scholarly journals Translating research to usual care of children with sickle cell disease in Northern Nigeria: lessons learned from the SPRING Trial Team

2022 ◽  
Vol 15 (1) ◽  
Author(s):  
Halima Bello-Manga ◽  
Lawal Haliru ◽  
Abdulkadir M. Tabari ◽  
Bilkisu Farouk ◽  
Aisha Suleiman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Sickle Cell ◽  
Organizational Support ◽  
Stroke Prevention ◽  
Controlled Trial ◽  
Routine Practice ◽  
Northern Nigeria ◽  
Randomized Controlled

Abstract Objectives Evidence-based practice for stroke prevention in high-income countries involves screening for abnormal transcranial Doppler (TCD) velocity and initiating regular blood transfusions for at least 1 year, followed by treatment with hydroxyurea. This practice has not been transferred to low-resource settings like Nigeria, the country with the highest global population density of SCD. Following a multi-center randomized controlled trial among children with SCA in northern Nigeria, screening for stroke and initiation of hydroxyurea was established as standard of care at the clinical trial sites and other locations. We aim to describe the critical steps we took in translating research into practice for stroke prevention in SCA in Nigeria. Guided by the PRISM framework, we describe how we translated results from a randomized controlled trial for primary prevention of stroke in children with sickle cell anemia into usual care for children with SCA in Kaduna, Nigeria. Results Findings from this study demonstrate the importance of organizational support and stakeholder involvement from the onset of a clinical trial. Having the dual objective of conducting an efficacy trial while simultaneously focusing on strategies for future implementation can significantly decrease the lag time between discovery and routine practice.

Effectiveness of spiritual care using spiritual pain assessment sheet for advanced cancer patients: A pilot non-randomized controlled trial

2019 ◽  
Vol 17 (1) ◽  
pp. 46-53
Author(s):  
Kaori Ichihara ◽  
Sayako Ouchi ◽  
Sachiko Okayama ◽  
Fukiko Kinoshita ◽  
Mitsunori Miyashita ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Pain Assessment ◽  
Spiritual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Assessment Sheet

AbstractObjectiveTo obtain preliminary knowledge to design a randomized controlled trial to clarify the effects of spiritual care using the Spiritual Pain Assessment Sheet (SpiPas).MethodThe study was designed as a nonrandomized controlled trial. The study took place between January 2015 and July 2015 in a hematology and oncology ward and two palliative care units in Japan. Among 54 eligible patients with advanced cancer, 46 were recruited (24 in the control group vs. 22 in the intervention group). The intervention group received spiritual care using SpiPas and usual care; the control group received usual care. The primary outcome was the Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp). The secondary outcomes were the Hospital Anxiety and Depression Scale (HADS) and Comprehensive Quality of Life Outcome (CoQoLo).ResultA total of 33 (72%) and 23 (50%) patients completed 2- and 3-week follow-up evaluations, respectively. The differences in the changes during 2 weeks in total scores of FACIT-Sp and HADS were significant (95% confidence intervals, 3.65, 14.4, p < 0.01; –11.2 to –1.09, p = .02, respectively). No significant changes were observed in the total score of CoQoLo.Significance of resultsSpiritual care using the SpiPas might be useful for improving patient spiritual well-being. This controlled clinical trial could be performed and a future clinical trial is promising if outcomes are obtained within 2 weeks.

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

Rationale, design, and challenges with implementing a clinical intervention to teach appropriate gestational weight gain (TAGG): Protocol of a Randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Awathif Mackeen ◽  
Danielle Downs ◽  
Vonda Hetherington ◽  
Shawnee Lutcher ◽  
Jacob Mowery ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Weight Gain ◽  
Gestational Diabetes ◽  
Usual Care ◽  
Gestational Weight Gain ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Household Food Security ◽  
Gestational Weight ◽  
Randomized Controlled

BACKGROUND Excessive gestational weight gain (GWG) has public health implications including preterm birth, preeclampsia, gestational diabetes, and cesarean delivery. In an effort to mitigate adverse consequences of excessive GWG, this study tests a health intervention that includes enhancements to improve knowledge and awareness of appropriate GWG, and patient-centered nutritional counseling to promote appropriate GWG. OBJECTIVE The primary objective of the study was to increase the proportion of women who are managing their GWG as recommended by the IOM.4,5 METHODS This randomized controlled trial was conducted at Geisinger in Pennsylvania where excessive GWG is common among women with pre-conception obesity. Eligible, consenting participants with pre-pregnancy body mass index >30.0 kg/m2 were randomized (1:1) to: 1) Usual Care: usual written educational materials and counseling by an obstetric care provider or 2) Enhanced Care: Usual Care plus a) a personalized letter from a physician detailing appropriate GWG, b) exposure to individualized GWG chart in the electronic health record via the patient portal, and c) a consult with a Registered Dietitian Nutritionist and follow-up via tele-health counseling (10-20 mins/1-2 weeks) for the duration of the pregnancy. RESULTS The primary outcome was the proportion of women that gain less than 20 pounds over the course of the pregnancy. Secondary outcomes include knowledge, expectations, and attitude about pregnancy weight gain; increased self-efficacy for ability to eat healthy and being physically active to manage weight; and eating behavior. Potential moderators that will be explored include sleep, perceived stress, perceived involvement in care, and household food security. Data collection has been completed as of November 2019. CONCLUSIONS As GWG care was initiated for mothers with pre-pregnancy BMI >30 kg/m2 within the first and second trimesters, the intervention may have the additional benefit of reducing other adverse pregnancy outcomes including the incidence of gestational diabetes due to healthier rates of GWG. In addition to assessing appropriate GWG, this project will assess eating habits, physical activity, GWG attitudes, sleep quality, and psychological measures, all of which are associated with GWG. Exploratory mediators including perceived stress and food insecurity will also be evaluated. CLINICALTRIAL ClinicalTrials.gov NCT02963428

scholarly journals Evaluation of FindMyApps: protocol for a randomized controlled trial of the effectiveness and cost-effectiveness of a tablet-based intervention to improve self-management and social participation of community-dwelling people with mild dementia, compared to usual tablet use

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
David Peter Neal ◽  
Yvonne J. F. Kerkhof ◽  
Teake P. Ettema ◽  
Majon Muller ◽  
Judith Bosmans ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Social Participation ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Self Management ◽  
Tablet Computer ◽  
Randomized Controlled ◽  
People With Dementia

Abstract Background For the rising number of people living with dementia, cost-effective community-based interventions to support psychosocial care are needed. The FindMyApps intervention has been developed with and for people with dementia and their caregivers, to help them use tablets to facilitate self-management and engagement in meaningful social activities. A feasibility study and exploratory pilot trial evaluating FindMyApps have been carried out. This definitive trial further evaluates the effectiveness of the intervention and, for the first time, the cost-effectiveness. Methods A randomized controlled non-blinded single-center two-arm superiority trial will be conducted. Community-dwelling people with Mild Cognitive Impairment (MCI), or dementia with a Mini Mental-State Examination (MMSE) of > 17 and < 26, or Global Deterioration Scale 3 or 4, with an informal caregiver and access to a wireless internet connection will be included. In total, 150 patient-caregiver dyads will be randomly allocated to receive either usual care (control arm – tablet computer; n = 75 dyads) or usual care and the FindMyApps intervention (experimental arm – tablet computer and FindMyApps; n = 75 dyads). The primary outcomes are: for people with dementia, self-management and social participation; for caregivers, sense of competence. In addition to a main effect analysis, a cost-effectiveness analysis will be performed. In line with MRC guidance for evaluation of complex interventions a process evaluation will also be undertaken. Discussion Results of the trial are expected to be available in 2023 and will be submitted for publication in international peer-reviewed scientific journals, in addition to conference presentations and reporting via the EU Marie Sklodowska-Curie DISTINCT ITN network. By providing evidence for or against the effectiveness and cost-effectiveness of the FindMyApps intervention, the results of the trial will influence national implementation of FindMyApps. We hope that the results of the trial will further stimulate research and development at the intersection of technology and psycho-social care in dementia. We hope to further demonstrate that the randomized controlled trial is a valuable and feasible means of evaluating new digital technologies, to stimulate further high-quality research in this growing field. Trial registration number Netherlands Trial Register: NL8157; registered 15th November 2019.

scholarly journals Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shicheng Wang ◽  
Wensheng Wang ◽  
Long Shao ◽  
Jing Ling
Keyword(s):  
Clinical Trial ◽  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Pain Control ◽  
Controlled Trial ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Total Knee ◽  
Postoperative Residual

Abstract Background Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group. Methods This randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. Discussion This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn) registration number: ChiCTR2000031674. Registered 07 April 2020.

Educational intervention to adopt selective laser trabeculoplasty as first-line glaucoma treatment: Randomized controlled trial: Educational intervention on selective laser trabeculoplasty

2021 ◽  
pp. 112067212110183
Author(s):  
Evelyn Tran ◽  
Carina Sanvicente ◽  
Lisa A Hark ◽  
Jonathan S Myers ◽  
Qiang Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Educational Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Selective Laser Trabeculoplasty ◽  
First Line ◽  
Randomized Controlled ◽  
Laser Trabeculoplasty ◽  
Glaucoma Treatment

Purpose: To determine the efficacy of an educational intervention on patient adoption and attitudes toward selective laser trabeculoplasty (SLT) as first-line treatment for glaucoma. Methods: This study is a randomized controlled trial. Subjects include 33 patients within 1-year diagnosis of either primary open-angle glaucoma, ocular hypertension, or pseudoexfoliation syndrome. After informed consent, subjects were randomly assigned to a Usual Care or Educational Intervention group. All subjects completed a pre-intervention questionnaire. The Educational Intervention group was shown a slideshow presentation and a 3-min video and given a post-intervention questionnaire. Follow-up examinations were reviewed for 6 months to determine subject completion of SLT, the primary outcome. Secondary outcomes include assessment of attitude toward SLT before and after intervention. Results: Age, gender, and baseline characteristics between the groups did not differ. The Usual Care group had a higher proportion of African Americans (77% vs 31%, p = 0.04). At 6 months following the intervention, 63% of subjects underwent SLT compared to 35% of Usual Care subjects ( p = 0.12). Older age was associated with decreased SLT uptake (OR 0.90, 95% CI 0.82–0.99, p = 0.03). Prior to the intervention, there were no differences in attitudes of both groups regarding SLT therapy. Nineteen percent of Educational Intervention subjects changed positively toward SLT ( p = 0.08) and 50% scheduled an SLT appointment after intervention ( p = 0.005). Conclusions: A slideshow and video-based educational intervention may positively enhance patient adoption of SLT. Clinical trial registration name, number, URL: Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment, NCT03365778, https://clinicaltrials.gov/ct2/show/NCT03365778

scholarly journals A double blinded placebo controlled comparative clinical trial to evaluate the effectiveness of Siddha medicines, Kaba Sura Kudineer (KSK) & Nilavembu Kudineer (NVK) along with standard Allopathy treatment in the management of symptomatic COVID 19 patients - a structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anurag Srivastava ◽  
Manickavasagam Rengaraju ◽  
Saurabh Srivastava ◽  
Vimal Narayan ◽  
Vivek Gupta ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
List Type ◽  
Rt Pcr ◽  
Randomized Controlled ◽  
End Of Treatment ◽  
Stay Time ◽  
Full Protocol ◽  
Double Blinded

Abstract Objectives The primary objectives of the study are to determine the effectiveness of the Kaba Sura Kudineer (KSK) & Nilavembu Kudineer (NVK) along with standard Allopathy Treatment to compared with Placebo (Decaffeinated Tea) with standard Allopathy Treatment in the management of Symptomatic COVID 19 patients and also in reduction of Hospital Stay Time & Changes in Immunological (IL6) and Bio Chemical Markers (Ferritin, CRP, D-Dimer and LDH). The secondary objectives are to evaluate the safety of the trial medicines and their effects in the reduce the risks of the disease. In addition, to document the profile of Symptomatic COVID 19 patients as per Siddha Principles. Trial Design A Double Blinded, Three arm, Single Centre, Placebo Controlled, Exploratory and comparative Randomized Controlled Trial Participants Patients who were admitted to the COVID Care Centre at Govt. Institute of Medical Sciences. Noida in India will be recruited. These will be patients with Mild and Moderate symptoms with laboratory confirmed COVID 19 (RT – PCR Tested Positive) aged 18-65, willing and consenting to participate. Intervention and comparator Arm I: Decaffeinated Tea (Placebo – similar in taste and appearance to the other Two Decoctions), 60 Ml Morning and Night after Food, along with standard Allopathy Treatment for 10 days. Arm II: Nilavembu Kudineer (The Siddha Medicines which is used as a standard Anti-Viral drug for the past Pandemics by Siddha Physicians) 60 Ml Morning and Night after Food, along with standard Allopathy Treatment for 10 days. Arm III: Kaba Sura Kudineer (The Siddha Medicine which is proposed to be used as a Treatment for COVID 19 based on Siddha Literature) 60 Ml Morning and Night after Food, along with standard Allopathy Treatment for 10 days. The investigational drugs are registered products under the Govt.of India and bought from GMP Certified Manufacturing Units. Main Outcomes Primary outcomes: Reduction in Viral load of SARS-CoV-2 at the end of treatment (10 days). 2. Time taken to convert Patient from symptomatic to Asymptomatic based on Reduction in clinical symptoms (10 days). 3. Effect of drugs inflammatory markers (IL6,) at the end of treatment (10 days). 4. Reduction in hospital stay time (20 days follow up). (Based on RT PCR CT Value 3rd, 6th if needed 10th day). (Based on IL 6 Value needed 10th day or IL6 value on turning negative. (entry level/exit level). Secondary outcomes (10 days): Reduction in use of Intensive Supportive Care. 2. Reduction in incidence of complications (Acute Respiratory Distress Syndrome, other systemic complications). 3. MuLBSTA score for viral pneumonia (multinodular infiltration, hypo-lymphocytosis, bacterial co infection, Total Leucocyte Count (TLC ≤ 0.8 x 109/L), smoking history, hyper-tension and age) score. 4. Laboratory markers (Haematological & Biochemical Markers). 5. Adverse events/effects Siddha-based measurements. 6. Siddha Udaliyal assessment by using Yakkai Ilakkanam (YI) Tool to diagnose body condition for covid-19 patients. Randomisation The assignment of the participants into 3 Groups will be allocated in 1:1:1 Ratio through randomization Blocks in Microsoft Excel by a Statistician who is not involved in the study. The allocation scheme will be made by another statistician by using a closed envelope after the assessment of eligibility and Informed consent procedures. The groups will be balanced for age and sex with 3:1 Ratio in each group for mild: severe COVID-19 symptoms. Blinding The Study is Double Blinded. Participants and Investigators were blinded. Numbers to be randomized (Sample size) Sample size could not be calculated, Since there are no prior trials on KSK and NVK as a comparative trial. In addition, there are no prior trials on KSK and NVK in this region. A total Number of 120 Patients, 40 each in 3 groups will be recruited in 1:1:1 Ratio. Trial Status Protocol Number : SCRUND GIMS Noida Study 1,Version: 2.0 Protocol Date : 20.08.2020 The recruitment period is completed for the trial. The Trial started its recruitment on 22.8.2020. We anticipate study including data analysis will finish in January 2021. This is to state that it was a late submission from authors for publication of the protocol to the BMC, after enrolment in the study was over. Trial Registration The trial protocol was registered with CTRI (Clinical Trial Registry of India) and number is CTRI/2020/08/027286 on 21.08.2020 Full Protocol The full Protocol is attached as an additional file, Accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated. This letter serves as a summary of the key elements of the full protocol. The Study protocol has been reported in accordance with the SPIRIT guidelines.

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