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.

scholarly journals A Mobile Phone–Based Telemonitoring Program for Heart Failure Patients After an Incidence of Acute Decompensation (Medly-AID): Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Emily Seto ◽  
Heather Ross ◽  
Alana Tibbles ◽  
Steven Wong ◽  
Patrick Ware ◽  
...  
Keyword(s):  
Heart Failure ◽  
Controlled Trial ◽  
Hospital Readmissions ◽  
Intervention Group ◽  
Self Care ◽  
Standard Of Care ◽  
Randomized Controlled ◽  
Acute Decompensation ◽  
The Impact

BACKGROUND Patients with heart failure (HF) are at the highest risk for hospital readmissions during the first few weeks after discharge when patients are transitioning from hospital to home. Telemonitoring (TM) for HF management has been found to reduce mortality risk and hospital readmissions if implemented appropriately; however, the impact of TM targeted for patients recently discharged from hospital, for whom TM might have the biggest benefit, is still unknown. Medly, a mobile phone–based TM system that is currently being used as a standard of care for HF at a large Canadian hospital, may be an effective tool for the management of HF in patients recently discharged from hospital. OBJECTIVE The objective of the <italic>Medly-After an Incidence of acute Decompensation</italic> (Medly-AID) trial is to determine the effect of Medly on the self-care and quality of life of patients with HF who have been recently discharged from hospital after an HF-related decompensation. METHODS A multisite multimethod randomized controlled trial (RCT) will be conducted at 2 academic hospitals and at least one community hospital to evaluate the impact of Medly-enabled HF management on the outcomes of patients with HF who had been hospitalized for HF-related decompensation and discharged during the 2 weeks before recruitment. The trial will include 144 participants with HF (74 in each control and intervention groups). Control patients will receive standard of care, whereas patients in the intervention group will receive standard of care and Medly. Specifically, patients in the intervention group will record daily weight, blood pressure, and heart rate and answer symptom-related questions via the Medly app. Medly will generate automated patient self-care messages such as to adjust diuretic medications, based on the rules-based algorithm personalized to the individual patient, and send real-time alerts to their health care providers as necessary. All patients will be followed for 3 months. Primary outcome measures are self-care and quality of life as measured through the validated questionnaires Self-Care of Heart Failure Index, EQ-5D-5L, and the Kansas City Cardiomyopathy Questionnaire-12. Secondary outcome measures for this study include cost of health care services used and health outcomes. RESULTS Patient recruitment began in November 2018 at the Sunnybrook Health Sciences Centre, with a total of 35 participants recruited by July 30, 2019 (17 in the intervention group and 18 in the control group). The final analysis is expected to occur in the fall of 2020. CONCLUSIONS This RCT will be the first to assess the effectiveness of the Medly TM system for use following discharge from hospital after a HF-related decompensation. CLINICALTRIAL ClinicalTrials.gov NCT03358303; https://clinicaltrials.gov/ct2/show/NCT03358303

scholarly journals A Mobile Phone–Based Telemonitoring Program for Heart Failure Patients After an Incidence of Acute Decompensation (Medly-AID): Protocol for a Randomized Controlled Trial

10.2196/15753 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e15753 ◽  
Author(s):  
Emily Seto ◽  
Heather Ross ◽  
Alana Tibbles ◽  
Steven Wong ◽  
Patrick Ware ◽  
...  
Keyword(s):  
Heart Failure ◽  
Controlled Trial ◽  
Hospital Readmissions ◽  
Intervention Group ◽  
Self Care ◽  
Standard Of Care ◽  
Randomized Controlled ◽  
Acute Decompensation ◽  
The Impact

Background Patients with heart failure (HF) are at the highest risk for hospital readmissions during the first few weeks after discharge when patients are transitioning from hospital to home. Telemonitoring (TM) for HF management has been found to reduce mortality risk and hospital readmissions if implemented appropriately; however, the impact of TM targeted for patients recently discharged from hospital, for whom TM might have the biggest benefit, is still unknown. Medly, a mobile phone–based TM system that is currently being used as a standard of care for HF at a large Canadian hospital, may be an effective tool for the management of HF in patients recently discharged from hospital. Objective The objective of the Medly-After an Incidence of acute Decompensation (Medly-AID) trial is to determine the effect of Medly on the self-care and quality of life of patients with HF who have been recently discharged from hospital after an HF-related decompensation. Methods A multisite multimethod randomized controlled trial (RCT) will be conducted at 2 academic hospitals and at least one community hospital to evaluate the impact of Medly-enabled HF management on the outcomes of patients with HF who had been hospitalized for HF-related decompensation and discharged during the 2 weeks before recruitment. The trial will include 144 participants with HF (74 in each control and intervention groups). Control patients will receive standard of care, whereas patients in the intervention group will receive standard of care and Medly. Specifically, patients in the intervention group will record daily weight, blood pressure, and heart rate and answer symptom-related questions via the Medly app. Medly will generate automated patient self-care messages such as to adjust diuretic medications, based on the rules-based algorithm personalized to the individual patient, and send real-time alerts to their health care providers as necessary. All patients will be followed for 3 months. Primary outcome measures are self-care and quality of life as measured through the validated questionnaires Self-Care of Heart Failure Index, EQ-5D-5L, and the Kansas City Cardiomyopathy Questionnaire-12. Secondary outcome measures for this study include cost of health care services used and health outcomes. Results Patient recruitment began in November 2018 at the Sunnybrook Health Sciences Centre, with a total of 35 participants recruited by July 30, 2019 (17 in the intervention group and 18 in the control group). The final analysis is expected to occur in the fall of 2020. Conclusions This RCT will be the first to assess the effectiveness of the Medly TM system for use following discharge from hospital after a HF-related decompensation. Trial Registration ClinicalTrials.gov NCT03358303; https://clinicaltrials.gov/ct2/show/NCT03358303 International Registered Report Identifier (IRRID) DERR1-10.2196/15753

scholarly journals Effect of an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial

2020 ◽  
Vol 7 (1) ◽  
pp. e000376
Author(s):  
Sivakami Janahiraman ◽  
Chan Yen Tay ◽  
Jie Min Lee ◽  
Wen Ling Lim ◽  
Chun Hoe Khiew ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Bowel Preparation ◽  
Controlled Trial ◽  
Tertiary Hospital ◽  
Educational Programme ◽  
Control Group ◽  
Randomised Controlled ◽  
The Impact ◽  
Experimental Group

ObjectivePreprocedural bowel preparation is necessary for optimal colonoscopy visualisation. However, it is challenging to achieve high-quality bowel preparation among patients scheduled for colonoscopy. This study aims to evaluate the impact of an intensive patient educational programme on the quality of bowel preparation.DesignAn accessor-blinded randomised controlled trial was carried out at the outpatient surgical clinic of a tertiary hospital. Patients were randomly assigned to the control group (received standard written and verbal instructions) or the experimental group (received an intensive and structured educational programme). All subjects completed a questionnaire before colonoscopy to assess their compliance, acceptability, and tolerability towards bowel preparation regime. Quality of bowel preparation was determined using the Boston Bowel Preparation Scale (BBPS).ResultsA total of 300 subjects who fulfilled the inclusion criteria were recruited. The experimental group had a significantly higher proportion of good quality bowel preparation than the control group (98.7% vs 52.3%, p<0.001). The median total BBPS score was also significantly higher in the experimental group (8 vs 5, p<0.001). Factors associated with good quality of bowel preparation included educational programme (OR: 22.79, 95% CI: 4.23 to 122.85, p<0.001), compliance to bowel cleansing agent (OR: 24.98, 95% CI 3.12 to 199.71, p<0.001), very difficult acceptability of preparation (OR: 0.11, 95% CI 0.03 to 0.38, p<0.001), tolerability towards bowel preparation (OR: 4.98, 95% CI 1.44 to 17.20, p<0.011) and hypomotility drugs (OR: 3.03, 95% CI 0.12 to 0.91, p<0.05).ConclusionAn intensive patient educational programme can significantly improve the quality of bowel preparation for colonoscopy.

Investigating bacterial decolonization for the prevention of radiation dermatitis: A randomized controlled trial and quality of life assessment.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS12137-TPS12137
Author(s):  
Karolina Mieczkowska ◽  
Alana Deutsch ◽  
Kosaku Shinoda ◽  
Johanna Daily ◽  
Nitin Ohri ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Life Assessment ◽  
Radiation Dermatitis ◽  
Low Grade ◽  
Randomized Controlled ◽  
The Impact

TPS12137 Background: Radiation dermatitis (RD) can be therapy-limiting and detrimental to quality of life for cancer patients receiving radiation therapy (RT). Bacteria play an important role in many inflammatory dermatoses. In an observational clinical study, our group discovered that nasal colonization with bacteria, specifically with Staphylococcus aureus (SA), prior to RT was an independent predictor of higher-grade RD (grade ≥2). Higher-grade RD patients were also found to have more SA on the irradiated skin after treatment. If successful, bacterial decolonization could be a safe and cost-effective method to prevent RD. Methods: This is a randomized controlled trial assessing the efficacy of universal bacterial decolonization in preventing RD. Subject inclusion criteria include patients who are aged ≥ 18 years with a diagnosis of a solid tumor of the breast or head and neck with plans for fractionated RT (≥ 15 fractions) with curative intent. Based on previous studies and power analyses, we plan to recruit a total of 80 patients. Patients in the control arm will be treated according to standard of care, including daily application of emollients and gentle bathing. In addition to standard of care, patients in the intervention arm will receive a decolonization regimen consisting of intranasal mupirocin ointment used twice daily and chlorhexidine wash used daily for 5 days prior to the initiation of RT and repeated for 5 days every other week throughout RT. Study evaluations for both groups will include bacterial cultures obtained via superficial swab from the nares, irradiated skin, and contralateral non-radiated skin performed at the beginning, middle, and end of RT. Additionally, standardized photographs of the skin at the radiated site will be performed prior to and at the completion of RT, which will be graded by a dermatologist blinded to study arm. Lastly, at identical timepoints, each patient will complete the SKINDEX-16 questionnaire, a validated quality of life (QoL) assessment. The primary endpoint is development of grade ≥ 2 RD, as compared to low-grade RD (grade 0-1), during RT. The secondary endpoint includes the impact of bacterial decolonization on QoL. Pearson’s chi square or Fisher’s exact tests will be used to compare the incidence rates of higher-grade RD between the interventional arm and control arm to assess if the intervention is associated with a lower incidence rate of higher-grade RD. Paired t-tests will be used to compare the QoL score change from baseline to after RT between the two arms. Linear regression models will be used in both analyses to adjust for covariates. Clinical trial information: NCT03883828.

scholarly journals Hippotherapy for patients with multiple sclerosis: A multicenter randomized controlled trial (MS-HIPPO)

2017 ◽  
Vol 24 (10) ◽  
pp. 1375-1382 ◽  
Author(s):  
Vanessa Vermöhlen ◽  
Petra Schiller ◽  
Sabine Schickendantz ◽  
Marion Drache ◽  
Sabine Hussack ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mean Difference ◽  
Control Group ◽  
Health Score ◽  
Multicenter Randomized Controlled Trial

Background: Evidence-based complementary treatment options for multiple sclerosis (MS) are limited. Objective: To investigate the effect of hippotherapy plus standard care versus standard care alone in MS patients. Methods: A total of 70 adults with MS were recruited in five German centers and randomly allocated to the intervention group (12 weeks of hippotherapy) or the control group. Primary outcome was the change in the Berg Balance Scale (BBS) after 12 weeks, and further outcome measures included fatigue, pain, quality of life, and spasticity. Results: Covariance analysis of the primary endpoint resulted in a mean difference in BBS change of 2.33 (95% confidence interval (CI): 0.03–4.63, p = 0.047) between intervention ( n = 32) and control ( n = 38) groups. Benefit on BBS was largest for the subgroup with an Expanded Disability Status Scale (EDSS) ⩾ 5 (5.1, p = 0.001). Fatigue (−6.8, p = 0.02) and spasticity (−0.9, p = 0.03) improved in the intervention group. The mean difference in change between groups was 12.0 ( p < 0.001) in physical health score and 14.4 ( p < 0.001) in mental health score of Multiple Sclerosis Quality of Life-54 (MSQoL-54). Conclusion: Hippotherapy plus standard care, while below the threshold of a minimal clinically important difference, significantly improved balance and also fatigue, spasticity, and quality of life in MS patients.

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 Early detection of anaemia in primary care with haemoglobinometry: ANHEMOG clinical trial protocol

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Boris Trenado Luengo ◽  
Rosa García-Sierra ◽  
Maria Asunción Wilke Trinxant ◽  
Esther Díaz Mondelo ◽  
Ramon Miralles Baseda ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Chronic Diseases ◽  
Response Times ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Monthly Basis ◽  
The Impact

Abstract Background Detecting, treating and monitoring anaemia has a functional, social and economic impact on patients’ quality of life and the health system, since inadequate monitoring can lead to more accident & emergency visits and hospitalizations. The aim of this study is to evaluate the impact in the patient clinical outcomes of using haemoglobinometry to early detect anaemia in patients with chronic anaemia in primary care. Methods Randomized controlled trial Capillary haemoglobin will be measured using a haemoglobinometer on a monthly basis in the intervention group. In the control group, the protocol currently in force at the primary care centre will be followed and venous haemoglobin will be measured. Any cases of anaemia detected in either group will be referred to the transfusion circuit of the reference hospital. Discusion The results will shed light on the impact of the intervention on the volume of hospitalizations and accident & emergency (A&E) visits due to anaemia, as well as patients’ quality of life. Chronic and repeated bouts of anaemia are detected late, thus leading to decompensation in chronic diseases and, in turn, more A&E visits and hospitalizations. The intervention should improve these outcomes since treatment could be performed without delay. Improving response times would decrease decompensation in chronic diseases, as well as A&E visits and hospitalizations, and improve quality of life. The primary care nurse case manager will perform the intervention, which should improve existing fragmentation between different care levels. Trial registration NCT04757909. Registered 17 February 2021. Retrospectively registered.

Dietary Patterns: A New Therapeutic Approach for Depression?

2019 ◽  
Vol 20 (2) ◽  
pp. 123-129 ◽  
Author(s):  
Mariana Jesus ◽  
Tânia Silva ◽  
César Cagigal ◽  
Vera Martins ◽  
Carla Silva
Keyword(s):  
Depressive Symptoms ◽  
Dietary Patterns ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
Dietary Intervention ◽  
Common Mental Disorder ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Inverse Association ◽  
The Impact

Introduction: The field of nutritional psychiatry is a fast-growing one. Although initially, it focused on the effects of vitamins and micronutrients in mental health, in the last decade, its focus also extended to the dietary patterns. The possibility of a dietary cost-effective intervention in the most common mental disorder, depression, cannot be overlooked due to its potential large-scale impact. Method: A classic review of the literature was conducted, and studies published between 2010 and 2018 focusing on the impact of dietary patterns in depression and depressive symptoms were included. Results: We found 10 studies that matched our criteria. Most studies showed an inverse association between healthy dietary patterns, rich in fruits, vegetables, lean meats, nuts and whole grains, and with low intake of processed and sugary foods, and depression and depressive symptoms throughout an array of age groups, although some authors reported statistical significance only in women. While most studies were of cross-sectional design, making it difficult to infer causality, a randomized controlled trial presented similar results. Discussion: he association between dietary patterns and depression is now well-established, although the exact etiological pathways are still unknown. Dietary intervention, with the implementation of healthier dietary patterns, closer to the traditional ones, can play an important role in the prevention and adjunctive therapy of depression and depressive symptoms. Conclusion: More large-scale randomized clinical trials need to be conducted, in order to confirm the association between high-quality dietary patterns and lower risk of depression and depressive symptoms.

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