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Randomized Controlled Trial Comparing Health Coach-Delivered Smartphone-Guided Self-Help With Standard Care for Adults With Binge Eating.
Hildebrandt, T, Michaeledes, A, Mayhew, M, Greif, R, Sysko, R, Toro-Ramos, T, DeBar, L
The American journal of psychiatry. 2020;(2):134-142
Abstract
OBJECTIVE Cognitive-behavioral therapy (CBT) has shown efficacy in the treatment of eating disorders. The authors conducted a randomized controlled telemedicine trial of CBT-guided self-help (CBT-GSH) assisted with a smartphone app, Noom Monitor, for binge eating with or without purging. They hypothesized that coach-delivered CBT-GSH telemedicine sessions plus Noom Monitor would yield greater reductions in symptoms of binge eating, purging, and eating disorders compared with standard care. METHODS Fifty-two-week outcomes for CBT-GSH plus Noom Monitor (N=114) were compared with outcomes for standard care (N=111) among members of an integrated health care system in the Pacific Northwest. Patients in the health system who met inclusion criteria were ≥18 years old, had a body mass index ≥18.5, met criteria for DSM-5 binge eating disorder or bulimia nervosa, had 12 months of continuous health care enrollment in Kaiser Permanente Northwest, and had a personal smartphone. Participants received eight CBT-GSH telemedicine sessions over 12 weeks administered by health coaches, and outcomes were assessed at baseline and at weeks 4, 8, 12, 26, and 52. The use of available treatment offered within the Kaiser Permanente health care system was permitted for participants assigned to standard care. RESULTS Participants who received CBT-GSH plus Noom Monitor reported significant reductions in objective binge-eating days (β=-0.66, 95% CI=-1.06, -0.25; Cohen's d=-1.46, 95% CI=-4.63, -1.09) and achieved higher rates of remission (56.7% compared with 30%; number needed to treat=3.74) at 52 weeks compared with participants in standard care, none of whom received any eating disorder treatment during the intervention period (baseline and weeks 1-12). Similar patterns emerged for compensatory behaviors (vomiting, use of laxatives, and excessive exercise; 76.3% compared with 56.8%; number needed to treat=5.11), eating disorder symptoms (body shape, weight, eating concerns, and dietary restraint), and clinical impairment (Cohen's d=-10.07, -2.15). CONCLUSIONS These results suggest that CBT-GSH plus Noom Monitor delivered via telemedicine by routine-practice health coaches in a nonacademic health care system yields reductions in symptoms and impairment over 52 weeks compared with standard care.
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Diagnostic Accuracy of Technology-based Eye Care Services: The Technology-based Eye Care Services Compare Trial Part I.
Maa, AY, Medert, CM, Lu, X, Janjua, R, Howell, AV, Hunt, KJ, McCord, S, Giangiacomo, A, Lynch, MG
Ophthalmology. 2020;(1):38-44
Abstract
PURPOSE Ophthalmologic telemedicine has the ability to provide eye care for patients remotely, and many countries have used screening tele-ophthalmology programs for several years. One such initiative at the Veterans Affairs (VA) Healthcare System is Technology-based Eye Care Services (TECS). The TECS services are located in primary care clinics and provide basic screening eye care, including vision, refraction, and retinal photography. Eye care providers ("readers") review the clinical data and recommend appropriate follow-up. One of the most common referrals from TECS has been for glaucoma, and this study was powered for glaucoma/glaucoma suspect detection. The current study was undertaken to identify aspects of the protocol that could be refined to enhance accuracy. DESIGN Prospective comparison between the standard TECS protocol versus a face-to-face (FTF) examination on 256 patients, all of whom had no known history of significant ocular disease. PARTICIPANTS Patients with no known ocular disease who were scheduled for an in-person eye appointment at the Atlanta VA. Patients underwent screening through the TECS protocol and received an FTF examination on the same day (gold standard). The TECS readers were masked to the results of the FTF examination. MAIN OUTCOME MEASURES Percent agreement, kappa, sensitivity, and specificity were calculated for the TECS readers' interpretations versus the FTF examination. RESULTS The TECS readers showed substantial agreement for cataract (κ ≥ 0.71) and diabetic retinopathy (κ ≥ 0.61) and moderate to substantial agreement for glaucoma/glaucoma suspect (κ ≥ 0.52) compared with an FTF examination. Age-related macular degeneration (AMD) showed moderate agreement (κ ≥ 0.34). Percent agreement with the TECS protocol was high (84.3%-98.4%) for each of the disease categories. Overall sensitivity and specificity were ≥75% and ≥55%, respectively, for any diagnosis resulting in referral. Inter-reader and intra-reader agreement was substantial for most diagnoses (κ > 0.61) with percent agreements ranging from 66% to 99%. CONCLUSIONS Our results indicate that the standard TECS protocol is accurate when compared with an FTF examination for the detection of common eye diseases. The inclusion of additional testing such as OCT could further enhance diagnostic capability.
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Short- and long-term effectiveness of a smartphone application for improving measures of adiposity: A randomised clinical trial - EVIDENT II study.
Gomez-Marcos, MA, Patino-Alonso, MC, Recio-Rodriguez, JI, Agudo-Conde, C, Romaguera-Bosch, M, Magdalena-Gonzalez, O, Gomez-Arranz, A, Mendizabal-Gallastegui, N, Angel Fernandez-Diez, J, Gomez-Sanchez, L, et al
European journal of cardiovascular nursing. 2018;(6):552-562
Abstract
BACKGROUND Evidence on the efficacy of smartphone applications (apps) for reducing body weight and other measurements of adiposity sustainably is not conclusive. OBJECTIVE To evaluate the effect of adding an app for 3 months to traditional counselling on physical activity (PA) and a heart-healthy diet for the modification of measurements of adiposity at 3 and 12 months after intervention. METHODS This randomised clinical trial included 833 subjects. The counselling and app group (IG) had 415 subjects, while 418 were included in the counselling only group (CG). The primary outcome was adiposity measurements at 3 and 12 months after intervention. The secondary outcome was the effect of the intervention by sex. INTERVENTION Counselling on a heart-healthy diet and PA was given to both groups. The IG also received training in the use of a smartphone app designed to promote a heart-healthy diet and PA, and this group was given access to this application for 3 months. Outcome measurements included waist circumference (WC), body mass index (BMI) and Clínica Universidad de Navarra - body adiposity estimator (CUN-BAE). RESULTS In the IG at 12 months, the following decreased: WC -0.72 cm (95% confidence interval [CI]: -2.35 to -0.02) and CUN-BAE -0.35 (95% CI: -0.63 to -0.06). These decreases were only observed in women. After baseline adjustment, the beneficial effect was maintained in the IG compared to the CG at 12 months in terms of WC (-0.67; 95% CI: -0.29 to -0.02) and CUN-BAE (-0.57; 95% CI: -1.10 to -0.04), but only in women. CONCLUSIONS An intervention of nutritional counselling and PA plus the smartphone app with personalised recommendations compared to CG showed beneficial results in terms of reduction of abdominal obesity and the percentage of body fat in women, but not in men.
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[Support of diabetes dietary management and self-management using mobile applications].
Szálka, B, Kósa, I, Vassányi, I, Mák, E
Orvosi hetilap. 2016;(29):1147-53
Abstract
The key components of successful diabetes therapy are pharmacotherapy, hospital care and lifestyle education. Lifestyle education, self-management, and composing the right diet can be effectively supported with mobile applications. In this paper Hungarian mobile applications are reviewed and compared to some international competitors. Besides plenty of useful functions some deficiencies are identified, based on dietary recommendations. The related improvements together with clinical trials validating effectiveness and reliability can strengthen medical evidence as well as the penetration of such mobile applications. Orv. Hetil., 2016, 157(29), 1147-1153.
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Long-term Comparative Effectiveness of Telemedicine in Providing Diabetic Retinopathy Screening Examinations: A Randomized Clinical Trial.
Mansberger, SL, Sheppler, C, Barker, G, Gardiner, SK, Demirel, S, Wooten, K, Becker, TM
JAMA ophthalmology. 2015;(5):518-25
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Abstract
IMPORTANCE Minimal information exists regarding the long-term comparative effectiveness of telemedicine to provide diabetic retinopathy screening examinations. OBJECTIVE To compare telemedicine to traditional eye examinations in their ability to provide diabetic retinopathy screening examinations. DESIGN, SETTING, AND PARTICIPANTS From August 1, 2006, through September 31, 2009, 567 participants with diabetes were randomized and followed up to 5 years of follow-up (last date of patient follow-up occurred on August 6, 2012) as part of a multicenter randomized clinical trial with an intent to treat analysis. We assigned participants to telemedicine with a nonmydriatic camera in a primary care medical clinic (n = 296) or traditional surveillance with an eye care professional (n = 271). Two years after enrollment, we offered telemedicine to all participants. MAIN OUTCOMES AND MEASURES Percentage of participants receiving annual diabetic retinopathy screening examinations, percentage of eyes with worsening diabetic retinopathy during the follow-up period using a validated scale from stage 0 (none) to stage 4 (proliferative diabetic retinopathy), and percentage of telemedicine participants who would require referral to an eye care professional for follow-up care using a cutoff of moderate diabetic retinopathy or worse, the presence of macular edema, or an unable-to-determine result for retinopathy or macular edema. RESULTS The telemedicine group was more likely to receive a diabetic retinopathy screening examination when compared with the traditional surveillance group during the 6-month or less (94.6% [280/296] vs 43.9% [119/271]; 95% CI, 46.6%-54.8%; P < .001) and greater than 6-month through 18-month (53.0% [157/296] vs 33.2% [90/271]; 95% CI, 16.5%-23.1%; P < .001) time bins. After we offered telemedicine to both groups, we could not identify a difference between the groups in the percentage of diabetic retinopathy screening examinations. Diabetic retinopathy worsened by 2 stages or more in 35 (8.6%) of 409 participants (95% CI, 5.8%-11.2%) and improved by 2 stages or more in 5 (1.2%) of 409 participants (95% CI, 0.1%-2.3%) during the 4-year period. The percent of telemedicine participants requiring referral ranged from 19.2% (52/271) to 27.9% (58/208). CONCLUSIONS AND RELEVANCE Telemedicine increased the percentage of diabetic retinopathy screening examinations, most participants did not require referral to an eye care professional, and diabetic retinopathy levels were generally stable during the study period. This finding suggests that primary care clinics can use telemedicine to screen for diabetic retinopathy and monitor for disease worsening over a long period. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01364129.
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Accuracy of a technology-assisted eye exam in evaluation of referable diabetic retinopathy and concomitant ocular diseases.
Conlin, PR, Asefzadeh, B, Pasquale, LR, Selvin, G, Lamkin, R, Cavallerano, AA
The British journal of ophthalmology. 2015;(12):1622-7
Abstract
BACKGROUND/AIMS: Digital retinal imaging using store-and-forward technology is used to screen for diabetic retinopathy (DR). Its usefulness in detecting non-diabetic eye diseases is uncertain. We determined the level of agreement between teleretinal imaging supplemented with visual acuity and intraocular pressure (IOP) measurements (ie, technology-assisted eye (TAE) exam) and a comprehensive eye exam in evaluation for DR and non-diabetic ocular conditions. METHODS We conducted a prospective, observational study with two parallel evaluations. Patients with diabetes (n=317) had a TAE exam and a comprehensive eye exam on the same day. A subset of participants with normal baseline exams (n=72) had follow-up exams 1 year later. We measured the level of agreement for referable ocular findings. RESULTS Agreement for referable ocular findings was moderate (n=389, agreement: 77%; κ: 0.55), due in part to ungradable exams (22%). However, about half of the ungradable exams had findings that warranted referral. There was substantial agreement for follow-up exams (n=72, agreement: 93%; κ: 0.63). Among all gradable exams (n=303), the TAE exam had 86% sensitivity and 84% specificity for referable ocular findings, with high agreement (≥94%) for DR and other major ocular diagnoses. CONCLUSIONS There was moderate-to-substantial agreement between a TAE exam and a comprehensive eye exam for referable ocular findings in patients with diabetes. Ungradable exams were a frequent marker of ocular pathology. Teleretinal imaging may be a useful evaluation for both diabetic and non-diabetic ocular conditions.
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How accurate is the diagnosis of diabetic retinopathy on telescreening? The Indian scenario.
Raman, R, Bhojwani, DN, Sharma, T
Rural and remote health. 2014;(4):2809
Abstract
CONTEXT Diabetes mellitus is a healthcare burden in India. Seventy-four percent of India's population lives in rural areas with limited access to healthcare resources. Telemedicine can play a big role in screening people with diabetes at grassroots level. In the telescreening model, single field 45-degree photographs are used for detecting diabetic retinopathy. The American Academy of Ophthalmology does not recommends single-field fundus photography as an adequate substitute for a comprehensive ophthalmic examination because it may lead to a higher rate of underdiagnosis. We conducted a telescreening project using single-field fundus photography to determine its accuracy compared to the traditional camp-based screenings. ISSUES In this project we compared the prevalence of diabetic retinopathy between an ophthalmologist-based and an ophthalmologist-led model on two different samples of people self-reporting with diabetes in rural South India. Between 2004 and 2005 in rural South India, 3522 people with diabetes mellitus underwent ophthalmologist-based diabetic retinopathy screening and 4456 people with diabetes underwent ophthalmologist-led (telescreening) diabetic retinopathy screening. The two population groups were randomly separated. In the ophthalmologist-based program, a trained retina specialist travels along with the camp team and screens patients at the camp site for diabetic retinopathy. In the ophthalmologist-led program (telescreening), fundus photographs are transmitted to the base hospital for further evaluation and grading. A total of 519 people (14.7%) were diagnosed to have diabetic retinopathy in the ophthalmologist-based model, and 853 people (19.1%) in the ophthalmologist-led model p < 0.0001). More sight-threatening retinopathies were found in the ophthalmologist-led model than in the ophthalmologist-based model (6.3% vs. 5%). LESSONS LEARNED The ophthalmologist-led (telescreening) model did not underestimate the prevalence of diabetic retinopathy. Therefore, because it obviates the need for travel by an ophthalmologist, it is a good method for diabetic retinopathy screening in rural areas of India.
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Therapeutic benefit of preventive telehealth counseling in the Community Outreach Heart Health and Risk Reduction Trial.
Nolan, RP, Upshur, RE, Lynn, H, Crichton, T, Rukholm, E, Stewart, DE, Alter, DA, Chessex, C, Harvey, PJ, Grace, SL, et al
The American journal of cardiology. 2011;(5):690-6
Abstract
We evaluated whether telehealth counseling augments lifestyle change and risk factor decrease in subjects at high risk for primary or secondary cardiovascular events compared to a recommended guideline for brief preventive counseling. Subjects at high risk or with coronary heart disease (35 to 74 years of age, n = 680) were randomized to active control (risk factor feedback, brief advice, handouts) or telehealth lifestyle counseling (active control plus 6 weekly 1-hour teleconferenced sessions to groups of 4 to 8 subjects). Primary outcome was questionnaire assessment of adherence to daily exercise/physical activity and diet (daily vegetable and fruit intake and restriction of fat and salt) after treatment and at 6-month follow-up. Secondary outcomes were systolic and diastolic blood pressures, ratio of total to high-density lipoprotein cholesterol, and 10-year absolute risk for coronary disease. After treatment and at 6-month follow-up, adherence increased for telehealth versus control in exercise (29.3% and 18.4% vs 2.5% and 9.3%, respectively, odds ratio 1.60, 95% confidence interval 1.2 to 2.1) and diet (37.1% and 38.1% vs 16.7% and 33.3%, respectively, odds ratio 1.41, 95% confidence interval 1.1 to 1.9). Telehealth versus control had greater 6-month decreases in blood pressure (mean ± SE, systolic -4.8 ± 0.8 vs -2.8 ± 0.9 mm Hg, p = 0.04; diastolic -2.7 ± 0.5 vs -1.5 ± 0.6 mm Hg, p = 0.04). Decreases in cholesterol ratio and 10-year absolute risk were significant for the 2 groups. In conclusion, telehealth counseling augments therapeutic lifestyle change in subjects at high risk for cardiovascular events compared to a recommended guideline for brief preventive counseling.
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Features of mobile diabetes applications: review of the literature and analysis of current applications compared against evidence-based guidelines.
Chomutare, T, Fernandez-Luque, L, Arsand, E, Hartvigsen, G
Journal of medical Internet research. 2011;(3):e65
Abstract
BACKGROUND Interest in mobile health (mHealth) applications for self-management of diabetes is growing. In July 2009, we found 60 diabetes applications on iTunes for iPhone; by February 2011 the number had increased by more than 400% to 260. Other mobile platforms reflect a similar trend. Despite the growth, research on both the design and the use of diabetes mHealth applications is scarce. Furthermore, the potential influence of social media on diabetes mHealth applications is largely unexplored. OBJECTIVE Our objective was to study the salient features of mobile applications for diabetes care, in contrast to clinical guideline recommendations for diabetes self-management. These clinical guidelines are published by health authorities or associations such as the National Institute for Health and Clinical Excellence in the United Kingdom and the American Diabetes Association. METHODS We searched online vendor markets (online stores for Apple iPhone, Google Android, BlackBerry, and Nokia Symbian), journal databases, and gray literature related to diabetes mobile applications. We included applications that featured a component for self-monitoring of blood glucose and excluded applications without English-language user interfaces, as well as those intended exclusively for health care professionals. We surveyed the following features: (1) self-monitoring: (1.1) blood glucose, (1.2) weight, (1.3) physical activity, (1.4) diet, (1.5) insulin and medication, and (1.6) blood pressure, (2) education, (3) disease-related alerts and reminders, (4) integration of social media functions, (5) disease-related data export and communication, and (6) synchronization with personal health record (PHR) systems or patient portals. We then contrasted the prevalence of these features with guideline recommendations. RESULTS The search resulted in 973 matches, of which 137 met the selection criteria. The four most prevalent features of the applications available on the online markets (n = 101) were (1) insulin and medication recording, 63 (62%), (2) data export and communication, 61 (60%), (3) diet recording, 47 (47%), and (4) weight management, 43 (43%). From the literature search (n = 26), the most prevalent features were (1) PHR or Web server synchronization, 18 (69%), (2) insulin and medication recording, 17 (65%), (3) diet recording, 17 (65%), and (4) data export and communication, 16 (62%). Interestingly, although clinical guidelines widely refer to the importance of education, this is missing from the top functionalities in both cases. CONCLUSIONS While a wide selection of mobile applications seems to be available for people with diabetes, this study shows there are obvious gaps between the evidence-based recommendations and the functionality used in study interventions or found in online markets. Current results confirm personalized education as an underrepresented feature in diabetes mobile applications. We found no studies evaluating social media concepts in diabetes self-management on mobile devices, and its potential remains largely unexplored.
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A randomized controlled trial on the efficacy of carbohydrate-reduced or fat-reduced diets in patients attending a telemedically guided weight loss program.
Frisch, S, Zittermann, A, Berthold, HK, Götting, C, Kuhn, J, Kleesiek, K, Stehle, P, Körtke, H
Cardiovascular diabetology. 2009;:36
Abstract
BACKGROUND We investigated whether macronutrient composition of energy-restricted diets influences the efficacy of a telemedically guided weight loss program. METHODS Two hundred overweight subjects were randomly assigned to a conventional low-fat diet and a low-carbohydrate diet group (target carbohydrate content: >55% energy and <40% energy, respectively). Both groups attended a weekly nutrition education program and dietary counselling by telephone, and had to transfer actual body weight data to our clinic weekly with added Bluetooth technology by mobile phone. Various fatness and fat distribution parameters, energy and macronutrient intake, and various biochemical risk markers were measured at baseline and after 6, and 12 months. RESULTS In both groups, energy intake decreased by 400 kcal/d compared to baseline values within the first 6 months and slightly increased again within the second 6 months. Macronutrient composition differed significantly between the groups from the beginning to month 12. At study termination, weight loss was 5.8 kg (SD: 6.1 kg) in the low-carbohydrate group and 4.3 kg (SD: 5.1 kg) in the low-fat group (p = 0.065). In the low-carbohydrate group, triglyceride and HDL-cholesterol levels were lower at month 6 and waist circumference and systolic blood pressure were lower at month 12 compared with the low-fat group (P = 0.005-0.037). Other risk markers improved to a similar extent in both groups. CONCLUSION Despite favourable effects of both diets on weight loss, the carbohydrate-reduced diet was more beneficial with respect to cardiovascular risk factors compared to the fat-reduced diet. Nevertheless, compliance with a weight loss program appears to be even a more important factor for success in prevention and treatment of obesity than the composition of the diet. TRIAL REGISTRATION Clinicaltrials.gov as NCT00868387.