Randomized controlled trial
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Aim: To report a trial protocol to determine if a self-care program enhances quality of life and sense of coherence in community-dwellers aged 65 years or over. Design: A randomized controlled trial with a two-group pretest and posttest will be conducted in a community activity center involving a sample of 64 community-dwellers who are 65 years or over. Methods: The intervention group will receive Resource Enhancement and Activation Program, a structured 12-week self-care program comprising 24 activities based on a salutogenic framework. The control group will receive the routine service. Both outcome and process evaluations will be used. Outcomes will be measured using standardized tools and these include quality of life, sense of coherence, satisfaction with life, activation measure, well-being, depression, loneliness and resilience. Focus group interviews will be conducted to explore participants’ views on the program. Conclusion: This study will provide evidence on the feasibility and effectiveness of a self-care program that is based on a salutogenic framework to promote quality of life and sense of coherence among older community-dwellers.
- MeSH
- denní stacionář pro seniory * metody MeSH
- komunitní ošetřovatelská péče MeSH
- kvalita života * MeSH
- lidé MeSH
- péče o sebe * klasifikace statistika a číselné údaje MeSH
- randomizované kontrolované studie jako téma statistika a číselné údaje MeSH
- senioři MeSH
- Check Tag
- lidé MeSH
- senioři MeSH
- Publikační typ
- práce podpořená grantem MeSH
elektronický časopis
- MeSH
- kardiovaskulární nemoci MeSH
- klinické zkoušky jako téma MeSH
- randomizované kontrolované studie jako téma MeSH
- Konspekt
- Patologie. Klinická medicína
- NLK Obory
- kardiologie
- NLK Publikační typ
- elektronické časopisy
In clinical practice, there is considerable variation in the timing of the initiation of maintenance dialysis for patients with stage V chronic kidney disease, with a worldwide trend toward early initiation. In this study, conducted at 32 centers in Australia and New Zealand, we examined whether the timing of the initiation of maintenance dialysis influenced survival among patients with chronic kidney disease. METHODS: We randomly assigned patients 18 years of age or older with progressive chronic kidney disease and an estimated glomerular filtration rate (GFR) between 10.0 and 15.0 ml per minute per 1.73 m2 of body-surface area (calculated with the use of the Cockcroft-Gault equation) to planned initiation of dialysis when the estimated GFR was 10.0 to 14.0 ml per minute (early start) or when the estimated GFR was 5.0 to 7.0 ml per minute (late start). The primary outcome was death from any cause. RESULTS: Between July 2000 and November 2008, a total of 828 adults (mean age, 60.4 years; 542 men and 286 women; 355 with diabetes) underwent randomization, with a median time to the initiation of dialysis of 1.80 months (95% confidence interval [CI], 1.60 to 2.23) in the early-start group and 7.40 months (95% CI, 6.23 to 8.27) in the late-start group. A total of 75.9% of the patients in the late-start group initiated dialysis when the estimated GFR was above the target of 7.0 ml per minute, owing to the development of symptoms. During a median follow-up period of 3.59 years, 152 of 404 patients in the early-start group (37.6%) and 155 of 424 in the late-start group (36.6%) died (hazard ratio with early initiation, 1.04; 95% CI, 0.83 to 1.30; P=0.75). There was no significant difference between the groups in the frequency of adverse events (cardiovascular events, infections, or complications of dialysis). CONCLUSIONS: In this study, planned early initiation of dialysis in patients with stage V chronic kidney disease was not associated with an improvement in survival or clinical outcomes. (Funded by the National Health and Medical Research Council of Australia and others; Australian New Zealand Clinical Trials Registry number, 12609000266268.)
- MeSH
- časové faktory MeSH
- chronické selhání ledvin komplikace mortalita terapie MeSH
- dialýza ledvin metody škodlivé účinky MeSH
- dospělí MeSH
- financování organizované MeSH
- hodnoty glomerulární filtrace MeSH
- infekce etiologie mortalita MeSH
- Kaplanův-Meierův odhad MeSH
- kardiovaskulární nemoci etiologie mortalita MeSH
- kvalita života MeSH
- lidé středního věku MeSH
- lidé MeSH
- proporcionální rizikové modely MeSH
- randomizované kontrolované studie jako téma MeSH
- uremie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- multicentrická studie MeSH
- MeSH
- blokátory receptorů AT1 pro angiotensin II terapeutické užití MeSH
- chronické selhání ledvin etiologie farmakoterapie prevence a kontrola MeSH
- imunosupresivní léčba metody MeSH
- inhibitory ACE terapeutické užití MeSH
- lidé MeSH
- membranózní glomerulonefritida farmakoterapie MeSH
- prospektivní studie MeSH
- proteinurie etiologie farmakoterapie MeSH
- takrolimus aplikace a dávkování terapeutické užití MeSH
- Check Tag
- lidé MeSH
- MeSH
- antikonvulziva aplikace a dávkování farmakologie terapeutické užití MeSH
- dospělí MeSH
- finanční podpora výzkumu jako téma MeSH
- hodnocení léčiv MeSH
- lidé MeSH
- migréna farmakoterapie patologie prevence a kontrola MeSH
- mladiství MeSH
- svalové křeče patologie MeSH
- výsledek terapie MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- randomizované kontrolované studie MeSH
Controlled clinical trials, ISSN 0197-2456 vol. 24, no. 6S, December 2003
268-328 s. : il, tab. ; 26 cm
- MeSH
- digitalisové glykosidy MeSH
- digoxin terapeutické užití MeSH
- klinické zkoušky kontrolované jako téma MeSH
- management farmakoterapie MeSH
- medicína založená na důkazech MeSH
- randomizované kontrolované studie jako téma MeSH
- sběr dat MeSH
- srdeční selhání farmakoterapie MeSH
- Publikační typ
- sborníky MeSH
- Konspekt
- Patologie. Klinická medicína
- NLK Obory
- lékařství
- kardiologie
- farmacie a farmakologie
- MeSH
- akupunkturní terapie MeSH
- dospělí MeSH
- finanční podpora výzkumu jako téma MeSH
- lidé MeSH
- migréna terapie MeSH
- placebo efekt MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- klinické zkoušky kontrolované MeSH
AIM: To describe a randomized controlled trial protocol that will evaluate the effectiveness of two web-based genomic nursing education interventions. BACKGROUND: Preparing future nurses to be competent in genetic and genomic concepts is fundamental to ensure appropriate clinical application. However, genetics-genomics concepts are still new in the field of nursing. Little is known about what type and kind of web-based nursing education is effective in improving the knowledge of nursing students. To address these knowledge gaps, a web-based 'Genomic Nursing Education Intervention' will be developed and compared with an existing online education programme. DESIGN: A randomized controlled trial of two groups with pre-test and repeated posttesting. METHODS: The Genomic Nursing Concept Inventory, a validated tool, will be used to assess the genetics-genomics knowledge of nursing students. Participants will be randomly allocated to either a control or an intervention group. The control group will receive the standard web-based nursing education, while the intervention group will receive a newly developed web-based education intervention. Outcome measures include the students' knowledge level of nursing genetics-genomics concepts. Participants will be retested at 3 and 6 months. CONCLUSION: Current evidence shows that ensuring nurses have adequate education in genetic-genomic concepts is challenging. This study will demonstrate which of two web-based nursing education methods is more effective in teaching genetic-genomic concepts. This research project will better prepare the nursing profession in their careers for the emerging advance technologies in genetics-genomics and personalized health care. IMPACT: Current evidence shows major challenges in ensuring that nurses have adequate education in genetics-genomics concepts. Less is known about what approaches to web-based education are effective to improve the knowledge gaps of nursing students in genetics-genomics concepts. This study will determine which type of web-based nursing education is effective in improving the genetics-genomics knowledge of nursing students. This research project will help better prepare nurses in dealing with advances in genetics-genomics in their careers. TRIAL REGISTRATION: This study is registered in ClinicalTrials.gov (ID number NCT03963687) https://clinicaltrials.gov/show/NCT03963687.
BACKGROUND AND AIM: Oral feeding following variceal ligation in cirrhotics is usually delayed due to fear of rebleeding. Solid diet is usually further delayed (until 72 h) despite lack of evidence. We aimed to compare the impact of early versus delayed feeding on rebleeding following variceal ligation. METHODS: This was a prospective randomized controlled trial including patients undergoing variceal ligation for active esophageal variceal bleeding. Patients were randomized into two groups. In the early-feeding group, liquid diet was given after 1 h following variceal ligation and a regular solid diet was resumed after 4 h. In the delayed-feeding group, patients fasted for the first 4 h after variceal ligation, liquid diet was given until 24 h, soft diet for the next 48 h and a regular solid diet after 72 h. RESULTS: There were 52 and 49 patients in the early and delayed feeding groups, respectively. Very early rebleeding rates [2 (3.84%) vs 1 (2.04%); P ≥ 0.99] and delayed rebleeding rates [2 (3.84%) vs 4 (8.16%); P = 0.75] were similar in both groups. Protein and calorie intake in the early-feeding group was significantly better and early infections in active bleeders were significantly lower compared to the delayed-feeding group. One-month mortality was similar in both groups [3 (5.76%) vs 4 (8.16%); P = 0.75]. CONCLUSION: Early feeding with a regular solid diet in conscious patients after successful variceal ligation for esophageal varices is safe, provides better nutrition and results in lower incidence of infections in bleeders compared to delayed feeding.
- MeSH
- čas zasáhnout při rozvinutí nemoci MeSH
- enterální výživa metody MeSH
- ezofageální a žaludeční varixy komplikace diagnóza terapie MeSH
- gastroenterologie * MeSH
- gastrointestinální endoskopie metody MeSH
- gastrointestinální krvácení diagnóza etiologie terapie MeSH
- jaterní cirhóza komplikace diagnóza terapie MeSH
- kongresy jako téma MeSH
- lidé MeSH
- ligace metody MeSH
- randomizované kontrolované studie jako téma * MeSH
- společnosti lékařské * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- úvodníky MeSH
Dietary vitamin K is thought to be an important factor that interferes with anticoagulation stability, but the clinical applicability of this interaction has not been evaluated adequately in prospective studies. METHODS AND RESULTS: In a randomized controlled trial that enrolled outpatients with a recent international normalized ratio (INR) outside the therapeutic target, we compared 2 strategies to optimize long-term oral anticoagulation: (1) a conventional approach based on changes in anticoagulant prescription and (2) a dietary vitamin K-guided strategy based on simple modifications of the amount of vitamin K-rich foods ingested per week. The primary efficacy end point was the percentage of patients who achieved a prespecified INR target at 90 days after randomization. Study population (n=132) predominantly included men with mechanical heart prostheses (58%) or atrial fibrillation (35%). Over time, patients allocated to the vitamin K-guided strategy reached the prespecified INR more frequently so that after 90 days of follow-up, 74% were on target compared with 58% of patients managed conventionally (P=0.04). Patients allocated to the dietary vitamin K-guided strategy had the same magnitude and direction of INR variation as those observed with the conventional approach in the short term (15 days) for both underanticaogulated and overanticoagulated patients. Minor bleeding or use of parenteral vitamin K were also marginally less frequent in patients managed according to the dietary intervention (1 [1.5%] versus 7 [11%]; P=0.06). CONCLUSIONS: A vitamin K-guided management strategy to adjust long-term oral anticoagulation is feasible and safe and may result in an increased chance of reaching target levels of INR.
- MeSH
- antikoagulancia aplikace a dávkování MeSH
- aplikace orální MeSH
- dieta MeSH
- dospělí MeSH
- financování organizované MeSH
- INR MeSH
- klinické křížové studie MeSH
- lidé středního věku MeSH
- lidé MeSH
- randomizované kontrolované studie jako téma MeSH
- senioři MeSH
- vitamin K aplikace a dávkování MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH