Gail D'Eramo Melkus

Abstract

eHealth interventions have been increasingly used to provide social support for self-management of type 2 diabetes. In this review, we discuss social support interventions, types of support provided, sources or providers of support, outcomes of the support interventions (clinical, behavioral, psychosocial), and logistical and clinical considerations for support interventions using eHealth technologies. Many types of eHealth interventions demonstrated improvements in self-management behaviors, psychosocial outcomes, and clinical measures, particularly HbA1c. Important factors to consider in clinical application of eHealth support interventions include participant preferences, usability of eHealth technology, and availability of personnel to orient or assist participants. Overall, eHealth is a promising adjunct to clinical care as it addresses the need for ongoing support in chronic disease management.

Abstract

Background: Despite current advances in cancer treatment, many breast cancer survivors still face long-Term post-operative challenges as a result of suffering from daily pain and other distressing symptoms related to lymphedema, ie, abnormal accumulation of lymph fluid in the ipsilateral upper limb or body. Grounded in research-driven behavioral strategies, The-Optimal-Lymph-Flow is a unique Web-and mobile-based system focusing on self-care strategies to empower, rather than inhibit, how breast cancer survivors manage daily pain and symptoms. It features a set of safe, feasible, and easily-integrated-into-daily-routine exercises to promote lymph flow and drainage, as well as guidance to maintain an optimal body mass index (BMI). Objective: To conduct a randomized clinical trial (RCT) to evaluate the efficacy of the Web-and mobile-based The-Optimal-Lymph-Flow system for managing chronic pain and symptoms related to lymphedema. The primary outcome includes pain reduction, and the secondary outcomes focus on symptom relief, limb volume difference by infra-red perometer, BMI, and quality of life (QOL) related to pain. We hypothesize that participants in the intervention group will have improved pain and symptom experiences, limb volume difference, body mass index, and QOL. Methods: A parallel RCT with a control-experimental, pre-and post-Test, repeated-measures design is used in this study. A total of 120 patients will be randomized according to the occurrence of pain. Participants will be recruited face-To-face at the point of care during clinical visits. Participants in the intervention group will receive the Web-and mobile-based The-Optimal-Lymph-Flow intervention and will have access to and learn about the program during the first in-person research visit. Participants in the control group will receive the Web-and mobile-based Arm Precaution program and will have access to and learn about the program during the first in-person research visit. Participants will be encouraged to enhance their learning by accessing the program and following the daily exercises during the study period. Participants will have monthly online self-report of pain and symptoms at 4 and 8 weeks post-intervention. During the two in-person research visits prior to and 12 weeks post-intervention, participants will be measured for limb volume difference, BMI, and complete self-report of pain, symptoms, self-care behaviors, and QOL. Results: This trial is currently open for recruitment. The anticipated completion date for the study is July 2017. The primary endpoint for the study is absence or reduction of pain reported by the participants at week 12 post-intervention. Conclusions: The-Optimal-Lymph-Flow is a unique Web-and mobile-based self-care and patient-reported outcome system designed to effectively help women treated for breast cancer manage daily pain and symptoms related to lymphedema. Patients learn self-care strategies from a Web-and mobile-based program and track their symptoms. The RCT will directly benefit all women treated for breast cancer who suffer from or at risk for pain and symptoms related to lymph fluid accumulation.

Abstract

Many breast cancer survivors have coexistent chronic diseases or comorbidities at the time of their cancer diagnosis. The purpose of the study was to evaluate the association of comorbidities on breast cancer survivors’ quality of life. A prospective design was used to recruit 140 women before cancer surgery , 134 women completed the study . Comorbidities were assessed using self-report and verified by medical record review and the Charlson Comorbidity Index (CCI) before and 12-month after cancer surgery . Quality of life was evaluated using Short-Form Health Survey (SF -36 v2) . Descriptive statistics, chi-square tests, t-tests, Fisher’s exact test, and correlations were performed for data analysis. A total of 28 comorbidities were identified. Among the 134 patients, 73.8% had at least one of the comorbidities, 54.7% had 2–4, and only 7.4% had 5–8. Comorbidities did not change at 12 months after surgery . Numbers of comorbidities by patients’ self-report and weighted categorization of comorbidities by CCI had a similar negative correlation with overall quality of life scores as well as domains of general health, physical functioning, bodily pain, and vitality . Comorbidities, specifically hypertension, arthritis, and diabetes, were associated with poorer quality of life in multiple domains among breast cancer survivors. Future research should consider the combined influence of comorbidity and cancer on patients’ quality of life.

Abstract

Background: Ongoing self-management improves outcomes for those with Type 2 diabetes (T2D); however, there are many barriers to patients receiving assistance in this from the healthcare system and peers. Findings from our pilot study showed that a virtual diabetes community on the Internet with real-time interaction among peers with T2D - and with healthcare professionals - is feasible and has the potential to influence clinical and psychosocial outcomes. Objective: The purpose of this article is to present the protocol for the Diabetes Learning in Virtual Environments (LIVE) trial. Protocol: Diabetes LIVE is a two-group, randomized controlled trial to compare effects of a virtual environment and traditional Web site on diet and physical activity. Our secondary aims will determine the effects on metabolic outcomes; effects of level of engagement and social network formation in LIVE on behavioral outcomes; potential mediating effects of changes in self-efficacy; and diabetes knowledge, diabetes-related distress, and social support on behavior change and metabolic outcomes. We will enroll 300 subjects at two sites (Duke University/Raleigh-Durham, NC and New York University/New York, NY) who have T2D and do not have serious complications or comorbidities. Those randomly assigned to the intervention group have access to the LIVE site where they can find information, synchronous classes with diabetes educators, and peer support to enhance self-management. Those in the control group have access to the same informational and educational content in a traditional asynchronous Web format. Measures of self-management, clinical outcomes, and psychosocial outcomes are assessed at baseline and 3, 6, 12, and 18 months. Discussion: Should LIVE prove effective in improved self-management of diabetes, similar interventions could be applied to other prevalent chronic diseases. Innovative programs such as LIVE have potential for improving healthcare access in an easily disseminated alternative model of care that potentially improves the reach of self-management training and support.

Abstract

To inform the development of a combined diabetes prevention and self-management intervention in partnership with church communities, this study sampled African American church leaders and members (N = 44) to qualitatively study religious beliefs and practices, diabetes prevention and self-management behaviors, and related community actions. Prior to commencing the study, internal review board approval was obtained. Although not required, community consent was officially provided by the church pastors. Individual consent was subsequently obtained from eligible community members who expressed an interest in participating in the study. Following a participatory action research approach, the inquiry group method was used. Qualitative data were analyzed with content analysis. Findings revealed Christian worldview, medical distrust and self-management as prominent themes. Findings suggest that diabetes providers address religious orientation in the provision of care with attention to rebuilding trust with the African-American community to improve health outcomes.

Abstract

Background: Patients undergoing hematopoietic cell transplantation (HCT) for hematological malignancies experience a number of challenges during treatment. There is growing evidence that malglycemia (hyperglycemia, hypoglycemia, and/or increased glycemic variability) contributes to HCT-related complications, even in patients without preexisting diabetes. The purpose of this pilot study was to investigate factors influencing glycemic status and associated infection occurrences in nondiabetic autologous HCT recipients. Methods: Oncology patients without preexisting diabetes treated with autologous HCT at a National Cancer Institute–designated cancer center were followed from admission through discharge or 28 days post-HCT. Patients had morning fasting laboratory tests. Descriptive statistics and Cox proportional hazards models were used to examine associations between BG levels and risk for infection while adjusting for baseline covariates including age, body mass index (BMI), cumulative glucocorticoid dose, and diagnosis. Results: The sample included 28 female and 25 male predominately non-Hispanic White patients (mean age 55.7 years, SD = 11.32). Blood glucose (BG) range was 35–325 mg/dl. Twenty-three patients incurred at least one infection. BMI ≥ 25 kg/m2 was associated with high BG and infections. In the multivariate Cox model, an increase of 1 interquartile range in BG 2 days before infection was associated with a moderately increased risk of infection (hazard ratio = 1.44, p =.008). Conclusions: Understanding the contributors to and consequences of malglycemic events can lead to better protocols for identifying patients at greater risk for infection. Further investigation is warranted for interventions to mitigate BG events for improved outcomes.

Abstract

To evaluate the efficacy of Parent Education Through Simulation–Diabetes (PETS-D; clinical trial registration NCT01517269) for parents of children <13 years old newly diagnosed with type 1 diabetes with 3 parent education vignette sessions using human patient simulation (HPS) as compared with formal parent-nurse education sessions (vignette only) regarding diabetes knowledge, problem-solving skills, hypoglycemia fear, anxiety, and self-efficacy. Subjects were randomized to the HPS parent diabetes education or the vignette-only arm. Using linear mixed modeling, we compared HPS and vignette-only groups at 2, 6, and 14 weeks. Effect modification of treatment by dichotomized child's age (<6 and ≥6 years old) and parent education (≤high school and >high school) was also tested. All analyses were intent to treat and adjusted for baseline outcome level and clustering within site. We recruited 191 parents (116 children). Mean baseline A1C was 12%. Overall treatment-related differences were modest. There was a statistically significant effect modification of HPS by child's age, with a larger HPS benefit among parents of younger children for several outcomes: A1C (8.16% vs 9.48% in control; P =.006), lower state anxiety (P =.0094), and higher fear of hypoglycemia (P =.03) for parents of children <6 years old in the HPS group. Modest treatment-related differences may reflect ceiling/floor effects in many of the outcomes; we also compared HPS with another intervention rather than to usual education. Parents of younger children receiving the intervention may feel more comfortable with lower A1C levels because of management awareness gleaned from the HPS experience. Future research will include a retrospective case-control study of very young children.

Abstract

Context Fatigue is the most common symptom in oncology patients during chemotherapy. Little is known about the predictors of interindividual variability in initial levels and trajectories of morning fatigue severity in these patients. Objectives An evaluation was done to determine which demographic, clinical, and symptom characteristics were associated with initial levels as well as the trajectories of morning fatigue and to compare findings with our companion paper on evening fatigue. Methods A sample of outpatients with breast, gastrointestinal, gynecological, and lung cancer (n = 586) completed demographic and symptom questionnaires a total of six times over two cycles of chemotherapy. Fatigue severity was evaluated using the Lee Fatigue Scale. Hierarchical linear modeling was used to answer the study objectives. Results A large amount of interindividual variability was found in the morning fatigue trajectories. A piecewise model fit the data best. Patients with higher body mass index, who did not exercise regularly, with a lower functional status, and who had higher levels of state anxiety, sleep disturbance, and depressive symptoms reported higher levels of morning fatigue at enrollment. Variations in the trajectories of morning fatigue were predicted by the patients' ethnicity and younger age. Conclusion The modifiable risk factors that were associated with only morning fatigue were body mass index, exercise, and state anxiety. Modifiable risk factors that were associated with both morning and evening fatigue included functional status, depressive symptoms, and sleep disturbance. Using this information, clinicians can identify patients at higher risk for more severe morning fatigue and evening fatigue, provide individualized patient education, and tailor interventions to address the modifiable risk factors.

Abstract

Background: The Stroke Impact Scale 3.0 (SIS 3.0) is widely used to measure quality of life in stroke survivors; however, previous studies have not tested the original 8-factor structure of the scale. In addition, previous studies have shown floor and ceiling effect and weak reliability within the scale. Objective: The aim of this study was to evaluate the psychometric characteristics of the SIS 3.0, including its construct validity (factorial structure, concurrent and contrasting group validity), floor and ceiling effect, and reliability. Method: A cross-sectional design was used to study 392 stroke survivors enrolled in 16 rehabilitation facilities across Italy. Factorial structure of the SIS 3.0 was tested with confirmatory factor analysis. Concurrent and contrasting group validities were evaluated with other scales measuring functional capacities, neurological functions, cognition, anxiety, depression, and generic quality of life. Floor and ceiling effects were evaluated by determining the percentages of patients with the minimum and the maximum score at SIS 3.0. Reliability was determined by Cronbach's α and test-retest. Results: Participants were 71 years old on average (SD, 11 years); 55% were men. Confirmatory factor analysis revealed a new 4-factor structure that fitted the data better than the original 8-factor structure did. Concurrent and contrasting group validity of the new 4-factor structure was supportive and no floor and ceiling effects were found. Internal consistency and test-retest reliability ranged between 0.79 and 0.98. Conclusion: The new factorial structure of the SIS 3.0 with 4 factors showed better psychometric properties than the original 8-factor structure did. This evidence supports further use of the SIS 3.0 in clinical practice and research.