Revisiting racial differences in ESRD due to ADPKD in the United States.

INTRODUCTION: Autosomal dominant polycystic kidney disease (ADPKD) affects all races. Whether the progression of ADPKD varies by race remains unclear. METHODS: In this retrospective cohort study from 2004 to 2013 non-Hispanic blacks and non-Hispanic whites of all ages classified in the US Renal Data System (USRDS) with incident ESRD from ADPKD (n = 23,647), hypertension/large vessel disease (n = 296,352), or diabetes mellitus (n = 451,760) were stratified into five-year age categories ranging from < 40 to > 75 (e.g., < 40, 40-44, 45-49, …, 75+). The Cochran-Mantel-Haenszel test was used to determine the association of race and incidence of ESRD from ADPKD, diabetes, or hypertension. The difference in the proportions of ESRD in non-Hispanic black and non-Hispanic white patients at each age categorical bin was compared by two-sample proportion test. The age of ESRD onset between non-Hispanic black and non-Hispanic white patients at each year was compared using two-sample t-test with unequal variance. RESULTS: 1.068% of non-Hispanic blacks and 2.778% of non-Hispanic whites had ESRD attributed to ADPKD. Non-Hispanic blacks were less likely than non-Hispanic whites to have ESRD attributed to ADPKD (odds ratio (OR) (95% CI) = 0.38 (0.36-0.39), p <  0.0001). Using US Census data as the denominator to adjust for population differences non-Hispanic blacks were still slightly under-represented (OR (95% CI) 0.94 (0.91-0.96), p = 0.004). However, non-Hispanic blacks with ADPKD had a younger age of ESRD (54.4 years ±13) than non-Hispanic whites (55.9 years ±12.8) (p <  0.0001). For those < 40 years old, more non-Hispanic blacks had incident ESRD from ADPKD than non-Hispanic whites (9.49% vs. 7.68%, difference (95% CI) = 1.81% (0.87-2.84%), p <  0.001) for the combined years examined. CONCLUSIONS: As previously shown, we find the incidence of ESRD from ADPKD in non-Hispanic blacks is lower than in non-Hispanic whites. Among the younger ADPKD population (age < 40), however, more non-Hispanic blacks initiated dialysis than non-Hispanic whites. Non-Hispanic blacks with ADPKD initiated dialysis younger than non-Hispanic whites. A potential implication of these findings may be that black race should be considered an additional risk factor for progression in ADPKD.

Acceptability of Mobile Phone-Based Nurse-Delivered Counseling Intervention to Improve HIV Treatment Adherence and Self-Care Behaviors Among HIV-Positive Women in India.

We assessed the acceptability of nurse-delivered mobile phone-based counseling to support adherence to antiretroviral treatment (ART) and self-care behaviors among HIV-positive women in India. We conducted open-ended, in-depth interviews with 27 HIV-positive women and 19 key informants at a government ART center in Karnataka, India. Data were analyzed with interpretive techniques. About half of the HIV-positive women owned a mobile phone and many had access to mobile phones of their family members. Most women perceived phone-based counseling as a personalized care approach to get information on demand. Also, women felt that they could discuss mental health issues and ask sensitive information that they would hesitate to discuss face-to-face. Findings indicate that, when compared with text messaging, mobile phone-based counseling could be a more acceptable way to engage with women on ART, especially those with limited literacy. Future studies should focus on testing mobile phone-based information/counseling and adherence interventions that take the local context into account.

I have no peace of mind-psychosocial distress expressed by rural women living with HIV in India as part of a mobile health intervention-a qualitative study.

This qualitative study assessed psychosocial concerns that rural women with HIV who had multiple psychosocial vulnerabilities were able to express and communicate during a mobile phone intervention delivered by nurses. The study is part of a pilot randomised controlled trial of an mHealth self-care intervention by nurses for women living with HIV in rural India. For the trial, 60 women were randomised to receive the mHealth intervention. All calls were recorded and call logs were maintained. Call logs of 59 women based on 1186 calls were scanned for psychosocial themes. Audio recordings of 400 calls rich in content were then transcribed and translated for analysis. Themes and subthemes were identified by two independent raters. Majority of the women had low literacy and more than half were widowed. Clinical depression was found in 18.6%. Of the 1186 call logs analysed, 932 calls had a record of at least one psychosocial concern and 493 calls recorded two psychosocial concerns. Some of the major themes that women discussed with nurses included worries about their own and their children's future; loneliness; stigma; inadvertent disclosure; death and dying; abandonment by partner; financial difficulties; body image; poor social support; emotions such as sadness, guilt, and anger; and need for social services. Almost all expressed appreciation for the intervention. Findings indicate the usefulness of mHealth-based self-care interventions delivered by nurses in hard to reach women in low- and middle-income countries, especially those with multiple psychosocial vulnerabilities.

MAHILA: a protocol for evaluating a nurse-delivered mHealth intervention for women with HIV and psychosocial risk factors in India.

BACKGROUND: Women living with HIV are vulnerable to a variety of psychosocial barriers that limit access and adherence to treatment. There is little evidence supporting interventions for improving access and treatment adherence among vulnerable groups of women in low- and middle-income countries. The M obile Phone-Based A pproach for H ealth I mprovement, L iteracy and A dherence (MAHILA) trial is assessing the feasibility, acceptability and preliminary efficacy of a novel, theory-guided mobile health intervention delivered by nurses for enhancing self-care and treatment adherence among HIV-infected women in India. METHODS/DESIGN: Women (n = 120) with HIV infection who screen positive for depressive symptoms and/or other psychosocial vulnerabilities are randomly assigned in equal numbers to one of two treatment arms: treatment as usual plus the mobile phone intervention (experimental group) or treatment as usual (control group). In addition to treatment as usual, the experimental group receives nurse-delivered self-care counselling via mobile phone at fixed intervals over 16 weeks. Outcome measures are collected at baseline and at 4, 12, 24 and 36 weeks post-baseline. Outcomes include antiretroviral treatment adherence, HIV-1 RNA, depressive symptoms, illness perceptions, internalized stigma and quality of life. DISCUSSION: The MAHILA trial will provide information about how a mobile health counselling intervention delivered by non specialist nurses may improve access to care and support the adherence and clinical outcomes of women with HIV infection living in low- and middle-income countries such as India. TRIAL REGISTRATION: NCT02319330 (First received: July 30, 2014; Last verified: January 2016).

Efficacy and implementation of an Internet psychoeducational program for teens with type 1 diabetes.

OBJECTIVE: The purpose of the study was to evaluate the participation and preliminary efficacy of an Internet psychoeducational program (Teens.Connect) shown to be efficacious under controlled conditions compared with an open-access diabetes website for youth (Planet D) on the primary outcomes of A1C and quality of life (QoL), and secondary outcomes of psychosocial and behavioral factors. RESEARCH DESIGN AND METHODS: Teens with type 1 diabetes (n = 124, 11-14 yr) from two clinical sites were randomly prescribed one of the programs and completed baseline, 3-month and 6-month data. A1C was obtained from clinic records. Participation data included number of log ins, posts to the discussion board, and lessons completed (Teens.Connect only). Descriptive and mixed model analyses were used. RESULTS: Eighty-five percent (85%) of consented teens registered for their prescribed program. Satisfaction and log ins were similar between groups (satisfaction ranged 3.3-3.5/5; mean log ins = 14/teen). Posts to the discussion forum were higher in Planet D (mean = 28 vs. 19). Participation in the Teens.Connect lessons was low, with only 69% of teens completing any lesson. After 6 months there were no significant differences in A1C, QoL or secondary outcomes between groups. Teens in the Teens.Connect group reported lower perceived stress over time (p < 0.01). CONCLUSIONS: Teens do not actively participate in an Internet psychoeducational program when they do not have frequent reminders, which may have contributed to a lack of treatment effect. Teens have many competing demands. Strategic implementation that includes targeted reminders and family support may be necessary to assure participation and improvement in health outcomes.

Costs of Development and Maintenance of an Internet Program for Teens with Type 1 Diabetes.

Many adolescents with type 1 diabetes (T1D) have difficulty completing self-management tasks within the context of their social environments. Group-based approaches to psycho-educational support have been shown to prevent declines in glucose control, but are challenging to implement due to youths' many activities and costs. A novel solution is providing psycho-educational support via the internet. The purpose of this study is to describe the cost of developing and maintaining two internet psycho-educational programs, both of which have been shown to improve health outcomes in adolescents with T1D. We calculated actual costs of personnel and programming in the development of TEENCOPE™ and Managing Diabetes, two highly interactive programs that were evaluated in a multi-site clinical trial (n=320). Cost calculations were set at U.S. dollars and converted to value for 2013 as expenses were incurred over 6 years. Development costs over 1.5 years totaled $324,609, with the majority of costs being for personnel to develop and write content in a creative and engaging format, to get feedback from teens on content and a prototype, and IT programming. Maintenance of the program, including IT support, a part-time moderator to assure safety of the discussion board (0.5-1 hour/week), and yearly update of content was $43,845/year, or $137.00 per youth over 4.5 years. Overall, program and site development were relatively expensive, but the program reach was high, including non-white youth from 4 geographically distinct regions. Once developed, maintenance was minimal. With greater dissemination, cost-per-youth would decrease markedly, beginning to offset the high development expense.

Self-management as a mediator of family functioning and depressive symptoms with health outcomes in youth with type 1 diabetes.

This study examined the relationship of family functioning and depressive symptoms with self-management, glycemic control, and quality of life in a sample of adolescents with type 1 diabetes. It also explored whether self-management mediates family functioning, depressive symptoms, and diabetes-related outcomes. Structural equation modeling was used to estimate parameters in the conceptual causal pathway and test mediation effects. Adolescents (n = 320) were primarily female (55%), younger adolescents (58%), and self-identified as White (63%). Self-management mediated the relationship between family conflict, family warmth-caring, parent guidance-control, and youth depressive symptoms with glycosylated hemoglobin (A1C). In addition, self-management mediated the relationship between family conflict and youth depressive symptoms with quality of life. Supporting optimal family functioning and treating elevated depressive symptoms in adolescents with type 1 diabetes has the potential to improve self-management, glycemic control, and quality of life.

An internet coping skills training program for youth with type 1 diabetes: six-month outcomes.

BACKGROUND: Managing Type 1 diabetes (T1D) during adolescence can be challenging, and there is a need for accessible interventions to help adolescents cope with diabetes-related stress. OBJECTIVES: The aim of this study was to compare an Internet coping skills training (TEENCOPE) intervention to an Internet educational intervention (Managing Diabetes) for adolescents with T1D. Moderators of program efficacy were evaluated. METHODS: The study was a multisite clinical trial (n = 320) with data collected at baseline, 3 months, and 6 months. Data were collected on the primary outcomes of physiologic (A1C) and psychosocial (quality of life) and on the secondary outcomes of behavioral (self-management) and psychosocial (stress, coping self-efficacy, social competence, family conflict) variables consistent with the conceptual framework. Data were analyzed using mixed-model analyses with an intent-to-treat approach. RESULTS: There were no significant between-group treatment effects 6 months postintervention on primary outcomes. The Managing Diabetes youth showed a significant increase in social competence compared to the TEENCOPE youth. There were significant time effects for TEENCOPE (decreased stress and increased coping) and Managing Diabetes (improved diabetes quality of life). DISCUSSION: Youth with T1D transitioning to adolescence may need both structured diabetes education and coping skills to improve health outcomes. There may be a higher potential to reach adolescents with Type 1 diabetes of varying race and ethnicity via Internet interventions.

A comparison of two internet programs for adolescents with type 1 diabetes: design and methods.

Implementing psycho-educational programs for youth with type 1 diabetes in clinical care and reaching diverse youth with type 1 diabetes is challenging due to youth, provider, and organizational barriers. This study was designed to compare the effectiveness of an internet coping skills training program with a control condition of internet diabetes education. Each program consists of 5 weekly interactive lessons; the coping skills training program also provides the ability for youth to interact with each other as well as a health coach. Approximately 300 youths with type 1 diabetes will be recruited to participate in this multi-site clinical trial. The primary outcomes are metabolic control, quality of life, and family conflict. Secondary outcomes include stress, coping, self-efficacy, and social competence. Usage, satisfaction, and cost will also be evaluated. In addition, mediators and moderators to intervention effects will be explored. An internet based psycho-educational program for youth with type 1 diabetes may be a promising approach that can be easily be integrated into clinical care.

Seasonal trends in depressive symptoms in adolescents with type 1 diabetes.

Adolescents with type 1 diabetes reported more clinically significant depressive symptoms in the spring/summer months (22% in April-September) than in the fall/winter months (11% in October-March) (χ(2)=5.67, p=.018). This seasonal pattern was stronger in low-income adolescents than in adolescents from higher-income families.

A pilot study of chromium picolinate for weight loss.

BACKGROUND: Chromium is an essential trace element and nutritional supplement that has garnered interest for use as a weight loss aid. OBJECTIVE: This trial assesses the effects of chromium picolinate supplementation, alone and combined with nutritional education, on weight loss in apparently healthy overweight adults. DESIGN: This was a randomized, double-blind, placebo-controlled trial of 80 otherwise healthy, overweight adults assessed at baseline for central adiposity measured by computerized tomography. Subjects were randomly assigned to daily ingestion of 1000 microg of chromium picolinate or placebo for 24 weeks. All subjects received passive nutritional education at the 12-week point in both the intervention and control groups. Outcomes include weight, height, blood pressure, percent body fat, serum, and urinary biomarkers. RESULTS: At baseline, both the chromium and placebo groups had similar mean body mass index (BMI) (chromium = 36 +/- 6.7 kg/m(2) versus placebo = 36.1 +/- 7.6 kg/m(2); p = 0.98). After 12 weeks, no change was seen in BMI in the intervention as compared to placebo (chromium = 0.3 +/- 0.8 kg/m(2) versus placebo = 0.0 +/- 0.4 kg/m(2); p = 0.07). No change was seen in BMI after 24 weeks in the intervention as compared to placebo (chromium = 0.1 +/- 0.2 kg/m(2) versus placebo = 0.0 +/- 0.5 kg/m(2); p = 0.81). Variation in central adiposity did not affect any outcome measures. CONCLUSIONS: Supplementation of 1000 microg of chromium picolinate alone, and in combination with nutritional education, did not affect weight loss in this population of overweight adults. Response to chromium did not vary with central adiposity.

Effects of coping skills training in school-age children with type 1 diabetes.

Children with type 1 diabetes are at risk for negative psychosocial and physiological outcomes, particularly as they enter adolescence. The purpose of this randomized trial (n = 82) was to determine the effects, mediators, and moderators of a coping skills training intervention (n = 53) for school-aged children compared to general diabetes education (n = 29). Both groups improved over time, reporting lower impact of diabetes, better coping with diabetes, better diabetes self-efficacy, fewer depressive symptoms, and less parental control. Treatment modality (pump vs. injections) moderated intervention efficacy on select outcomes. Findings suggest that group-based interventions may be beneficial for this age group.

Intravenous micronutrient therapy (Myers' Cocktail) for fibromyalgia: a placebo-controlled pilot study.

OBJECTIVES: Intravenous micronutrient therapy (IVMT), and specifically the Myers' Cocktail, is a popular approach for treating fibromyalgia syndrome (FMS) among complementary and alternative medicine practitioners, but its efficacy is uncertain. This trial assessed the feasibility, safety, and provided insights into the efficacy of this therapy. DESIGN: This was a randomized, double-blind, placebo-controlled pilot study. LOCATIONS: The study locations were an academic research center, teaching hospital, and affiliated Integrative Medicine Center in Derby, CT. SUBJECTS: The subjects were 34 adults with American College of Rheumatology (ACR)-defined FMS. INTERVENTION: Subjects were randomly assigned either to treatment (weekly infusions of IVMT) or to placebo (weekly infusions of lactated Ringer's solution) for 8 weeks. OUTCOME MEASURES: Primary outcome was change in the Tender Point Index, assessed 8 and 12 weeks after initiation. Secondary measures included a Visual Analog Scale to assess global pain, and validated measures of physical function (Fibromyalgia Impact Questionnaire), mood (Beck Depression Index), and quality of life (Health Status Questionnaire 2.0). RESULTS: Clinically significant improvements were noted (of a magnitude similar to other effective interventions). However, in part because of the high placebo response and the small sample size, no statistically significant differences were seen between groups, in any outcome measure, at 8 and 16 weeks. Statistically significant within-group differences were seen in both the intervention and placebo groups, demonstrating a treatment effect for both IVMT and placebo. At 8 weeks, the IVMT group experienced significantly improved tender points, pain, depression, and quality of life directly following treatment (all p < or = 0.02), while the placebo group experienced significantly improved tender points only (p < or = 0.05). The treatment effects of IVMT persisted at 4 weeks postintervention for tender points, pain, and quality of life, while placebo effects persisted only for tender points. A single minor adverse event was noted in one subject in the intervention group. CONCLUSIONS: This first controlled pilot study established the safety and feasibility of treating FMS with IVMT. Most subjects experienced relief as compared to baseline, but no statistically significant differences were seen between IVMT and placebo. The efficacy of IVMT for fibromyalgia, relative to placebo, is as yet uncertain.

Evaluating the impact of mobile telephone technology on type 2 diabetic patients' self-management: the NICHE pilot study.

RATIONALE, AIMS AND OBJECTIVES: Utilizing information technology, such as Internet and cellphones, holds great promise in enhancing diabetic care. Yet few studies have examined the impact of cellphone technology on type 2 diabetics' self-care. The primary aim of the study is to examine the feasibility of utilizing this technology to assist with diabetes self-care in a clinic population as well as its impact on clinical outcomes. METHODS: Thirty patients with a diagnosis of type 2 diabetes at two Community Health Centers were randomized to intervention or control. Intervention patients participated in a brief intervention and received tailored daily messages via cellphone prompting them to enhance their diabetic self-care behaviour. Patients at the control site continued with their standard diabetes self-management. RESULTS: A mean improvement in HbA1c levels was apparent (-0.1, SD = 0.3%; P = 0.1534) in the intervention group, compared with a mean deterioration in the control (0.3, SD = 1.0%; P = 0.3813), yet without statistical significance. Self-efficacy scores improved significantly in the intervention group (-0.5, SD = 0.6; P = 0.0080) compared with no improvement in the control (0.0, SD = 1.0; P = 0.9060). Participants encountered numerous technological barriers when attempting to adhere to the intervention protocol. CONCLUSION: The results indicate the intervention had a positive impact on some clinical outcome and self-efficacy. Although the technology appears feasible in a clinical setting technology must be made more user-friendly before a larger phase II trial is conducted.

A randomized controlled trial of meditation and massage effects on quality of life in people with late-stage disease: a pilot study.

CONTEXT: Certain meditation practices may effectively address spiritual needs near end-of-life, an often overlooked aspect of quality of life (QOL). Among people subject to physical isolation, meditation benefits may be blunted unless physical contact is also addressed. OBJECTIVE: To evaluate independent and interactive effects of Metta meditation and massage on QOL in people with acquired immunodeficiency syndrome (AIDS). DESIGN: Randomized controlled blinded factorial pilot trial conducted from November 2001 to September 2003. SETTING: An AIDS-dedicated skilled nursing facility in New Haven, Connecticut. PARTICIPANTS: Fifty-eight residents (43% women) with late stage disease (AIDS or comorbidity). INTERVENTIONS: Residents were randomized to 1 month of meditation, massage, combined meditation and massage, or standard care. The meditation group received instruction, then self-administered a meditation audiocassette daily. A certified massage therapist provided the massage intervention 30 minutes per day 5 days per week. OUTCOME MEASURE: Changes on Missoula-Vitas QOL Index overall and transcendent (spiritual) scores at 8 weeks. RESULTS: The combined group showed improvement in overall (p = 0.005) and transcendent (p = 0.01) scores from baseline to 8 weeks, a change significantly greater (p < 0.05) than the meditation, massage, and control groups. CONCLUSIONS: The combination of meditation and massage has a significantly favorable influence on overall and spiritual QOL in late-stage disease relative to standard care, or either intervention component alone.