scholarly journals P033 Randomised controlled trial on the efficacy of Audio-visual Health Educational materials on CPAP ADherence: The AHEAD trial

2021 ◽  
Vol 2 (Supplement_1) ◽  
pp. A32-A32
Author(s):  
C Ellender ◽  
C Samaranayake ◽  
B Duce ◽  
M Boyde ◽  
S Winter ◽  
...  
Keyword(s):  
Health Literacy ◽  
Low Cost ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Eligibility Criteria ◽  
Cpap Adherence ◽  
Low Health Literacy ◽  
Significant Difference ◽  
Educational Videos ◽  
Video Education

Abstract OSA is a prevalent chronic disease with significant health implications, for which achieving >4 hours/night on continuous positive airway pressure (CPAP) is essential for effective treatment. Educational videos to improve CPAP adherence are of interest as a low-cost intervention, however trials have shown mixed results. This study aimed to compare CPAP usage following standard of care education (SOCE), with the usage following the addition of educational videos, customised to incorporate low health literacy communication, motivational and self-efficacy techniques. Methods Adults with OSA recommended treatment with CPAP, were recruited and randomised in a single blinded method, to watch short educational videos following their in laboratory CPAP study or SOCE. The primary outcome was CPAP usage at 2mths and secondary outcomes were usage at 12mth and proportion of patients with adequate usage >4hrs/night. Results 195 patients met the eligibility criteria and were randomised to video education (n = 96) or to SOCE (n = 99). There was no significant difference in compliance at 2mths (median usage 1.7hrs IQR 0–6.2 SOCE, 4.4hrs IQR 0–6.7 video education p = 0.1), however at 12mths there was increased usage in the video education arm (median 0hrs IQR 0–5.4 standard of care, 3.8hrs IQR 0–6.87 p = 0.05). The proportion with adequate CPAP usage >4hrs/night at 12mths was higher in the video education group (33, 33% versus 48, 50% p = 0.01). Conclusions Long-term adherence to CPAP is enhanced by the addition of educational videos that incorporate low health literacy communication and motivational techniques, compared to SOCE.

scholarly journals The Feasibility of Health Trainer Improved Patient Self-Management in Patients with Low Health Literacy and Poorly Controlled Diabetes: A Pilot Randomised Controlled Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-11 ◽  
Author(s):  
Joanne Protheroe ◽  
Trishna Rathod ◽  
Bernadette Bartlam ◽  
Gillian Rowlands ◽  
Gerry Richardson ◽  
...  
Keyword(s):  
Health Literacy ◽  
Usual Care ◽  
Low Cost ◽  
Controlled Trial ◽  
Illness Perception ◽  
Cost Effective ◽  
Outcome Data ◽  
Disadvantaged Population ◽  
Low Health Literacy ◽  
Randomised Controlled

Type 2 diabetes mellitus is most prevalent in deprived communities and patients with low health literacy have worse glycaemic control and higher rates of diabetic complications. However, recruitment from this patient population into intervention trials is highly challenging. We conducted a study to explore the feasibility of recruitment and to assess the effect of a lay health trainer intervention, in patients with low health literacy and poorly controlled diabetes from a socioeconomically disadvantaged population, compared with usual care. Methods. A pilot RCT comparing the LHT intervention with usual care. Patients with HbA1c > 7.5 (58 mmol/mol) were recruited. Baseline and 7-month outcome data were entered directly onto a laptop to reduce patient burden. Results. 76 patients were recruited; 60.5% had low health literacy and 75% were from the most deprived areas of England. Participants in the LHT arm had significantly improved mental health (p=0.049) and illness perception (p=0.040). The intervention was associated with lower resource use, better patient self-care management, and better QALY profile at 7-month follow-up. Conclusion. This study describes successful recruitment strategies for hard-to-reach populations. Further research is warranted for this cost-effective, relatively low-cost intervention for a population currently suffering a disproportionate burden of diabetes, to demonstrate its sustained impact on treatment effects, health, and health inequalities.

A phase III study of Æ-941 with induction chemotherapy (IC) and concomitant chemoradiotherapy (CRT) for stage III non- small cell lung cancer (NSCLC) (NCI T99–0046, RTOG 02–70, MDA 99–303)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7527-7527 ◽  
Author(s):  
C. Lu ◽  
J. J. Lee ◽  
R. Komaki ◽  
R. S. Herbst ◽  
W. K. Evans ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Performance Status ◽  
Stage Iiib ◽  
Phase Iii ◽  
Stage Iii ◽  
Type I ◽  
Eligibility Criteria ◽  
Unresectable Stage ◽  
Significant Difference ◽  
Stage Iii Nsclc

7527 Background: Æ-941 is a shark cartilage extract with antiangiogenic properties. We conducted a placebo-controlled trial testing Æ-941, with IC and CRT, in unresectable stage III NSCLC. Methods: Eligibility criteria included performance status (PS) < 2, weight loss < 10%. Subjects received one of two treatment regimens depending on site of enrollment: carboplatin (C) (AUC 6) and paclitaxel (P) (200 mg/m2) × 2 cycles followed by CRT (60 Gy/30 fractions) with weekly C (AUC 2) and P (45 mg/m2) × 6 doses or cisplatin (CDDP) (75 mg/m2, d1) and vinorelbine (V) (30 mg/m2, d1 and 8) × 2 cycles followed by CRT (60 Gy/30 fractions) with CDDP (75 mg/m2, day 1) and V (15 mg/m2, d1 and 8) × 2 cycles. Subjects were randomized to receive Æ-941 (Arm A) or placebo (Arm B), 120 mL orally twice daily, at the start of IC and continuing after CRT as maintenance therapy. Randomization was stratified for stage, gender, and type of chemotherapy. The primary endpoint was overall survival (OS), with a planned sample size of 756 subjects providing 80% power to detect a 25% difference in OS, assuming a control arm median survival time (MST) of 13 months, type I error 0.05. Results: Between 6/00 and 2/06, 384 subjects were enrolled onto the trial and randomized. In 2/06 the trial was closed to new patient entry due to insufficient accrual. This final analysis is based on 379 randomized and eligible subjects (188 arm A, 191 arm B). Subject characteristics: 60% male, median age 63 years (range 37–84), 56% stage IIIB, 58% C-based chemotherapy, median follow-up 3.7 years. There was no significant difference in OS between arms A and B, with MSTs of 14.4 (95% CI 12.6–17.9) and 15.6 (95% CI 13.8–18.1) months, respectively (log-rank p=0.73). OS by pre-specified stratification factors: stage IIIB vs IIIA (MST 13.9 vs. 17.4 months, p=0.25), C vs. CDDP chemotherapy (MST 14.4 vs. 16.7 months, p=0.13), and male vs. female (MST 15.7 vs. 15.1 months, p=0.74). The study drug was well tolerated. Fewer subjects in arm A experienced grade 3 or higher adverse events (66% vs. 77%, p=0.018). Conclusions: The addition of Æ−941 to IC and CRT does not improve OS in patients with unresectable stage III NSCLC. No significant financial relationships to disclose.

Yoga in women undergoing treatment for breast cancer: Impact on quality of life in a randomized controlled trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 527-527
Author(s):  
Nita S. Nair ◽  
Nishu Singh Goel ◽  
Rohini W Hawaldar ◽  
Shabina Siddique ◽  
Vani Parmar ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Adjuvant Therapy ◽  
Low Cost ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Disease Free Survival ◽  
Complementary Therapy ◽  
Significant Difference

527 Background: Yoga has been tested in multiple small-randomized studies for its impact on quality of life (QOL) on breast cancer (BC). We propose to study the effect of yoga on disease free survival as the primary endpoint in women with operable breast cancer. (Study methodology details refer to NCT02161900). Methods: Women with non-metastatic BC were randomized to yoga and conventional exercise (YCE) versus conventional exercise only (CE) in addition to standard therapy. Over and above documentation of recurrence and death, QOL was assessed in these women using the EORTC QLQC30, BR23, Brief fatigue inventory (BFI), Visual pain scores (VPS) and a spirituality questionnaire (SQ). EORTC QLQ was assessed at baseline (BL), 6-9 months (mo), 18-21 mo. BFI and VPS at BL, 6-8 mo and 12-15 mo and SQ at BL and 12-15 mo. We report the first interim analysis of QOL in 605 patients randomized to the study with atleast 1 year of follow up. The groups were balanced in both arms with respect to clinico-pathological factors. Results: At 6-9 mo (completion of adjuvant therapy), there was no significant difference in global QOL scores (p = 0.08), however 52% women on YCE showed an improvement from baseline compared to 42% in CE. At 18-21 mo emotional function scores were better in YCE (p = 0.002); with lesser systemic side effects in YCE arm (44% vs 56% p = NS). The median score of fatigue after adjuvant therapy measured by QLQ C30 was lower in YCE (17.37vs22.22, p = 0.003) which was similar to that observed by BFI at 12-15 mo (1.6vs 2, p = 0.04). Also in YCE there was lower reporting of detriment in general activity (41%vs 59%) and mood (34%vs66%) (p = NS). In VPS at 12-15mo, the median scores for pain intensity (p = 0.042), pain on movement (p = 0.038), pain on mobilization (p = 0.008) were lower in YCE. Lastly SQ assessed spirituality and showed no difference, but less deterioration compared to baseline scores in YCE. Conclusions: Yoga did not show a significant difference in global QOL but had a major benefit reaching statistical significance in fatigue, emotional score and pain. Yoga is a low-risk, low-cost complementary therapy that may improve compliance to therapy by improving parameters that can affect day-to-day activity in women with breast cancer. Clinical trial information: NCT02161900.

Educational Video Intervention Effects on Periprocedural Anxiety Levels Among Cardiac Catheterization Patients: A Randomized Clinical Trial

2016 ◽  
Vol 30 (1) ◽  
pp. 70-84 ◽  
Author(s):  
Shahnaz Mohammed Ayasrah ◽  
Muayyad M. Ahmad
Keyword(s):  
Cardiac Catheterization ◽  
Controlled Trial ◽  
Test Procedure ◽  
Group Versus ◽  
Educational Video ◽  
Video Intervention ◽  
Significant Difference ◽  
Anxiety Levels ◽  
Experimental Group ◽  
Video Education

Purpose: To explore the effectiveness of an educational video intervention in lowering periprocedural anxiety among Jordanian patients hospitalized for cardiac catheterization (CATH). There are many potential reasons of anxiety related to CATH including involvement of the heart and the actual test procedure. Methods: A randomized controlled trial took place in a specialized heart institute in Jordan. The sample size was 186 patients who had undergone CATH procedure. Patients anxiety levels were measured by physiological parameters of anxiety (blood pressure, heart rate, and respiratory rate) and by the Spielberger State Anxiety Inventory (SAI). Results: After video education, there was a significant difference in periprocedural perceived anxiety between the groups: preprocedural anxiety levels (M = 39.03, SD = 5.70) for the experimental group versus (M = 49.34, SD = 6.00) for the control, p < .001, and postprocedural perceived anxiety for the experimental group (M = 29.18, SD = 5.42) versus (M = 41.73, SD = 5.41) for the control. Conclusion: Providing an educational video intervention about CATH may effectively decrease periprocedural anxiety levels.

scholarly journals A multi centre randomized open label trial of chloroquine for the treatment of adults with SARS-CoV-2 infection in Vietnam

2020 ◽  
Vol 5 ◽  
pp. 141
Author(s):  
Evelyne Kestelyn ◽  
Nguyen Thi Phuong Dung ◽  
Yen Lam Minh ◽  
Le Manh Hung ◽  
Nguyen Minh Quan ◽  
...  
Keyword(s):  
Low Cost ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Rapid Decline ◽  
Tolerability Profile ◽  
Open Label ◽  
Field Hospital ◽  
Novel Coronavirus ◽  
Randomised Controlled ◽  
Evidence Based Guidelines

Background: COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent COVID-19 or therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate chloroquine as a potential therapeutic for the treatment of hospitalised people with COVID-19. We hypothesise that chloroquine slows viral replication in patients with COVID-19, attenuating the infection, and resulting in more rapid decline of viral load in throat/nose swabs. This viral attenuation should be associated with improved patient outcomes. Method: The study will start with a 10-patient prospective observational pilot study following the same entry and exclusion criteria as for the randomized trial and undergoing the same procedures. The main study is an open label, randomised, controlled trial with two parallel arms of standard of care (control arm) versus standard of care with 10 days of chloroquine (intervention arm) with a loading dose over the first 24 hours, followed by 300mg base orally once daily for nine days. The study will recruit patients in three sites in Ho Chi Minh City, Vietnam: the Hospital for Tropical Diseases, the Cu Chi Field Hospital, and the Can Gio COVID hospital. The primary endpoint is the time to viral clearance from throat/nose swab, defined as the time following randomization until the midpoint between the last positive and the first of the negative throat/nose swabs. Viral presence will be determined using RT-PCR to detect SARS-CoV-2 RNA. Discussion: The results of the study will add to the evidence-based guidelines for management of COVID-19. Given the enormous experience of its use in malaria chemoprophylaxis, excellent safety and tolerability profile, and its very low cost, if proved effective then chloroquine would be a readily deployable and affordable treatment for patients with COVID-19. Trial registration: Clinicaltrials.gov NCT04328493 31/03/2020

A randomized study comparing physician-directed or fixed-dose dexamethasone replacement following incomplete steroid premedication for docetaxel chemotherapy.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6610-6610
Author(s):  
Tina Hsu ◽  
Carol Stober ◽  
Dean Fergusson ◽  
Kelly Daigle ◽  
Noorza Moledina ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Randomized Study ◽  
Randomised Trial ◽  
Standard Of Care ◽  
Fluid Retention ◽  
Fixed Dose ◽  
Significant Difference ◽  
Chemotherapy Patients ◽  
Randomised Controlled ◽  
Clinical Trial Information

6610 Background: Prior to receiving docetaxel-based chemotherapy patients often incorrectly take all or part of their steroid-premedication. The lack of standardised steroid-replacement strategies can lead to variability in care and delays in starting chemotherapy while nursing/pharmacy/physicians establish an individualized patient plan, which can use up valuable chemotherapy chair time. A randomised controlled trial comparing a fixed-oral dose of dexamethasone and physician-directed replacement was performed. Methods: Patients who missed at least one dose of steroid-premedication were randomised to either standard replacement with dexamethasone 8mg orally or physician-directed replacement (any steroid, dose or route). The primary outcome was time from randomisation to starting docetaxel. Secondary outcomes included rates of acute and delayed hypersensitivity reactions, fluid retention and skin rashes. Results: Sixty patients were randomized. Most patients were enrolled during cycle 1 (47.5%) and cycle 2 (22%) of docetaxel. The most frequent total doses of dexamethasone omitted were 24 mg (27%), 12 mg (20%), and 8 mg (19%). There were 7 different replacement strategies used by physicians. The most frequently used strategies were: dexamethasone 8mg IV (34.5%), 12mg IV (17.2%) and 20mg IV (13.8%). Patients in the fixed-dose arm received docetaxel earlier than patients in the physician-choice arm, at a median of 47.5 and 61 minutes after randomization (mean = 62.2 vs 83.4 minutes) (p = 0.033). No significant difference in rates of acute (0 vs 2)/delayed allergic reactions (1 vs 0), fluid retention (2 vs 1), or skin rashes (1 vs 0) was observed between the fixed-dose and physician-choice arms respectively. Conclusions: This is the first randomised trial to compare steroid-replacement strategies in this patient population. Fixed-dose replacement with dexamethasone 8 mg PO should be the preferred standard of care, as it reduces both the time to starting docetaxel and treatment variability, with no apparent increase in toxicity. Clinical trial information: NCT02815319.

The Effectiveness of an Active Learning Program in Promoting a Healthy Lifestyle among Older Adults with Low Health Literacy: A Randomized Controlled Trial

Gerontology ◽  
2020 ◽  
pp. 1-11
Author(s):  
Kazuki Uemura ◽  
Minoru Yamada ◽  
Hiroshi Okamoto
Keyword(s):  
Older Adults ◽  
Health Literacy ◽  
Active Learning ◽  
Healthy Lifestyle ◽  
Controlled Trial ◽  
Intervention Group ◽  
Network Size ◽  
Control Group ◽  
Learning Program ◽  
Low Health Literacy

<b><i>Background:</i></b> Older adults often have a greater need for health information and health care services because access to these helps them manage their health and the chronic conditions of aging. Therefore, low health literacy bears a special significance for the population of older adults. <b><i>Objectives:</i></b> The aim of this study was to examine the effects of an active learning program on health literacy, lifestyle behaviors, physical function, and mental health among community-dwelling older adults with low health literacy. <b><i>Methods:</i></b> This single-blind, randomized controlled trial involved 60 participants aged ≥65 years with a low health literacy who were randomly assigned to an intervention (<i>n</i> = 30) or control (<i>n</i> = 30) group. Across 24 weeks, the intervention group attended weekly 90-min active learning program sessions, which involved exploratory learning, group work, and the self-planning of behavior changes that promote a healthy lifestyle. The control group attended a 90-min class, which was taught in accordance with the didactic teaching method. For both groups, the programs focused on the role of exercise, diet/nutrition, and cognitive activity for promoting health among older adults. The outcome measures were administered at baseline and week 24. Comprehensive health literacy (i.e., primary outcome) was assessed using the Health Literacy Scale-14. Lifestyle factors (i.e., physical activity, dietary variety, life-space mobility, and social network size), physical function, and depressive symptoms were measured. We used a linear mixed model to estimate the intervention effects in accordance with the intention-to-treat approach. <b><i>Results:</i></b> When compared to the control group, the intervention group demonstrated a significant improvement in communicative health literacy, step count, engagement in moderate-to-vigorous physical activity, dietary variety, life-space mobility, social network size, grip strength, gait speed, and depressive symptoms. <b><i>Conclusions:</i></b> The active learning program can promote a healthy lifestyle and prevent functional decline among older adults who lack the confidence to engage in health communication.

Evaluating the use of educational videos to support the tuberculosis care cascade in remote Madagascar

2020 ◽  
Vol 24 (1) ◽  
pp. 28-35
Author(s):  
H. Reeves ◽  
S. Grandjean Lapierre ◽  
K. Razafindrina ◽  
A. Andriamiadanarivo ◽  
N. Rakotosamimanana ◽  
...  
Keyword(s):  
Low Cost ◽  
Low Literacy ◽  
Video Training ◽  
Significant Difference ◽  
Post Test ◽  
Cascade Of Care ◽  
Educational Videos ◽  
Health Education Materials ◽  
And Control ◽  
The Impact

SETTING: Access to information about tuberculosis (TB) is vital to ensure timely diagnosis, treatment, and control among vulnerable communities. Improved approaches for distributing health education materials to remote populations are needed.OBJECTIVE: To evaluate the impact of two comprehensive video training curricula in improving patient, community member, and community health worker knowledge of TB in a remote area of Madagascar.DESIGN: A pre-test/post-test design was used to measure knowledge acquisition. Educational videos were short, culturally appropriate films presented at critical moments in the TB cascade of care.RESULTS: Of the total 146 participants, 86 (58.9%) improved their score on the post-test, 50 (34.2%) obtained the same score, and 10 (6.8%) received a worse score. A statistically significant difference was observed between the pre- and post-test scores, wherein scores increased by a median of 10.0% (interquartile range 0.0–20.0) after viewing the videos (P < 0.001). There was a significant difference between the number of correct answers on the pre-test and the number of correct answers on the post-test (P < 0.001).CONCLUSION: Educational videos were found to significantly improve TB knowledge among a low-literacy, remote population in Madagascar. Our findings suggest educational videos could be a powerful, low-cost, and sustainable tool to improve access to TB education materials globally.

scholarly journals Effects of Peer-Facilitated, Video-Based and Combined Peer-and-Video Education on Anxiety Among Patients Undergoing Coronary Angiography: Randomised controlled trial

2018 ◽  
Vol 18 (1) ◽  
pp. 61 ◽  
Author(s):  
Hosein Habibzadeh ◽  
Zahra D. Milan ◽  
Moloud Radfar ◽  
Audrey Cund
Keyword(s):  
Coronary Angiography ◽  
Controlled Trial ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Patient Anxiety ◽  
Post Intervention ◽  
Persian Language ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Video Education

Objectives: Coronary angiography can be stressful for patients and anxiety-caused physiological responses during the procedure increase the risk of dysrhythmia, coronary artery spasms and rupture. This study therefore aimed to investigate the effects of peer, video and combined peer-and-video training on anxiety among patients undergoing coronary angiography. Methods: This single-blinded randomised controlled clinical trial was conducted at two large educational hospitals in Iran between April and July 2016. A total of 120 adult patients undergoing coronary angiography were recruited. Using a block randomisation method, participants were assigned to one of four groups, with those in the control group receiving no training and those in the three intervention groups receiving either peer-facilitated training, video-based training or a combination of both. A Persian-language validated version of the State-Trait Anxiety Inventory was used to measure pre- and post-intervention anxiety. Results: There were no statistically significant differences in mean pre-intervention anxiety scores between the four groups (F = 0.31; P = 0.81). In contrast, there was a significant reduction in post-intervention anxiety among all three intervention groups compared to the control group (F = 27.71; P <0.01); however, there was no significant difference in anxiety level in terms of the type of intervention used. Conclusion: Peer, video and combined peer-and-video education were equally effective in reducing angiography-related patient anxiety. Such techniques are recommended to reduce anxiety amongst patients undergoing coronary angiography in hospitals in Iran.

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