Evaluation of the Use of Exenatide Once-Weekly Suspension Autoinjector Among Patients With Type 2 Diabetes Mellitus and Health Care Professionals.

BACKGROUND: Ease of injection is important to patients. An autoinjector was developed to deliver exenatide, a glucagon-like peptide-1 receptor agonist for type 2 diabetes mellitus. For autoinjection, 0.06-mm exenatide-containing microspheres are suspended in medium-chain triglycerides. Herein, we report design verification and usability testing of the autoinjector for exenatide once-weekly suspension (QWS) delivery. METHODS: Exenatide QWS in a single-chamber cartridge is self-injected subcutaneously with three main steps: mix, unlock, and inject. Design verification testing used validated testing methodology. A summative validation study with simulated-use scenarios evaluated unassisted performance on critical tasks (ease of use and the injection process). RESULTS: The autoinjector met specified design requirements for dose accuracy and torque/force. Of 104 participants enrolled (73 lay users, 16 health care professionals, and 15 pharmacists), 90 independently referred to instructions for use during testing. Users successfully achieved critical tasks on first attempt 87-100% of the time. Approximately 78% of participants successfully completed the full injection scenario, including 72% of lay users reporting visual or dexterity impairments. Initial use errors on critical tasks included not mixing well (n = 12), not removing needle cap (n = 8), and not holding needle to the skin for complete injection (n = 5). Untrained injection-naïve and trained injection-experienced lay users made the fewest errors (7% and 3%, respectively). Trained and untrained participants took 2:33 and 5:03 minutes, respectively, to complete a weekly injection. CONCLUSIONS: Users with a range of injection experience can rapidly learn to administer exenatide QWS autoinjector correctly, thus minimizing patient effort to manage their diabetes with injectable therapy.

African American Dementia Caregiver Problem Inventory: Descriptive analysis and initial psychometric evaluation.

OBJECTIVES: The primary objectives of the present study were: (a) to develop the African American Dementia Caregiver Problem Inventory (DCPI-A) that assesses the types and frequency of problems reported by African American dementia caregivers seeking cognitive-behavioral intervention, (b) to evaluate the intercoder reliability of the DCPI-A, and (c) to measure the perceived severity of common problems reported by this caregiver population. METHOD: The development of the DCPI-A was divided into 3 major steps: (a) creating an initial sample pool of caregiver problems derived from 2 parent randomized clinical trials, (b) formulating a preliminary version of the DCPI-A, and (c) finalizing the development of the DCPI-A that includes 20 problem categories with explicit coding rules, definitions, and illustrative examples. RESULTS: The most commonly reported caregiver problems fell into 5 major categories: (a) communication problems with care recipients, family members, and/or significant others, (b) problems with socialization, recreation, and personal enhancement time; (c) problems with physical health and health maintenance, (d) problems in managing care recipients' activities of daily living; and (e) problems with care recipients' difficult behaviors. Intercoder reliability was moderately high for both percent agreement and Cronbach's kappa. A similar positive pattern of results was obtained for the analysis of coder drift. CONCLUSIONS: The descriptive analysis of the types and frequency of problems of African American dementia caregivers coupled with the outcomes of the psychometric evaluation bode well for the adoption of the DCPI-A in clinical settings. (PsycINFO Database Record

Diabetes educators: assessment of evolving practice.

A survey evaluating the professional characteristics and practice patterns of diabetes educators was distributed across the United States. The specific survey aims were to assess whether (1) there continues to be a growing trend among US health professionals who consider themselves diabetes educators to obtain certification as certified diabetes educators (CDEs), (2) duties/services associated with diabetes self-management training (DSMT) and medical/medication management differ between diabetes educators who are CDEs versus those who are non-CDEs, and (3) educator practice patterns differ across the major geographic regions of the United States. Of the 507 diabetes educators completing the survey, 83% identified themselves as CDEs. Diabetes educators responding to similar surveys done in 1992 and 1999, 51% and 63%, respectively, identified themselves as CDEs. In this survey, a similar percentage of CDEs and non-CDEs employed DSMT practices of relatively low complexity (eg, general diabetes education) whereas a significantly higher percentage (P < .001) of CDEs employed DSMT practices of relatively high complexity (eg, insulin pump training). Significantly (P < .001) more CDEs provided medical/medication management services compared to non-CDEs. Finally, the practice patterns among CDEs were minimally influenced by region of the country. These results suggest that (1) the trend toward increased certification among diabetes educators has continued, (2) certification is associated with a greater likelihood of delivering complex DSMT services and medical/medication management, and (3) this pattern is consistent across the nation as a whole.

Telephone-based, cognitive-behavioral therapy for African American dementia caregivers with depression: initial findings.

OBJECTIVES: Discuss initial findings of a randomized clinical trial comparing the effects of telephone-based and face-to-face (f-to-f) cognitive-behavioral therapy (CBT) on changes in caregiver (CG) burden, assistance support, depression, and health status for African American (AA) CGs with depression. DESIGN: Pilot study using a prepost, two-group design with 14 enrolled and randomized participants. MEASURES: Subjective Burden subscale of the Caregiver Appraisal Inventory, Assistance Support subscale of the Interpersonal Support Evaluation List, Physical Symptoms subscale of the Caregiver Health and Health Behavior Inventory and the Center for Epidemiologic Studies Depression Scale. RESULTS: Prepost improvements were found on 11 completers across all measures for both telephone and f-to-f CBT. Moderate and similar effects sizes for CG subjective burden and assistance support were found for both the telephone and f-to-f groups. Effect sizes for physical symptoms and depression varied from low to moderate, respectively, with a trend toward smaller improvements in f-to-f CBT than in telephone CBT. Qualitative analysis highlighted CGs' perceptions of the active ingredients of treatment and provided indirect support for similar gains in emotional and psychosocial functioning across the two treatment modalities. CONCLUSIONS: Both telephone-based and f-to-f CBT showed improvements in depression, subjective burden, and assistance support in dementia AA CGs. Replication with a larger sample size (N = 106) is currently in progress. Study limitations and future directions for research are also addressed.