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Intervention Subjects (intervention + subject)
Selected AbstractsRandomized controlled trial of a brief intervention for problematic prescription drug use in non-treatment-seeking patientsADDICTION, Issue 1 2009Anne Zahradnik ABSTRACT Aims Dependence on or problematic use of prescription drugs (PD) is estimated to be between 1 and 2% in the general population. In contrast, the proportion of substance-specific treatment in PD use disorders at 0.5% is comparatively low. With an estimated prevalence of 4.7%, PD-specific disorders are widespread in general hospitals compared to the general population. Brief intervention delivered in general hospitals might be useful to promote discontinuation or reduction of problematic prescription drug use. Design A randomized, controlled clinical trial. Setting Internal, surgical and gynaecological wards of a general and a university hospital. Participants One hundred and twenty-six patients fulfilling criteria for either regular use of PD (more than 60 days within the last 3 months) or dependence on or abuse of PD, respectively, were allocated randomly to two conditions. Intervention Subjects received two counselling sessions based on Motivational Interviewing plus an individualized written feedback (intervention group, IG) or a booklet on health behaviour (control group, CG). Measurements The outcome was measured as reduction (>25%) and discontinuation of PD intake in terms of defined daily dosages (DDD). Findings After 3 months, more participants in the IG reduced their DDD compared to the participants in the CG (51.8% versus 30%; ,2 = 6.17; P = 0.017). In the IG 17.9%, in the CG 8.6% discontinued use of PD (,2 = 2.42; P = 0.17). Conclusions Brief intervention based on Motivational Interviewing is effective in reducing PD intake in non-treatment-seeking patients. [source] Kenosha County Falls Prevention Study: A Randomized, Controlled Trial of an Intermediate-Intensity, Community-Based Multifactorial Falls InterventionJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 4 2007Jane E. Mahoney MD OBJECTIVES: To decrease the rate of falls in high-risk community-dwelling older adults. DESIGN: Randomized, controlled trial. SETTING: Community-based. PARTICIPANTS: Three hundred forty-nine adults aged 65 and older with two falls in the previous year or one fall in the previous 2 years with injury or balance problems. INTERVENTION: Subjects received two in-home visits from a trained nurse or physical therapist who assessed falls risk factors using an algorithm. The intervention consisted of recommendations to the subject and their primary physician, referrals to physical therapy and other providers, 11 monthly telephone calls, and a balance exercise plan. Control subjects received a home safety assessment. MEASUREMENTS: The primary outcome was rate of falls per year in the community. Secondary outcomes included all-cause hospitalizations and nursing home admissions per year. RESULTS: There was no difference in rate of falls between the intervention and control groups (rate ratio (RR)=0.81, P=.27). Nursing home days were fewer in the intervention group (10.3 vs 20.5 days, P=.04). Intervention subjects with a Mini-Mental State Examination (MMSE) score of 27 or less had a lower rate of falls (RR=0.55; P=.05) and, if they lived with someone, had fewer hospitalizations (RR=0.44, P=.05), nursing home admissions (RR=0.15, P=.003), and nursing home days (7.5 vs 58.2, P=.008). CONCLUSION: This multifactorial intervention did not decrease falls in at-risk community-living adults but did decrease nursing home utilization. There was evidence of efficacy in the subgroup who had an MMSE score of 27 or less and lived with a caregiver, but validation is required. [source] Reducing Suicidal Ideation in Depressed Older Primary Care PatientsJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 10 2006Jürgen Unützer MD OBJECTIVES: To determine the effect of a primary care,based collaborative care program for depression on suicidal ideation in older adults. DESIGN: Randomized, controlled trial. SETTING: Eighteen diverse primary care clinics. PARTICIPANTS: One thousand eight hundred one adults aged 60 and older with major depression or dysthymia. INTERVENTION: Participants randomized to collaborative care had access to a depression care manager who supported antidepressant medication management prescribed by their primary care physician and offered a course of Problem Solving Treatment in Primary Care for 12 months. Participants in the control arm received care as usual. MEASUREMENTS: Participants had independent assessments of depression and suicidal ideation at baseline and 3, 6, 12, 18, and 24 months. Depression was assessed using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (SCID). Suicidal ideation was determined using the SCID and the Hopkins Symptoms Checklist. RESULTS: At baseline, 139 (15.3%) intervention subjects and 119 (13.3%) controls reported thoughts of suicide. Intervention subjects had significantly lower rates of suicidal ideation than controls at 6 months (7.5% vs 12.1%) and 12 months (9.8% vs 15.5%) and even after intervention resources were no longer available at 18 months (8.0% vs 13.3%) and 24 months (10.1% vs 13.9%). There were no completed suicides in either group. Information on suicide attempts or hospitalization for suicidal ideation was not available. CONCLUSION: Primary care,based collaborative care programs for depression represent one strategy to reduce suicidal ideation and potentially the risk of suicide in older primary care patients. [source] Multiple Imputation Methods for Treatment Noncompliance and Nonresponse in Randomized Clinical TrialsBIOMETRICS, Issue 1 2009L. Taylor Summary Randomized clinical trials are a powerful tool for investigating causal treatment effects, but in human trials there are oftentimes problems of noncompliance which standard analyses, such as the intention-to-treat or as-treated analysis, either ignore or incorporate in such a way that the resulting estimand is no longer a causal effect. One alternative to these analyses is the complier average causal effect (CACE) which estimates the average causal treatment effect among a subpopulation that would comply under any treatment assigned. We focus on the setting of a randomized clinical trial with crossover treatment noncompliance (e.g., control subjects could receive the intervention and intervention subjects could receive the control) and outcome nonresponse. In this article, we develop estimators for the CACE using multiple imputation methods, which have been successfully applied to a wide variety of missing data problems, but have not yet been applied to the potential outcomes setting of causal inference. Using simulated data we investigate the finite sample properties of these estimators as well as of competing procedures in a simple setting. Finally we illustrate our methods using a real randomized encouragement design study on the effectiveness of the influenza vaccine. [source] Effectiveness of educational materials designed to change knowledge and behaviors regarding crying and shaken-baby syndrome in mothers of newborns: a randomized, controlled trialCHILD: CARE, HEALTH AND DEVELOPMENT, Issue 4 2009Richard Reading Effectiveness of educational materials designed to change knowledge and behaviors regarding crying and shaken-baby syndrome in mothers of newborns: a randomized, controlled trial . BarrR. G., RivaraF. P., BarrM., CummingsP., TaylorJ., LenguaL. J. & Meredith-BenitzE. ( 2009 ) Pediatrics , 123 , 972 , 980 . DOI: 10.1542/peds.2008-0908 . Background Infant crying is an important precipitant for shaken-infant syndrome. Objective To determine if parent education materials [The Period of PURPLE Crying (PURPLE)] change maternal knowledge and behaviour relevant to infant shaking. Methods This study was a randomized, controlled trial conducted in prenatal classes, maternity wards and pediatric practices. There were 1374 mothers of newborns randomly assigned to the PURPLE intervention and 1364 mothers to the control group. Primary outcomes were measured by telephone 2 months after delivery. These included two knowledge scales about crying and the dangers of shaking; three scales about behavioural responses to crying generally and to unsoothable crying, and caregiver self-talk in response to unsoothable crying; and three questions concerning the behaviours of sharing of information with others about crying, walking away if frustrated and the dangers of shaking. Results The mean infant crying knowledge score was greater in the intervention group (69.5) compared with controls (63.3). Mean shaking knowledge was greater for intervention subjects (84.8) compared with controls (83.5). For reported maternal behavioural responses to crying generally, responses to unsoothable crying, and for self-talk responses, mean scores for intervention mothers were similar to those for controls. For the behaviours of information sharing, more intervention mothers reported sharing information about walking away if frustrated and the dangers of shaking, but there was little difference in sharing information about infant crying. Intervention mothers also reported increased infant distress. Conclusions Use of the PURPLE education materials seem to lead to higher scores in knowledge about early infant crying and the dangers of shaking, and in sharing of information behaviours considered to be important for the prevention of shaking. [source] | ||||||||||