scholarly journals Telephone-Based Reeducation of Drug Administration for Helicobacterpylori Eradication: A Multicenter Randomized Controlled Study

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Yan Zhao ◽  
Mudan Ren ◽  
Xin Wang ◽  
Guifang Lu ◽  
Xinlan Lu ◽  
...  
Keyword(s):  
Eradication Rate ◽  
Symptom Relief ◽  
Intervention Group ◽  
Eradication Therapy ◽  
Incidence Rates ◽  
Controlled Study ◽  
Control Group ◽  
Intention To Treat ◽  
Event Rates

Poor adherence to treatment instructions may play an important role in the failure of Helicobacter pylori eradication. The aim of this study was to evaluate the effects of telephone-based reeducation on 14-day quadruple H. pylori eradication therapy. In total, 162 patients were randomly assigned (1 : 1) to either the intervention group (patients received telephone-based reeducation on the 4th, 7th, and 10th days of the course) or the control group (patients received instructions only at the time of getting the prescriptions). All patients received a 14-day quadruple H. pylori eradication therapy. The primary outcome was the H. pylori eradication rate. The secondary outcomes included the symptom relief rates and the incidence rates of adverse events. Seventy-five patients in the reeducation group and 74 patients in the control group completed the follow-up. The H. pylori eradication rate in the reeducation group was statistically higher than that in the control group (intention-to-treat: 72.8% vs. 50.6%, P=0.006; per-protocol: 78.7% vs. 55.4%, P=0.003). However, the symptom relief rates and the adverse event rates in these two groups were not significantly different. Overall, the results from this study suggest that telephone-based reeducation can be potentially applied to improve the H. pylori eradication rate in clinical practice, without significantly increasing the adverse effects.

scholarly journals Adding Bismuth to Rabeprazole-Based First-Line Triple Therapy Does Not Improve the Eradication of Helicobacter pylori

2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Meng-Chieh Wu ◽  
Yao-Kuang Wang ◽  
Chung-Jung Liu ◽  
Fang-Jung Yu ◽  
Fu-Chen Kuo ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Triple Therapy ◽  
Eradication Rate ◽  
Therapy Group ◽  
Resistance Rate ◽  
Controlled Study ◽  
First Line ◽  
Intention To Treat ◽  
Bismuth Subcitrate

This randomized controlled study aimed to evaluate whether adding bismuth to the standard first-line triple therapy could improve the eradication rate of Helicobacter pylori. A total of 162 patients with Helicobacter pylori infection were randomly assigned to either the 7-day triple therapy group (RAK regimen: rabeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg bid; n=81) or the bismuth plus triple therapy group (n=81). In the RBAK group, bismuth subcitrate 360 mg twice daily was added to the RAK regimen. A follow-up endoscopy or urea breath test was performed at least 4 weeks after eradication to confirm the treatment efficacy. Comparable compliance and Helicobacter pylori eradication rates were observed in both groups in either intention-to-treat [RAK 72.8% (59/81) versus RBAK 77.8% (63/81); p=0.47] or per protocol analysis [RAK 74.7% (59/79) versus RBAK 81.8% (63/77); p=0.26]. Adverse effects were commonly reported (50.6% for both groups) although most of these did not cause cessation of treatment. The resistance rate was 27.2% for metronidazole and 12.3% for clarithromycin. Adding bismuth to the standard 7-day triple therapy did not substantially increase the eradication rate. Further study is needed clarifying whether extending the duration of RBAK regimen to 10–14 days can lead to a better result.

scholarly journals Curative effect of Omeprazole under different treatment courses in treatment of children with PU and HP infection and its influence on inflammatory factors

2020 ◽  
Vol 36 (7) ◽  
Author(s):  
Shaohui Zhang ◽  
Yuan-da Zhang ◽  
Qing-wei Dong ◽  
Fang Gu
Keyword(s):  
Adverse Reactions ◽  
Eradication Rate ◽  
Clinical Symptoms ◽  
Statistical Significance ◽  
Symptom Relief ◽  
Inflammatory Factors ◽  
Controlled Study ◽  
Control Group ◽  
Observation Group ◽  
Curative Effect

Objective: To compare curative effect and safety of omeprazole under different treatment courses in treatment of children with peptic ulcer (PU, diameter ≤1.0cm) and helicobacter pylori (HP) infection and its influence on inflammatory cytokines. Methods: The study was a randomized controlled study and conducted at Baoding children’s hospital from June 2015 to June 2018. In this study 100 PU children with positive HP were chosen and classified into two groups at random. The 58 cases in the observation group were given omeprazole + amoxicillin + clarithromycin, and the antibiotics were not used two weeks later. Then, omeprazole was used to treat for two weeks. 42 cases in the control group were given omeprazole + amoxicillin + clarithromycin for two weeks. Curative effect, HP eradication rate, clinical symptoms, incidence of adverse reactions, level of serum inflammatory cytokine interleukin-6 (IL-6) and level of tumor necrosis factor-a (TNF-a) in two groups were compared. Results: Total effective rate, HP eradication rate and clinical symptom relief of observation group were better than those of control group, and the differences showed statistical significance (P<0.05). The differences of two groups in the incidence of adverse reactions had no statistical significance (P<0.05). Serum IL-6 level and TNF-a level of observation group were significantly lower than those of control group and before the treatment, and the differences had statistical significance (P<0.05). Conclusion: The application of omeprazole in treatment of PU patients with positive HP for four weeks can significantly improve PU cure rate and HP eradication rate, relieve clinical symptoms and reduce inflammatory response, so it deserves to be promoted clinically. doi: https://doi.org/10.12669/pjms.36.7.3048 How to cite this:Zhang S, Zhang Y, Dong Q, Gu F. Curative effect of Omeprazole under different treatment courses in treatment of children with PU and HP infection and its influence on inflammatory factors. Pak J Med Sci. 2020;36(7):---------. doi: https://doi.org/10.12669/pjms.36.7.3048 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

A Multicentre Randomised Controlled Study Evaluating the Effect of a Standardised Education Programme on Quality of Life, Disease Severity, and Disease Knowledge in Patients with Moderate-To-Severe Psoriasis: The EDUPSO Study

Dermatology ◽  
2021 ◽  
pp. 1-10
Author(s):  
Fatma Jendoubi ◽  
Stefana Balica ◽  
Marie Aleth Richard ◽  
Christine Chiaverini ◽  
Claire Bernier ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Intervention Group ◽  
Education Programme ◽  
Controlled Study ◽  
Control Group ◽  
Randomised Controlled Study ◽  
Randomised Controlled ◽  
To Receive

<b><i>Background:</i></b> Psoriasis is a chronic inflammatory skin disease that has a profound effect on health-related quality of life (HRQoL). Patient education programmes may help patients to gain life-long control over their chronic disease. <b><i>Objective:</i></b> This multicentre randomised controlled study evaluated whether a standardised multidisciplinary education programme was beneficial to psoriasis patients. <b><i>Methods:</i></b> Adults with moderate-to-severe psoriasis were randomly assigned (1:1) to an intervention group to receive an educational programme or to a control group to receive usual care. Randomization was stratified by previous treatment history. The primary outcome was HRQoL, assessed by scoring the Skindex-29 domains emotion, symptom, and functioning. Psoriasis severity was assessed using the psoriasis area severity index (PASI). Levels of perceived stress, patient knowledge about psoriasis, and patient satisfaction were also assessed. Follow-up evaluations were performed at 3, 6, and 12 months. <b><i>Results:</i></b> A total 142 patients formed the intention-to-treat population: 70 in the control group and 72 in the intervention group. Skindex component scores and the PASI were significantly lower at 3, 6, and 12 months as compared to baseline in both groups, but no significant differences were found between the groups. Knowledge about psoriasis improved significantly during follow-up amongst patients from the intervention group compared to controls (68% of correct answers vs. 56%; <i>p</i> &#x3c; 0.01). Patient satisfaction with psoriasis management and treatment was also better in the intervention group. <b><i>Conclusions:</i></b> The standardised education programme did not improve HRQoL and disease severity in psoriasis, but led to a significant improvement in patient knowledge about the disease and increased patient satisfaction.

scholarly journals Impact of Testing on Sexually Transmitted Infections among Female Brothel Sex Workers in Bangladesh: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Asad Islam ◽  
HongQi Alexis Tan ◽  
Claire C. Bristow ◽  
Md Golam Hasnain ◽  
Russell Smyth ◽  
...  
Keyword(s):  
Sexually Transmitted Infections ◽  
Sex Workers ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Study ◽  
Baseline Survey ◽  
Control Group ◽  
Sexually Transmitted ◽  
Randomized Controlled

Past studies that have designed interventions to reduce the prevalence of sexually transmitted infections (STIs) have typically provided onsite treatment to sex workers who tested positive, which were expensive and difficult to implement. The purpose of this study was to examine the effect of an intervention which tested for STIs and provided information on the closest treatment facility on reducing the prevalence of STIs among female brothel-based sex workers (BSWs) in Bangladesh. The study adopted a pre–post interventional design as well as a randomized controlled study design. A baseline sample and follow-up urine sample were collected to evaluate the prevalence of STIs among participants in the treatment, but not control group. A baseline survey and interviews were also conducted for both the groups. The study found a nonsignificant reduction from baseline to follow-up in STI prevalence among intervention participants (adjusted odds ratio [aOR]: 0.74; 95% CI: 0.38, 1.45). However, the participants in the intervention group were significantly more likely to have a repeat client (aOR: 1.60; 95% CI: 1.12, 2.29) and nonsignificantly less likely to engage with a client suspected of having an STI (aOR: 0.62; 95% CI: 0.39, 1.00) than participants in the control group. The intervention testing of STIs and providing information to the positive cases about nearest treatment facilities were not effective in reducing the prevalence of STIs among BSWs. Further study of the clinical and behavioral impacts of such efforts to reduce STIs among BSWs is warranted.

scholarly journals Mindfulness-Based Intervention for Children with Mental Health Problems: a 2-Year Follow-up Randomized Controlled Study

Mindfulness ◽  
2021 ◽  
Author(s):  
Katarina Laundy ◽  
Peter Friberg ◽  
Walter Osika ◽  
Yun Chen
Keyword(s):  
Mental Health ◽  
Disruptive Behavior ◽  
Mental Health Problems ◽  
Intervention Group ◽  
Health Problems ◽  
Controlled Study ◽  
Control Group ◽  
Registration Number ◽  
Group A

Abstract Objectives Moderate mental health problems are highly prevalent and increasing in Swedish schoolchildren, elevating risk for future mental and somatic disability. The aim of this study was to determine whether an 8-week mindfulness-based intervention, Training for Mindfulness and Resilience (TMR), mitigates mental health symptoms and increases resilience during a 2-year follow-up. Methods Schoolchildren (aged 9–14 years) reporting moderate mental health problems were randomized into either TMR intervention group (N = 22) or control group, receiving best current practice (N = 12). We used validated questionnaires to measure anxiety, depression, anger, disruptive behavior, self-concept, resilience, stress, and mindfulness before treatment with either TMR or control, as well as at 6 months, 1 year, and 2 years follow-up. Results We found a statistically significant effect of TMR intervention vs control, on resilience, anxiety, anger, and disruptive behavior. Compared to baseline, TMR increased the level of resilience at 6 months (p < .001); anxiety at 1 (p <  = .033) and 2 years (p = .04); anger at 6 months (p = .004) and 2 years (p = .039); disruptive behavior at 6 months (p = .006). In the control group, a decrease in resilience between 6 months and 2 years (p = .05) was observed. No other significant effects were found in the control group. Conclusions This study suggested that TMR improved mental health in schoolchildren with effects on anxiety and anger lasting for 2 years, and on resilience and disruptive behavior lasting for 6 months. Trial Registration Number NCT04806542, date of registration 18th of March 2021, retrospectively registered.

scholarly journals One-Year Follow-Up of the Effectiveness of Cognitive Behavioral Group Therapy for Patients’ Depression: A Randomized, Single-Blinded, Controlled Study

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
Kai-Jo Chiang ◽  
Tsai-Hui Chen ◽  
Hsiu-Tsu Hsieh ◽  
Jui-Chen Tsai ◽  
Keng-Liang Ou ◽  
...  
Keyword(s):  
Group Therapy ◽  
Rating Scale ◽  
Intervention Group ◽  
Automatic Thoughts ◽  
Controlled Study ◽  
Control Group ◽  
Cognitive Behavioral Group Therapy ◽  
One Year

The aim of the study was to investigate the long-term (one year) effectiveness of a 12-session weekly cognitive behavior group therapy (CBGT) on patients with depression. This was a single-blind randomized controlled study with a 2-arm parallel group design. Eighty-one subjects were randomly assigned to 12 sessions intervention group (CBGT) or control group (usual outpatient psychiatric care group) and 62 completed the study. The primary outcome was depression measured with Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD). The secondary outcomes were automatic thoughts measured by automatic thoughts questionnaire (ATQ). Both groups were evaluated at the pretest (before 2 weeks), posttest (after 12 therapy sessions), and short- (3 months), medium- (6 months), and long-term (12 months) follow-up. After receiving CBGT, the experimental group had a statistically significant reduction in the BDI-II from 40.30 at baseline to 17.82 points at session eight and to 10.17 points at postintervention(P<0.001). Similar effects were seen on the HRSD. ATQ significantly decreased at the 12th session, 6 months after sessions, and 1 year after the sessions ended(P<0.001). We concluded that CBGT is effective for reducing depression and continued to be effective at 1 year of follow-up.

Diabetes Transitional Care from Inpatient to Outpatient Setting

2012 ◽  
Vol 26 (2) ◽  
pp. 120-124 ◽  
Author(s):  
Mansi Shah ◽  
CaTanya A. Norwood ◽  
Sol Farias ◽  
Sonia Ibrahim ◽  
Pang H. Chong ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Transitional Care ◽  
Intervention Group ◽  
Outpatient Setting ◽  
Controlled Study ◽  
Adherence Rate ◽  
Control Group ◽  
Diabetes Medication ◽  
Counseling Intervention

Purpose: Diabetes transitional care from the inpatient to outpatient setting is understudied. This study evaluated the effect of inpatient pharmacist discharge counseling on outpatient diabetes medication adherence. Research methods: Prospective, randomized, controlled study compared pharmacist discharge counseling (intervention) with usual patient care (control) in 127 patients with established diabetes and an A1C ≥8% who had a provider and medications filled within the county health system. The primary outcome was diabetes medication adherence rate measured using the prescription of days covered (PDC) method. Results: Patients in the intervention, compared with control group, had greater diabetes medication adherence rate 150 days after discharge (55.2% vs 34.8%; P = .002), rate of follow-up visits (60.5% vs 43.9%; P = .01) and reduction in A1C (−1.97% vs +0.114%; P = .003). Being in the intervention group and having greater adherence with follow-up visits correlated independently with lower follow-up A1C. Conclusion: Transitional care in the form of inpatient education geared to improve self-management after hospital discharge. This may serve as a paradigm to improve outpatient adherence rate with medications, follow-up visits, and A1C reduction.

scholarly journals An Electronic Medication Module to Improve Health Literacy in Patients With Type 2 Diabetes Mellitus: Pilot Randomized Controlled Trial

10.2196/13746 ◽  
2020 ◽  
Vol 4 (4) ◽  
pp. e13746 ◽  
Author(s):  
Hanna Marita Seidling ◽  
Cornelia Mahler ◽  
Beate Strauß ◽  
Aline Weis ◽  
Marion Stützle ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Health Literacy ◽  
Intervention Group ◽  
Controlled Study ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Null Effect

Background In primary care, patients play a crucial role in managing care processes and handling drug treatment. A decisive factor for success is their health literacy, and several interventions have been introduced to support patients in fulfilling their responsibility. Objective The aim of this study is to assess the influence of such an intervention (ie, a medication module) within a patient-led electronic health record on patients’ health literacy. Methods We conducted a randomized controlled study among community-dwelling patients with type 2 diabetes mellitus. Patients were recruited from primary care practices. After randomization, patients either had access to an internet-based medication module allowing them to store their medication information, look up drug information, and print a medication schedule (intervention group), or they received an information brochure on the importance of medication schedules (control group). After 4-8 weeks, all patients were invited to attend a structured medication review (ie, follow-up visit). Data were collected via questionnaires before the start of the intervention and during the follow-up visit. The main outcome measure was the mean difference in health literacy between baseline and follow-up assessments of patients in the control and intervention groups. Results Of 116 recruited patients, 107 (92.2%) completed the follow-up assessment and were eligible for intention-to-treat analyses. Only 73 patients, of which 29 were in the intervention group, followed the study protocol and were eligible for per-protocol analysis. No differences in overall health literacy were observed in either the intention-to-treat or in the per-protocol cohorts. Reasons for a null effect might be that the cohort was not particularly enriched with participants with low health literacy, thus precluding measurable improvement (ie, ceiling effect). Moreover, the success of implementation was considered poor because both the correct application of the study procedure (ie, randomization according to the protocol and dropout of 29 patients) and the actual interaction with the medication module was modest (ie, dropout of 9 patients). Conclusions The conduct of this randomized controlled study was challenging, leaving it open whether inadequate implementation, too short of a duration, or insufficient efficacy of the intervention, as such, contributed to the null effect of this study. This clearly outlines the value of piloting complex interventions and the accompanying process evaluations.

scholarly journals Eight-Year Post-Trial Follow-up of Morbidity and Mortality of Telephone Health Coaching

2021 ◽  
Author(s):  
Erja Mustonen ◽  
Iiris Hörhammer ◽  
Kristiina Patja ◽  
Pilvikki Absetz ◽  
Johanna Lammintakanen ◽  
...  
Keyword(s):  
Heart Failure ◽  
Primary Outcome ◽  
Intervention Group ◽  
Health Coaching ◽  
Control Group ◽  
Mortality And Morbidity ◽  
Intention To Treat ◽  
Post Trial

Abstract Background: Health coaching is a patient-centred approach to supporting self-management for the chronic conditions. However, long-term evidence of effectiveness of health coaching remains scarce. The object of this study was to evaluate the long-term effect of telephone health coaching (THC) on mortality and morbidity among people with type 2 diabetes (T2D), coronary artery disease (CAD) and congestive heart failure (CHF) with a population of 112,000 in Finland.Methods: 1535 T2D, CAD and CHF patients with unmet treatment targets were randomly allocated to receive usual health care (control group, n = 501) or a combination of usual care and individual THC for 12 months (intervention group, n = 1034). The primary outcome was a composite of death from cardiovascular causes, non-fatal stroke, non-fatal myocardial infarction (AMI) or unstable angina pectoris (UAP) during a follow-up of eight years. Three other composite variables were also followed; cardiovascular mortality or morbidity, events of death from any cause, non-fatal AMI, non-fatal stroke, renal insufficiency, peripheral vascular disease and hospitalization due to congestive heart failure (CHF). Randomized controlled trial (RCT) data was linked to Finnish national health and social care registries and electronic health records (EHR). Post-trial eight-year evaluation was conducted using intention-to-treat (ITT) and per-protocol (PP) analysis. Results: The composite primary outcome event rate per 100 person years was lower in the intervention group (3.45) than in control group (3.88) in ITT -analysis, but the difference was not statistically significant (hazard ratio in the intervention group 0.87; 95% CI, 0.71 to 1.07; P = 0.19). In the subgroup (T2D, CAD/CHF) analysis, there were no statistically significant effects. The secondary PP-analysis showed statistically significant benefits for those who participated to the study. Conclusions: No statistically significant effect of health coaching on mortality and morbidity was found in intention to treat analysis. The results suggest, however, that the intervention may be effective among patients who are willing and able to participate in health coaching. More research is needed to identify patients most likely to benefit from low-intensity health coaching. Trial registration: NCT00552903 (registration date: the 1st of November 2007, updated the 3rd of February 2009)

scholarly journals Eight-year post-trial follow-up of morbidity and mortality of telephone health coaching

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Erja Mustonen ◽  
Iiris Hörhammer ◽  
Kristiina Patja ◽  
Pilvikki Absetz ◽  
Johanna Lammintakanen ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Intervention Group ◽  
Health Coaching ◽  
Control Group ◽  
Mortality And Morbidity ◽  
Intention To Treat ◽  
Composite Endpoints ◽  
Post Trial

Abstract Background Health coaching is a patient-centred approach to supporting self-management for the chronic conditions. However, long-term evidence of effectiveness of health coaching remains scarce. The object of this study was to evaluate the long-term effect of telephone health coaching (THC) on mortality and morbidity among people with type 2 diabetes (T2D), coronary artery disease (CAD) and congestive heart failure (CHF).. Methods 1535 T2D, CAD and CHF patients with unmet treatment targets were randomly allocated into an intervention group (n = 1034) and control group (n = 501). Intervention group received monthly individual strength-based, autonomy supportive THC sessions (average 30 min) for behavior change with a specially trained nurse for 12 months additional to usual health care. Control group received usual health care services. The primary outcome was a composite of death from cardiovascular causes or non-fatal stroke or non-fatal myocardial infarction (AMI) or unstable angina pectoris (UAP) during a follow-up of 8 years Three other composite endpoints with distinct combinations of fatal and non-fatal cardiovascular events and death from any cause were used as secondary outcomes. Other outcomes followed were the most relevant components of the composite endpoints. Randomized controlled trial (RCT) data was linked to Finnish national health and social care registries and electronic health records (EHR). Post-trial eight-year evaluation was conducted using intention-to-treat (ITT) and per-protocol (PP) analysis. Results The composite primary outcome event rate per 100 person years was lower in the intervention group (3.45) than in control group (3.88) in ITT -analysis, but the difference was not statistically significant (hazard ratio in the intervention group 0.87; 95% CI, 0.71 to 1.07; P = 0.19). In the subgroup (T2D, CAD/CHF) analysis, there were no statistically significant effects. The secondary PP-analysis showed statistically significant benefits for those who participated in the study. Conclusions No statistically significant effect of health coaching on mortality and morbidity was found in intention to treat analysis. The per protocol results suggest, however, that the intervention may be effective among patients who are willing and able to participate in health coaching. More research is needed to identify patients most likely to benefit from low-intensity health coaching. Trial registration NCT00552903 (registration date: the 1st of November 2007, updated the 3rd of February 2009).

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