Charlene C. Quinn

Mobile health technology evaluation: the mHealth evidence workshop.

Creative use of new mobile and wearable health information and sensing technologies (mHealth) has the potential to reduce the cost of health care and improve well-being in numerous ways. These applications are being developed in a variety of domains, but rigorous research is needed to examine the potential, as well as the challenges, of utilizing mobile technologies to improve health outcomes. Currently, evidence is sparse for the efficacy of mHealth. Although these technologies may be appealing and seemingly innocuous, research is needed to assess when, where, and for whom mHealth devices, apps, and systems are efficacious. In order to outline an approach to evidence generation in the field of mHealth that would ensure research is conducted on a rigorous empirical and theoretic foundation, on August 16, 2011, researchers gathered for the mHealth Evidence Workshop at NIH. The current paper presents the results of the workshop. Although the discussions at the meeting were cross-cutting, the areas covered can be categorized broadly into three areas: (1) evaluating assessments; (2) evaluating interventions; and (3) reshaping evidence generation using mHealth. This paper brings these concepts together to describe current evaluation standards, discuss future possibilities, and set a grand goal for the emerging field of mHealth research.

Dementia as a risk factor for falls and fall injuries among nursing home residents.

Objectives: To compare rates of falling between nursing home residents with and without dementia and to examine dementia as an independent risk factor for falls and fall injuries.

Cluster-Randomized Trial of a Mobile Phone Personalized Behavioral Intervention for Blood Glucose Control

OBJECTIVE To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with standard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS A cluster-randomized clinical trial, the Mobile Diabetes Intervention Study, randomly assigned 26 primary care practices to one of three stepped treatment groups or a control group (usual care). A total of 163 patients were enrolled and included in analysis. The primary outcome was change in glycated hemoglobin levels over a 1-year treatment period. Secondary outcomes were changes in patient-reported diabetes symptoms, diabetes distress, depression, and other clinical (blood pressure) and laboratory (lipid) values. Maximal treatment was a mobile- and web-based self-management patient coaching system and provider decision support. Patients received automated, real-time educational and behavioral messaging in response to individually analyzed blood glucose values, diabetes medications, and lifestyle behaviors communicated by mobile phone. Providers received quarterly reports summarizing patient’s glycemic control, diabetes medication management, lifestyle behaviors, and evidence-based treatment options. RESULTS The mean declines in glycated hemoglobin were 1.9% in the maximal treatment group and 0.7% in the usual care group, a difference of 1.2% (P = 0.001) over 12 months. Appreciable differences were not observed between groups for patient-reported diabetes distress, depression, diabetes symptoms, or blood pressure and lipid levels (all P > 0.05). CONCLUSIONS The combination of behavioral mobile coaching with blood glucose data, lifestyle behaviors, and patient self-management data individually analyzed and presented with evidence-based guidelines to providers substantially reduced glycated hemoglobin levels over 1 year.

Current Science on Consumer Use of Mobile Health for Cardiovascular Disease Prevention A Scientific Statement From the American Heart Association

Although mortality for cardiovascular disease (CVD) has declined for several decades, heart disease and stroke continue to be the leading causes of death, disability, and high healthcare costs. Unhealthy behaviors related to CVD risk (eg, smoking, sedentary lifestyle, and unhealthful eating habits) remain highly prevalent. The high rates of overweight, obesity, and type 2 diabetes mellitus (T2DM); the persistent presence of uncontrolled hypertension; lipid levels not at target; and the ≈18% of adults who continue to smoke cigarettes pose formidable challenges for achieving improved cardiovascular health.1,2 It is apparent that the performance of healthful behaviors related to the management of CVD risk factors has become an increasingly important facet of the prevention and management of CVD.3 In 2010, the American Heart Association (AHA) made a transformative shift in its strategic plan and added the concept of cardiovascular health.2 To operationalize this concept, the AHA targeted 4 health behaviors in the 2020 Strategic Impact Goals: reduction in smoking and weight, healthful eating, and promotion of regular physical activity. Three health indicators also were included: glucose, blood pressure (BP), and cholesterol. On the basis of the AHA Life’s Simple 7 metrics for improved cardiovascular health, 30% have not reached the target levels for lipids or BP. National Health and Nutrition Examination Survey (NHANES) data revealed that people who met ≥6 of the cardiovascular health metrics had a significantly better risk profile (hazard ratio for all-cause mortality, 0.49) compared with individuals who had achieved only 1 metric or none.2 The studies reviewed in this statement targeted these behaviors (ie, smoking, physical activity, healthful eating, and maintaining a healthful weight) and cardiovascular health indicators (ie, blood …

Adult day care for the frail elderly: outcomes, satisfaction, and cost.

Objectives: To assess outcomes and satisfaction among frail elderly day care clients and their informal caregivers and the impact of adult day care on the cost of health services. Methods:One-hundred eight elderly participants were randomly assigned to the experimental group (immediate admission to an adult day care center) and 104 participants to the control group (3 months on a waiting list). Results:Participants’ and caregivers’ subjective perceptions of the day center’s effects were positive. However, using standard research instruments, there was no evidence of an effect of day center attendance on the client’s anxiety, depression, or functional status; on caregiver burden; or on the cost of health services. Discussion:It is difficult to demonstrate objectively the benefits of programs and interventions that are perceived by clients, caregivers, and staff to have positive effects. In future studies, maintenance of high levels of participation should be incorporated as an explicit program goal.

Testing the feasibility of implementation of clinical practice guidelines in long-term care facilities.

OBJECTIVES The purpose of this study was to explore the feasibility of implementing two specific Clinical Practice Guidelines (CPGs), Pain Management and Falls and Fall Risk, developed by the American Medical Directors Association. DESIGN This study used a combined quantitative and qualitative design using a single-group repeated-measures design for the quantitative component. SETTING The study was done in 23 long-term care facilities in Maryland. PARTICIPANTS Of 40 facilities that participated in a training program for CPG implementation, 32 were interested in implementing CPGs and 23 volunteered to participate in the study. Evaluation of the Falls CPG was based on 127 randomly selected cases preimplementation and 119 randomly selected cases postimplementation from the 23 facilities. Evaluation of the Pain CPG included 64 randomly selected cases preimplementation and 74 randomly selected cases postimplementation from the 23 facilities. Qualitative data was obtained from 20 of the directors of nursing. INTERVENTION Thirteen of the facilities implement-ed the Falls CPG, 10 facilities implemented the Pain CPG, and eight facilities implemented both CPGs. MEASUREMENTS Process indicators of CPG implementation were used in this study. Process indicators included five measurable items that were indicative of CPG implementation such as evidence of a pain assessment. RESULTS Less than half (45%) of the original 40 facilities actually implemented at least one of the CPGs. Based on process indicators in those facilities that did implement the CPGs, there was evidence that the guidelines were being implemented. Qualitative data led to the development of four major themes: challenges to implementation, benefits of implementation, process recommendations, and recommendations for changes in the CPGs. CONCLUSION The study provides some support for the feasibility of CPG implementation in facilities that voluntarily attempted to implement the guidelines. In addition, the findings provide some useful suggestions for how to facilitate the implementation process.

Mobile diabetes intervention study: Testing a personalized treatment/behavioral communication intervention for blood glucose control

BACKGROUND National data find glycemic control is within target (A1c<7.0%) for 37% of patients with diabetes, and only 7% meet recommended glycemic, lipid, and blood pressure goals. OBJECTIVES To compare active interventions and usual care for glucose control in a randomized clinical trial (RCT) among persons with diabetes cared for by primary care physicians (PCPs) over the course of 1 year. METHODS Physician practices (n=36) in 4 geographic areas are randomly assigned to 1 of 4 study groups. The intervention is a diabetes communication system, using mobile phones and patient/physician portals to allow patient-specific treatment and communication. All physicians receive American Diabetes Association (ADA) Guidelines for diabetes care. Patients with poor diabetes control (A1c> or =7.5%) at baseline (n=260) are enrolled in study groups based on PCP randomization. All study patients receive blood glucose (BG) meters and a years supply of testing materials. Patients in three treatment groups select one of two mobile phone models, receive one-year unlimited mobile phone data and service plan, register on the web-based individual patient portal and receive study treatment phone software based on study assignment. Control group patients receive usual care from their PCP. The primary outcome is mean change in A1c over a 12-month intervention period. CONCLUSION Traditional methods of disease management have not achieved adequate control for BG and other conditions important to persons with diabetes. Tools to improve communication between patients and PCPs may improve patient outcomes and be satisfactory to patients and physicians. This RCT is ongoing.

Mortality and Adverse Health Events in Newly Admitted Nursing Home Residents with and without Dementia

Objectives: To evaluate the association between dementia and mortality, adverse health events, and discharge disposition of newly admitted nursing home residents. It was hypothesized that residents with dementia would die at a higher rate and develop more adverse health events (e.g., infections, fevers, pressure ulcers, falls) than residents without dementia because of communication and self‐care difficulties.

Telehealth Remote Monitoring Systematic Review Structured Self-monitoring of Blood Glucose and Impact on A1C

Aims: The aim was to summarize research on telehealth remote patient monitoring interventions that incorporate key elements of structured self-monitoring of blood glucose (SMBG) identified as essential for improving A1C. Methods: A systematic review was conducted using the Medline, Cumulative Index to Nursing and Allied Health Literature, EMBASE, and OVID Medline databases with search terms “Telemedicine” AND “Monitoring, Physiologic” AND “Diabetes Mellitus, Type 2.” Study selection criteria included original randomized clinical trials evaluating the impact of telehealth remote patient monitoring on A1C among adults with type 2 diabetes and incorporated 1 or more essential elements of SMBG identified by the International Diabetes Federation (patient education, provider education, structured SMBG profile, SMBG goals, feedback, data used to modify treatment, interactive communication or shared decision making). Results: Fifteen studies were included, with interventions ranging from 3 to 12 months (mean 8 months) with sample sizes from 30 to 1665. Key SMBG elements were grouped into 3 categories: education, SMBG protocols, and feedback. Research incorporating 5 of the 7 elements consistently achieved significant A1C improvements between study groups. Interventions using more SMBG elements are associated with an improvement in A1C. Studies with the largest A1C decrease incorporated 6 of the 7 elements and computer decision support. Two studies with 5 of the 7 elements and active medication management achieved significant A1C decreases. Conclusion: Telehealth remote patient monitoring interventions in type 2 diabetes have not included all structured monitoring elements recommended by the IDF. Incorporating more elements of structured SMBG is associated with improved A1C.

TELEmedicine for Patients with Inflammatory Bowel Disease (TELE-IBD): Design and implementation of randomized clinical trial☆

BACKGROUND Inflammatory bowel diseases (IBD), comprised of ulcerative colitis and Crohns disease, are chronic disorders characterized by worsening of symptoms followed by symptom-free periods. Symptoms have a profound negative impact on quality of life and are associated with increased health care utilization. Despite effective treatments, outcomes are suboptimal secondary to nonadherence, medication intolerance, inconsistent monitoring, poor patient knowledge and limited access to care. OBJECTIVES Compare disease activity and quality of life over 1 year in a randomized trial of IBD patients receiving standard care versus telemedicine. METHODS Patients evaluated at 3 IBD referral centers with worsening symptoms within the last 2 years are eligible for randomization to one of two interventions or standard care. The interventions consist of either every other week or weekly assessment of symptoms, side effects, weight and delivery of medication prompts and education via texts to the participants mobile phone. Individualized alerts and action plans are created on a secure portal. Participants in the standard care group undergo routine and urgent follow-up visits and telephone calls. The primary outcomes group comparisons of changes in disease activity and quality of life scores from baseline to 6 and 12 months. CONCLUSIONS Methods such as telemedicine are needed to improve monitoring, adherence, self-efficacy, and patient knowledge in IBD. If effective, telemedicine should decrease symptoms, improve quality of life, and decrease health care utilization. The burden associated with use of telemedicine for patients and providers needs to be assessed. The trial is ongoing and will be completed in July 2016.