908 resultados para Randomised control trial


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 Background
Provision of high quality transitional care is a challenge for health care providers in many western countries. This systematic review was conducted to (1) identify and synthesise research, using randomised control trial designs, on the quality of transitional care interventions compared with standard hospital discharge for older people with chronic illnesses, and (2) make recommendations for research and practice.

Methods

Eight databases were searched; CINAHL, Psychinfo, Medline, Proquest, Academic Search Complete, Masterfile Premier, SocIndex, Humanities and Social Sciences Collection, in addition to the Cochrane Collaboration, Joanna Briggs Institute and Google Scholar. Results were screened to identify peer reviewed journal articles reporting analysis of quality indicator outcomes in relation to a transitional care intervention involving discharge care in hospital and follow-up support in the home. Studies were limited to those published between January 1990 and May 2013. Study participants included people 60 years of age or older living in their own homes who were undergoing care transitions from hospital to home. Data relating to study characteristics and research findings were extracted from the included articles. Two reviewers independently assessed studies for risk of bias.

Results
Twelve articles met the inclusion criteria. Transitional care interventions reported in most studies reduced re-hospitalizations, with the exception of general practitioner and primary care nurse models. All 12 studies included outcome measures of re-hospitalization and length of stay indicating a quality focus on effectiveness, efficiency, and safety/risk. Patient satisfaction was assessed in six of the 12 studies and was mostly found to be high. Other outcomes reflecting person and family centred care were limited including those pertaining to the patient and carer experience, carer burden and support, and emotional support for older people and their carers. Limited outcome measures were reported reflecting timeliness, equity, efficiencies for community providers, and symptom management.

Conclusions
Gaps in the evidence base were apparent in the quality domains of timeliness, equity, efficiencies for community providers, effectiveness/symptom management, and domains of person and family centred care. Further research that involves the person and their family/caregiver in transitional care interventions is needed.

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BACKGROUND: While it is common for an economic evaluation of health care to rely on trial participants for self-reported health service utilisation, there is variability in the accuracy of this data due to potential recall bias. The aim of this study was to quantify the level of recall bias in self-reported primary health care general practitioner (GP) visits following inpatient rehabilitation over a 12 month period.

METHODS: This report is a secondary analysis from a larger randomised control trial of an economic evaluation of additional Saturday inpatient rehabilitation. Participants were adults who had been discharged into the community following admission to an acute general rehabilitation hospital. Participants were asked to recall primary health care visits, including community GP visits, via a telephone questionnaire which was administered at 6 and 12 months following discharge from inpatient rehabilitation. Participants were asked to recall health service utilisation over each preceding 6 month period. The self-reported data were compared to equivalent claims data from the national insurer, over the same period.

RESULTS: 751 participants (75% of the full trial) with a mean age of 74 years (SD 13) were included in this analysis. Over the 12 month period following discharge from rehabilitation there was an under-reporting of 14% in self-reported health service utilisation for GP visits compared to national insurer claims data over the same period. From 0 to 6 months following discharge from rehabilitation, there was an over-reporting of self-reported GP visits of 35% and from 7 to 12 months there was an under-reporting of self-reported GP visits of 36%, compared to national insurer claims data over the same period. 46% of patients reported the same or one number difference in self-reported GP visits between the 0 to 6 and the 7 to 12 month periods.

CONCLUSION: Based on these findings we recommend that an economic evaluation alongside a clinical trial for an elderly adult rehabilitation population include a sensitivity analysis that inflates self-reported GP visits by 16% over 12 months. However caution is required when utilising self-reported GP visits as the data may contain periods of both over and under reporting. Where general practitioner visits are expected to vary significantly between intervention and control groups we recommend that administrative data be included in the trial to accurately capture resources for an economic evaluation.

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Background: Food allergy affects quality of life in patients and parents and mothers report high levels of anxiety and stress. Cognitive Behaviour Therapy (CBT) may be helpful in reducing the psychological impact of food allergy. The aim of this study was to examine the appropriateness and effectiveness of CBT to improve psychological outcomes in parents of children with food allergy. Methods: Five parents (all mothers) from a local allergy clinic requested to have CBT; six mothers acted as controls and completed questionnaires only. CBT was individual and face-to face and lasted 12 weeks. All participants completed measures of anxiety and depression, worry, stress, general mental health, generic and food allergy specific quality of life at baseline and at 12 weeks. Results: Anxiety, depression and worry in the CBT group significantly reduced and overall mental health and QoL significantly improved from baseline to 12 weeks (all p < 0.05) in mothers in the CBT group; control group scores remained stable. Conclusions: CBT appears to be appropriate and effective in mothers of children with food allergy and a larger randomised control trial now needs to be conducted. Ways in which aspects of CBT can be incorporated into allergy clinic visits need investigation.

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This article describes the process and results of a Randomized Controlled Trial (RCT) on teachers' ability to manage the emotions of preschool children during a constrained play activity. Thirty early childhood education teachers participated in the study. Half of the participants were taught strategies to enhance their own emotional competence. The control group was provided with standard information on child development. The experimental group was trained in active strategies on emotion coaching, emotional schemas, reflective practice focused on emotions, and mindfulness training. The teachers' outcomes were assessed in situ during a pretend play session with small groups of preschoolers. The dependent variables were observed occurrences of different components of emotional competence in teachers. Significant statistical differences were found between the two groups across the three different emotional competence skills (regulation, expression, and knowledge) demonstrated by the early childhood teachers during a game situation. This experimental study highlights the processes through which teachers support the emotional competence of young children, and the importance of the role of early childhood teachers' own emotional competence on the socialisation of children's emotions. Most importantly, it provides evidence, based on the influence of emotion-focused teacher-training and reflective practices, that teachers' emotional skills should be supported such that they can optimally meet the emotional needs of young children.

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Background: Adolescents suffer daytime consequences from sleep loss. Sleep education programs have been developed in an attempt to increase sleep knowledge and/or duration. This paper presents data from three trials of the Aus-tralian Centre for Education in Sleep (ACES) program for adolescents.

Methods: The ACES program was delivered to 69 Australian adolescents in a pre-post cross-sectional design (mean age 15.2) and 29 New Zealand adolescents in a randomised control trial (mean age 14.8 years). Assessments in sleep parame-ters were undertaken at baseline and post intervention.

Results: Where sleep knowledge was evaluated (Australian trials), significant improvements were shown in all trials (All p <0.05). Where sleep duration was assessed (New Zealand trial) significant improvements were found in week and weekend sleep duration [F(1, 27)=4.26, p=0.04). Both, students and teachers found the program feasible, interesting, and educational.

Conclusions: ACES sleep education programmes can improve both sleep knowledge and sleep duration in adolescents. Improving the programme so sleep knowledge attained equates to actual sleep behaviour change are areas for future direc-tion. Collectively these findings provide encouraging signs that adolescents can improve their sleep knowledge and behav-iour with sleep education which bodes well for sleep-related health and psycho-social issues.

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AIMS: School-based psychological interventions encompass: universal interventions targeting youth in the general population; and indicated interventions targeting youth with subthreshold depression. This study aimed to: (1) examine the population cost-effectiveness of delivering universal and indicated prevention interventions to youth in the population aged 11-17 years via primary and secondary schools in Australia; and (2) compare the comparative cost-effectiveness of delivering these interventions using face-to-face and internet-based delivery mechanisms. METHODS: We reviewed literature on the prevention of depression to identify all interventions targeting youth that would be suitable for implementation in Australia and had evidence of efficacy to support analysis. From this, we found evidence of effectiveness for the following intervention types: universal prevention involving group-based psychological interventions delivered to all participating school students; and indicated prevention involving group-based psychological interventions delivered to students with subthreshold depression. We constructed a Markov model to assess the cost-effectiveness of delivering universal and indicated interventions in the population relative to a 'no intervention' comparator over a 10-year time horizon. A disease model was used to simulate epidemiological transitions between three health states (i.e., healthy, diseased and dead). Intervention effect sizes were based on meta-analyses of randomised control trial data identified in the aforementioned review; while health benefits were measured as Disability-adjusted Life Years (DALYs) averted attributable to reductions in depression incidence. Net costs of delivering interventions were calculated using relevant Australian data. Uncertainty and sensitivity analyses were conducted to test model assumptions. Incremental cost-effectiveness ratios (ICERs) were measured in 2013 Australian dollars per DALY averted; with costs and benefits discounted at 3%. RESULTS: Universal and indicated psychological interventions delivered through face-to-face modalities had ICERs below a threshold of $50 000 per DALY averted. That is, $7350 per DALY averted (95% uncertainty interval (UI): dominates - 23 070) for universal prevention, and $19 550 per DALY averted (95% UI: 3081-56 713) for indicated prevention. Baseline ICERs were generally robust to changes in model assumptions. We conducted a sensitivity analysis which found that internet-delivered prevention interventions were highly cost-effective when assuming intervention effect sizes of 100 and 50% relative to effect sizes observed for face-to-face delivered interventions. These results should, however, be interpreted with caution due to the paucity of data. CONCLUSIONS: School-based psychological interventions appear to be cost-effective. However, realising efficiency gains in the population is ultimately dependent on ensuring successful system-level implementation.

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Background: Stroke prevention in atrial fibrillation (AF), most commonly with warfarin, requires maintenance of a narrow therapeutic target (INR 2.0 to 3.0) and is often poorly controlled in practice. Poor patient-understanding surrounding AF and its’ treatment may contribute to patient’s willingness to adhere to recommendations. Method: A theory-driven intervention, developed using patient interviews and focus groups, consisting of a one-off group session (1-6 patients) utilising an ‘expert-patient’ focussed DVD, educational booklet, self-monitoring diary and worksheet, was compared in a randomised controlled trial (ISRCTN93952605) against usual care, with patient postal follow-ups at 1, 2, 6, and 12-months. Ninety-seven warfarin-naïve AF patients were randomised to intervention (n=46, mean age (SD) 72.0 (8.2), 67.4% men), or usual care (n=51, mean age (SD) 73.7 (8.1), 62.7% men), stratified by age, sex, and recruitment centre. Primary endpoint was time within therapeutic range (TTR); secondary endpoints included knowledge, quality of life, anxiety/depression, beliefs about medication, and illness perceptions. Main findings: Intervention patients had significantly higher TTR than usual care at 6-months (76.2% vs. 71.3%; p=0.035); at 12-months these differences were not significant (76.0% vs. 70.0%; p=0.44). Knowledge increased significantly across time (F (3, 47) = 6.4; p<0.01), but there were no differences between groups (F (1, 47) = 3.3; p = 0.07). At 6-months, knowledge scores predicted TTR (r=0.245; p=0.04). Patients’ scores on subscales representing their perception of the general harm and overuse of medication, as well as the perceived necessity of their AF specific medications predicted TTR at 6- and 12-months. Conclusions: A theory-driven educational intervention significantly improves TTR in AF patients initiating warfarin during the first 6-months. Adverse clinical outcomes may potentially be reduced by improving patients’ understanding of the necessity of warfarin and reducing their perception of treatment harm. Improving education provision for AF patients is essential to ensure efficacious and safe treatment.

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Objectives This randomised, controlled trial compared the effectiveness of 0.12% chlorhexidine (CHX) gel and 304% fluoride toothpaste to prevent early childhood caries (ECC) in a birth cohort by 24 months. Methods The participants were randomised to receive either (i) twice daily toothbrushing with toothpaste and once daily 0.12% CHX gel (n = 110) or (ii) twice daily toothbrushing with toothpaste only (study controls) (n = 89). The primary outcome measured was caries incidence and the secondary outcome was percentage of children with mutans streptococci (MS). All mothers were contacted by telephone at 6, 12, and 18 months. At 24 months, all children were examined at a community dental clinic. Results At 24 months, the caries prevalence was 5% (3/61) in the CHX and 7% (4/58) in the controls (P = 0.7). There were no differences in percentages of MS-positive children between the CHX and control groups (54%vs 53%). Only 20% applied the CHX gel once daily and 80% less than once daily. Conclusions Toothbrushing using 304% fluoride toothpaste with or without the application of chlorhexidine gel (0.12%) reduces ECC from 23% found in the general community to 5–7%. The lack of effect with chlorhexidine is likely to be due to low compliance.

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Background Malnutrition is common in patients with advanced epithelial ovarian cancer (EOC), and is associated with impaired quality of life (QoL), longer hospital stay and higher risk of treatment-related adverse events. This phase III multi-centre randomised clinical trial tested early enteral feeding versus standard care on postoperative QoL. Methods From 2009 to 2013, 109 patients requiring surgery for suspected advanced EOC, moderately to severely malnourished were enrolled at five sites across Queensland and randomised to intervention (n = 53) or control (n = 56) groups. Intervention involved intraoperative nasojejunal tube placement and enteral feeding until adequate oral intake could be maintained. Despite being randomised to intervention, 20 patients did not receive feeds (13 did not receive the feeding tube; 7 had it removed early). Control involved postoperative diet as tolerated. QoL was measured at baseline, 6 weeks postoperatively and 30 days after the third cycle of chemotherapy. The primary outcome measure was the difference in QoL between the intervention and the control group. Secondary endpoints included treatment-related adverse event occurrence, length of stay, postoperative services use, and nutritional status. Results Baseline characteristics were comparable between treatment groups. No significant difference in QoL was found between the groups at any time point. There was a trend towards better nutritional status in patients who received the intervention but the differences did not reach statistical significance except for the intention-to-treat analysis at 7 days postoperatively (11.8 intervention vs. 13.8 control, p 0.04). Conclusion Early enteral feeding did not significantly improve patients' QoL compared to standard of care but may improve nutritional status.

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Background: Inadequate fruit and vegetable consumption in childhood increases the risk of developing chronic disease. Despite this, a substantial proportion of children in developed nations, including Australia, do not consume sufficient quantities of fruits and vegetables. Parents are influential in the development of dietary habits of young children but often lack the necessary knowledge and skills to promote healthy eating in their children. The aim of this study is to assess the efficacy of a telephone-based intervention for parents to increase the fruit and vegetable consumption of their 3- to 5-year-old children.
Methods/Design: The study, conducted in the Hunter region of New South Wales, Australia, employs a cluster randomised controlled trial design. Two hundred parents from 15 randomly selected preschools will be randomised to receive the intervention, which consists of print resources and four weekly 30-minute telephone support calls delivered by trained telephone interviewers. The calls will assist parents to increase the availability and accessibility of fruit and vegetables in the home, create supportive family eating routines and role-model fruit and vegetable consumption. A further two hundred parents will be randomly allocated to the control group and will receive printed nutrition information only. The primary outcome of the trial will be the change in the child's consumption of fruit and vegetables as measured by the fruit and vegetable subscale of the Children's Dietary Questionnaire. Pre-intervention and post-intervention parent surveys will be administered over the telephone. Baseline surveys will occur one to two
weeks prior to intervention delivery, with follow-up data collection calls occurring two, six, 12 and 18 months following baseline data collection.
Discussion: If effective, this telephone-based intervention may represent a promising public health strategy to increase fruit and vegetable consumption in childhood and reduce the risk of subsequent chronic disease.
Trial registration: Australian Clinical Trials Registry ACTRN12609000820202

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Objectives:
To determine the effectiveness of 
collaborative care in reducing depression in primary care patients with diabetes or heart disease using practice nurses as case managers.

Design:
A two-arm open randomised cluster trial with wait-list control for 6 months. The intervention was followed over 12 months.
Setting:
Eleven Australian general practices, five randomly allocated to the intervention and six to the control.
Participants:
400 primary care patients (206 intervention, 194 control) with depression and type 2 diabetes, coronary heart disease or both.
Intervention:
The practice nurse acted as a case manager identifying depression, reviewing pathology results, lifestyle risk factors and patient goals and priorities. Usual care continued in the controls.
Main outcome measure:
A five-point reduction in depression scores for patients with moderate-to-severe depression. Secondary outcome was improvements in physiological measures.
Results:
Mean depression scores after 6 months of intervention for patients with moderate-to-severe depression decreased by 5.7±1.3 compared with 4.3±1.2 in control, a significant (p=0.012) difference. (The plus–minus is the 95% confidence range) Intervention practices demonstrated adherence to treatment guidelines and intensification of treatment for depression, where exercise increased by 19%, referrals to exercise programmes by 16%, referrals to mental health workers (MHWs) by 7% and visits to MHWs by 17%. Control-practice exercise did not change, whereas referrals to exercise programmes dropped by 5% and visits to MHWs by 3%. Only referrals to MHW increased by 12%. Intervention improvements were sustained over 12 months, with a significant (p=0.015) decrease in 10-year cardiovascular disease risk from 27.4±3.4% to 24.8±3.8%. A review of patients indicated that the study’s safety protocols were followed.
Conclusions:
TrueBlue participants showed significantly improved depression and treatment intensification, sustained over 12 months of intervention and reduced 10-year cardiovascular disease risk. Collaborative care using practice nurses appears to be an effective primary care intervention.

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Background

Cardiovascular disease accounts for a large burden of disease, but is amenable to prevention through lifestyle modification. This paper examines patient and practice predictors of referral to a lifestyle modification program (LMP) offered as part of a cluster randomised controlled trial (RCT) of prevention of vascular disease in primary care.

Methods

Data from the intervention arm of a cluster RCT which recruited 36 practices through two rural and three urban primary care organisations were used. In each practice, 160 eligible high risk patients were invited to participate. Practices were randomly allocated to intervention or control groups. Intervention practice staff were trained in screening, motivational interviewing and counselling and encouraged to refer high risk patients to a LMP involving individual and group sessions. Data include patient surveys; clinical audit; practice survey on capacity for preventive care; referral records from the LMP. Predictors of referral were examined using multi-level logistic regression modelling after adjustment for confounding factors.

Results

Of 301 eligible patients, 190 (63.1%) were referred to the LMP. Independent predictors of referral were baseline BMI ≥ 25 (OR 2.87 95%CI:1.10, 7.47), physical inactivity (OR 2.90 95%CI:1.36,6.14), contemplation/preparation/action stage of change for physical activity (OR 2.75 95%CI:1.07, 7.03), rural location (OR 12.50 95%CI:1.43, 109.7) and smaller practice size (1–3 GPs) (OR 16.05 95%CI:2.74, 94.24).

Conclusions

Providing a well-structured evidence-based lifestyle intervention, free of charge to patients, with coordination and support for referral processes resulted in over 60% of participating high risk patients being referred for disease prevention. Contrary to expectations, referrals were more frequent from rural and smaller practices suggesting that these practices may be more ready to engage with these programs.

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BACKGROUND There is little information on the interaction between magnesium sulphate (MgSO4) and rocuronium in elderly patients. With a growing number of older patients who need surgical procedures, it is increasingly important to study this age group. OBJECTIVE To evaluate the effects of MgSO4 administration on the pharmacodynamics of rocuronium in patients aged 60 years or older. DESIGN A randomised controlled trial. SETTING A tertiary care hospital. PATIENTS Sixty-four patients, aged 60 years or older, American Society of Anesthesiologists (ASA) physical status classes I to III, scheduled for elective oncological head and neck surgery. Exclusion criteria were severe renal insufficiency (calculated creatinine clearance <30 ml min-1), preoperatorive serum magnesium concentration of more than 1.25 mmol l1 and patients receiving drugs known to affect neuromuscular function. INTERVENTIONS Patients were randomly allocated to one of two groups: in the magnesium group, patients received MgSO4 30mgkg1 intravenously, for 10 min, and then a continuous intravenous infusion at a rate of 1 g h-1. The control group received the same volume of physiological saline. Neuromuscular function was evaluated continuously in both groups. MAIN OUTCOME MEASURES Total recovery time was the primary outcome. Onset time, clinical duration, recovery index and recovery time were considered as secondary endpoints. Values are given as mean [SD]. RESULTS Total recovery time from neuromuscular block (NMB) was 113 [36] min in the magnesium group and 101 [39] min in the control group. Clinical duration was 69 [23] min in the magnesium group and 59 [28] min in the control group. Recovery index was 19 [36] min in the magnesium group and 17 [6] min in the control group. Recovery timewas 44 [22] min in the magnesium group and 42 [18] min in the control group. There were no statistically significant differences between the groups in any of the recovery indices. In the magnesium group, the mean onset time was 144 [58] s, significantly shorter than the onset time in the group that received physiological saline, which was 187 [90] s (P-0.03). Group variances were compared using an F test: onset time varied significantly less in the magnesium group (P-0.02). CONCLUSION In oncology patients of 60 or more years of age, preadministration of MgSO4, with the doses used in this study, significantly reduced the onset time of NMB induced by rocuronium. © 2013 European Society of Anaesthesiology.

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BACKGROUND Prostate cancer (PCa) is the second most common disease among men worldwide. It is important to know survival outcomes and prognostic factors for this disease. Recruitment for the largest therapeutic randomised controlled trial in PCa-the Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: A Multi-Stage Multi-Arm Randomised Controlled Trial (STAMPEDE)-includes men with newly diagnosed metastatic PCa who are commencing long-term androgen deprivation therapy (ADT); the control arm provides valuable data for a prospective cohort. OBJECTIVE Describe survival outcomes, along with current treatment standards and factors associated with prognosis, to inform future trial design in this patient group. DESIGN, SETTING, AND PARTICIPANTS STAMPEDE trial control arm comprising men newly diagnosed with M1 disease who were recruited between October 2005 and January 2014. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Overall survival (OS) and failure-free survival (FFS) were reported by primary disease characteristics using Kaplan-Meier methods. Hazard ratios and 95% confidence intervals (CIs) were derived from multivariate Cox models. RESULTS AND LIMITATIONS A cohort of 917 men with newly diagnosed M1 disease was recruited to the control arm in the specified interval. Median follow-up was 20 mo. Median age at randomisation was 66 yr (interquartile range [IQR]: 61-71), and median prostate-specific antigen level was 112 ng/ml (IQR: 34-373). Most men (n=574; 62%) had bone-only metastases, whereas 237 (26%) had both bone and soft tissue metastases; soft tissue metastasis was found mainly in distant lymph nodes. There were 238 deaths, 202 (85%) from PCa. Median FFS was 11 mo; 2-yr FFS was 29% (95% CI, 25-33). Median OS was 42 mo; 2-yr OS was 72% (95% CI, 68-76). Survival time was influenced by performance status, age, Gleason score, and metastases distribution. Median survival after FFS event was 22 mo. Trial eligibility criteria meant men were younger and fitter than general PCa population. CONCLUSIONS Survival remains disappointing in men presenting with M1 disease who are started on only long-term ADT, despite active treatments being available at first failure of ADT. Importantly, men with M1 disease now spend the majority of their remaining life in a state of castration-resistant relapse. PATIENT SUMMARY Results from this control arm cohort found survival is relatively short and highly influenced by patient age, fitness, and where prostate cancer has spread in the body.

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A randomised controlled trial was conducted to determine if physicians' advice to promote physical activity to patients was more effective if the advice was tailored to the management of hypertension, compared with more general health promotion advice. Participants included inactive 40- to 70-year-old patients visiting the physicians' during study recruitment period. Physicians provided verbal physical activity advice and written materials, both tailored to either general health promotion messages or specifically as a means for treating or managing hypertension. Seventy-five physicians and 98% (767/780) of screened eligible patients participated in the study. Differences between intervention and control groups self-reported physical activity were assessed over 6 months. Follow-up response rates were 92 and 84% at the 2- and 6-month assessments. There were no consistent, significant differences between groups at the 2- or 6-month assessments. Thus, neither intervention strategy resulted in significant changes in patients self-reported physical activity, regardless of the whether the advice was tailored to hypertension management or general health promotion advice. (c) 2004 Elsevier Ireland Ltd. All rights reserved.