Erik J. Groessl

Effect of Structured Physical Activity on Prevention of Major Mobility Disability in Older Adults: The LIFE Study Randomized Clinical Trial

IMPORTANCE In older adults reduced mobility is common and is an independent risk factor for morbidity, hospitalization, disability, and mortality. Limited evidence suggests that physical activity may help prevent mobility disability; however, there are no definitive clinical trials examining whether physical activity prevents or delays mobility disability. OBJECTIVE To test the hypothesis that a long-term structured physical activity program is more effective than a health education program (also referred to as a successful aging program) in reducing the risk of major mobility disability. DESIGN, SETTING, AND PARTICIPANTS The Lifestyle Interventions and Independence for Elders (LIFE) study was a multicenter, randomized trial that enrolled participants between February 2010 and December 2011, who participated for an average of 2.6 years. Follow-up ended in December 2013. Outcome assessors were blinded to the intervention assignment. Participants were recruited from urban, suburban, and rural communities at 8 centers throughout the United States. We randomized a volunteer sample of 1635 sedentary men and women aged 70 to 89 years who had physical limitations, defined as a score on the Short Physical Performance Battery of 9 or below, but were able to walk 400 m. INTERVENTIONS Participants were randomized to a structured, moderate-intensity physical activity program (n = 818) conducted in a center (twice/wk) and at home (3-4 times/wk) that included aerobic, resistance, and flexibility training activities or to a health education program (n = 817) consisting of workshops on topics relevant to older adults and upper extremity stretching exercises. MAIN OUTCOMES AND MEASURES The primary outcome was major mobility disability objectively defined by loss of ability to walk 400 m. RESULTS Incident major mobility disability occurred in 30.1% (246 participants) of the physical activity group and 35.5% (290 participants) of the health education group (hazard ratio [HR], 0.82 [95% CI, 0.69-0.98], P = .03).Persistent mobility disability was experienced by 120 participants (14.7%) in the physical activity group and 162 participants (19.8%) in the health education group (HR, 0.72 [95% CI, 0.57-0.91]; P = .006). Serious adverse events were reported by 404 participants (49.4%) in the physical activity group and 373 participants (45.7%) in the health education group (risk ratio, 1.08 [95% CI, 0.98-1.20]). CONCLUSIONS AND RELEVANCE A structured, moderate-intensity physical activity program compared with a health education program reduced major mobility disability over 2.6 years among older adults at risk for disability. These findings suggest mobility benefit from such a program in vulnerable older adults. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01072500.

Chronic disease self-management and adherence to HIV medications.

Summary: Although it is widely recognized that potent antiretroviral therapies have transformed HIV from an acute to a chronic illness, it is less often recognized that with this change, a different model of care is appropriate. People living with chronic HIV must function independently, taking personal long‐term, day‐to‐day responsibility for care. The role of doctors and the healthcare system is to help them do this. The authors present a conceptual framework for the self‐management of chronic HIV disease and discuss the components of an HIV self‐management program. The ability to take antiretroviral medications well and consistently is a key part of self‐management but should be nested within an array of important skills, including symptom‐management skills, goal setting and planning, communication, and accessing information and resources.

Yoga for Veterans with Chronic Low-Back Pain

OBJECTIVES Chronic back pain affects a large proportion of both the general population and of military veterans. Although numerous therapies exist for treating chronic back pain, they can be costly and tend to have limited effectiveness. Thus, demonstrating the efficacy and cost-effectiveness of additional treatment alternatives is important. The purpose of our study was to examine the benefits of a yoga intervention for Veterans Administration (VA) patients. SUBJECTS/INTERVENTION: VA patients with chronic back pain were referred by their primary care providers to a yoga program as part of clinical care. Before starting yoga, a VA physician trained in yoga evaluated each patient to ensure that they could participate safely. DESIGN The research study consisted of completing a short battery of questionnaires at baseline and again 10 weeks later. OUTCOME MEASURES Questionnaires included measures of pain, depression, energy/fatigue, health-related quality of life, and program satisfaction. Paired t-tests were used to compare baseline scores to those at the 10-week follow-up for the single group, pre-post design. Correlations were used to examine whether yoga attendance and home practice were associated with better outcomes. RESULTS Baseline and follow-up data were available for 33 participants. Participants were VA patients with a mean age of 55 years. They were 21% female, 70% white, 52% married, 68% college graduates, and 44% were retired. Significant improvements were found for pain, depression, energy/fatigue, and the Short Form-12 Mental Health Scale. The number of yoga sessions attended and the frequency of home practice were associated with improved outcomes. Participants appeared highly satisfied with the yoga instructor and moderately satisfied with the ease of participation and health benefits of the yoga program. CONCLUSIONS Preliminary data suggest that a yoga intervention for VA patients with chronic back pain may improve the health of veterans. However, the limitations of a pre-post study design make conclusions tentative. A larger randomized, controlled trial of the yoga program is planned.

Lifestyle Interventions and Independence for Elders Study: Recruitment and Baseline Characteristics

BACKGROUND Recruitment of older adults into long-term clinical trials involving behavioral interventions is a significant challenge. The Lifestyle Interventions and Independence for Elders (LIFE) Study is a Phase 3 multicenter randomized controlled multisite trial, designed to compare the effects of a moderate-intensity physical activity program with a successful aging health education program on the incidence of major mobility disability (the inability to walk 400 m) in sedentary adults aged 70-89 years, who were at high risk for mobility disability (scoring ≤ 9 on the Short Physical Performance Battery) at baseline. METHODS Recruitment methods, yields, efficiency, and costs are described together with a summary of participant baseline characteristics. Yields were examined across levels of sex, race and ethnicity, and Short Physical Performance Battery, as well as by site. RESULTS The 21-month recruiting period resulted in 14,812 telephone screens; 1,635 participants were randomized (67.2% women, 21.0% minorities, 44.7% with Short Physical Performance Battery scores ≤ 7). Of the telephone-screened participants, 37.6% were excluded primarily because of regular participation in physical activity, health exclusions, or self-reported mobility disability. Direct mailing was the most productive recruitment strategy (59.5% of randomized participants). Recruitment costs were

Lifestyle Interventions and Independence for Elders Pilot Study: Recruitment and Baseline Characteristics

840 per randomized participant. Yields differed by sex and Short Physical Performance Battery. We accrued 11% more participant follow-up time than expected during the recruitment period as a result of the accelerated recruitment rate. CONCLUSIONS The LIFE Study achieved all recruitment benchmarks. Bulk mailing is an efficient method for recruiting high-risk community-dwelling older persons (including minorities), from diverse geographic areas for this long-term behavioral trial.

Management of Chronic Hepatitis C in Veterans: The Potential of Integrated Care Models

OBJECTIVES: To describe several recruitment parameters derived from the Lifestyle Interventions and Independence for Elders pilot (LIFE‐P) study for use in a full‐scale trial of mobility disability prevention.

Cost Effectiveness of Direct-Acting Antiviral Therapy for Treatment-Naive Patients With Chronic HCV Genotype 1 Infection in the Veterans Health Administration

The prevalence of hepatitis C virus (HCV) infection is higher among veterans than nonveterans, but only about 14% of all identified infected veterans have ever received antiviral therapy. High rates of comorbid psychiatric and substance use disorders are major barriers to receiving antiviral treatment for veterans, and characteristics associated with poor virologic response are more common in this population. However, accumulating evidence indicates that patients with psychiatric and substance use disorders can successfully receive interferon-based antiviral therapies in an integrated or multidisciplinary health-care setting. The broad aims of integrated care models include reducing fragmentation and improving continuity and coordination of care. Although, to date, there are no randomized controlled trials of specific care models for patients with HCV, studies of integrated care for other chronic diseases suggest several strategies for optimizing outcomes for patients with HCV. Components of an HCV clinic incorporating these principles have been tested in a nonrandomized setting and include routine screening of all patients for psychiatric and substance use disorder risk factors, collaboration with mental health providers within the HCV clinic, following a defined integrated medical/psychiatric clinical protocol, provision of ongoing integrated support during antiviral treatment or retreatment, and educating patients on principles of chronic disease self-management.

A cost analysis of self-management programs for people with chronic illness.

BACKGROUND & AIMS The Veterans Health Administration (VHA) is the largest single provider of care for hepatitis C virus (HCV) infection in the United States. We analyzed the cost effectiveness of treatment with the HCV protease inhibitors boceprevir and telaprevir in a defined managed care population of 102,851 patients with untreated chronic genotype 1 infection. METHODS We used a decision-analytic Markov model to examine 4 strategies: standard dual-therapy with pegylated interferon-alfa and ribavirin (PR), the combination of boceprevir and PR triple therapy, the combination of telaprevir and PR, or no antiviral treatment. A sensitivity analysis was performed. Sources of data included published rates of disease progression, the census bureau, and VHA pharmacy and hospitalization cost databases. RESULTS The estimated costs for treating each patient were

Living with Hepatitis C: Qualitative Interviews with Hepatitis C-infected Veterans

8000 for PR,

Integrated Care Increases Treatment and Improves Outcomes of Patients With Chronic Hepatitis C Virus Infection and Psychiatric Illness or Substance Abuse

31,300 for boceprevir and PR, and