A Randomized Controlled Trial to Evaluate the Effectiveness of a Distance Asthma Learning Program for Pediatricians

Objectives. To assess provider acceptability of a distance learning program for pediatric asthma and pilot test its effects on physician knowledge, attitudes and treatment practices. Design. Randomized controlled trial. Setting. Louisville and the surrounding central Kentucky region. Participants. Twenty-four pediatricians in clinical practice. Interventions. A distance learning program for pediatric asthma consisting of Web- or CD-ROM–based multimedia learning modules and two teleconference calls. Outcome Measures. Learner satisfaction and change in physician asthma knowledge, attitudes, and treatment behavior at 1 to 4 months (short term) and 6 to 8 months (long term). Results. Pediatricians had graduated from medical school a mean of 11.6 years before baseline (SD ±8.9); 56% were female. On all learner satisfaction items, the average score was a 4.0 or greater on a 5-point scale, indicating a favorable response from the participants. Participants in the education group reported increased familiarity with asthma guideline for prescribing daily-inhaled corticosteroids compared to control physicians (p = .03) at short-term follow-up. Participants also expressed increased confidence in selecting a medicine for patients requiring a low-dose inhaled steroid (p = .03). However, these differences were not seen at long-term follow-up. Compared to the control group, there was no significant increase in the proportion of patients receiving inhaled steroids for persistent asthma at short- or long-term follow-up. Conclusions. Pediatricians utilizing an asthma distance learning program expressed a high degree of learner satisfaction. The program was associated with a temporary increase in familiarity and confidence in implementing components of the asthma guidelines.     

Effectiveness of a Lifestyle Intervention on Metabolic Syndrome. A Randomized Controlled Trial

BACKGROUND Intensive lifestyle intervention significantly reduces the progression to diabetes in high-risk individuals. OBJECTIVE It is not known whether a program of moderate intervention might effectively reduce metabolic abnormalities in the general population. DESIGN Two-arm randomized controlled 1-year trial. PATIENTS Three hundred and thirty-five patients participated from a dysmetabolic population-based cohort of 375 adults aged 45–64 years in northwestern Italy. MEASUREMENTS We compared the effectiveness of a general recommendation-based program of lifestyle intervention carried out by trained professionals versus standard unstructured information given by family physicians at reducing the prevalence of multiple metabolic and inflammatory abnormalities. RESULTS At baseline, clinical/anthropometric/laboratory and lifestyle characteristics of the intervention (n = 169) and control (n = 166) groups were not significantly different. The former significantly reduced total/saturated fat intake and increased polyunsaturated fat/fiber intake and exercise level compared to the controls. Weight, waist circumference, high-sensitivity C-reactive protein, and most of the metabolic syndrome components decreased in the intervention group and increased in the controls after 12 months. Lifestyle intervention significantly reduced metabolic syndrome (odds ratio [OR] = 0.28; 95% CI 0.18–0.44), with a 31% (21–41) absolute risk reduction, corresponding to 3.2 (2–5) patients needing to be treated to prevent 1 case after 12 months. The intervention significantly reduced the prevalence of central obesity (OR = 0.33; 0.20–0.56), and hypertriglyceridemia (OR = 0.48; 0.31–0.75) and the incidence of diabetes (OR = 0.23; 0.06–0.85). CONCLUSION A lifestyle intervention based on general recommendations was effective in reducing multiple metabolic/inflammatory abnormalities. The usual care by family physicians was ineffective at modifying progressive metabolic deterioration in high-risk individuals.     

Effectiveness of Educational Interventions on Asthma Self-Management in Punjabi and Chinese Asthma Patients: A Randomized Controlled Trial

Background. Asthma tends to be less well controlled among ethnic minority groups, and its prevalence in new immigrants increases significantly the longer they are in Canada; mainly due to their lack of familiarity with English and difficulty understanding information regarding the disease, health literacy, cultural issues, housing conditions, and lack of access to appropriate care services. Objective. To explore the effectiveness of different formats of culturally relevant information and its impact on asthma patients’ self-management within the Punjabi, Mandarin, and Cantonese communities. Methods. Using a participatory approach, we developed and tested knowledge and community educational videos (with similar information, but used a different approach, i.e., scientific vs. colloquial) and a pictorial pamphlet. A total of 92 physician-diagnosed adult asthma patients (47 Chinese and 45 Punjabi) were assigned at random to three experimental groups (watched one or both videos) and one comparison group (read pictorial pamphlet) and participated in three in-person interviews and one telephone interview within a 9-month period. Patients received education on asthma self-management via videos and pamphlet and outcomes, including their knowledge of asthma triggers (environmental-related and behavioral-related triggers) and symptoms; inhaler use skills and patient-reported medication adherence were measured. Results. Knowledge of asthma symptoms, inhaler use, and understanding of physician’s instructions improved significantly from pretest to 3 months post-intervention follow-up among all participants. Conclusions. Participants performed significantly better at follow-up than they did at baseline assessment, with the most notable improvements observed in the group that watched both community and knowledge videos. The results suggest that short, simple, culturally, and linguistically appropriate interventions can promote knowledge gain about asthma and improve inhaler use that can be sustained over the short term. Such interventions that provide authentic learning materials that draw on patients’ life experiences and sociocultural context can overcome certain limitations of conventional patient education approaches.     

Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial

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A Randomized Controlled Trial of a Community-based Behavioral Counseling Program

Background

The US Preventive Services Task Force (USPSTF) recommends that clinicians refer obese adults for intensive, multicomponent behavioral counseling, yet most obese Americans choose a self-help approach to lose weight. The current study examined weight loss between a community-based, intensive behavioral counseling program (Weight Watchers program) and a self-help condition.

Methods

A total of 292 participants were randomized to either a Weight Watchers condition (WW) (n = 147) or a self-help condition (n = 145). Participants in the WW condition were provided with 3 ways to access the treatment: weekly meetings; WW mobile application; and WW online tools. Weights were measured at baseline and at 3 and 6 months. Additionally, self-report use of access modes was collected at 3 and 6 months.

Results

Participants in the WW condition significantly decreased their body mass index at 6 months (F = 36.7, P <.001) and were 8.0 and 8.8 times more likely to achieve a 5% and 10% reduction in weight, respectively, compared with those in the self-help condition. In a secondary analysis, high usage of all 3 access modes resulted in the greatest weight loss (P <.001).

Conclusion

Use of the WW program yielded significantly greater weight loss than a self-help approach, suggesting it is a viable community-based provider of weight loss treatment, as recommended by the USPSTF. Further, high usage of 3 access modes was associated with greater weight loss results.     

Characteristics of Yoga Users: Results of a National Survey

Background  There are limited data on the characteristics of yoga users in the U.S. Objective  To characterize yoga users, medical reasons for use, perceptions of helpfulness, and disclosure of use to medical professionals. Methods  Utilizing cross-sectional survey data from the 2002 National Health Interview Survey (NHIS) Alternative Medicine Supplement (n = 31044), we examined correlates of yoga use for health. The estimated prevalence from 2002 NHIS of yoga for health was 5.1% corresponding to over 10 million adults. Results  In 2002, yoga users were predominately Caucasian (85%) and female (76%) with a mean age of 39.5 years. Compared to non-yoga users, yoga users were more likely female (OR 3.76, 95% CI 3.11–4.33); less likely black than white (OR 0.65, 95% CI 0.53–0.80); tended to be younger; and more likely college educated (OR 2.70, 95% CI 2.37–3.08). Musculoskeletal conditions (OR 1.61, 95% CI 1.42–1.83), mental health conditions (OR 1.43, 95% CI 1.22–1.67), severe sprains in the last 12 months (OR 1.49, 95% CI 1.22–1.81), and asthma (OR 1.27, 95% CI 1.05–1.54) were independently associated with higher yoga use, while hypertension (OR 0.78, 95% CI 0.64–0.95) and chronic obstructive lung disease (OR 0.69, 95% CI 0.48–1.00) were associated with lower use. Yoga was most commonly used to treat musculoskeletal or mental health conditions, and most users reported yoga to be helpful for these conditions. A majority of yoga users (61%) felt yoga was important in maintaining health, though only 25% disclosed yoga practice to their medical professional. Conclusions  We found that yoga users are more likely to be white, female, young and college educated. Yoga users report benefit for musculoskeletal conditions and mental health, indicating that further research on the efficacy of yoga for the treatment and/or prevention of these conditions is warranted.     

Effects of a Renal Rehabilitation Exercise Program in Patients with CKD: A Randomized,Controlled Trial

Background and objectives

Patients with CKD have a high prevalence of cardiovascular disease associated with or exacerbated by inactivity. This randomized, controlled study investigated whether a renal rehabilitation exercise program for patients with stages 3 or 4 CKD would improve their physical function and quality of life.

Design, setting, participants, & measurements

In total, 119 adults with CKD stages 3 and 4 were randomized, and 107 of these patients proceeded to usual care or the renal rehabilitation exercise intervention consisting of usual care plus guided exercise two times per week for 12 weeks (24 sessions). Physical function was determined by three well established performance-based tests: 6-minute walk test, sit-to-stand test, and gait-speed test. Health-related quality of life was assessed by the RAND 36-Item Short Form Health Survey.

Results

At baseline, no differences in self-reported level of activity, 6-minute walk test, and sit-to-stand test scores were observed between the usual care (n=48) and renal rehabilitation exercise (n=59) groups, although baseline gait-speed test score was higher in the renal rehabilitation exercise group (P<0.001). At follow-up, the renal rehabilitation exercise group but not the usual care group showed significant improvements in the 6-minute walk test (+210.4±266.0 ft [19% improvement] versus −10±219.9 ft; P<0.001), the sit-to-stand test (+26.9±27% of age prediction [29% improvement] versus +0.7±12.1% of age prediction; P<0.001), and the RAND-36 physical measures of role functioning (P<0.01), physical functioning (P<0.01), energy/fatigue levels (P=0.01), and general health (P=0.03) and mental measure of pain scale (P=0.04). The renal rehabilitation exercise regimen was generally well tolerated.

Conclusions

A 12-week/24-session renal rehabilitation exercise program improved physical capacity and quality of life in patients with CKD stages 3 and 4. Longer follow-up is needed to determine if these findings will translate into decreased mortality rates.     

宝乐安散剂治疗急慢性腹泻61例随机双盲双模拟对照试验

目的观察宝乐安散剂治疗急慢性腹泻的临床疗效和安全性。方法采用多中心随机双盲、双模拟对照试验。宝乐安散剂61例,po,1.0g(10×108cfu),tid;对照药米雅片65例,po,0.7g(7.0×108cfu),tid。疗程急性腹泻3～7d,慢性腹泻14～21d。结果宝乐安散剂治疗急性腹泻有效率为100.0%(29/29),慢性腹泻有效率为100.0%(32/32);对照药米雅片分别为100.0%(32/32)和100.0%(33/33)。两药疗效间差异均无显著性(χ2=0.0,P>0.05),均未出现不良反应。结论宝乐安散剂是治疗急性、慢性腹泻安全有效的微生态制剂,其疗效和安全性均相当于进口药米雅片。     

Improving Asthma Care for the Elderly: A Randomized Controlled Trial Using a Simple Telephone Intervention

Background. Several studies suggest that asthma is undertreated in the elderly population. Objective. To determine if the use of a simple telephone intervention can improve asthma care in the elderly. Methods. Fifty-two elderly subjects with asthma who required their rescue inhalers more than twice a week and had at least one emergency department or urgent care visit in the previous year were randomized to an intervention or control group. All subjects received two telephone calls over a 12-month period. The intervention group received an asthma-specific questionnaire and the control group received a general health questionnaire. Medication use and health care utilization were evaluated at the beginning and end of a 12-month period. Results. The study was completed by 23 control and 25 intervention subjects. Baseline data were similar in both groups. After 12 months, 72% (n = 18) of the intervention group were on an inhaled corticosteroid compared with 40% (n = 10) of the control group (p = 0.08). The intervention group had fewer emergency department visits when compared with the control group (p = 0.21). Sixty-four percent (n = 16) of the intervention group had an asthma action plan compared with 26% (n = 6) in the control group (p = 0.01). Conclusion. This study suggests that asthma care in the elderly can be improved using a simple telephone intervention. Clinical implications. Clinicians need to recognize that under treatment of asthma in the elderly still exists and to use alternative methods such as a simple telephone questionnaire to improve care in this population.     

Effectiveness of Lifestyle and Drug Intervention on Hypertensive Patients: a Randomized Community Intervention Trial in Rural China

BackgroundStrict medication guidance and lifestyle interventions to manage blood pressure (BP) in hypertensive patients are typically difficult to follow.ObjectiveTo evaluate the 1-year effectiveness of lifestyle and drug intervention in the management of rural hypertensive patients.DesignRandomized community intervention trial.ParticipantsThe control group comprised 967 patients who received standard antihypertensive drug intervention therapy from two communities, whereas the intervention group comprised 1945 patients who received antihypertensive drug and lifestyle intervention therapies from four communities in rural China.Main MeasuresData on lifestyle behaviors and BP measurements at baseline and 1-year follow-up were collected. A difference-in-difference logistic regression model was used to assess the effect of the intervention.Key ResultsBP control after the 1-year intervention was better than that at baseline in both groups. The within-group change in BP control of 59.3% in the intervention group was much higher than the 25.2% change in the control group (P < 0.001). Along with the duration of the follow-up period, systolic and diastolic BP decreased rapidly in the early stages and then gradually after 6 months in the intervention group (P < 0.001). In the intervention group, drug therapy adherence was increased by 39.5% (from 48.1% at 1 month to 87.6% at 1 year) (P < 0.001), more in women (45.6%) than in men (31.2%; P < 0.001). The net effect of the lifestyle intervention improved the rate of BP control by 56.1% (70.8% for men and 44.7% for women). For all physiological and biochemical factors, such as body mass index, waist circumference, lipid metabolism, and glucose control, improvements were more significant in the behavioral intervention group than those in the control group (all P < 0.001).ConclusionThe addition of lifestyle intervention by physicians or nurses helps control BP effectively and lowers BP better than usual care with antihypertensive drug therapy alone.Electronic supplementary materialThe online version of this article (10.1007/s11606-019-05601-7) contains supplementary material, which is available to authorized users.KEY WORDS: hypertension, lifestyle intervention, effectiveness, blood pressure control rate     

Yoga Decreases Kyphosis in Senior Women and Men with Adult-Onset Hyperkyphosis: Results of a Randomized Controlled Trial

OBJECTIVES: To assess whether a specifically designed yoga intervention can reduce hyperkyphosis.
DESIGN: A 6-month, two-group, randomized, controlled, single-masked trial.
SETTING: Community research unit.
PARTICIPANTS: One hundred eighteen women and men aged 60 and older with a kyphosis angle of 40° or greater. Major exclusions were serious medical comorbidity, use of assistive device, inability to hear or see adequately for participation, and inability to pass a physical safety screen.
INTERVENTION: The active treatment group attended hour-long yoga classes 3 days per week for 24 weeks. The control group attended a monthly luncheon and seminar and received mailings.
MEASUREMENTS: Primary outcomes were change (baseline to 6 months) in Debrunner kyphometer-assessed kyphosis angle, standing height, timed chair stands, functional reach, and walking speed. Secondary outcomes were change in kyphosis index, flexicurve kyphosis angle, Rancho Bernardo Blocks posture assessment, and health-related quality of life (HRQOL).
RESULTS: Compared with control participants, participants randomized to yoga experienced a 4.4% improvement in flexicurve kyphosis angle ( P =.006) and a 5% improvement in kyphosis index ( P =.004). The intervention did not result in statistically significant improvement in Debrunner kyphometer angle, measured physical performance, or self-assessed HRQOL (each P >.1).
CONCLUSION: The decrease in flexicurve kyphosis angle in the yoga treatment group shows that hyperkyphosis is remediable, a critical first step in the pathway to treating or preventing this condition. Larger, more-definitive studies of yoga or other interventions for hyperkyphosis should be considered. Targeting individuals with more-malleable spines and using longitudinally precise measures of kyphosis could strengthen the treatment effect.     

Effect of a Predictive Analytics-Targeted Program in Patients on Opioids: a Stepped-Wedge Cluster Randomized Controlled Trial

BackgroundRisk of overdose, suicide, and other adverse outcomes are elevated among sub-populations prescribed opioid analgesics. To address this, the Veterans Health Administration (VHA) developed the Stratification Tool for Opioid Risk Mitigation (STORM)—a provider-facing dashboard that utilizes predictive analytics to stratify patients prescribed opioids based on risk for overdose/suicide.ObjectiveTo evaluate the impact of the case review mandate on serious adverse events (SAEs) and all-cause mortality among high-risk Veterans.DesignA 23-month stepped-wedge cluster randomized controlled trial in all 140 VHA medical centers between 2018 and 2020.ParticipantsA total of 44,042 patients actively prescribed opioid analgesics with high STORM risk scores (i.e., percentiles 1% to 5%) for an overdose or suicide-related event.InterventionA mandate requiring providers to perform case reviews on opioid analgesic-prescribed patients at high risk of overdose/suicide.Main MeasuresNine serious adverse events (SAEs), case review completion, number of risk mitigation strategies, and all-cause mortality.Key ResultsMandated review inclusion was associated with a significant decrease in all-cause mortality within 4 months of inclusion (OR: 0.78; 95% CI: 0.65–0.94). There was no detectable effect on SAEs. Stepped-wedge analyses found that mandated review patients were five times more likely to receive a case review than non-mandated patients with similar risk (OR: 5.1; 95% CI: 3.64–7.23) and received more risk mitigation strategies than non-mandated patients (0.498; CI: 0.39–0.61).ConclusionsAmong VHA patients prescribed opioid analgesics, identifying high risk patients and mandating they receive an interdisciplinary case review was associated with a decrease in all-cause mortality. Results suggest that providers can leverage predictive analytic-targeted population health approaches and interdisciplinary collaboration to improve patient outcomes.Trial RegistrationISRCTN16012111Supplementary InformationThe online version contains supplementary material available at 10.1007/s11606-022-07617-y.KEY WORDS: opioids, predictive algorithms, serious adverse events, mortality, risk mitigation, veterans     

Yoga for the management of pain and sleep in rheumatoid arthritis: a pilot randomized controlled trial

Objective

The aim of the present study was to determine the feasibility of a relaxation‐based yoga intervention for rheumatoid arthritis, designed and reported in accordance with Delphi recommendations for yoga interventions for musculoskeletal conditions.

Methods

Participants were recruited from a hospital database, and randomized to either eight weekly 75‐min yoga classes or a usual care control. Feasibility was determined by recruitment rates, retention, protocol adherence, participant satisfaction and adverse events. Secondary physical and psychosocial outcomes were assessed using self‐reported questionnaires at baseline (week 0), week 9 (primary time point) and week 12 (follow‐up).

Results

Over a 3‐month period, 26 participants with mild pain, mild to moderate functional disability and moderate disease activity were recruited into the study (25% recruitment rate). Retention rates were 100% for yoga participants and 92% for usual care participants at both weeks 9 and 12. Protocol adherence and participant satisfaction were high. Yoga participants attended a median of seven classes; additionally, seven of the yoga participants (54%) reported continuing yoga at home during the follow‐up period. No serious adverse events were related to the study. Secondary outcomes showed no group effects of yoga compared with usual care.

Conclusions

A relaxation‐based yoga programme was found to be feasible and safe for participants with rheumatoid arthritis‐related pain and functional disability. Adverse events were minor, and not unexpected from an intervention including physical components. This pilot provides a framework for larger intervention studies, and supports further exploration of yoga as a complex intervention to assist with the management of rheumatoid arthritis.     

A Randomized Controlled Trial of a Close Monitoring Program for Minor Depression and Distress

BACKGROUND  Minor depression is almost twice as common in primary care (PC) as major depression. Despite the high prevalence, few evidence-based algorithms exist for managing patients with minor depression or patients presenting solely with distress. OBJECTIVES  The aim of this study was to test the effectiveness of a telephone-based close monitoring program to manage PC patients with minor depression or distress. DESIGN  Subjects were randomly assigned to either the control arm (usual care; UC) or the intervention arm (close monitoring; CM). We hypothesized that those randomized to CM would exhibit less depression and be less likely to have symptoms progress to the point of meeting diagnostic criteria. SUBJECTS  Overall, 223 PC subjects with minor depression or distress consented to participation in this trial. MEASUREMENTS  At baseline, subjects completed a telephone-based evaluation comprised of validated diagnostic assessments of depression and other MH disorders. Outcomes were assessed at six months utilizing this same battery. Chart reviews were conducted to track care received, such as prescribed antidepressants and MH and primary care visits. RESULTS  Subjects in the CM arm exhibited fewer psychiatric diagnoses than those in the UC arm (χ² = 4.04, 1 df, p = 0.04). In addition, the intervention group showed improved overall physical health (SF-12 PCS scores) (M = 45.1, SD = 11.8 versus M = 41.5, SD = 12.4) (χ² = 5.90, 1 df, p = .02). CONCLUSIONS  Those randomized to CM exhibited less MH problems at the conclusion of the trial, indicating that the close monitoring program is effective, feasible and valuable. The findings of this study will allow us to enhance clinical care and support the integration of mental health services and primary care.     

The Role of Gastroesophageal Reflux in Exercise-Triggered Asthma: A Randomized Controlled Trial

Background Exercise-triggered asthma (ETA) develops when physical activity triggers asthma symptoms during or directly after exercise. In patients prone to symptoms of supra-esophageal reflux, exercise may trigger gastroesophageal reflux (GER), resulting in such symptoms. Aims To determine the prevalence of abnormal pH in patients with ETA and to determine whether acid suppression improves symptoms in ETA patients. Methods We performed a randomized double-blind trial of rabeprazole versus placebo in the treatment of patients with ETA. Patients underwent treadmill protocol to determine their VO_2max. Next, pH testing was initiated while undergoing a 30-min treadmill program exercising them at 65% of their VO_2max. They were subsequently randomized to rabeprazole or placebo for 10 weeks. At the end of 10 weeks, exercise testing was repeated. Results A total of 31 patients completed the study (20 asthmatics, 11 non-asthmatics). Twenty-two out of 30 (73%) subjects had abnormal pH studies. For all subjects, rabeprazole improved symptoms more than placebo (P = 0.03). The association was stronger in the pH-positive group (P = 0.009). Conclusion Acid reflux is common in ETA patients. Many patients with exercise-related respiratory symptoms are misdiagnosed as chronic asthmatics. Exercise-related symptoms improve with the use of acid suppression. This study suggests that ETA patients may benefit from acid suppression.