Use of ceramic water filtration in the prevention of diarrheal disease: a randomized controlled trial in rural South Africa and zimbabwe

To determine the effectiveness of ceramic filters in reducing diarrhea, we conducted a randomized controlled trial in Zimbabwe and South Africa, in which 61 of 115 households received ceramic filters. Incidence of non-bloody and bloody diarrhea was recorded daily over 6 months using pictorial diaries for children 24-36 months of age. Poisson regression was used to compare incidence rates in intervention and control households. Adjusted for source quality, intervention household drinking water showed reduced Escherichia coli counts (relative risk, 0.67; 95% CI, 0.50-0.89). Zero E. coli were obtained for drinking water in 56.9% of intervention households. The incidence rate ratio for bloody diarrhea was 0.20 (95% CI, 0.09-0.43; P < 0.001) and for non-bloody diarrhea was 0.17 (95% CI, 0.08-0.38; P < 0.001), indicating much lower diarrhea incidence among filter users. The results suggest that ceramic filters are effective in reducing diarrheal disease incidence.     

Efficacy of a lay health worker led group antiretroviral medication adherence training among non-adherent HIV-positive patients in KwaZulu-Natal,South Africa: Results from a randomized trial

There is a lack of theory-based randomized controlled trials to examine the effect of antiretroviral adherence in sub-Saharan Africa. We assessed the effectiveness of a lay health worker lead structured group intervention to improve adherence to antiretroviral therapy (ART) in a cohort of HIV-infected adults. This two-arm randomized controlled trial was undertaken at an HIV clinic in a district hospital in South Africa. A total of 152 adult patients on ART and with adherence problems were randomized 1:1 to one of two conditions, a standard adherence intervention package plus a structured three session group intervention or to a standard adherence intervention package alone. Self-reported adherence was measured using the Adult AIDS Clinical Trials Group adherence instrument prior to, post intervention and at follow-up. Baseline characteristics were similar for both conditions. At post-intervention, adherence information knowledge increased significantly in the intervention condition in comparison to the standard of care, while adherence motivation and skills did not significantly change among the conditions over time. There was a significant improvement in ART adherence and CD4 count and a significant reduction of depression scores over time in both conditions, however, no significant intervention effect between conditions was found. Lay health workers may be a useful adjunct to treatment to enhance the adherence information component of the medication adherence intervention, but knowledge may be necessary but not sufficient to increase adherence in this sample. Psychosocial informational interventions may require more advanced skill training in lay health workers to achieve superior adherence outcomes in comparison standard care in this resource-constrained setting.     

Syndromic management training for non-formal care providers in Pakistan improves quality of care for sexually transmitted diseases STD care: a randomized clinical trial

We conducted a randomized, controlled, three-armed trial to assess whether training in syndromic management, with provision of packets, could improve the quality of STD services provided among non-formal care providers. The quality of STD case management service, observed by "incognito patients" in both intervention groups, improved substantially compared to the control group (p < 0.05). The training-and-packets group performed better in service delivery, HIV-testing referral, and condom provision when compared to the training-only group (all p < 0.05). The training-and-packets group also retained more knowledge and practiced more skillfully at six months post-intervention when compared to the training-only group (p < 0.05). Exit interviews of clients suggested that 81% of providers in the intervention groups offered advice on condom use when compared to none of those in the control group (p < 0.001). Syndromic management training and free syndrome packets for non-formal providers had a positive impact on the quality of STD care among the trained providers.     

Multifaceted intervention to improve rheumatologists' management of glucocorticoid-induced osteoporosis: a randomized controlled trial

OBJECTIVE: To assess the effectiveness of a multifaceted intervention to improve the management of glucocorticoid-induced osteoporosis (GIOP). METHODS: Of 21 rheumatologists, 11 were randomly assigned to a 3-part intervention consisting of a lecture and discussion regarding optimal management of GIOP, a confidential doctor-specific audit regarding management of GIOP, and a reminder mailing including concise pharmacologic recommendations. The remaining 10 rheumatologists received no special education. Patients with rheumatoid arthritis (RA) taking oral glucocorticoids seen in the 2 months after the intervention were followed for 6 months. Medical records were assessed to determine the proportion undergoing bone mineral density testing or receiving pharmacologic interventions for GIOP during the 6 months before and 6 months after the intervention. RESULTS: There were 373 patients with RA taking oral glucocorticoids whose records were assessed. Patients in both arms of the trial were similar with respect to age, sex, menopausal status, glucocorticoid dosage and duration, duration of RA, disease-modifying antirheumatic drug use, and the proportion with comorbid conditions. At baseline, there was no significant difference between the patients with respect to osteoporosis medication use (intervention 32% versus control 34%) or bone densitometry use (intervention 9% versus control 5%). After the intervention and a 6-month followup period, there were no differences in treatment (intervention 33% versus control 38%) or bone densitometry use (intervention 8% versus control 8%). Adjusting for patient and physician characteristics did not significantly change these results. CONCLUSION: A multifaceted intervention for GIOP, including doctor education, practice audit, and treatment suggestions, had no significant benefit on testing or treatment by rheumatologists over a 6-month followup period. Other intervention approaches need to be tested.     

Multiple-modality exercise and mind-motor training to improve cardiovascular health and fitness in older adults at risk for cognitive impairment: A randomized controlled trial

BackgroundThe effects of multiple-modality exercise on arterial stiffening and cardiovascular fitness has not been fully explored.ObjectivesTo explore the influence of a 24-week multiple-modality exercise program associated with a mind-motor training in cardiovascular health and fitness in community-dwelling older adults, compared to multiple-modality exercise (M2) alone.MethodsParticipants (n = 127, aged 67.5 [7.3] years, 71% females) were randomized to either M4 or M2 groups. Both groups received multiple-modality exercise intervention (60 min/day, 3 days/week for 24-weeks); however, the M4 group underwent additional 15 min of mind-motor training, whereas the M2 group received 15 min of balance training. Participants were assessed at 24-weeks and after a 28-week non-contact follow-up (52-weeks).Resultsat 52-weeks, the M4 group demonstrated a greater VO2max (ml/kg/min) compared to the M2 group (mean difference: 2.39, 95% CI: 0. 61 to 4.16, p = 0.009). Within-group analysis indicated that the M4 group demonstrated a positive change in VO2max at 24-weeks (mean change: 1.93, 95% CI: 0.82 to 3.05, p = 0.001) and 52-weeks (4.02, 95% CI: 2.71 to 5.32, p = 0.001). Similarly, the M2 group increased VO2max at 24-weeks (2.28, 95% CI: 1.23 to 3.32, p < 0.001) and 52-weeks (1.63, 95% CI: 0.43 to 2.83, p = 0.008). Additionally, the M2 group decreased 24 h SBP (mmHg) at 24-weeks (−2.31, 95% CI: −4.61 to −0.01, p = 0.049); whereas the M4 group improved 24 h DBP (−1.6, 95% CI: −3.03 to −0.17, p = 0.028) at 52-weeks.ConclusionMind-motor training associated with multiple-modality exercise can positively impact cardiovascular fitness to the same extent as multiple-modality exercise alone.     

Impact on perinatal mortality of missed opportunities to treat maternal syphilis in rural South Africa: baseline results from a clinic randomized controlled trial

OBJECTIVE: To demonstrate the impact on perinatal mortality of inadequate treatment for maternal syphilis despite adequate screening. METHOD: In 12 clinics providing antenatal care in Hlabisa, South Africa 1783 pregnant women were screened for syphilis at their first antenatal visit between June and October 1998. Pregnancy outcome was determined among those with syphilis. RESULTS: A total of 158 women were diagnosed with syphilis: prevalence 9% (95% CI 8-10%). Mean gestation at first antenatal visit was 24 weeks. Thirty women (19%) received no treatment and 96 (61%) received all three recommended doses of penicillin. Among those receiving at least one dose, mean delay to the first dose was 20 days. Among those fully treated mean delay to treatment completion was 34 days. Pregnancy outcome was known for 142 women (90%) and there were 17 perinatal deaths among 15 women (11%). Eleven of 43 women (26%) who received one or fewer doses of penicillin experienced a perinatal death whilst only four of 99 women (4%) who received two or more doses of penicillin did so (P = 0.0001). Protection from perinatal death increased with the number of doses of penicillin: linear modelling suggests that one dose reduced the risk by 41%, two doses by 65% and three doses by 79%, compared with no doses. A dose-specific, categorical model confirmed reduction in risk by 79% for all three doses. CONCLUSION: Despite effective screening, many pregnant women with syphilis remain inadequately treated, resulting in avoidable perinatal mortality. Delays in starting and finishing treatment, as well as incomplete treatment occur. Near-patient syphilis testing in the antenatal clinic with early treatment could improve treatment of syphilis and reduce perinatal mortality, and a randomized trial to test this is underway.     

Effects of continuous and interval training programs in the management of hypertension: a randomized controlled trial

The purpose of the present study was to determine and compare the effect of interval and continuous training programs in the management of hypertension. Three hundred fifty-seven male patients with essential hypertension were age matched and grouped into interval, continuous, and control groups. The interval (n=140; 58.90±7.35 years) and continuous (n=112; 58.63±7.22 years) groups were involved in 8 weeks of interval (60%-79% maximum heart rate) and continuous (60%-79% maximum heart rate) programs of between 45 to 60 minutes, while the control group (n=105; 58.27±6.24 years) remained sedentary during this period. Findings of the study revealed significant effect of both training programs on maximum oxygen consumption, systolic blood pressure, diastolic blood pressure, heart rate, pulse pressure, and mean arterial pressure at P<.05. The maximum oxygen consumption significantly and negatively correlated with systolic blood pressure, diastolic blood pressure, rate-pressure product, pulse pressure, and mean arterial pressure at P<.01. It was concluded that both training programs are effective adjunct nonpharmacological management of hypertension. The recommendation of the paper was that both interval and continuous training programs should form part of the kit in the management of hypertension.     

Exercise training in recently hospitalized heart failure patients enrolled in a disease management programme: design of the EJECTION-HF randomized controlled trial

AIMS: The Exercise Joins Education: Combined Therapy to Improve Outcomes in Newly-discharged Heart Failure (EJECTION-HF) study will evaluate the impact of a supervised exercise training programme (ETP) on clinical outcomes in recently hospitalized heart failure patients attending a disease management programme (DMP). Methods This multisite, pragmatic randomized controlled trial enrols patients discharged from participating hospitals with clinical evidence of heart failure who are willing and able to participate in a DMP and considered clinically safe to exercise. Enrolment includes participants with impaired and preserved left ventricular systolic function. Baseline assessment and programme commencement occur within 6 weeks of hospital discharge. The control group DMP includes individualized education and follow-up from a multidisciplinary heart failure team; a weekly education programme for 12 weeks; self-management advice; and medical follow-up. Home exercise is recommended for all participants. In addition, intervention participants are offered 36 supervised, structured gym-based 1 h exercise sessions over 24 weeks. Sessions are tailored to exercise capacity and include aerobic, resistance, and balance exercises. Enrolment target is 350 participants. Primary outcome is 12-month mortality and readmissions. Secondary outcomes include blinded evaluation of depressive symptoms, sleep quality, cognition, and functional status (activities of daily living, 6 min walk distance, grip strength) at 3 and 6 months. A cost-utility analysis will be conducted. CONCLUSION: This study will enrol a representative group of hospitalized heart failure patients and measure a range of patient and health service outcomes to inform the design of post-hospital DMPs for heart failure. Enrolment will be completed in 2013. ACTRN12608000263392.     

Nurse case management to improve the hepatitis C care continuum in HIV co‐infection: Results of a randomized controlled trial

The opportunity to eliminate hepatitis C virus (HCV) is at hand, but challenges remain that negatively influence progress through the care continuum, particularly for persons co‐infected with HIV who are not well engaged in care. We conducted a randomized controlled trial to test the effect of nurse case management (NCM) on the HCV continuum among adults co‐infected with HIV compared to usual care (UC). Primary outcomes included linkage to HCV care (attendance at an HCV practice appointment within 60 days) and time to direct‐acting antiviral (DAA) initiation (censored at 6 months). Sixty‐eight participants were enrolled (NCM n = 35; UC n = 33). Participants were 81% Black/African American, 85% received Medicaid, 46% reported illicit drug use, 41% alcohol use, and 43% had an undetectable HIV viral load. At day 60, 47% of NCM participants linked to HCV care compared to 25% of UC participants (P = .031; 95% confidence bound for difference, 3.2%‐40.9%). Few participants initiated DAAs (12% NCM; 25% UC). There was no significant difference in mean time to treatment initiation (NCM = 86 days; UC = 110 days; P = .192). Engagement in HCV care across the continuum was associated with drinking alcohol, knowing someone who cured HCV and having a higher CD4 cell count (P < .05). Our results support provision of NCM as a successful strategy to link persons co‐infected with HIV to HCV care, but interventions should persist beyond linkage to care. Capitalizing on social networks, treatment pathways for patients who drink alcohol, and integrated substance use services may help improve the HCV care continuum.     

Multifaceted intervention to improve rheumatologists' management of glucocorticoid‐induced osteoporosis: A randomized controlled trial

Objective

To assess the effectiveness of a multifaceted intervention to improve the management of glucocorticoid‐induced osteoporosis (GIOP).

Methods

Of 21 rheumatologists, 11 were randomly assigned to a 3‐part intervention consisting of a lecture and discussion regarding optimal management of GIOP, a confidential doctor‐specific audit regarding management of GIOP, and a reminder mailing including concise pharmacologic recommendations. The remaining 10 rheumatologists received no special education. Patients with rheumatoid arthritis (RA) taking oral glucocorticoids seen in the 2 months after the intervention were followed for 6 months. Medical records were assessed to determine the proportion undergoing bone mineral density testing or receiving pharmacologic interventions for GIOP during the 6 months before and 6 months after the intervention.

Results

There were 373 patients with RA taking oral glucocorticoids whose records were assessed. Patients in both arms of the trial were similar with respect to age, sex, menopausal status, glucocorticoid dosage and duration, duration of RA, disease‐modifying antirheumatic drug use, and the proportion with comorbid conditions. At baseline, there was no significant difference between the patients with respect to osteoporosis medication use (intervention 32% versus control 34%) or bone densitometry use (intervention 9% versus control 5%). After the intervention and a 6‐month followup period, there were no differences in treatment (intervention 33% versus control 38%) or bone densitometry use (intervention 8% versus control 8%). Adjusting for patient and physician characteristics did not significantly change these results.

Conclusion

A multifaceted intervention for GIOP, including doctor education, practice audit, and treatment suggestions, had no significant benefit on testing or treatment by rheumatologists over a 6‐month followup period. Other intervention approaches need to be tested.

     

Endurance exercise training in orthostatic intolerance: a randomized, controlled trial

Orthostatic intolerance is a syndrome characterized by chronic orthostatic symptoms of light-headedness, fatigue, nausea, orthostatic tachycardia, and aggravated norepinephrine levels while standing. The aim of this study was to assess the protective effect of exercise endurance training on orthostatic symptoms and to examine its usefulness in the treatment of orthostatic intolerance. 2768 military recruits were screened for orthostatic intolerance by questionnaire. Tilt-table testing identified 36 cases of orthostatic intolerance out of the 2768 soldiers. Subsequently, 31 of these subjects with orthostatic intolerance entered a randomized, controlled trial. The patients were allocated randomly to either a "training" (3 months jogging) or a "control" group. The influence of exercise training on orthostatic intolerance was assessed by determination of questionnaire scores and tilt-table testing before and after intervention. After training, only 6 individuals of 16 still had orthostatic intolerance compared with 10 of 11 in the control group. The Fisher exact test showed a highly significant difference in diagnosis between the 2 groups (P=0.008) at the end of the study. Analysis of the questionnaire-score showed significant interaction between time and group (P=0.001). The trained subjects showed an improvement in the average symptom score from 1.79+/-0.4 to 1.04+/-0.4, whereas the control subjects showed no significant change in average symptom score (2.09+/-0.6 and 2.14+/-0.5, respectively). Our data demonstrate that endurance exercise training leads to an improvement of symptoms in the majority of patients with orthostatic intolerance. Therefore, we suggest that endurance training should be considered in the treatment of orthostatic intolerance patients.     

Strength training, walking, and social activity improve sleep in nursing home and assisted living residents: randomized controlled trial

OBJECTIVES: To compare the effects of physical resistance strength training and walking (E), individualized social activity (SA), and E and SA (ESA) with a usual care control group on total nocturnal sleep time in nursing home and assisted living residents. DESIGN: Pretest–posttest experimental design with assignment to one of four groups for 7 weeks: E (n=55), SA (n=50), ESA (n=41), and usual care control (n=47). SETTING: Ten nursing homes and three assisted living facilities. PARTICIPANTS: One hundred ninety‐three residents were randomly assigned; 165 completed the study. INTERVENTION: The E group participated in high‐intensity physical resistance strength training 3 days a week and on 2 days walked for up to 45 minutes, the SA group received social activity 1 hour daily 5 days a week, the ESA group received both E and SA, and the control group participated in usual activities provided in the homes. MEASUREMENT: Total nocturnal sleep time was measured using 2 nights of polysomnography before and 2 nights of polysomnography after the intervention. Sleep efficiency (SE), non‐rapid eye movement (NREM) sleep, rapid eye movement sleep, and sleep onset latency were also analyzed. RESULTS: Total nocturnal sleep time was significantly greater in the ESA group than in the control group (adjusted means 364.2 minutes vs 328.9 minutes), as was SE and NREM sleep. CONCLUSION: High‐intensity physical resistance strength training and walking combined with social activity significantly improved sleep in nursing home and assisted living residents. The interventions by themselves did not have significant effects on sleep in this population.     

Behavioural management of aggression in dementia: a randomized controlled trial

OBJECTIVE: To evaluate the efficacy of a brief behaviour management training programme for family carers of patients with dementia and aggressive behaviour. DESIGN: A randomized controlled trial of a four-session, community-based behaviour management programme. The primary outcome measure was the Rating Scale for Aggressive Behaviour in the Elderly. PARTICIPANTS: 62 patients with dementia, and their co-resident carers. RESULTS: There were no significant differences in aggression scores between behaviour management and control groups at follow-up. After adjusting for baseline differences in Rating Scale for Aggressive Behaviour in the Elderly scores, there was a trend towards a reduction in aggressive behaviour in the patients in the behaviour management group compared with those in the control group (F = 3.37, P = 0.071). CONCLUSIONS: This study adds to the small evidence base for the effectiveness of behavioural management strategies in dementia.     

A randomized controlled trial of an enhanced balance training program to improve mobility and reduce falls in elderly patients

OBJECTIVES: To evaluate the effectiveness of an enhanced balance training program in improving mobility and well-being of elderly people with balance problems. DESIGN: Prospective, single-blind, randomized, controlled trial. SETTING: District general hospital. PARTICIPANTS: One hundred ninety-nine patients aged 60 and older with a Berg Balance Scale (BBS) score of less than 45. INTERVENTIONS: Six weeks enhanced balance training consisting of a series of repetitive tasks of increasing difficulty specific to functional balance. The control group received physiotherapy conforming to existing practice in elderly patients with mobility problems. MEASUREMENTS: Ten-meter timed walk test (TWT), BBS, Frenchay Activities Index (FAI), Falls Handicap Inventory (FHI), and European Quality of Life questionnaire (Euroqol) measured at 6, 12, and 24 weeks after intervention. RESULTS: The mean age +/- standard deviation of subjects was 82.7 +/- 5.6, and baseline characteristics were comparable between the groups. Both groups showed improvements in TWT (intervention: 22.5-16.5 seconds, P =.001; control: 20.5-15.8 seconds, P =.054), BBS (intervention: 33.3-42.7, P =.001; control: 33.4-42.0, P <.0001), FAI (18-21, P =.02 in both groups), FHI score (intervention: 31-17, P =.0001; control: 33-17, P =.0001) and Euroqol score (intervention: 58-65, P =.04; control: 60-65, P =.07). There were no intergroup differences at any time. More patients reported increased confidence in walking indoors (36% vs 28%; P =.04) and outdoors (27% vs 18%; P =.02) in the enhanced balance-training group. CONCLUSION: Exercise programs significantly improve balance and mobility in patients with balance problems, independent of strategy. Enhanced balance training may, in addition, improve confidence and quality of life but needs further investigation.