The Initiating Dialysis Early and Late (Ideal) Study: Study Rationale and Design

2004 ◽  
Vol 24 (2) ◽  
pp. 176-181 ◽  
Author(s):  
◽  
Bruce A. Cooper ◽  
Pauline Branley ◽  
Liliana Bulfone ◽  
John F. Collins ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Optimal Time ◽  
Early Start ◽  
Multicenter Randomized Controlled Trial ◽  
Ideal Study ◽  
Late Start ◽  
The Impact ◽  
The Ideal

Objectives The primary objective of the IDEAL study is to determine whether the timing of dialysis initiation has an effect on survival in subjects with end-stage renal disease (ESRD). The secondary objectives are to determine the impact of “early start” versus “late start” dialysis on nutritional and cardiac morbidity, quality of life, and economic cost. Design Prospective multicenter randomized controlled trial. Patients are randomized to commence dialysis at a glomerular filtration rate (by Cockcroft–Gault) of either 10 – 14 mL/minute/1.73 m2 (“early start”) or 5 – 7 mL/min/1.73 m2 (“late start”), with stratification for dialysis modality (hemodialysis vs peritoneal dialysis), study center, and the presence or not of diabetes mellitus. Setting Dialysis units throughout Australia and New Zealand. Patients Patients with ESRD commencing chronic dialysis therapy. Outcome Measures Three years from randomization, all-cause mortality, morbidity, and economic impact; structural and functional cardiac status, nutritional state, and quality of life will be assessed. Results To date, 388 patients of a minimum 800 patients have been entered and randomized into the study. Current recruitment rates suggest sufficient patients will be enrolled by December 2004 and follow-up completed by December 2007. Conclusions The IDEAL study will provide evidence for the optimal time to commence dialysis.

scholarly journals The impact of co-morbidity on the quality of life of people with dementia: findings from the IDEAL study

2018 ◽  
Vol 48 (3) ◽  
pp. 361-367 ◽  
Author(s):  
Sharon M Nelis ◽  
Yu-Tzu Wu ◽  
Fiona E Matthews ◽  
Anthony Martyr ◽  
Catherine Quinn ◽  
...  
Keyword(s):  
Quality Of Life ◽  
People With Dementia ◽  
Co Morbidity ◽  
Ideal Study ◽  
The Impact ◽  
The Ideal

scholarly journals Impact of simple, specific, verbal instructions on the quality of bowel preparation in hospitalized patients undergoing colonoscopy: a multicenter randomized controlled trial

2021 ◽  
Vol 09 (03) ◽  
pp. E378-E387
Author(s):  
Konstantinos Triantafyllou ◽  
Paraskevas Gkolfakis ◽  
Alexandros Skamnelos ◽  
Georgia Diamantopoulou ◽  
Athanasios Dagas ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Intervention Group ◽  
Standard Of Care ◽  
Hospitalized Patients ◽  
Verbal Instructions ◽  
Multicenter Randomized Controlled Trial ◽  
The Impact

Abstract Background and study aims Bowel preparation for colonoscopy is frequently inadequate in hospitalized patients. We explored the impact of specific verbal instructions on the quality of inpatients bowel preparation and factors associated with preparation failure. Patients and methods Randomized (1:1), two strata (mobilized vs. bedridden; 3:2) trial of consecutive inpatients from four tertiary centers, who received either specific, verbal instructions or the standard of care (SOC) ward instructions about bowel preparation. The rate of adequate bowel preparation (Boston Bowel Preparation Score [BBPS] ≥ 6, no segment < 2) comprised the primary endpoint. Mean BBPS score, good (BBPS score ≥ 7, no segment score < 2) and excellent (BBPS = 9) were among secondary endpoints. Results We randomized 300 inpatients (180 mobile) aged 71.7 ± 15.1 years in the intervention (49.7 %) and SOC (50.3 %) groups, respectively. Overall, more patients in the intervention group achieved adequate bowel preparation, but this difference did not reach statistical significance neither in the intention-to-treat [90/149 (60.4 %) vs. 82/151 (54.3 %); P = 0.29] nor in the per-protocol analysis [90/129 (69.8 %) vs. 82/132 (62.1 %); P = 0.19]. Overall BBPS score did not differ statistical significantly in the two groups, but the provision of specific verbal instructions was associated with significant higher rates of good (58.1 % vs. 43.2 %; P = 0.02) and excellent (31.8 % vs. 16.7 %; P = 0.004) bowel preparation compared to the SOC group. Administration of same-day bowel preparation and patient American Society of Anesthesiologists score > 2 were identified as risk factors for inadequate bowel preparation. Conclusions Provision of specific verbal instructions did not increase the rate of adequate bowel preparation in a population of mobilized and bedridden hospitalized patients.

P–504 A randomised controlled trial comparing expectant management or intrauterine-insemination in couples with unexplained subfertility and a poor prognosis for natural conception: the impact on health-related-quality-of-life

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
F Mol ◽  
J Wessel ◽  
H A Verhoeve ◽  
J Maas ◽  
J P D Bruin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Poor Prognosis ◽  
Intrauterine Insemination ◽  
Controlled Trial ◽  
Expectant Management ◽  
Mean Difference ◽  
Anxiety And Depression ◽  
Depression Disorders ◽  
The Impact

Abstract Study question Is health-related quality of life (HRQoL) in women with unexplained subfertility and a poor prognosis influenced by expectant management or intrauterine insemination with ovarian stimulation? Summary answer HRQoL did not differ, except for the relational domain which was lower after expectant management. Anxiety and depression disorders occurred frequently in both groups. What is known already In couples with unexplained subfertility and a poor prognosis, IUI with ovarian stimulation (IUI-OS) is a first line treatment. Not much is known about quality of live or depression and anxiety in these couples. The Fertility Quality of Life (FertiQoL) is reliable for assessment within relational and social domains, the Hospital Anxiety and Depression Scale (HADS) is a reliable tool to detect anxiety and depression disorders. Study design, size, duration We performed a multicentre RCT in couples with unexplained subfertility with a poor prognosis of conceiving naturally within one year. Women were allocated 1:1 to six months expectant management or to six months IUI-OS. HRQoL was assessed with standard self-administered psychometric measures with established reliability and validity: FertiQol and HADS. We intended to include 1091 couples but after almost 4 years, the study had to stop due to slow inclusion and therefore lack of funding. Participants/materials, setting, methods Between June 2017 and September 2020, we recruited 178 women of wich 92 were assigned expectant management and 86 IUI-OS. All women who participated and could read Dutch were eligible for the HRQoL measurements because HRQoL questionnaires in foreign languages were not yet available online. Women completed the questionnaires before randomisation, 3 and 6 months after randomisation. We used mixed model analyses to assess differences between treatment groups and the effect of time. Main results and the role of chance One hundred sixty-two women could read Dutch and were invited (162/178 (91%)). Analyzable data of the FertiQol questionnaire were available for 80% (130/162). Compared to women allocated to IUI-OS, women allocated to expectant management had a lower FertiQol score in the relational domain (mean difference –4.3 (95% CI –7.3 to –1.3) but not in the social domain (mean diff van –0.8 (95% CI –4.5 to 2.9). Data of the HADS questionnaire were available of 156 women (96% (156/162)). Both groups had comparable scores in the Anxiety (mean difference –0.20; 95% CI 0.63; –0.99 to 0.6) and Depressions score (mean difference 0.002; 95% CI –0.67 to 0.67) at all three moments. At baseline, the incidence of an anxiety disorder (definition score 8 or higher) was 19% (30/156) and increased to 30% and 29% at 3 months and 6 months respectively. The incidence of a depression disorder (definition score 8 or higher) was 5% (7/156) and increased to 16% and 18% at 3 months and 6 months respectively. The incidences of anxiety or depression disorders did not differ significantly between expectant management and IUI. Limitations, reasons for caution Our randomized controlled trial did not reach the planned sample size. The results are only applicable to women with unexplained subfertility and a poor prognosis and not to all women with unexplained subfertility. Wider implications of the findings: Although often assumed, IUI-OS does not improve HRQoL compared to expectant management in all domains. IUI might prevent loss of quality of the relationship, but the impact seems small. Future studies should look into the high incidence of anxiety and depression disorders in these women and how to support them. Trial registration number Trial register NL5455 (NTR5599)

scholarly journals Ropivacaine 75mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women- The ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trial.

2020 ◽  
Author(s):  
Claire CARDAILLAC ◽  
Stéphane Ploteau ◽  
Aurélie Le Thuaut ◽  
Vincent Dochez ◽  
Norbert Winer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Perineal Pain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Mediolateral Episiotomy ◽  
The Impact

Abstract Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical rating scale of pain (ENS NRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS NRS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show approximately 30% relative risk reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. Discussion Ropivacaine is a promising candidate drug, inexpensive, easy to administer, and would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy.

scholarly journals Effectiveness of a Randomized Controlled Trial of Individual Reminiscence Therapy on Cognition, Mood and Quality of Life in Azorean Older Adults with Neurocognitive Disorders

2021 ◽  
Vol 10 (22) ◽  
pp. 5395
Author(s):  
Susana I. Justo-Henriques ◽  
Enrique Pérez-Sáez ◽  
João L. Alves Apóstolo ◽  
Janessa O. Carvalho
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Neurocognitive Disorders ◽  
Cognitive Stimulation ◽  
Reminiscence Therapy ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial

Reminiscence therapy (RT) is a form of cognitive stimulation therapy that incorporates discussion of past activities, events, and experiences to stimulate individual memories; it has had some success in treating persons with neurocognitive disorders. This research aims to evaluate the ability of individual RT, using a simple reminiscence format, to improve the overall cognitive function, memory, executive functions, emotional status, and quality of life in older adults with neurocognitive disorders who received social care and support services. A multicenter randomized controlled trial was completed in the Azores archipelago (an independent region of Portugal) using repeated measures (pre-intervention, post-intervention, and follow-up). The intervention group underwent individual RT sessions, twice weekly for 13 weeks, while the control group completed regular activities administered as part of their program. Results did not reveal any significant differences between the intervention and control groups. While results did not reveal significant effects, a number of historical and contextual factors are considered as possible explanations for the lack of effects—namely, data collection occurring during the COVID-19 global pandemic, participant cohort effects, and therapist heterogeneity.

A Proposal of an innovative program for informal caregivers of patients with mood disorders

2017 ◽  
Vol 41 (S1) ◽  
pp. S603-S603
Author(s):  
J. Cabral ◽  
C. Barreto Carvalho ◽  
P. Castilho Freitas ◽  
C. Pato
Keyword(s):  
Quality Of Life ◽  
Mood Disorders ◽  
Negative Impact ◽  
Controlled Trial ◽  
Informal Caregivers ◽  
Well Being ◽  
Control Group ◽  
Compassion Focused Therapy ◽  
The Impact

IntroductionIntervention with informal caregivers (IC) of psychiatric patients is internationally recognized as relevant and a priority. However, the existing responses in this area are still insufficient, especially regarding caregivers of individuals with mood disorders (MD). Mindfulness and compassion focused therapy have proven to be an effective approach in stress reduction and in improving emotional and social well-being of caregivers of patients with other conditions. However, no studies testing these new approaches in IC of patients with MD have been carried out. The objective of this work is to present a research project that aims to develop, implement and empirically test the effectiveness of an innovative group program to help informal caregivers of individuals with mood disorders to cope with the negative impact of the disease and reduce caregiver burdens.MethodsThe design of this experimental study to test the program's efficacy is a non-randomised controlled trial (nrct) with 12 months follow-up, with a mixed assessment methodology (quantitative and qualitative analysis). A sample of 60 informal caregivers of individuals with chronic MD will be constituted (n = 30 Control group; n= 30 Experimental group).ResultsWe expect the program to promote significant changes in participants in terms of several emotional variables (eg: burden, stress, resilience, compassion and quality of life).ConclusionsFurther efforts to continue studying the impact of interventions in caregivers should be carried out, as a way to improve the quality of life of caregivers and their ability to provide informal care to MD patients.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep and Well-being: A Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Kathleen P. O'Hora ◽  
Raquel A. Osorno ◽  
Dena Sadeghi-Bahmani ◽  
Mateo Lopez ◽  
Allison Morehouse ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Early Treatment ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact ◽  
Insomnia Symptoms

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

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