Página 1 dos resultados de 5756 itens digitais encontrados em 0.018 segundos

A randomised controlled trial evaluating the effect of immersion bath on labour pain

SILVA, Flora Maria Barbosa da; OLIVEIRA, Sonia Maria Junqueira Vasconcellos de; NOBRE, Moacyr Roberto Cuce
Fonte: ELSEVIER SCI LTD Publicador: ELSEVIER SCI LTD
Tipo: Artigo de Revista Científica
ENG
Relevância na Pesquisa
96.16%
Objective: to evaluate the effect of an immersion bath on pain magnitude during the first stage of tabour. Design: a randomised controlled trial comparing the pain scores of bathing and non-bathing nulliparous women during birth was employed. Setting: the study was conducted at the Normal Birth Center of Amparo Maternal, Sao Paulo, Brazil. Participants: 108 birthing women, with 54 women randomly assigned to each group. Interventions: when the birthing women presented at 6-7cm of cervical dilation, they were placed in an immersion bath for 60 mins. Outcome measures: pain scores, using a behavioural pain scale and a numeric scale, were recorded at two evaluation time points: at 6-7cm of cervical dilation and 1 h after the first pain score evaluation. Findings: at the first evaluation, on the behavioural scale, the means were 2.1 for both groups (p = 0.914; 95% confidence intervals (CI) 1.9-2.3 for the control group and 2.0-2.2 for the experimental group). On the numeric scale, the means were 8.7 and 8.5 for the control and experimental groups, respectively (p = 0.235; 95% Cl 8.2-9.2 for the control group and 8.1-8.9 for the experimental group). At the second evaluation, the pain score means for both scales were statistically higher in the control group than in the experimental group. On the behavioural scale...

Estudio Parto: postpartum diabetes prevention program for hispanic women with abnormal glucose tolerance in pregnancy: a randomised controlled trial – study protocol

Chasan-Taber, Lisa; Marcus, Bess H; Rosal, Milagros C; Tucker, Katherine L; Hartman, Sheri J; Pekow, Penelope; Braun, Barry; Moore Simas, Tiffany A; Solomon, Caren G; Manson, JoAnn E; Markenson, Glenn
Fonte: BioMed Central Publicador: BioMed Central
Tipo: Artigo de Revista Científica
EN_US
Relevância na Pesquisa
96.29%
Background: Diabetes and obesity have reached epidemic proportions in the U.S. with rates consistently higher among Hispanics as compared to non-Hispanic whites. Among Hispanic women diagnosed with gestational diabetes mellitus (GDM), 50% will go on to develop type 2 diabetes within 5 years of the index pregnancy. Although randomised controlled trials among adults with impaired glucose tolerance have shown that diet and physical activity reduce the risk of type 2 diabetes, such programs have not been tested in high-risk postpartum women. The overall goal of this randomised controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce risk factors for type 2 diabetes and cardiovascular disease among postpartum Hispanic women with a history of abnormal glucose tolerance during pregnancy. Methods/Design Hispanic pregnant women who screen positive for GDM will be recruited and randomly assigned to a Lifestyle Intervention (n = 150) or a Health & Wellness (control) Intervention (n = 150). Multimodal contacts (i.e., in-person, telephone, and mailed materials) will be used to deliver the intervention from late pregnancy (29 weeks gestation) to 12 months postpartum. Targets of the intervention are to achieve Institute of Medicine Guidelines for postpartum weight loss; American Congress of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and addresses the specific cultural and environmental challenges faced by low-income Hispanic women. Assessments will be conducted at enrollment...

Online cognitive behaviour training for the prevention of postnatal depression in at-risk mothers: a randomised controlled trial protocol

Jones, Bethany A; Griffiths, Kathleen M; Christensen, Helen; Ellwood, David; Bennett, Kylie; Bennett, Anthony
Fonte: BioMed Central Publicador: BioMed Central
Tipo: Artigo de Revista Científica Formato: 8 pages
Relevância na Pesquisa
96.2%
Background Postnatal depression (PND) is the most common disorder of the puerperium with serious consequences for both mother and child if left untreated. While there are effective treatments, there are many barriers for new mothers needing to access them. Prevention strategies may offer a more acceptable means of addressing the problem. Internet interventions can help overcome some barriers to reducing the impact of PND. However, to date there are no published studies that investigate the efficacy of internet interventions for the prevention of PND. Methods/Design The proposed study is a two-arm double blind randomised controlled trial. 175 participants will be recruited in the immediate postnatal period at an Australian community hospital. Women who meet inclusion criteria (internet access, email address, telephone number, over 18, live birth, fluent English) will complete the Edinburgh Postnatal Depression Scale (EPDS). Those with a score above 9 will undertake the Structured Clinical Interview for DSM Disorders (SCID). Those with a clinical diagnosis of depression, or a lifetime diagnosis of bipolar disorder or psychosis on the SCID will be excluded. Following completion of the baseline battery women will be randomised using a computer-generated algorithm to either the intervention or control condition. The intervention will consist of 5 modules of automated...

The Sleep Or Mood Novel Adjunctive therapy (SOMNA) trial: a study protocol for a randomised controlled trial evaluating an internet-delivered cognitive behavioural therapy program for insomnia on outcomes of standard treatment for depression in men

Cockayne, Nicole L.; Christensen, Helen M.; Griffiths, Kathleen M.; Naismith, Sharon L.; Hickie, Ian B.; Thorndike, Frances P.; Ritterband, Lee M.; Glozier, Nick S.
Fonte: BioMed Central Publicador: BioMed Central
Tipo: Artigo de Revista Científica
Relevância na Pesquisa
96.23%
BACKGROUND: Insomnia is a significant risk factor for depression onset, can result in more disabling depressive illness, and is a common residual symptom following treatment cessation that can increase the risk of relapse. Internet-based cognitive behavioural therapy for insomnia has demonstrated efficacy and acceptability to men who are less likely than women to seek help in standard care. We aim to evaluate whether internet delivered cognitive behavioural therapy for insomnia as an adjunct to a standard depression therapeutic plan can lead to improved mood outcomes.METHODS/DESIGN: Male participants aged 50 years or more, meeting Diagnostic and Statistical Manual of Mental Disorders criteria for current Major Depressive Episode and/or Dysthymia and self-reported insomnia symptoms, will be screened to participate in a single-centre double-blind randomised controlled trial with two parallel groups involving adjunctive internet-delivered cognitive behavioural therapy for insomnia and an internet-based control program. The trial will consist of a nine-week insomnia intervention period with a six-month follow-up period. During the insomnia intervention period participants will have their depression management coordinated by a psychiatrist using standard guideline-based depression treatments. The study will be conducted in urban New South Wales...

Evaluation of a decision aid for women with breech presentation at term: a randomised controlled trial [ISRCTN14570598]

Nassar, N.; Roberts, C.; Raynes-Greenow, C.; Barratt, A.; Peat, B.
Fonte: Blackwell Publishing Ltd Publicador: Blackwell Publishing Ltd
Tipo: Artigo de Revista Científica
Publicado em //2007 EN
Relevância na Pesquisa
96.2%
Objectives To evaluate the effectiveness of a decision aid for women with a breech presentation compared with usual care. Design Randomised controlled trial. Setting Tertiary obstetric hospitals offering external cephalic version (ECV). Population Women with a singleton pregnancy were diagnosed antenatally with a breech presentation at term, and were clinically eligible for ECV. Methods Women were randomised to either receive a decision aid about the management options for breech presentation in addition to usual care or to receive usual care only with standard counselling from their usual pregnancy care provider. The decision aid comprised a 24-page booklet supplemented by a 30-minute audio-CD and worksheet that was designed for women to take home and review with a partner. Main outcome measures Decisional conflict (uncertainty), knowledge, anxiety and satisfaction with decision making, and were assessed using self-administered questionnaires. Results Compared with usual care, women reviewing the decision aid experienced significantly lower decisional conflict (mean difference −8.92; 95% CI −13.18, −4.66) and increased knowledge (mean difference 8.40; 95% CI 3.10, 13.71), were more likely to feel that they had enough information to make a decision (RR 1.30; 95% CI 1.14...

A prospective randomised controlled trial of femoral ring allograft versus a titanium cage in circumferential lumbar spinal fusion with minimum 2-year clinical results

McKenna, P.; Freeman, B.; Mulholland, R.; Grevitt, M.; Webb, J.; Mehdian, H.
Fonte: Springer Publicador: Springer
Tipo: Artigo de Revista Científica
Publicado em //2005 EN
Relevância na Pesquisa
96.29%
The literature reports on the safety and efficacy of titanium cages (TCs) with additional posterior fixation for anterior lumbar interbody fusion. However, these papers are limited to prospective cohort studies. The introduction of TCs for spinal fusion has resulted in increased costs, without evidence of superiority over the established practice. There are currently no prospective controlled trials comparing TCs to femoral ring allografts (FRAs) for circumferential fusion in the literature. In this prospective, randomised controlled trial, our objective was to compare the clinical outcome following the use of FRA (current practice) to the use of TC in circumferential lumbar spinal fusion. Full ethical committee approval and institutional research and development departmental approval were obtained. Power calculations estimated a total of 80 patients (40 in each arm) would be required to detect clinically relevant differences in functional outcome. Eighty-three patients were recruited for the study fulfilling strict entry requirements (>6 months chronic discogenic low back pain, failure of conservative treatment, one- or two-level discographically proven discogenic low back pain). The patients completed the Oswestry Disability Index (ODI)...

Does acupuncture improve the endometrium for women undergoing an embryo transfer: A pilot randomised controlled trial

Smith, C.; Coyle, M.; Norman, R.
Fonte: Australian Acupuncture and Chinese Medicine Association Publicador: Australian Acupuncture and Chinese Medicine Association
Tipo: Artigo de Revista Científica
Publicado em //2009 EN
Relevância na Pesquisa
96.16%
Background: There is a growing body of research suggesting acupuncture may increase pregnancy and live births, when administered on the day of embryo transfer. The physiological effects of acupuncture that may influence the outcome from embryo transfer remain unclear. Aims: To examine the effects of acupuncture on uterine endometrium thickness and pattern, and the level of hormonal medication during an IVF cycle. Design: Randomised controlled trial. Subjects: Women undergoing an IVF cycle with a planned embryo transfer at day 3 or day 5. Setting: A reproductive medicine unit in South Australia. Intervention: Women were randomly allocated to acupuncture or standard care. Women in the acupuncture group received three treatments, the first undertaken on day 9 of stimulating injections, and two on the day of embryo transfer. Outcome measures: The primary outcomes were change in endometrial thickness and pattern, and levels of plasma progesterone, and oestradiol during the IVF cycle, through to seven days post-egg retrieval. Secondary outcomes included number of oocytes retrieved, number of oocytes fertilised, and biochemical pregnancy rate. Results: Endometrial thickness and pattern and levels of hormonal medication did not differ between groups on the day of embryo transfer or in the luteal phase (p > 0.05). There were no differences in any secondary outcomes. Discussion and Conclusion: The results of this pilot study suggest acupuncture did not influence the endometrium or levels of hormonal medication during the IVF cycle. The small number of subjects and incomplete data make conclusions difficult...

Home versus day rehabilitation: a randomised controlled trial

Crotty, M.; Giles, L.; Halbert, J.; Harding, J.; Miller, M.
Fonte: Oxford Univ Press Publicador: Oxford Univ Press
Tipo: Artigo de Revista Científica
Publicado em //2008 EN
Relevância na Pesquisa
96.19%
Objective: to assess the effect of home versus day rehabilitation on patient outcomes. Design: randomised controlled trial. Setting: post-hospital rehabilitation. Participants: two hundred and twenty-nine hospitalised patients referred for ambulatory rehabilitation. Interventions: hospital-based day rehabilitation programme versus home-based rehabilitation programme. Main Outcome Measures: at 3 months, information was collected on hospital readmission, transfer to residential care, functional level, quality of life, carer stress and carer quality of life. At 6 months, place of residence, hospital re-admissions and mortality status were collected. Results: there were significant improvements in the functional outcomes from baseline to 3 months for all participants. At discharge, carers of patients in day hospital reported higher Caregiver Strain Index (CSI) scores in comparison to home rehabilitation carers (4.95 versus 3.56, P = 0.047). Patients in day hospital had double the risk of readmission compared to those in home rehabilitation (RR = 2.1; 95% CI 1.2–3.9). This effect persisted at 6 months. Conclusions: day hospital patients are more likely to be readmitted to hospital possibly due to increased access to admitting medical staff. This small trial favours the home as a better site for post-hospital rehabilitation.; Maria Crotty...

Effect of electroacupuncture on opioid consumption in patients with chronic musculoskeletal pain: protocol of a randomised controlled trial

Xue, C.; Helme, R.; Gibson, S.; Hogg, M.; Arnold, C.; Somogyi, A.; Da Costa, C.; Wang, Y.; Lu, S.C.
Fonte: BioMed Central Ltd. Publicador: BioMed Central Ltd.
Tipo: Artigo de Revista Científica
Publicado em //2012 EN
Relevância na Pesquisa
96.31%
BACKGROUND Chronic musculoskeletal pain is common and has been increasingly managed by opioid medications, of which the long-term efficacy is unknown. Furthermore, there is evidence that long-term use of opioids is associated with reduced pain control, declining physical function and quality of life, and could hinder the goals of integrated pain management. Electroacupuncture (EA) has been shown to be effective in reducing postoperative opioid consumption. Limited evidence suggests that acupuncture could assist patients with chronic pain to reduce their requirements for opioids. The proposed research aims to assess if EA is an effective adjunct therapy to standard pain and medication management in reducing opioids use by patients with chronic musculoskeletal pain. METHODS In this multicentre, randomised, sham-acupuncture controlled, three-arm clinical trial, 316 patients regularly taking opioids for pain control and meeting the defined selection criteria will be recruited from pain management centres and clinics of primary care providers in Victoria, Australia. After a four-week run-in period, the participants are randomly assigned to one of three treatment groups to receive EA, sham EA or no-EA with a ratio of 2:1:1. All participants receive routine pain medication management delivered and supervised by the trial medical doctors. Twelve sessions of semi-structured EA or sham EA treatment are delivered over 10 weeks. Upon completion of the acupuncture treatment period...

The IDEAL study: investigation of dietary advice and lifestyle for women with borderline gestational diabetes: a randomised controlled trial - study protocol

Crowther, C.; Hague, W.; Middleton, P.; Baghurst, P.; McPhee, A.; Tran, T.; Yelland, L.; Ashwood, P.; Han, S.; Dodd, J.; Robinson, J.
Fonte: BioMed Central Ltd. Publicador: BioMed Central Ltd.
Tipo: Artigo de Revista Científica
Publicado em //2012 EN
Relevância na Pesquisa
96.27%
BACKGROUND: The Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) showed that treatment of pregnant women with mild gestational diabetes mellitus is beneficial for both women and their infants. It is still uncertain whether there are benefits of similar treatment for women with borderline gestational diabetes. This trial aims to assess whether dietary and lifestyle advice and treatment given to pregnant women who screen for borderline gestational diabetes reduces neonatal complications and maternal morbidities. METHODS/DESIGN: Design: Multicentre, randomised controlled trial. Inclusion criteria: Women between 240 and 346 weeks gestation with a singleton pregnancy, a positive oral glucose challenge test (venous plasma glucose ≥7.8 mmol/L) and a normal oral 75 gram glucose tolerance test (fasting venous plasma glucose <5.5 mmol/L and a 2 hour glucose <7.8 mmol/L) with written, informed consent. Trial entry and randomisation: Women with an abnormal oral glucose tolerance test (fasting venous plasma glucose ≥5.5 mmol/L or 2 hour glucose ≥7.8 mmol/L) will not be eligible and will be offered treatment for gestational diabetes, consistent with recommendations based on results of the ACHOIS trial. Eligible women will be randomised into either the ‘Routine Care Group’ or the ‘Intervention Group’. Study groups: Women in the ‘Routine Care Group’ will receive routine obstetric care reflecting current clinical practice in Australian hospitals. Women in the ‘Intervention Group’ will receive obstetric care...

Coaching older adults and carers to have their preferences heard (COACH): a randomised controlled trial in an intermediate care setting (study protocol)

Masters, S.; Gordon, J.; Whitehead, C.; Davies, O.; Giles, L.; Ratcliffe, J.
Fonte: Australasian Medical Journal Pty Ltd Publicador: Australasian Medical Journal Pty Ltd
Tipo: Artigo de Revista Científica
Publicado em //2012 EN
Relevância na Pesquisa
96.19%
BACKGROUND: Frail older people who are considering movement into residential aged care or returning home following a hospital admission often face complex and diffiult decisions. Despite research interest in this area, a recent Cochrane review was unable to identify any studies of interventions to support decision-making in this group that met the experimental or quasi-­experimental study design criteria. AIMS: This study tests the impact of a multi-component coaching intervention on the quality of preparation for care transitions, targeted to older adults and informal carers. In addition, the study assesses the impact of investing specialist geriatric resources into consultations with families in an intermediate care setting where decisions about future care needs are being made. METHOD: This study was a randomised controlled trial of 230 older adults admitted to intermediate care in Australia. Masked assessment at 3 and 12 months examined physical functioning, health-­‐related quality of life and utilisation of health and aged care resources. A geriatrician and specialist nurse delivered a coaching intervention to both the older person and their carer/family. Components of the intervention included provision of a Question Prompt List prior to meeting with a geriatrician (to clarify medical conditions and treatments...

The DIAMIND study: postpartum SMS reminders to women who have had gestational diabetes mellitus to test for type 2 diabetes: a randomised controlled trial - study protocol

Heatley, E.; Middleton, P.; Hague, W.; Crowther, C.
Fonte: BioMed Central Ltd. Publicador: BioMed Central Ltd.
Tipo: Artigo de Revista Científica
Publicado em //2013 EN
Relevância na Pesquisa
96.29%
BACKGROUND Postpartum follow up of women who have been found to have gestational diabetes during pregnancy is essential because of the strong association of gestational diabetes with subsequent type 2 diabetes. Postal reminders have been shown to increase significantly attendance for oral glucose tolerance testing postpartum. It is possible that a short message service (text) reminder system may also be effective. This trial aims to assess whether a text message reminder system for women who have experienced gestational diabetes in their index pregnancy will increase attendance for oral glucose tolerance testing within six months after birth. METHODS/DESIGN Design: Single centre (Women’s and Children’s Hospital, South Australia), parallel group randomised controlled trial. Inclusion criteria: Women diagnosed with gestational diabetes in their index pregnancy (oral glucose tolerance test with fasting glucose ≥ 5.5 mmol/L and/or two hour glucose ≥ 7.8 mmol/L), with access to a mobile phone, whose capillary blood glucose profile measurements prior to postnatal discharge are all normal (fasting glucose < 6.0 mmol/L, postprandial glucoses < 8.0 mmol/L). Exclusion criteria: Pregestational diabetes mellitus, triplet/higher order multiple birth or stillbirth in the index pregnancy...

Exploring the feasibility of implementing self-management and patient empowerment through a structured diabetes education programme in Yogyakarta City Indonesia: a pilot cluster randomised controlled trial.

Agrimon, Oryzati Hilman
Fonte: Universidade de Adelaide Publicador: Universidade de Adelaide
Tipo: Tese de Doutorado
Publicado em //2014
Relevância na Pesquisa
96.19%
BACKGROUND Diabetes is a global public health problem which can cause serious disabling complications. Indonesia is among the top four countries with the highest numbers of diabetes. Diabetes self-management education (DSME) is widely recognized as an essential element of diabetes care. Patient empowerment has long served as the philosophical foundation for DSME. However, self-management and patient empowerment are largely unknown in diabetes education and care in Indonesia. The current traditional diabetes education found in hospitals and publicly funded community health centres (CHCs) does not incorporate these two concepts. Therefore, there is a particular need for research on DSME and patient empowerment for people with type 2 diabetes (T2D) in Indonesia. AIMS The main aims of this research project were to develop a pilot model of a structured diabetes education programme promoting diabetes self-management and patient empowerment for people with T2D in the primary care setting in Indonesia, and to evaluate its effectiveness on clinical outcomes and diabetes-related scores of knowledge, health beliefs, self-care behaviours, and self-efficacy. The research project also aimed to cross-culturally adapt the 24-item Diabetes Knowledge Questionnaire (DKQ-24)...

A randomised controlled trial of personalised decision support delivered via the internet for bowel cancer screening with a faecal occult blood test: the effects of tailoring of messages according to social cognitive variables on participation

Wilson, C.J.; Flight, I.H.; Turnbull, D.; Gregory, T.; Cole, S.R.; Young, G.P.; Zajac, I.T.
Fonte: BioMed Central Publicador: BioMed Central
Tipo: Artigo de Revista Científica
Publicado em //2015 EN
Relevância na Pesquisa
96.19%
BACKGROUND: In Australia, bowel cancer screening participation using faecal occult blood testing (FOBT) is low. Decision support tailored to psychological predictors of participation may increase screening. The study compared tailored computerised decision support to non-tailored computer or paper information. The primary outcome was FOBT return within 12 weeks. Additional analyses were conducted on movement in decision to screen and change on psychological variables. METHODS: A parallel, randomised controlled, trial invited 25,511 people aged 50-74 years to complete an eligibility questionnaire. Eligible respondents (n = 3,408) were assigned to Tailored Personalised Decision Support (TPDS), Non-Tailored PDS (NTPDS), or Control (CG) (intention-to-treat, ITT sample). TPDS and NTPDS groups completed an on-line baseline survey (BS) and accessed generic information. The TPDS group additionally received a tailored intervention. CG participants completed a paper BS only. Those completing the BS (n = 2270) were mailed an FOBT and requested to complete an endpoint survey (ES) that re-measured BS variables (per-protocol, PP sample). RESULTS: FOBT return: In the ITT sample, there was no significant difference between any group (χ (2)(2) = 2.57...

Impact of a pharmaceutical care programme on health-related quality of life among women with epilepsy: a randomised controlled trial (IPHIWWE study)

Losada-Camacho, Martha; Guerrero-Pab??n, Mario F.; Garc??a-Delgado, Pilar; Mart??nez-Mart??nez, Fernando
Fonte: Biomed Central Publicador: Biomed Central
Tipo: Artigo de Revista Científica
ENG
Relevância na Pesquisa
96.16%
This paper was presented in part at the II Congreso Colombiano de Atenci??n Farmac??utica, Medell??n, Colombia, September 27, 2013.; Background: Epilepsy is a complex chronic disorder which affects health-related quality of life (HRQOL), especially in women. Pharmaceutical care (PC) allows direct intervention between the pharmacist, the patient and the other healthcare team members to optimise treatments in order to reduce negative outcomes related to medication and contribute to improving HRQOL. The aim of the study was to establish the impact of the application of a pharmaceutical care programme on the HRQOL of women with epilepsy.; Methods: This study is a pragmatic randomised controlled trial involving women with epilepsy (WWE) over 18 years of age. The intervention group (IG) received a pharmaceutical care programme consisting of medication review follow-up according to D??der???s method, health education and therapeutic drug monitoring of anticonvulsants. The impact was assessed by changes in seizure frequency, in the self-administered questionnaires (the QOLIE-31, Liverpool AEP, CES-D, Haynes-Sackett test and Moriski-Green test) and between the first interview and the one at the end of six months of follow-up. A Student???s t-test was performed to compare the final QOLIE-31 score between groups and a paired Student???s t-test was used to determine the change in each group between the start and the end of follow-up.; Results: One hundred eighty-two WWE entered the study and 144 (79.1%) completed it. The t-test for comparing the final QOLIE-31 scores between groups yielded a t???=??????2.166 and confidence interval (CI) (95%): ???10.125; ???0.4625...

An outreach geriatric medication advisory service in residential aged care: a randomised controlled trial of case conferencing

Crotty, M.; Halbert, J.; Rowett, D.; Giles, L.; Birks, R.; Williams, H.; Whitehead, C.
Fonte: Oxford Univ Press Publicador: Oxford Univ Press
Tipo: Artigo de Revista Científica
Publicado em //2004 EN
Relevância na Pesquisa
96.16%
Background: efficient strategies are needed to provide specialist advice in nursing homes to ensure quality medical care. We describe a case conference intervention involving a multidisciplinary team of health professionals. Objectives: to evaluate the impact of multidisciplinary case conferences on the appropriateness of medications and on patient behaviours in high-level residential aged care facilities. Design: cluster-randomised controlled trial. Setting: ten high-level aged care facilities. Participants: 154 residents with medication problems and/or challenging behaviours were selected for case conference by residential care staff. Intervention: two multidisciplinary case conferences involving the resident's general practitioner, a geriatrician, a pharmacist and residential care staff were held at the nursing home for each resident. Measurements: outcomes were assessed at baseline and 3 months. The primary outcome was the Medication Appropriateness Index (MAI). The behaviour of each resident was assessed via the Nursing Home Behaviour Problem Scale. Results: 45 residents died before follow-up. Medication appropriateness improved in the intervention group [MAI mean change 4.1, 95% confidence interval (CI) 2.1–6.1] compared with the control group (MAI mean change 0.4...

The effectiveness of an aged care specific leadership and management program on workforce, work environment, and care quality outcomes: design of a cluster randomised controlled trial

Jeon, Yun-Hee; Simpson, Judy M; Chenoweth, Lynn; Cunich, Michelle; Kendig, Hal
Fonte: BioMed Central Publicador: BioMed Central
Tipo: Artigo de Revista Científica Formato: 10 pages
Relevância na Pesquisa
96.27%
BACKGROUND: A plethora of observational evidence exists concerning the impact of management and leadership on workforce, work environment, and care quality. Yet, no randomised controlled trial has been conducted to test the effectiveness of leadership and management interventions in aged care. An innovative aged care clinical leadership program (Clinical Leadership in Aged Care − CLiAC) was developed to improve managers’ leadership capacities to support the delivery of quality care in Australia. This paper describes the study design of the cluster randomised controlled trial testing the effectiveness of the program. METHODS: Twenty-four residential and community aged care sites were recruited as managers at each site agreed in writing to participate in the study and ensure that leaders allocated to the control arm would not be offered the intervention program. Sites undergoing major managerial or structural changes were excluded. The 24 sites were randomly allocated to receive the CLiAC program (intervention) or usual care (control), stratified by type (residential vs. community, six each for each arm). Treatment allocation was masked to assessors and staff of all participating sites. The objective is to establish the effectiveness of the CLiAC program in improving work environment...

Protocol of a multi-centre randomised controlled trial of a web-based information intervention with nurse-delivered telephone support for haematological cancer patients and their support persons

Bryant, Jamie; Sanson-Fisher, Rob; Stevenson, William; Smits, Rochelle; Henskens, Frans; Wei, Andrew; Tzelepis, Flora; D’Este, Catherine; Paul, Christine; Carey, Mariko
Fonte: BioMed Central Publicador: BioMed Central
Tipo: Artigo de Revista Científica Formato: 13 pages
Relevância na Pesquisa
96.2%
BACKGROUND High rates of anxiety, depression and unmet needs are evident amongst haematological cancer patients undergoing treatment and their Support Persons. Psychosocial distress may be minimised by ensuring that patients are sufficiently involved in decision making, provided with tailored information and adequate preparation for potentially threatening procedures. To date, there are no published studies evaluating interventions designed to reduce psychosocial distress and unmet needs specifically in patients with haematological cancers and their Support Persons. This study will examine whether access to a web-based information tool and nurse-delivered telephone support reduces depression, anxiety and unmet information needs for haematological cancer patients and their Support Persons. METHODS/DESIGN A non-blinded, parallel-group, multi-centre randomised controlled trial will be conducted to compare the effectiveness of a web-based information tool and nurse-delivered telephone support with usual care. Participants will be recruited from the haematology inpatient wards of five hospitals in New South Wales, Australia. Patients diagnosed with acute myeloid leukaemia, acute lymphoblastic leukaemia, Burkitt's lymphoma, Lymphoblastic lymphoma (B or T cell)...

What is a randomised controlled trial?

O'Gorman, Clodagh S; Macken, Alan P; Cullen, Walter; Saunders, Jean; Dunne, Colum; Higgins, M.F.
Fonte: Irish Medical Organization Publicador: Irish Medical Organization
Tipo: info:eu-repo/semantics/article; all_ul_research; ul_published_reviewed
ENG
Relevância na Pesquisa
96.29%
peer-reviewed; A randomised controlled trial (RCT), also known as a randomised controlled clinical trial, is a study in which participants are assigned randomly to one of two or more arms (groups with different interventions) of a clinical trial. Occasionally, a placebo is used as one of the interventions, but, generally, if there is a recognised and accepted intervention that works (the “gold standard”), then a new drug, device or intervention is tested against this gold standard rather than against placebo. Where a gold standard drug or intervention exists, it would be unethical to randomise to a placebo and, by doing so, make an effective treatment unavailable to some participants. Generally, RCTs are conducted because there is equipoise (or uncertainty) about whether a new intervention is potentially better than an existing one. The trialists (the team of people that plan, conduct, supervise and analyse the results of the trial) start with the hypothesis that there is no difference between the two interventions (this is “the null hypothesis”). The purpose of the RCT is to reject or accept the null hypothesis. If they manage to reject the null hypothesis, they can accept the “alternative hypothesis”...

Pilot study to evaluate a tailored text message intervention for pregnant smokers (MiQuit): study protocol for a randomised controlled trial

Cooper, Sue; Foster, Katharine; Naughton, Felix; Leonardi-Bee, Jo; Sutton, Stephen; Ussher, Michael; Leighton, Matthew; Montgomery, Alan; Parrott, Steve; Coleman, Tim
Fonte: BioMed Central Publicador: BioMed Central
Tipo: Article; published version
EN
Relevância na Pesquisa
96.28%
This is the final version of the article. It first appeared at http://www.trialsjournal.com/content/16/1/29.; Background Smoking in pregnancy is a public health problem. Self-help smoking cessation support can help pregnant women to stop smoking, but the effects of delivering this kind of support via SMS text message are not known. A previous randomised controlled trial (RCT) demonstrated the feasibility and acceptability of providing such support to pregnant smokers using an automated, tailored text message intervention called MiQuit. This larger RCT will estimate key parameters for and will test the feasibility of delivering a major trial run within the United Kingdom National Health Service settings aimed at providing definitive evidence on the utility of MiQuit for helping pregnant smokers to stop. Methods/Design This will be a multi-centre, parallel group RCT. Participants are being identified in 16 English antenatal care settings and must be >16 years old, pregnant, <25 weeks gestation, smoke >1 daily cigarette, have smoked >5 daily cigarettes before pregnancy, and able to understand texts in English. After consenting and the collection of baseline data, participants are randomised to control or intervention groups in a 1:1 ratio; randomisation is stratified by trial site and gestation and employs computer-generated pseudo-random code using random permuted blocks of randomly varying size...