James T. Fitzgerald

Patient Empowerment: Results of a randomized controlled trial

OBJECTIVE The purpose of this study was to determine if participation in a patient empowerment program would result in improved psychosocial self-efficacy and attitudes toward diabetes, as well as a reduction in blood glucose levels. RESEARCH DESIGN AND METHODS This study was conducted as a randomized, wait-listed control group trial. The intervention group received a six-session (one session per week) patient empowerment education program; the control group was assigned to a wait-list. At the end of 6 weeks, the control group completed the six-session empowerment program. Six weeks after the program, both groups provided follow-up data. RESULTS The intervention group showed gains over the control group on four of the eight self-efficacy subscales and two of the five diabetes attitude subscales. Also, the intervention group showed a significant reduction in glycated hemoglobin levels. Within groups, analysis of data from all program participants showed sustained improvements in all of the self-efficacy areas and two of the five diabetes attitude subscales and a modest improvement in blood glucose levels. CONCLUSIONS This study indicated that patient empowerment is an effective approach to developing educational interventions for addressing the psychosocial aspects of living with diabetes. Furthermore, patient empowerment is conducive to improving blood glucose control. In an ideal setting, patient education would address equally blood glucose management and the psychosocial challenges of living with diabetes.

The Reliability and Validity of a Brief Diabetes Knowledge Test

OBJECTIVE To examine the reliability and validity of a brief diabetes knowledge test. The diabetes knowledge test has two components: a 14-item general test and a 9-item insulin-use subscale. RESEARCH DESIGN AND METHODS Two populations completed the test. In one population, patients received diabetes care in their community from avariety of providers, while the other population received care from local health departments. Cronbachs coefficient a was used to calculate scale reliability for each sample. To determine validity, patient group differences were examined. It was hypothesized that test scores would be higher for patients with type 1 diabetes, for patients with more education, and for patients who had received diabetes education. RESULTS The coefficient as for the general test and the insulin-use subscale indicate that both are reliable, α ≥ 0.70. In the community sample, patients with type 1 diabetes scored higher than patients with type 2 diabetes on the general test and the insulin-use subscale. In the health department sample, patients with type 1 scored higher than patients with type 2 on the insulin-use subscale. For both samples, scores increased as the years of formal education completed increased, and patients who received diabetes education scored higher than patients who did not. CONCLUSIONS Although the samples differed demographically, the reliability and validity of the test were supported in both the community andthe health department samples. This suggests that the test is appropriate for a variety of settings and patient populations.

Development and Validation of the Diabetes Care Profile

To determine the reliability and the validity of the Diabetes Care Profile (DCP), an instrument that assesses the social and psychological factors related to diabetes and its treatment, two studies with separate populations and methodologies were conducted In the first study, the DCP was administered to, and physiologic measures collected from, individuals with diabetes being cared for in a community setting (n = 440). In the second study, the DCP and several previously validated scales were administered to individuals with diabetes receiving care at a university medical center (n = 352). Cronbachs alphas of individual DCP scales ranged from .60 to .95 (Study 1) and from .66 to .94 (Study 2). Glycohemoglobin levels correlated with three DCP scales (Study 1). Several DCP scales discriminated among patients with different levels of disease severity. The results of the studies indicate that the DCP is a reliable and valid instrument for measuring the psychosocial factors related to diabetes and its treatment.

A Comparison of Global Versus Disease-Specific Quality-of-Life Measures in Patients With NIDDM

OBJECTIVE This study was conducted to compare the Short Form 36 (SF-36) (a global measure of health-related quality of life) and the Diabetes Care Profile (DCP) (a diabetes-specific measure of self-care and diabetes-related quality of life) in patients with NIDDM. RESEARCH DESIGN AND METHODS This study was conducted as part of a larger study initiated in 1991 using a randomly selected sample of communities, physicians, and patients with diabetes located throughout Michigan. A total of 255 patients with NIDDM participated. The study examined the relationship between the two measures and diabetes variables, such as glycosylated hemoglobin level and number of complications. RESULTS The SF-36 and the DCP have both common and discrete measurement domains. Both instruments have acceptable subscale reliability. The DCP has predictive validity regarding glycemic control, whereas the SF-36 does not. Both measures correlate with the number of complications for patients who have NIDDM treated with insulin. CONCLUSIONS This study suggests that for examining relationships within diabetes, e.g., the impact of acute complications and/or regimen on quality of life, the DCP is the appropriate measure. Conversely, when examining relationships between the patients experience of living with diabetes and quality of life and other chronic diseases, the SF-36 would be an appropriate measure. Both instruments can be used to illuminate the experience and behavior of patients living with and caring for NIDDM.

Zinc decreases C-reactive protein, lipid peroxidation, and inflammatory cytokines in elderly subjects: a potential implication of zinc as an atheroprotective agent

BACKGROUND Chronic inflammation and oxidative stress are common risk factors for atherosclerosis. Zinc is an essential micronutrient that can function as an antiinflammatory and antioxidative agent, and as such, it may have atheroprotective properties. OBJECTIVE We hypothesized that zinc down-regulates the production of atherosclerosis-related cytokines/molecules in humans. DESIGN To examine these effects, we conducted a randomized, double-blinded, placebo trial of zinc supplementation in elderly subjects. We recruited 40 healthy elderly subjects (aged 56-83 y) and randomly assigned them to 2 groups. One group was given an oral dose of 45 mg zinc/d as a gluconate for 6 mo. The other group was given a placebo. Cell culture models were conducted to study the mechanism of zinc as an atheroprotective agent. RESULTS After 6 mo of supplementation, the intake of zinc, compared with intake of placebo, increased the concentrations of plasma zinc and decreased the concentrations of plasma high-sensitivity C-reactive protein (hsCRP), interleukin (IL)-6, macrophage chemoattractant protein 1 (MCP-1), vascular cell adhesion molecule 1 (VCAM-1), secretory phospholipase A2, and malondialdehyde and hydroxyalkenals (MDA+HAE) in elderly subjects. Regression analysis showed that changes in concentrations of plasma zinc were inversely associated with changes in concentrations of plasma hsCRP, MCP-1, VCAM-1, and MDA+HAE after 6 mo of supplementation. In cell culture studies, we showed that zinc decreased the generation of tumor necrosis factor-alpha, IL-1beta, VCAM-1, and MDA+HAE and the activation of nuclear transcription factor kappaB and increased antiinflammatory proteins A20 and peroxisome proliferator-activated receptor-alpha in human monocytic leukemia THP-1 cells and human aortic endothelial cells compared with zinc-deficient cells. CONCLUSION These findings suggest that zinc may have a protective effect in atherosclerosis because of its antiinflammatory and antioxidant functions.

Barriers to following dietary recommendations in Type 2 diabetes

Aims  To evaluate barriers to following dietary recommendations in patients with Type 2 diabetes.

Zinc supplementation decreases oxidative stress, incidence of infection, and generation of inflammatory cytokines in sickle cell disease patients

Zinc deficiency is common in adult sickle-cell disease (SCD) patients. We previously demonstrated that zinc supplementation to adult SCD patients decreased the incidences of infections and hospital admissions. We hypothesize that zinc supplementation improves T-helper cell function and decreases vascular endothelial cell activation, oxidative stress, and nuclear factor-kappa B (NF-kappaB)-DNA binding in mononuclear cells (MNCs) in SCD patients. To test this hypothesis, 36 SCD patients were recruited and randomly divided into 2 groups. One group (n = 18) received 25-mg zinc orally thrice a day for 3 months. The other group (n = 18) received placebo. The results indicate that the zinc-supplemented group had decreased incidence of infections compared with the placebo group. After zinc supplementation, red blood cell, hemoglobin (Hb), hematocrit, (Hct), plasma zinc, and antioxidant power increased; plasma nitrite and nitrate (NOx), lipid peroxidation products, DNA oxidation products, and soluble vascular cell adhesion molecule-1 decreased in the zinc-supplemented group, compared with the placebo group. Zinc-supplemented patients exhibited significant decreases in lipopolysaccharide-induced tumor necrosis factor-alpha (TNF-alpha) and IL-1beta mRNAs, and TNF-induced nuclear factor of kappaB-DNA binding in MNCs, compared with the placebo group. Ex vivo addition of zinc to MNCs isolated from the placebo subjects decreased TNF-alpha and IL-1beta mRNAs. Zinc supplementation also increased relative levels of IL-2 and IL-2Ralpha mRNAs in phytohemagglutinin-p-stimulated MNCs. These results suggest that zinc supplementation may be beneficial to SCD patients.

Effect of Zinc Supplementation on Incidence of Infections and Hospital Admissions in Sickle Cell Disease (SCD)

Zinc deficiency is a common nutritional problem in adult sickle‐cell disease (SCD) patients. Hyperzincuria and increased requirement of zinc due to continued hemolysis in SCD are probable bases for zinc deficiency in these patients. Zinc deficiency affects adversely T‐helper1 (TH1) functions and cell mediated immunity and interleukin (IL)‐2 production is decreased in zinc deficient subjects. We hypothesized that zinc supplementation will improve T‐helper1 function and decrease incidence of infections in patients with SCD. We tested this hypothesis in 32 SCD subjects who were divided in three groups (Grs A, B, and C). Grs A (n = 11) and B (n = 10) were zinc deficient based on cellular zinc criteria and Gr C (n = 11) were zinc sufficient. Gr A subjects were observed for 1 year (baseline), following which they received zinc acetate (50 to 75 mg of elemental zinc orally daily) for 3 years. Gr B subjects were observed for 1 year (baseline), following which they received placebo for 1 year and then switched to zinc supplementation (50 to 75 mg of elemental zinc orally daily) for 2 years. Gr C subjects did not receive any intervention inasmuch as they were zinc sufficient. Prolonged zinc supplementation resulted in an increase in lymphocyte and granulocyte zinc (P = 0.0001), and an increase in interleukin‐2 production (P = 0.0001), decreased incidence of documented bacteriologically positive infections (P = 0.0026), decreased number of hospitalizations and decreased number of vaso‐occlusive pain crisis (P = 0.0001). The predominant pathogens isolated were staphylococci and streptococci involving the respiratory tract and aerobic gram‐negative bacteria, particularly Escherichia coli, involving the urinary tract. Further confirmation of our observations will require prospective studies of zinc supplementation in a larger number of SCD patients. Am. J. Hematol. 61:194–202, 1999.

The Third Version of the Diabetes Attitude Scale

OBJECTIVE The objective of this study was to develop a third version of the Diabetes Attitude Scale (DAS-3) that is congruent with current scientific knowledge about diabetes, has improved subscale internal reliability scores, and is shorter than the earlier versions of this instrument. RESEARCH DESIGN AND METHODS The second DAS was revised and rewritten by a panel of diabetes experts, including patients, associated with the University of Michigan Diabetes Research and Training Center. The revised version of the instrument was sent to physicians, nurses, dietitians, and patients with diabetes. Completed and usable questionnaires were obtained from 384 patients with diabetes, 321 physicians, 540 nurses, and 569 dietitians. The total number of surveys used for these analyses was 1,814. RESULTS The study resulted in a revised DAS with 33 items and five discrete subscales. The subscales were attitudes toward the following: 1) need for special training to provide diabetes care, 2) seriousness of type 2 diabetes, 3) value of tight glucose control, 4) pyschosocial impact of diabetes, and 5) attitude toward patient autonomy. Overall, the subscale reliabilities of the DAS-3 were superior to the earlier versions of the scale. CONCLUSIONS The DAS-3 is a valid and reliable general measure of diabetes-related attitudes and is most suitable for comparisons across different groups of health care professionals and/or patients. The DAS-3 is also suitable for the evaluation of patient and/or professional education programs if those programs focus on the specific topic areas measured by the five DAS-3 subscales.

Using Focus Groups to Identify Psychosocial Issues of Urban Black Individuals With Diabetes

The purpose of this focus group research was to identify issues that could serve as topics for a series of educational videos portraying psychosocial issues of urban black individuals with diabetes. Four focus groups involving 34 black adults were conducted in the Detroit area. Psychosocial issues were identified and rated in order of priority by an expert panel. The major psychosocial issues identified were the importance of food and eating in the black culture, the necessity for learning more about diabetes and its complications, learning to interact effectively with healthcare providers and systems, and the need for help and support in managing psychosocial issues related to diabetes. Black individuals with diabetes face unique psychosocial challenges. Focus groups are an effective method for obtaining relevant, culturally specific, in-depth information about living with diabetes from patients who are members of minority groups.