonomy and functionality.
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Efficacy of an internet-based exposure treatment for flying phobia (NO-FEAR Airlines) with and without therapist guidance: a randomized controlled trial.
Campos, D, Bretón-López, J, Botella, C, Mira, A, Castilla, D, Mor, S, Baños, R, Quero, S
BMC psychiatry. 2019;(1):86
Abstract
BACKGROUND Internet-based treatments appear to be a promising way to enhance the in vivo exposure approach, specifically in terms of acceptability and access to treatment. However, the literature on specific phobias is scarce, and, as far as we know, there are no studies on Flying Phobia (FP). This study aims to investigate the effectiveness of an Internet-based exposure treatment for FP (NO-FEAR Airlines) that includes exposure scenarios composed of images and sounds, versus a waiting-list control group. A secondary aim is to explore two ways of delivering NO-FEAR Airlines, with and without therapist guidance. METHODS A randomized controlled trial (RCT) was conducted in which 69 participants were allocated to: 1) NO-FEAR Airlines totally self-applied, 2) NO-FEAR Airlines with therapist guidance, 3) a waiting-list control group. Primary outcome measures were the Fear of Flying Questionnaire-II and the Fear of Flying Scale. Secondary outcomes included the Fear and Avoidance Scales, Clinician Severity Scale, and Patient's Improvement scale. Behavioral outcomes (post-treatment flights and safety behaviors) were also included. Mixed-model analyses with no ad hoc imputations were conducted for primary and secondary outcome measures. RESULTS NO-FEAR Airlines (with and without therapist guidance) was significantly effective, compared to the waiting list control group, on all primary and secondary outcomes (all ps < .05), and no significant differences were found between the two ways of delivering the intervention. Significant improvements on diagnostic status and reliable change indexes were also found in both treatment groups at post-treatment. Regarding behavioral outcomes, significant differences in safety behaviors were found at post-treatment, compared to the waiting list. Treatment gains were maintained at 3- and 12-month follow-ups. CONCLUSION FP can be treated effectively via the Internet. NO-FEAR Airlines helps to enhance the exposure technique and provide access to evidence-based psychological treatment to more people in need. These data are congruent with previous studies highlighting the usefulness of computer-assisted exposure programs for FP, and they contribute to the literature on Internet-based interventions. To the best of our knowledge, this is the first RCT to investigate the effectiveness of an Internet-based treatment for FP and explore two ways of delivering the intervention (with and without therapist guidance). TRIAL REGISTRATION Clinicaltrials.gov: NCT02298478 ( https://clinicaltrials.gov/ct2/show/NCT02298478 ). Trial registration date 3 November 2014.
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Dietary Self-Monitoring Through Calorie Tracking but Not Through a Digital Photography App Is Associated with Significant Weight Loss: The 2SMART Pilot Study-A 6-Month Randomized Trial.
Dunn, CG, Turner-McGrievy, GM, Wilcox, S, Hutto, B
Journal of the Academy of Nutrition and Dietetics. 2019;(9):1525-1532
Abstract
BACKGROUND Dietary self-monitoring (DSM) of foods and beverages is associated with weight loss in behavioral interventions; however, DSM may be burdensome, and adherence may decrease over time. Novel methods of DSM, including apps that track food using photographs, may decrease burden, increase DSM adherence, and improve weight loss. OBJECTIVE The objective was to test a mobile photo DSM app compared to a calorie-tracking DSM app on tracking frequency and weight loss in a remotely delivered behavioral weight-loss intervention. DESIGN This was a 6-month (October 2016 to April 2017) randomized trial. PARTICIPANTS/SETTING Participants were adults (n=41) classified as overweight or obese (body mass index 25 to 49.9) from South Carolina. INTERVENTION Participants received remotely delivered twice-weekly behavioral weight-loss podcasts and tracked diet using a calorie-tracking DSM app (Calorie Group) or a photo DSM app (Photo Group). MAIN OUTCOME MEASURES Main outcomes were the number of days diet was tracked, podcasts downloaded, and weight change at 6 weeks and 6 months. STATISTICAL ANALYSES Researchers used nonparametric Wilcoxon rank sum tests and χ2 analysis to test for differences between groups at baseline; repeated-measures models to estimate weight change and Spearman correlations to determine relationships between DSM frequency, podcasts downloaded, and weight change at 6 months. RESULTS There were no differences between groups for the number of days that diet was recorded (P=0.18), which was low overall (<30% of days) but was statistically significantly and strongly correlated with weight change for all participants pooled (r=0.63; P<0.001) and for the calorie tracking group (r=0.70; P=0.004), but not the photo tracking group (r=0.51; P=0.06). Participants in both groups had significant weight loss at 6 months (Photo Group, -2.5±0.9 kg; P=0.008; Calorie Group -2.4±0.9 kg; P=0.007), with no differences between groups at either 6 weeks (P=0.66) or at 6 months (P=0.74). CONCLUSIONS As part of a remotely delivered weight loss intervention, frequency of DSM was significantly associated with overall weight loss for participants using a calorie DSM app but not a photo DSM app. DSM was low regardless of group and weight loss was significant, although minimal. Increasing user engagement with any DSM may be important to increase self-monitoring and improve weight loss.
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Effect of a new self-care guide package on maternal and neonatal outcomes in gestational diabetes: A randomized control trial.
Kolivand, M, Rahimi, MA, Keramat, A, Shariati, M, Emamian, MH
Journal of diabetes. 2019;(2):139-147
Abstract
BACKGROUND The aim of this study was to determine the effect of a new self-care guide package on gestational diabetes mellitus (GDM). METHODS This randomized clinical trial was conducted on 152 women with GDM. The intervention group was provided with the self-care guide package and three face-to-face educational sessions. The control group received routine clinical services, including physician visits and short training regarding nutrition, blood glucose control, and insulin injections. The primary outcomes were fasting and 2-h postprandial blood glucose and self-efficacy measured at the beginning of the study and 1 month after the end of the intervention. Secondary outcomes included Apgar scores, birth weight, type of delivery, and newborn hospitalization. Data were analyzed using t-tests, as well as Mann-Whitney, Chi-squared, and linear and logistic regression tests. RESULTS The mean (±SD) self-efficacy score was higher in the intervention than control group (74.4 ± 7.0 vs 36.4 ± 5.2, respectively; P < 0.001). There was no significant difference in mean fasting plasma glucose between the two groups (P = 0.163), but mean 2-h postprandial plasma glucose was lower in the intervention than control group (105.1 ± 17.6 vs 127.2 ± 20.4 mg/dL, respectively; P < 0.001). There were no significant differences in the weight and age of the neonate at delivery or in the type of delivery between the two groups. However, the newborn hospitalization rate was higher in the control group (P < 0.001). CONCLUSION The use of a self-care package had a positive effect on maternal self-efficacy and 2-h postprandial plasma glucose, Apgar scores, and neonatal hospitalization.