Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study.

BACKGROUND: The Diabetes Prevention Program (DPP) intensive lifestyle intervention resulted in significant weight loss, reducing the development of diabetes, but needs to be adapted to primary care provider (PCP) practices. OBJECTIVES: To compare a DPP-translation using individual (IC) vs. conference (CC) calls delivered by PCP staff for the outcome of percent weight loss over 2 years. DESIGN: Randomized clinical trial. SETTING: Five PCP sites. PARTICIPANTS: Obese patients with metabolic syndrome, without diabetes (IC, n = 129; CC, n = 128). INTERVENTION: Telephone delivery of the DPP Lifestyle Balance intervention [16-session core curriculum in year 1, 12-session continued telephone contact in year 2 plus telephone coaching sessions (dietitians). MAIN MEASURES: Weight (kg), body mass index (BMI), and waist circumference. BASELINE DATA: age = 52 years, BMI = 39 kg/m(2), 75 % female, 85 % non-Hispanic White, 13 % non-Hispanic Black, and 48 % annual incomes <$40,000/year. In the intention-to-treat analyses at year 2, mean percent weight loss was -5.6 % (CC, p < 0.001) and -1.8 % (IC, p = 0.046) and was greater for CC than for IC (p = 0.016). At year 2, mean weight loss was 6.2 kg (CC) and 2.2 kg (IC) (p < 0.001). There was similar weight loss at year 1, but between year 1 and year 2 CC participants continued to lose while IC participants regained. At year 2, 52 % and 43 % (CC) and 29 % and 22 % (IC) of participants lost at least 5 % and 7 % of initial weight. BMI also decreased more for CC than IC (-2.1 kg/m(2) vs. -0.8 kg/m(2) p < 0.001). Waist circumference decreased by 3.1 cm (CC) and 2.4 cm (IC) at year 2. Completers (≥9 of 16 sessions; mean 13.3 sessions) lost significantly more weight than non-completers (mean 4.3 sessions). CONCLUSIONS: PCP staff delivery of the DPP lifestyle intervention by telephone can be effective in achieving weight loss in obese people with metabolic syndrome. Greater weight loss may be attained with a group telephone intervention.

Use of telemedicine to improve glycemic management in a skilled nursing facility: a pilot study.

The objective of this study was to evaluate the feasibility of using telemedicine to improve glycemic control (reduce episodes of hypoglycemia and severe hyperglycemia) for residents with diabetes in a skilled nursing facility. This randomized pilot study enrolled residents with diabetes (n=23; mean age, 83 years; 91% insulin-treated) and compared usual care (control; n=11) with usual care plus weekly/biweekly teleconsultations with an endocrinologist (n=12) for up to 6 months. A nurse and dietitian from the skilled nursing facility were at all televisits. Residents who were able and willing attended the televisits. Family members were also invited and occasionally were present. The endocrinologist reviewed glucose levels from point-of-care glucose meter downloads, dietary intake, medications, and medical status and recommended changes in glycemic therapy as needed. Measurements included glucose levels from point-of-care glucose meter downloads, hemoglobin A1c (A1c) levels, and a nurse satisfaction survey. Results showed that 7 of 10 insulin-treated intervention subjects had basal doses reduced (18-69%) compared with 2 of 11 control subjects (reduced 10% and 25%, respectively). There was a decrease in percentage of intervention participants with episodes of hypoglycemia (<80 mg/dL) over the previous month from baseline (42%) to end of study (22%) versus a rise in the control group (from 36% to 45%) and less hyperglycemia (>400 mg/dL) (intervention, from 33% to 22%; control, from 22% to 55%). There were no end-of-study A1c values >8.0% in the intervention group versus 44% in controls. Nursing staff at the skilled nursing facility expressed high satisfaction. Results suggest that telemedicine diabetes consultations to skilled nursing facilities can improve glycemic management.

Lessened decline in physical activity and impairment of older adults with diabetes with telemedicine and pedometer use: results from the IDEATel study.

OBJECTIVE: to examine the effects of the Informatics for Diabetes Education and Telemedicine (IDEATel) telemedicine intervention and pedometer use on physical activity (PA) and impairment in older adults with diabetes. DESIGN: randomised clinical trial. Subjects ethnically diverse medically underserved Medicare beneficiaries with diabetes (n= 1,650). METHODS: participants received home videovisits with a diabetes educator every 4-6 weeks or usual care. All received a pedometer. Annual measurements included hemoglobin A1c, Comprehensive Assessment and Referral Evaluation Activities of Daily Living, Diabetes Self-Care Activities, Charlson Comorbidity Index, Luben Social Support and pedometer use. Mixed model analyses were performed using random effects to adjust for clustering within primary care physicians. RESULTS: in the telemedicine group compared with the usual care group, the rate of decline in PA (P= 0.0128) and physical impairment (PI) (P= 0.0370) was significantly less over time. Significant mean endpoint differences were observed for PA (P= 0.003). Pedometer use was significantly associated with PA (P= 0.0006) and PI (P< 0.0001). Baseline characteristics associated with greater PA included having fewer comorbid conditions (P= 0.0054), less depression (P< 0.0001), more social networking (P< 0.0001), lower BMI (P< 0.0001), male gender (P< 0.0001) and lower hemoglobin A1c level (P= 0.0045). Similar predictors were observed for PI, except duration of diabetes also predicted increased impairment (P< 0.0001). Significant indirect effects were observed through use of the pedometer on reduced decline in PA (P= 0.0024, 0.0013) and PI (P= 0.0024, P< 0.0001). CONCLUSIONS: this telemedicine intervention reduced rates of decline in PA and impairment in older adults with diabetes. Pedometers may be a helpful inexpensive adjunct to diabetes initiatives delivered remotely with emerging technologies. ClinicalTrials.gov identifier NCT 00271739.

Use of three computer training methods in elderly underserved rural patients enrolled in a diabetes telemedicine program.

A telephone survey of Medicare beneficiaries with diabetes living in rural underserved areas and enrolled in the Informatics for Diabetes Education and Telemedicine project identified 109 subjects who requested further training in functions of the home telemedicine unit after initial in-home training by regional nurse installers. The initial training provided the skills needed to videoconferences with nurse case managers and to transmit blood glucose and blood pressure readings, but further instruction was needed for access to Web-based education features and messaging. This study evaluated these elderly patients' perceptions of the helpfulness of three additional telemedicine training methods:in-home visit with an regional nurse installer referencing a user's manual, unassisted patient use of the user's manual, and telephone-based training not using regional nurse installers reinforcing the user's manual. Eligible subjects rated the helpfulness of the three computer training methods on a five-point Likert scale (1 = "not helpful at all," 5 = "very helpful"). Participants rated "in-home" training with an regional nurse installer significantly higher than they did for the user's manual alone (P < .01). In response to this finding and other companion usability studies, Informatics for Diabetes Education and Telemedicine deployed home telemedicine units with enhanced remote training capabilities to better emulate characteristics of in-person training.

School-centered telemedicine for children with type 1 diabetes mellitus.

OBJECTIVES: To test the feasibility and effectiveness of telemedicine to improve care of children with type 1 diabetes in schools. STUDY DESIGN: Subjects, ages 5 to 14 years (grades kindergarten through eighth) were randomized to usual care (18 students; 13 schools) or intervention (23 students; 12 schools). Usual care included medical visits every 3 months and communication between school nurse and diabetes team as needed by phone. The intervention group received usual care plus a telemedicine unit in the school nurse office to videoconference between the school nurse, child, and diabetes team every month. Hemoglobin A1c and pediatric quality of life were measured every 3 months for 1 year. Analyses used multilevel modeling. RESULTS: A1c values increased from baseline to 6 months for students in the usual care group and decreased in the telemedicine cohort (P < .02). Lower A1c levels in the telemedicine group were maintained over the next several months, and significant improvements in several subscales of the Pediatric Diabetes Quality of Life questionnaire were observed. In the telemedicine group, urgent diabetes-related calls initiated by the school nurse were significantly reduced, and there were fewer hospitalizations and emergency department visits. CONCLUSIONS: A school telemedicine program can improve diabetes care in grades kindergarten through eighth.

A randomized trial comparing telemedicine case management with usual care in older, ethnically diverse, medically underserved patients with diabetes mellitus: 5 year results of the IDEATel study.

CONTEXT Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions and lower access to care. OBJECTIVES To examine the effectiveness of a telemedicine intervention to achieve clinical management goals in older, ethnically diverse, medically underserved patients with diabetes. DESIGN, Setting, and Patients A randomized controlled trial was conducted, comparing telemedicine case management to usual care, with blinded outcome evaluation, in 1,665 Medicare recipients with diabetes, aged >/= 55 years, residing in federally designated medically underserved areas of New York State. Interventions Home telemedicine unit with nurse case management versus usual care. Main Outcome Measures The primary endpoints assessed over 5 years of follow-up were hemoglobin A1c (HgbA1c), low density lipoprotein (LDL) cholesterol, and blood pressure levels. RESULTS Intention-to-treat mixed models showed that telemedicine achieved net overall reductions over five years of follow-up in the primary endpoints (HgbA1c, p = 0.001; LDL, p < 0.001; systolic and diastolic blood pressure, p = 0.024; p < 0.001). Estimated differences (95% CI) in year 5 were 0.29 (0.12, 0.46)% for HgbA1c, 3.84 (-0.08, 7.77) mg/dL for LDL cholesterol, and 4.32 (1.93, 6.72) mm Hg for systolic and 2.64 (1.53, 3.74) mm Hg for diastolic blood pressure. There were 176 deaths in the intervention group and 169 in the usual care group (hazard ratio 1.01 [0.82, 1.24]). CONCLUSIONS Telemedicine case management resulted in net improvements in HgbA1c, LDL-cholesterol and blood pressure levels over 5 years in medically underserved Medicare beneficiaries. Mortality was not different between the groups, although power was limited. Trial Registration http://clinicaltrials.gov Identifier: NCT00271739.

Record media used by primary care providers in medically underserved regions of upstate New York was not pivotal to clinical result in the Informatics for Diabetes Education and Telemedicine (IDEATel) project.

PURPOSE: To examine integration of electronic medical records (EMRs) by primary care providers (PCPs) in a diabetes telemedicine project (IDEATel) in medically underserved rural areas and assess if access to digital records is associated with diabetes intermediate outcomes. METHOD: PCPs (n=61) with patients in IDEATel participated in structured interviews to determine current (2006 to 2007) and projected (2007 to 2008) use of paper and/or electronic medical data. T-tests examined group differences. RESULTS: 28% (17/61) of PCPs had comprehensive EMRs, but most electronic data were non-interoperative between offices; 6% of PCPs solely used paper; 92% of PCPs used mixed paper/electronic records. Half of 61 PCPs anticipated no migration within one year to an electronic record for common patient data, while one third anticipated that function would become greatly more electronic. Among 31 PCPs interviewed in depth in person, 70% (7/10) in private practice and 69% (9/13) in networks anticipated greater electronic media migration through system change, whereas 100% of responding academic PCPs (n=6) expected only system modifications. PCPs were most interested in data exchange for chronic disease management (94%), regional benchmarking (84%) and quality improvement (87%). Patient personal electronic health records were rarely mentioned. IDEATel patients of PCPs with or without access to comprehensive EMRs achieved similar haemoglobin A1c, blood pressure, LDL-cholesterol, and body mass index, but the small number invokes cautious interpretation. CONCLUSIONS: Our findings suggest an effective and complementary element of national health information technology (HIT) strategy, telemedicine, can be implemented by PCPs with success despite the lack of a concurrent EMR for efficient data exchange.

A qualitative study of the experiences and satisfaction of direct telemedicine providers in diabetes case management.

Telehealth interventions are feasible and efficacious. While patients are the focus of both quantitative and qualitative studies that assess their response to telehealth, little is known about the view of providers of telehealth services. The purpose of this study was to better understand the experiences of providers and the factors that they perceive to contribute to the success of telehealth interventions as well as to their own satisfaction. Face-to-face or telephone interviews were conducted with 10 diabetes educators (nurses and dietitians) who served as providers of a telemedicine case management intervention for older adults who have diabetes. Qualitative analyses revealed that providers were very satisfied with their experience and felt their efforts with patients were generally successful. Providers also identified a number of unique benefits to telehealth interventions. These included opportunities for more frequent contact with patients, greater relaxation and information due to the ability to interact with the patients in their own homes, increased ability to reach the underserved, more timely and accurate medical monitoring, and improved management of data. The primary disadvantages of telehealth they identified were technology problems and a concern about the lack of physical contact with patients. Findings illustrate providers' perspectives on the unique advantages of telehealth and offer insight as to how to make telehealth interventions more effective, as well as more satisfying for those who do the day-to-day work of providing the interventions.

Diabetes management assisted by telemedicine: patient perspectives.

This qualitative research focuses on understanding the experiences of elderly patients with diabetes who participated in a telemedicine case management intervention, to better understand the barriers to success of telemedicine with the elderly. Telephone interviews were conducted with elderly patients with diabetes prior to and 6 and 12 months after participating in a case management intervention delivered via a computer that allowed them to teleconference with a nurse and dietitian, upload blood glucose and blood pressure data, and access educational materials. Qualitative analyses revealed that patients enrolled primarily because healthcare providers encouraged them. Their goals were to improve diabetes control, with few expectations of an effect on emotional health or family relationships. After involvement, they particularly valued the emphasis on monitoring of health outcomes and supportive contact with diabetes staff to encourage, remind, and answer questions. Findings illustrate the potential value of telemedicine with elderly patients with diabetes, if supported by primary care providers and including consistent, supportive interactions with knowledgeable diabetes healthcare providers.

Primary care providers' perceptions of home diabetes telemedicine care in the IDEATel project.

CONTEXT: Few telemedicine projects have systematically examined provider satisfaction and attitudes. PURPOSE: To determine the acceptability and perceived impact on primary care providers' (PCP) practices of a randomized clinical trial of the use of telemedicine to electronically deliver health care services to Medicare patients with diabetes in federally designated medically underserved areas of upstate New York, primarily those in rural areas and small towns with limited access to primary care. METHODS: A longitudinal phone survey was completed by 116 PCPs with patients with diabetes in the treatment arm of the trial, and conducted 12 and 24 months after a PCP's first patient was randomized to the home telemedicine arm of the trial. The 36-item survey included measures of acceptability (to PCPs, time required), impact (on patient knowledge, confidence, perceived health outcomes), and communication. Six open-ended questions were analyzed qualitatively. RESULTS: The quantitative data indicated positive responses in terms of acceptability of the telemedicine intervention to the PCPs and of the impact on the PCPs' patients. This was most evident in issues critical to good control of diabetes: patient knowledge, ability to manage diabetes, confidence, and compliance in managing diabetes. Key qualitative themes, on the positive end, were more patient control and motivation, helpfulness of having extra patient data, and involvement of nurses and dieticians. Negative themes were excessive paperwork and duplication taking more PCP time, and conflicting advice and management decisions from the telemedicine team, some without informing the PCP but none involving medications. CONCLUSIONS: Telemedicine was reported to be a positive experience for predominantly rural PCPs and their Medicare-eligible patients from medically underserved areas; several inefficiencies need to be refined.

Depression and glycemic control in elderly ethnically diverse patients with diabetes: the IDEATel project.

OBJECTIVE: The purpose of the study was to investigate the effect of comorbid depression on glycemic control and on response to a telemedicine case management intervention for elderly, ethnically diverse diabetic patients. RESEARCH DESIGN AND METHODS: Medicare beneficiaries in underserved areas were participants (n = 1,665) in the Informatics for Diabetes Education and Telemedicine (IDEATel) project and randomized to a telemedicine case management intervention or usual care. The data analyzed include baseline demographics (age, sex, race/ethnicity, marital status, insulin use, years of education, years of diabetes, and pack-years smoked) and measures of glycemic control (HbA(1c) [A1C]), comorbidity, diabetes symptom severity, functional disability and depression, and 1-year (n = 1,578) A1C. The association between depression and glycemic control was analyzed cross-sectionally and prospectively. RESULTS: At baseline, there was a significant correlation between depression and A1C and a trend for depression to predict A1C when other factors were controlled. However, in prospective analyses, depression did not predict change in A1C, either in the control or intervention group. CONCLUSIONS: In this large sample of elderly diabetic patients, a weak relationship between depression and A1C was found, but depression did not prospectively predict change in glycemic control. Thus, there is no evidence that depression should be used to exclude patients from interventions. Also, we should evaluate the impact of depression on outcomes other than glycemic control.

Poor air quality in homes of Medicare recipients with diabetes.

Poor air quality has been associated with chronic illness such as diabetes. This can be of particular importance for older adults with diabetes and other chronic conditions who spend most of their time indoors. The purpose of this study was to assess home air quality and residents' awareness and concerns about air quality in rural underserved areas of upstate New York. Implications for home care clinicians are discussed.

Food insecurity and food choices in rural older adults with diabetes receiving nutrition education via telemedicine.

OBJECTIVE: To evaluate differences between rural older adults with diabetes reporting the presence or absence of food insecurity with respect to meal planning, preparation, shopping, obesity, and glycemic control after receiving nutrition counseling through telemedicine. METHODS: Food insecurity data were obtained by telephone survey (n=74). Group differences for continuous variables were measured by t tests; categorical variables by Pearson chi-square tests. RESULTS: Participants reporting mild food insecurity (23%) had higher body mass index (35.5±7.1 kg/m2 vs 30.5±6.0 kg/m2, P=.01) and lower household incomes (P=.03) and were more likely to consider cost of ingredients in food preparation compared to food-secure participants (P=.03). Most purchased fresh produce (97%) and considered the dietitian's advice when purchasing food. Both groups report similar adherence to dietitians' advice and had similar glycemic control. CONCLUSIONS AND IMPLICATIONS: Strategies to address higher levels of obesity associated with food insecurity are needed.

Medicare payments, healthcare service use, and telemedicine implementation costs in a randomized trial comparing telemedicine case management with usual care in medically underserved participants with diabetes mellitus (IDEATel).

Objective To determine whether a diabetes case management telemedicine intervention reduced healthcare expenditures, as measured by Medicare claims, and to assess the costs of developing and implementing the telemedicine intervention. Design We studied 1665 participants in the Informatics for Diabetes Education and Telemedicine (IDEATel), a randomized controlled trial comparing telemedicine case management of diabetes to usual care. Participants were aged 55 years or older, and resided in federally designated medically underserved areas of New York State. Measurements We analyzed Medicare claims payments for each participant for up to 60 study months from date of randomization, until their death, or until December 31, 2006 (whichever happened first). We also analyzed study expenditures for the telemedicine intervention over six budget years (February 28, 2000- February 27, 2006). Results Mean annual Medicare payments (SE) were similar in the usual care and telemedicine groups, $9040 ($386) and $9669 ($443) per participant, respectively (p>0.05). Sensitivity analyses, including stratification by censored status, adjustment by enrollment site, and semi-parametric weighting by probability of dropping-out, rendered similar results. Over six budget years 28 821 participant/months of telemedicine intervention were delivered, at an estimated cost of $622 per participant/month. Conclusion Telemedicine case management was not associated with a reduction in Medicare claims in this medically underserved population. The cost of implementing the telemedicine intervention was high, largely representing special purpose hardware and software costs required at the time. Lower implementation costs will need to be achieved using lower cost technology in order for telemedicine case management to be more widely used.

The role of nurses in installing telehealth technology in the home.

Home telehealth involves the use of video conferencing or remote monitoring equipment in patients' homes. The installation of hardware and training of patients has historically been performed by nurses, typically RNs. This article examines the experience of RNs as telehealth installers in the Informatics for Diabetes Education and Telemedicine (IDEATel) project, where RNs were responsible for the installation of the Home Telemedicine Units (HTUs) and for training patients in the use of the HTUs, blood pressure cuffs, and fingerstick glucose meters. Average installation and training time was 166 minutes (SD 51 min). Structured interviews with RN installers revealed that patient education and training accounted for roughly two thirds of the in-home time. Technology-related problems, especially those related to telecommunications, were the primary cause of installation difficulties. Thematic analysis of installer interviews identified eight major themes and confirmed the importance of both clinical and technical knowledge during the telehealth installation process.

Usability in the real world: assessing medical information technologies in patients' homes.

OBJECTIVE: This paper presents an approach to usability evaluation of computer-based health care systems designed for patient use in their homes. Although such devices are becoming more prevalent, there is very little known about their usability. DESIGN: The theoretical foundations for the methods are discussed. The approach incorporates a cognitive walkthrough usability evaluation and new methods for usability testing that can be conducted in patient's homes. The method was applied to the IDEATel intervention, a multi-institution randomized controlled trial of the feasibility, acceptability, and clinical utility of a home-based telemedicine system for diabetic Medicare population. The usability study was designed to assess barriers to optimal use of the system. The focus was both on dimensions of the interface and on dimensions of patient skills and competency. The usability field research involved testing 25 patients in their homes using the system. The analysis included a range of video-analytic methods of varying levels of granularity. RESULTS: The usability evaluation revealed aspects of the interface that were sub-optimal and impeded the performance of certain tasks. It also found a range of patient-related factors such as numeracy and psychomotor skills that constituted barriers to productive use. CONCLUSIONS: A multifaceted usability approach provided important insight regarding use of technology by an elderly chronic-care patient population and more generally, for understanding how home health initiatives can more effectively use such technology.

A cognitive framework for understanding barriers to the productive use of a diabetes home telemedicine system.

Telemedicine has the potential to transcend geographic and socio-cultural barriers to the delivery of high quality health care to the medically underserved populations. However, there are significant cognitive and usability barriers. This paper presents a multifaceted cognitive evaluation of the IDEATel diabetes education and telemedicine program. The evaluation included a cognitive walkthrough analysis to characterize task complexity and identify potential problems as well as field usability testing in patients' homes. The study revealed dimensions of the interface that impeded optimal access to system resources. In addition, we found significant obstacles corresponding to perceptual-motoric skills, mental models of the system, and health literacy. The objective of this work is to contribute to a design framework so that participants with a wide range of skills can better manage their chronic illnesses.