Does allocation to a control condition in a Randomized Controlled Trial affect the routine care foster parents receive?

Introduction. Stable angina (SA) in coronary heart disease is a common ischemic heart disease endangering the patient’s quality of life and longevity. Clinical trials have demonstrated that the Chinese herbal formula Xuefu Zhuyu (XFZY) has benefits for SA patients. However, there remains a lack of high-quality evidence to support clinical decision-making. Therefore, we designed a randomized controlled trial (RCT) to evaluate the efficacy and safety of XFZY for SA. Methods and Analysis. This multicenter, double-blinded RCT will be conducted in China. 152 eligible participants will be randomly assigned to either an XFZY group or a control group at a 1 : 1 ratio. Participants in the XFZY group will receive XFZY plus routine care, while those in the control group will receive placebo plus routine care. The study period is 26 weeks, including a 2-week run-in period, a 12-week treatment period, and a 12-week follow-up. The primary outcome is the change in visual analogue scale score for angina pain intensity from baseline to 12 weeks. The secondary outcomes are the angina attack frequency and duration, the nitroglycerin dosage consumed, the Canadian Cardiovascular Society grading of effort angina, the Seattle Angina Questionnaire, the EuroQol-5-Dimensions-5-Level, the incidence of major adverse cardiac events, health cost evaluation, and overall assessment for study drugs. Ethics and Dissemination. The study has been approved by the ethics committee of Guangdong Provincial Hospital of Chinese Medicine (approval no. BF2019-175-01). Results will be submitted for publication in peer-reviewed journals and disseminated at scientific conferences. This trial is registered with ChiCTR1900026899, registered on 26 October 2019.

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Reduction of the long-term use of proton pump inhibitors by a patient-oriented electronic decision support tool (arriba-PPI): study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-019-3728-2 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Anja Rieckert ◽

Annette Becker ◽

Norbert Donner-Banzhof ◽

Annika Viniol ◽

Bettina Bücker ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Decision Support ◽

Controlled Trial ◽

Decision Support Tool ◽

Routine Care ◽

Electronic Decision Support ◽

Support Tool ◽

Randomized Controlled ◽

Cluster Randomized

Abstract Background Proton pump inhibitors (PPIs) are increasingly being prescribed, although long-term use is associated with multiple side effects. Therefore, an electronic decision support tool with the aim of reducing the long-term use of PPIs in a shared decision-making process between general practitioners (GPs) and their patients has been developed. The developed tool is a module that can be added to the so-called arriba decision support tool, which is already used by GPs in Germany in routine care. In this large-scale cluster-randomized controlled trial we evaluate the effectiveness of this arriba-PPI tool. Methods The arriba-PPI tool is an electronic decision support system that supports shared decision-making and evidence-based decisions around the long-term use of PPIs at the point of care. The tool will be evaluated in a cluster-randomized controlled trial involving 210 GP practices and 3150 patients in Germany. GP practices will be asked to recruit 20 patients aged ≥ 18 years regularly taking PPIs for ≥ 6 months. After completion of patient recruitment, each GP practice with enrolled patients will be cluster-randomized. Intervention GP practices will get access to the software arriba-PPI, whereas control GPs will treat their patients as usual. After an observation period of six months, GP practices will be compared regarding the reduction of cumulated defined daily doses of PPI prescriptions per patient. Discussion Our principal hypothesis is that the application of the arriba-PPI tool can reduce PPI prescribing in primary care by at least 15% compared to conventional strategies used by GPs. A positive result implies the implementation of the arriba-PPI tool in routine care. Trial registration German Clinical Trials Register, DRKS00016364. Registered on 31 January 2019.

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The effect of cryotherapy on chemotherapy induced oral mucositis in Egyptian cancer patients: A randomized controlled trial

Journal of Nursing Education and Practice ◽

10.5430/jnep.v9n11p63 ◽

2019 ◽

Vol 9 (11) ◽

pp. 63

Author(s):

Hanan Mohamed Mohamed Soliman

Keyword(s):

Randomized Controlled Trial ◽

Cancer Patients ◽

Oral Mucositis ◽

Health Care Professionals ◽

Controlled Trial ◽

Routine Care ◽

Control Group ◽

Adverse Side Effect ◽

Randomized Controlled ◽

Oral Cryotherapy

Background and objective: Oral Mucositis (OM) is a common adverse side-effect caused by cancer treatments (chemotherapy and/or radiotherapy). And can lead to mucosa toxicity. Patients with OM may experience extreme pain and may not be able to eat, drink and talk and, as a result, their quality of life is impaired. Treatment and prevention of OM in adult patients treated with chemotherapy are challenging issues for health care professionals. The aim of this study was to evaluate the effect of cryotherapy on incidence and severity of chemotherapy-induced OM and OM related pain in patients treated with combined chemotherapy (Fluorouracil and Leucovorin).Methods: This study is a randomized controlled trial with a random assignment to cryotherapy and control groups. The study was conducted on 40 cancer patients who underwent chemotherapy. The 20 patients in cryotherapy group were received instructions for sucking ice cubes in their mouth for five minutes before, during and shortly after chemotherapy. The 20 patients in control group received routine care. OM and pain severity were evaluated at 7th, 14th and 21st days of the study after chemotherapy using WHO Mucositis grading and-Numeric Pain Rating Scale.Results: In the majority of patients in cryotherapy group, oral Mucositis was not detected (Grade 0) at 7th, 14th and 21st days similarly incidence of grade 1 and 2 of OM in cryotherapy group significantly lowered when compared with control group where p < .001. During the study period, patients in the control group exhibit a significantly higher level of oral discomfort (p = .001).Conclusions: Oral cryotherapy due to its easy administration, tolerability and lack of adverse effects which makes it a very important method for decreasing the severity and incidence of OM and OM associated pain. The oncology nurses have a pivotal role in the application and success of cryotherapy.

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An individualized decision aid for physicians and patients for total knee replacement in osteoarthritis (Value-based TKR study): study protocol for a multi-center, stepped wedge, cluster randomized controlled trial

BMC Musculoskeletal Disorders ◽

10.1186/s12891-021-04546-5 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Toni Lange ◽

Stefanie Deckert ◽

Franziska Beyer ◽

Waldemar Hahn ◽

Natascha Einhart ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Decision Aid ◽

Controlled Trial ◽

Routine Care ◽

Decision Quality ◽

Stepped Wedge ◽

Randomized Controlled ◽

Total Knee ◽

Cluster Randomized ◽

Study Sites

Abstract Background Total knee replacement (TKR) is one of the most commonly performed routine procedures in the world. Prognostic studies indicate that the number of TKR will further increase constituting growing burden on healthcare systems. There is also substantial regional heterogeneity in TKR rates within and between countries. Despite the known therapeutic effects, a subset of patients undergoing TKR does not benefit from the procedure as intended. To improve the appropriateness of TKR indication, the EKIT initiative (“evidence and consensus based indication critera for total arthroplasty”) developed a clinical guideline for Germany on the indication of TKR. This guideline is the basis for a digital medical decision aid (EKIT tool) to facilitate shared decision making (SDM) in order to improve decision quality for elective surgery. The aim of this cluster randomized trial is to investigate the effectiveness of the EKIT tool on decision quality. Methods The Value-based TKR study is a prospective pragmatic multi-center, stepped wedge, cluster randomized controlled trial (SW-RCT). The EKIT tool provides (1) a systematic presentation of individual patient and disease-specific information (symptoms, expectations), (2) the fulfillment of the indication criteria and (3) health information about safety and effectiveness of TKR. All study sites will follow routine care as control clusters until the start of the intervention. In total, there will be 10 clusters (study sites) and 6 sequential steps over 16 month, with clusters receiving the intervention with a minimum 2 months of standard routine care. The primary outcome is patients’ decision quality measured with the Decision Quality Instrument (DQI)-Knee Osteoarthritis questionnaire. Furthermore, we will collect information on global patient satisfaction, patient reported outcome measures and the fulfilment of the individual expectations 12 months after SDM. The power calculation yielded an estimated power of 89% using robust Poisson regression under the following assumptions: 10 study sites with a total of N=1,080 patients (including a dropout rate of 11%), a 10% increase in decision quality due to the use of the EKIT tool, and a significance level of 5%. Discussion There is a high potential for transferring the intervention into routine practice if the evaluation is positive. Trial registration ClinicalTrials.gov: NCT04837053. Registered on 08/04/2021.

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Effect of adding a psychological intervention to routine care of common mental disorders in a specialized mental healthcare facility in Pakistan: a randomized controlled trial

10.21203/rs.3.rs-26484/v1 ◽

2020 ◽

Author(s):

Syed Usman Hamdani ◽

Zill-e- Huma ◽

Aqsa Masood ◽

Kiana Zhou ◽

Zainab Ahmed ◽

...

Keyword(s):

Mental Health ◽

Health Care ◽

Randomized Controlled Trial ◽

Common Mental Disorders ◽

Psychological Intervention ◽

Controlled Trial ◽

Routine Care ◽

Anxiety And Depression ◽

Randomized Controlled ◽

Care Facilities

Abstract Background In many low resource settings, the provision of government mental health care services is limited to specialized psychiatry units in urban hospital care facilities, where the most common treatment for common mental disorders (CMDs) is pharmacotherapy, occasionally with adjunct nonspecific psychological support. We aimed to evaluate the effectiveness of adding a low intensity, psychological intervention, Problem Management Plus (PM+) for CMDs into routine care in a specialized mental health care facility in Pakistan. Methods A two arm, single-blind individual randomized controlled trial (RCT) was carried out with adults (N=192), referred for psychological support by psychiatrists. The study participants were randomized (1:1) to PM+ plus Treatment as Usual (TAU) (n = 96) or TAU only (n = 96). The primary outcomes were symptoms of anxiety and depression, measured by the Hospital Anxiety and Depression Scale (HADS) and functional impairment as measured by WHO Disability Assessment Schedule (WHODAS-12) at 20-weeks after baseline. Results The analysis was done on intention-to-treat principle. The linear mixed model analysis showed that at 20-weeks after baseline, there was a significant reduction in symptoms of anxiety and depression (mean [SD], 16.23 [8.81] vs 19.79 [7.77]; AMD, -3.10; 95% CI, −0.26 to −5.76); p =0.03 and improvement in functioning (mean [SD], 22.94 [9.37] vs 27.37 [8.36]; AMD, -4.35; 95% CI, -1.45 to -7.24); p =0.004 in PM+ plus TAU versus TAU group. The follow-up rate was 67% at primary end-point. Conclusions Specialized care facilities in LMICs may consider adding brief, evidence-based psychological treatments for CMDs to their routine care.

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A randomized controlled trial comparing a telemedicine therapeutic intervention with routine care in adults with type 1 diabetes mellitus treated by insulin pumps

Acta Diabetologica ◽

10.1007/s00592-019-01300-1 ◽

2019 ◽

Vol 56 (6) ◽

pp. 667-673 ◽

Cited By ~ 6

Author(s):

Marianna Yaron ◽

Bruria Sher ◽

Daniel Sorek ◽

Mina Shomer ◽

Noa Levek ◽

...

Keyword(s):

Diabetes Mellitus ◽

Randomized Controlled Trial ◽

Type 1 Diabetes ◽

Type 1 Diabetes Mellitus ◽

Therapeutic Intervention ◽

Controlled Trial ◽

Routine Care ◽

Insulin Pumps ◽

Randomized Controlled

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An automated structured education intervention based on a smartphone app in Chinese patients with type 1 diabetes: a protocol for a single-blinded randomized controlled trial

Trials ◽

10.1186/s13063-020-04835-9 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Fansu Huang ◽

Xinyin Wu ◽

Yuting Xie ◽

Fang Liu ◽

Juan Li ◽

...

Keyword(s):

Diabetes Mellitus ◽

Randomized Controlled Trial ◽

Type 1 Diabetes ◽

Controlled Trial ◽

Routine Care ◽

Chinese Patients ◽

Smartphone App ◽

Structured Education ◽

Randomized Controlled

Abstract Background Although evidence had demonstrated the effectiveness of smartphone apps in diabetes care, the majority of apps had been developed for type 2 diabetes mellitus (T2DM) patients and targeted at populations outside of China. The effects of applying a smartphone app with structured education on glycemic control in type 1 diabetes mellitus (T1DM) are unclear. A digital, culturally tailored structured education program was developed in a smartphone app (Yi tang yun qiao) to provide an automated, individualized education program aimed at improving self-management skills in patients with T1DM in China. This trial aims to investigate the effectiveness of this smartphone app among Chinese T1DM patients. Methods and analysis This single-blinded, 24-week, parallel-group randomized controlled trial of a smartphone app versus routine care will be conducted in Changsha, China. We plan to recruit 138 patients with T1DM who will be randomly allocated into the intervention group (automated, individualized education through an app) or routine care group. The intervention will last for 24 weeks. The primary outcome will be the change in glycated hemoglobin (HbA1c) from baseline to week 24. The secondary outcomes will include time in range, fasting blood glucose, levels of serum triglycerides and cholesterol, blood pressure, body mass index, quality of life, diabetes self-care activities, diabetes self-efficacy, depression, anxiety, and patient satisfaction. Adverse events will be formally documented. Data analysis will be conducted using the intention-to-treat principle with appropriate univariate and multivariate methods. Missing data will be imputed with a multiple imputation method under the “missing at random” assumption. Discussion This trial will investigate the effectiveness of an app-based automated structured education intervention for Chinese patients with T1DM. If the intervention is effective, this study will provide a strategy that satisfies the need for effective lifelong diabetes care to reduce the disease burden and related complications resulting from T1DM. Trial registration ClinicalTrials.gov NCT04016987. Registered on 29 October 2019.

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Family Minds: A randomized controlled trial of a group intervention to improve foster parents’ reflective functioning

Development and Psychopathology ◽

10.1017/s095457942000214x ◽

2021 ◽

pp. 1-15

Author(s):

Tina Adkins ◽

Samantha Reisz ◽

Dilara Hasdemir ◽

Peter Fonagy

Keyword(s):

Randomized Controlled Trial ◽

Parenting Stress ◽

Group Intervention ◽

Internalizing Symptoms ◽

Foster Parents ◽

Controlled Trial ◽

Reflective Functioning ◽

Internalizing Behavior ◽

Control Group ◽

Randomized Controlled

AbstractFamily Minds is a brief group psychoeducational parenting intervention designed to increase the reflective functioning (RF) and mentalization skills of foster parents. RF is important for foster parents who have to build relationships with children whose adverse experiences increase their risk for psychosocial challenges. A randomized controlled trial (RCT) for Family Minds was conducted in Texas with 89 foster parents. The main aims of this study were to examine whether the intervention could significantly increase the RF/mentalization skills of the foster parents and decrease their parenting stress. After 6 weeks, compared with the control group, intervention foster parents improved their RF via a lowering of pre-mentalizing and also significantly decreased parenting stress related to parent–child dysfunctional interactions. Other measures of RF and parenting stress showed no significant differences between groups. Foster child behavior was not significantly different between groups, although data at 6 months showed a possible lowering of internalizing symptoms for children of intervention parents. This RCT provides some encouraging evidence that Family Minds may increase RF in foster parents, improve parental sensitivity and their ability to emotionally regulate, decrease parenting stress related to challenging interactions with their foster children, and possibly decrease children's internalizing behavior.

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