263 resultados para Controlled-trial
Resumo:
Background Broad community access to high quality evidence-based primary mental health care is an ongoing challenge around the world. In Australia one approach has been to broaden access to care by funding psychologists and other allied health care professionals to deliver brief psychological treatments to general practitioners' patients. To date, there has been a scarcity of studies assessing the efficacy of social worker delivered psychological strategies. This study aims to build the evidence base by evaluating the impact of a brief educational intervention on social workers' competence in delivering cognitive behavioural strategies (strategies derived from cognitive behavioural therapy). Methods A randomised controlled trial design was undertaken with baseline and one-week follow-up measurement of both objective and self-perceived competence. Simulated consultations with standardised depressed patients were recorded on videotape and objective competence was assessed by blinded reviewers using the Cognitive Therapy Scale. Questionnaires completed by participants were used to measure self-perceived competence. The training intervention was a 15 hour face-to-face course involving presentations, video example consultations, written materials and rehearsal of skills in pairs. Results 40 Melbourne-based (Australia) social workers enrolled and were randomised and 9 of these withdrew from the study before the pre training simulated consultation. 30 of the remaining 31 social workers (97%) completed all phases of the intervention and evaluation protocol (16 from intervention and 14 from control group). The intervention group showed significantly greater improvements than the control group in objective competence (mean improvement of 14.2 (7.38-21.02) on the 66 point Cognitive Therapy Scale) and in subjective confidence (mean improvement of 1.28 (0.84-1.72) on a 5 point Likert scale). On average, the intervention group improved from below to above the base competency threshold on the Cognitive Therapy Scale whilst the control group remained below. Conclusions Social workers can attain significant improvements in competency in delivering cognitive behavioural strategies from undertaking brief face to face training. This is relevant in the context of health reforms that involve social worker delivery of evidence based psychological care. Further research is required to assess how these improvements in competence translate into performance in practice and clinical outcomes for patients.
Resumo:
Background
Many inpatients receive little or no rehabilitation on weekends. Our aim was to determine what effect providing additional Saturday rehabilitation during inpatient rehabilitation had on functional independence, quality of life and length of stay compared to 5 days per week of rehabilitation.
Methods
This was a multicenter, single-blind (assessors) randomized controlled trial with concealed allocation and 12-month follow-up conducted in two publically funded metropolitan inpatient rehabilitation facilities in Melbourne, Australia. Patients were eligible if they were adults (aged ≥18 years) admitted for rehabilitation for any orthopedic, neurological or other disabling conditions excluding those admitted for slow stream rehabilitation/geriatric evaluation and management. Participants were randomly allocated to usual care Monday to Friday rehabilitation (control) or to Monday to Saturday rehabilitation (intervention). The additional Saturday rehabilitation comprised physiotherapy and occupational therapy. The primary outcomes were functional independence (functional independence measure (FIM); measured on an 18 to 126 point scale), health-related quality of life (EQ-5D utility index; measured on a 0 to 1 scale, and EQ-5D visual analog scale; measured on a 0 to 100 scale), and patient length of stay. Outcome measures were assessed on admission, discharge (primary endpoint), and at 6 and 12 months post discharge.
Results
We randomly assigned 996 adults (mean (SD) age 74 (13) years) to Monday to Saturday rehabilitation (n = 496) or usual care Monday to Friday rehabilitation (n = 500). Relative to admission scores, intervention group participants had higher functional independence (mean difference (MD) 2.3, 95% confidence interval (CI) 0.5 to 4.1, P = 0.01) and health-related quality of life (MD 0.04, 95% CI 0.01 to 0.07, P = 0.009) on discharge and may have had a shorter length of stay by 2 days (95% CI 0 to 4, P = 0.1) when compared to control group participants. Intervention group participants were 17% more likely to have achieved a clinically significant change in functional independence of 22 FIM points or more (risk ratio (RR) 1.17, 95% CI 1.03 to 1.34) and 18% more likely to have achieved a clinically significant change in health-related quality of life (RR 1.18, 95% CI 1.04 to 1.34) on discharge compared to the control group. There was some maintenance of effect for functional independence and health-related quality of life at 6-month follow-up but not at 12-month follow-up. There was no difference in the number of adverse events between the groups (incidence rate ratio = 0.81, 95% CI 0.61 to 1.08).
Conclusions
Providing an additional day of rehabilitation improved functional independence and health-related quality of life at discharge and may have reduced length of stay for patients receiving inpatient rehabilitation.
Resumo:
Letter to the editor: Harris and colleagues report failure to obtain reduction in several important risk factor-based intermediate outcomes for vascular disease from their lifestyle intervention in the Health Improvement and Prevention Study (HIPS).1 Using intention-to-treat analysis, if only 117 of 384 participants completed at least two of six group sessions, a positive result could not be expected. We know that interventions for prevention of cardiovascular disease (CVD) and diabetes can be run successfully in Australian primary care, which raises questions about the design of Harris et al’s intervention.
Resumo:
Objective:
Method:
A cluster randomized controlled design was used to compare the referral rates for residents in seven facilities randomly allocated into one of three conditions: staff training, staff training plus a screening and referral protocol and wait-list control. Participants were 216 aged care residents (M age = 87 years), who agreed to a 12-month audit of their facility file.
Results:
Staff training on its own did not increase the rate of referrals for depression; however, staff training plus the screening protocol and referral guidelines did lead to a significant increase in the number of residents who were referred to a medical practitioner for further assessment. However, this increase in care staff referrals did not result in substantial changes in the treatment prescribed for residents.
Conclusion:
Staff training in depression, supplemented with a protocol for routine screening and guidelines on referring residents, can improve pathways to care. However, strategies to overcome barriers to appropriate subsequent treatment of depression are required for staff-focused initiatives to translate into better outcomes for depressed older adults. Methodological limitations of this study are discussed.
Resumo:
Background/Objectives:
Invasive procedures such as surgery cause immunosuppression, leading to increased risk of complications, infections and extended hospital stay. Emerging research around immune-enhancing nutrition supplements and their ability to reduce postoperative complications and reduce treatment costs is promising. This randomised controlled trial aims to examine the effect of preoperative immunonutrition supplementation on length of hospital stay (LOS), complications and treatment costs in both well-nourished and malnourished gastrointestinal surgery patients.
Subjects/Methods:
Ninety-five patients undergoing elective upper and lower gastrointestinal surgery were recruited. The treatment group (n=46) received a commercial immuno-enhancing supplement 5 days preoperatively. The control group (n=49) received no supplements. The primary outcome measure was LOS, and secondary outcome measures included complications and cost.
Results:
A nonsignificant trend towards a shorter LOS within the treatment group was observed (7.1±4.1 compared with 8.8±6.5 days; P=0.11). For malnourished patients, this trend was greater with hospital stay reduced by 4 days (8.3±3.5 vs 12.3±9.5 days; P=0.21). Complications and unplanned intensive care admission rates were very low in both the groups. The average admission cost was reduced by AUD1576 in the treatment group compared with the control group (P=0.37).
Conclusions:
Preoperative immunonutrition therapy in gastrointestinal surgery has the potential to reduce the LOS and cost, with greater treatment benefit seen in malnourished patients; however, there is a need for additional research with greater patient numbers.
Resumo:
Background:
Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals.
Methods/Design:
The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups.
Discussion:
This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population.
Resumo:
Introduction:
Methods and analysis:
The proposed three-group, parallel, randomised controlled trial will recruit patients diagnosed in the past 4 months with breast, prostate, colorectal cancer or melanoma through their treating clinician. Patients and their partners will be randomised to (1) a minimal ethical care (MEC) condition—selected Cancer Council New South Wales booklets and a brochure for the Cancer Council Helpline, (2) Coping-Together generic—MEC materials, the six Coping-Together booklets and DVD, the Cancer Council Queensland relaxation audio CD and login to the Coping-Together website or (3) Coping-Together tailored—MEC materials, the Coping-Together DVD, the login to the website and only those Coping-Together booklet sections that pertain to their direct concerns. Anxiety (primary outcome), distress, depression, dyadic adjustment, quality of life, illness or caregiving appraisal, self-efficacy and dyadic and individual coping will be assessed before receiving the study material (ie, baseline) and again at 3, 6 and 12 months postbaseline. Intention-to-treat and per protocol analysis will be conducted.
Ethics and dissemination:
This study has been approved by the relevant local area health and University ethics committees. Study findings will be disseminated not only through peer-reviewed publications and conference presentations but also through educational outreach visits, publication of lay research summaries in consumer newsletters and publications targeting clinicians.
Resumo:
Aim
To determine the effect of parent education on adaptive behaviour, autism symptoms and cognitive/language skills of young children with autistic disorder.
Method
A randomised group comparison design involving a parent education and counselling intervention and a parent education and behaviour management intervention to control for parent skills training and a control sample. Two rural and two metropolitan regions were randomly allocated to intervention groups (n = 70) or control (n = 35). Parents from autism assessment services in the intervention regions were randomly allocated to parent education and behaviour management (n = 35) or parent education and counselling (n = 35).
Results
Parent education and behaviour management resulted in significant improvement in adaptive behaviour and autism symptoms at 6 months follow-up for children with greater delays in adaptive behaviour. Parent education and behaviour management was superior to parent education and counselling. We conclude that a 20-week parent education programme including skills training for parents of young children with autistic disorder provides significant improvements in child adaptive behaviour and symptoms of autism for low-functioning children.
Resumo:
Background
Methods
Transform-Us! is a clustered randomised school-based intervention with four groups: sedentary behaviour intervention (SB-I), PA intervention (PA-I), combined PA+SB-I and control group. All children in grade 3 from 20 participating primary schools in Melbourne, Australia were eligible to complete annual evaluation assessments. The outcomes were the proportion of time spent in moderate-to-vigorous PA (MVPA) and light PA (LPA) during recess and lunchtime assessed by accelerometers. Potential mediators included: perceived social support from teachers; perceived availability of line markings; perceived accessibility of sports equipment; and perceived school play environment. Generalised linear models were used and mediation effects were estimated by product-of-coefficients (a·b) approach.
Results
268 children (8.2 years, 57% girls at baseline) provided complete data at both time points. A significant intervention effect on MVPA during recess in the SB-I and PA-I groups compared with the control group (proportional difference in MVPA time; 38% (95% CI 21% to 57%) and 40% (95% CI 20% to 62%), respectively) was found. The perceived school play environment was significantly positively associated with MVPA at recess among girls. An increase in perceived social support from teachers suppressed the PA+SB-I effect on light PA during recess (a·b= −0.03, 95% CI −0.06 to −0.00). No significant mediating effects on PA during recess and lunchtime were observed.
Conclusions
A positive perception of the school play environment was associated with higher MVPA during recess among girls. Future studies should conduct mediation analyses to explore underlying mechanisms of PA interventions.
Resumo:
Background
There is increasing community and government recognition of the magnitude and impact of adolescent depression. Family based interventions have significant potential to address known risk factors for adolescent depression and could be an effective way of engaging adolescents in treatment. The evidence for family based treatments of adolescent depression is not well developed. The objective of this clinical trial is to determine whether a family based intervention can reduce rates of unipolar depressive disorders in adolescents, improve family functioning and engage adolescents who are reluctant to access mental health services.
Methods/Design
The Family Options study will determine whether a manualized family based intervention designed to target both individual and family based factors in adolescent depression (BEST MOOD) will be more effective in reducing unipolar depressive disorders than an active (standard practice) control condition consisting of a parenting group using supportive techniques (PAST). The study is a multicenter effectiveness randomized controlled trial. Both interventions are delivered in group format over eight weekly sessions, of two hours per session. We will recruit 160 adolescents (12 to 18 years old) and their families, randomized equally to each treatment condition. Participants will be assessed at baseline, eight weeks and 20 weeks. Assessment of eligibility and primary outcome will be conducted using the KID-SCID structured clinical interview via adolescent and parent self-report. Assessments of family mental health, functioning and therapeutic processes will also be conducted. Data will be analyzed using Multilevel Mixed Modeling accounting for time x treatment effects and random effects for group and family characteristics. This trial is currently recruiting. Challenges in design and implementation to-date are discussed. These include diagnosis and differential diagnosis of mental disorders in the context of adolescent development, non-compliance of adolescents with requirements of assessment, questionnaire completion and treatment attendance, breaking randomization, and measuring the complexity of change in the context of a family-based intervention.
Resumo:
Background
Depression is a common affliction for young adults, and is associated with a range of adverse outcomes. Cognitive-reminiscence therapy is a brief, structured intervention that has been shown to be highly effective for reducing depressive symptoms, yet to date has not been evaluated in young adult populations. Given its basis in theory-guided reminiscence-based therapy, and incorporation of effective therapeutic techniques drawn from cognitive therapy and problem-solving frameworks, it is hypothesized to be effective in treating depression in this age group.
Methods and design
This article presents the design of a randomized controlled trial implemented in a community-based youth mental health service to compare cognitive-reminiscence therapy with usual care for the treatment of depressive symptoms in young adults. Participants in the cognitive-reminiscence group will receive six sessions of weekly, individual psychotherapy, whilst participants in the usual-care group will receive support from the youth mental health service according to usual procedures. A between-within repeated-measures design will be used to evaluate changes in self-reported outcome measures of depressive symptoms, psychological wellbeing and anxiety across baseline, three weeks into the intervention, post-intervention, one month post-intervention and three months post-intervention. Interviews will also be conducted with participants from the cognitive-reminiscence group to collect information about their experience receiving the intervention, and the process underlying any changes that occur.
Discussion
This study will determine whether a therapeutic approach to depression that has been shown to be effective in older adult populations is also effective for young adults. The expected outcome of this study is the validation of a brief, evidence-based, manualized treatment for young adults with depressive symptoms.
Resumo:
Background Osteoporosis is a debilitating disease and its risk can be reduced through adequate calcium consumption and physical activity. This protocol paper describes a workplace-based intervention targeting behaviour change in premenopausal women working in sedentary occupations. Method/Design A cluster-randomised design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the clusters and units of randomisation and intervention. Sample size calculations incorporated the cluster design. Final number of clusters was determined to be 16, based on a cluster size of 20 and calcium intake parameters (effect size 250 mg, ICC 0.5 and standard deviation 290 mg) as it required the highest number of clusters. Sixteen workplaces were recruited from a pool of 97 workplaces and randomly assigned to intervention and control arms (eight in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organisation wide educational activities. Workplaces in the control/standard care arm received print resources. Intervention workshops were guided by self-efficacy theory and included participatory activities such as goal setting, problem solving, local food sampling, exercise trials, group discussion and behaviour feedback. Outcomes measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, four weeks and six months post intervention. Discussion This study addresses the current lack of evidence for behaviour change interventions focussing on osteoporosis prevention. It addresses missed opportunities of using workplaces as a platform to target high-risk individuals with sedentary occupations. The intervention was designed to modify behaviour levels to bring about risk reduction. It is the first to address dietary and physical activity components each with unique intervention strategies in the context of osteoporosis prevention. The intervention used locally relevant behavioural strategies previously shown to support good outcomes in other countries. The combination of these elements have not been incorporated in similar studies in the past, supporting the study hypothesis that the intervention will be more efficacious than standard practice in osteoporosis prevention through improvements in calcium intake and physical activity.
