Thanh Xuan Nguyen, Huyen Thi Thanh Vu, T. Nguyen, A. Esterman, Luc Viet Tran, Janani Thillainadesan, V. Naganathan, H. Brodaty, Anh Trung Nguyen
{"title":"A Multidomain Intervention Program for Older People with Dementia: A Pilot Study","authors":"Thanh Xuan Nguyen, Huyen Thi Thanh Vu, T. Nguyen, A. Esterman, Luc Viet Tran, Janani Thillainadesan, V. Naganathan, H. Brodaty, Anh Trung Nguyen","doi":"10.2147/oajct.s403282","DOIUrl":"https://doi.org/10.2147/oajct.s403282","url":null,"abstract":"","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"1 1","pages":""},"PeriodicalIF":1.2,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41779052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Soad A Mohamad, S. M. Sayed, A. A. Sadek, A. Badawi
Background: Olfactory anomalies are the most common diseases among post-COVID-19 disorders. Only 15% of patients completed their prescribed treatment plans, even though several different treatment strategies were recommended;this had a detrimental effect on the patients' physical, social, and emotional wellbeing.Purpose: The aim of this study was approving intranasal fast-dissolving insulin films as the treatment of choice for anosmia in comparison to the control group, and the innovative treatment for anosmic post-COVID-19 is assessed in terms of the patients' health-related quality of life (HRQoL).Methods: For therapy and evaluation, a randomized clinical trial with forty adult anosmic post-viral patients was performed. The recruited participants were recruited between October 1 and March 8 of 2021 based on predetermined criteria. A validated smell assessment questionnaire concerning the participants' olfactory, physical, and psychological outcomes was given to them. Recruited patients were randomly subdivided into two groups: intervention and control group. Intervention was treated with insulin intranasal films, while control group took plain films (placebo).Results: The physical, emotional, and social health quality of life were significantly (p-value <0.0001) improved after 4 consecutive weeks of treatment with the intervention group compared to the control group. The data were analyzed statistically with the aid of GraphPad Prism 9.1.0.Conclusion: The lowest HRQoLs, which significantly impact their quality of life, are found in post-COVID-19 anosmic patients treated with insulin films. It is advised to employ this new intervention (insulin films) as the main therapy approach and to gather additional industry data for its development and dissemination. Problems with self-hygiene, eating, sense of danger and emotional satisfaction were significantly enhanced with insulin intervention versus placebo.
{"title":"Randomized Clinical Trial Comparing Insulin Fast Dissolving Films versus Control Group for Anosmic Patients for Improving Their Health and Social Qualities of Life","authors":"Soad A Mohamad, S. M. Sayed, A. A. Sadek, A. Badawi","doi":"10.2147/oajct.s389489","DOIUrl":"https://doi.org/10.2147/oajct.s389489","url":null,"abstract":"Background: Olfactory anomalies are the most common diseases among post-COVID-19 disorders. Only 15% of patients completed their prescribed treatment plans, even though several different treatment strategies were recommended;this had a detrimental effect on the patients' physical, social, and emotional wellbeing.Purpose: The aim of this study was approving intranasal fast-dissolving insulin films as the treatment of choice for anosmia in comparison to the control group, and the innovative treatment for anosmic post-COVID-19 is assessed in terms of the patients' health-related quality of life (HRQoL).Methods: For therapy and evaluation, a randomized clinical trial with forty adult anosmic post-viral patients was performed. The recruited participants were recruited between October 1 and March 8 of 2021 based on predetermined criteria. A validated smell assessment questionnaire concerning the participants' olfactory, physical, and psychological outcomes was given to them. Recruited patients were randomly subdivided into two groups: intervention and control group. Intervention was treated with insulin intranasal films, while control group took plain films (placebo).Results: The physical, emotional, and social health quality of life were significantly (p-value <0.0001) improved after 4 consecutive weeks of treatment with the intervention group compared to the control group. The data were analyzed statistically with the aid of GraphPad Prism 9.1.0.Conclusion: The lowest HRQoLs, which significantly impact their quality of life, are found in post-COVID-19 anosmic patients treated with insulin films. It is advised to employ this new intervention (insulin films) as the main therapy approach and to gather additional industry data for its development and dissemination. Problems with self-hygiene, eating, sense of danger and emotional satisfaction were significantly enhanced with insulin intervention versus placebo.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"1 1","pages":""},"PeriodicalIF":1.2,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413732","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Katharina Kapoor, D. Wilhelm, C. Neumeister, M. R. Götz, U. Schwantes, G. Bleckert, Lilli Gerstenmaier, A. Jambrecina
{"title":"Treatment of Oropharyngeal Symptoms: A Prospective, Single-Dose, Placebo-Controlled, Randomized Clinical Trial","authors":"Katharina Kapoor, D. Wilhelm, C. Neumeister, M. R. Götz, U. Schwantes, G. Bleckert, Lilli Gerstenmaier, A. Jambrecina","doi":"10.2147/oajct.s331883","DOIUrl":"https://doi.org/10.2147/oajct.s331883","url":null,"abstract":"","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"1 1","pages":""},"PeriodicalIF":1.2,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413711","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
: For many clinical trials, the issue of post-trial access to research treatments is straightforward. Sponsors offer a range of follow-on studies, compassionate use programs or expanded access programs to allow participants to continue accessing beneficial experimental treatments. But there are times when this is not always the case and participants are required to stop beneficial treatments and return to standard care. Guidance states that post-trial access should be made available for “those participants who still need an intervention identified as beneficial”. This broad statement has allowed sponsors to make their own interpretation of when an intervention is still “needed” and when it is “beneficial”. As a result, there have been a number of situations where participants of clinical trials have been left afterwards with feelings of abandonment. Participants involved in studies with long-term, invasive treatments can be seen as being particularly vulnerable. Optogenetic technology has the potential to offer hope to people with neurological conditions, especially people who may not respond to current approved treatments. Optogenetics typically involves two components: a gene therapy medicinal product (GTMP) that induces long-term expression of light-reactive proteins within cells, and an active implantable device to stimulate the light-sensitised cells. Neither works without the other, hence for long-term patient benefit, both must remain active and may therefore require maintenance or replacement. With the potential life-long consequences of both components and the difficulty of accessing the brain, there is a need to reconsider post-trial guidelines and whether they are suitable to support early phase optogenetic trial participants. This paper considers the ethical and regulatory requirements in place for post-trial access and care in relation to optogenetic treatments of neurological conditions. We propose that a new perspective with wider responsibilities for sponsors is required when it comes to these types of novel therapies.
{"title":"Post-Trial Considerations for an Early Phase Optogenetic Trial in the Human Brain","authors":"Michael White, R. Whittaker","doi":"10.2147/oajct.s345482","DOIUrl":"https://doi.org/10.2147/oajct.s345482","url":null,"abstract":": For many clinical trials, the issue of post-trial access to research treatments is straightforward. Sponsors offer a range of follow-on studies, compassionate use programs or expanded access programs to allow participants to continue accessing beneficial experimental treatments. But there are times when this is not always the case and participants are required to stop beneficial treatments and return to standard care. Guidance states that post-trial access should be made available for “those participants who still need an intervention identified as beneficial”. This broad statement has allowed sponsors to make their own interpretation of when an intervention is still “needed” and when it is “beneficial”. As a result, there have been a number of situations where participants of clinical trials have been left afterwards with feelings of abandonment. Participants involved in studies with long-term, invasive treatments can be seen as being particularly vulnerable. Optogenetic technology has the potential to offer hope to people with neurological conditions, especially people who may not respond to current approved treatments. Optogenetics typically involves two components: a gene therapy medicinal product (GTMP) that induces long-term expression of light-reactive proteins within cells, and an active implantable device to stimulate the light-sensitised cells. Neither works without the other, hence for long-term patient benefit, both must remain active and may therefore require maintenance or replacement. With the potential life-long consequences of both components and the difficulty of accessing the brain, there is a need to reconsider post-trial guidelines and whether they are suitable to support early phase optogenetic trial participants. This paper considers the ethical and regulatory requirements in place for post-trial access and care in relation to optogenetic treatments of neurological conditions. We propose that a new perspective with wider responsibilities for sponsors is required when it comes to these types of novel therapies.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"1 1","pages":""},"PeriodicalIF":1.2,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48850333","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Cocaine use disorder is a worldwide problem. Presently, however, no adequate treatments exist. Gabapentin has been explored recently as an alternative for treating different substance use disorders, including cocaine. Methods: The aim of the present paper is to assess the effectiveness of gabapentin for treating cocaine use disorders. For this purpose, a systematic review of the literature was performed using the publication database, PubMed, with search limits from January 1, 1983 to February 28, 2018. The search terms used were combined as follows: “gabapentin” AND “cocaine”. Initially, 41 articles were identified, with additional 23 articles identified through reference exploration or web search. These 23 complementary articles relate mainly to the general description of gabapentin and discussion. After the analysis of the titles and abstracts, 18 references were removed, resulting in 46 articles for further analysis. Results and Discussion: Gabapentin is inadequate for treating cocaine dependence and relapse, and alleviating the subjective effects of cocaine. More research is necessary for exploring gabapentin alleviation of cocaine intoxication, and further investigation is required for confirming the gabapentin’s utility for treating cocaine addiction.
{"title":"Reviewing Treatments for Cocaine Consume Problems: The Gabapentinoid Alternative","authors":"Gabriel C Quintero Garzola","doi":"10.2147/OAJCT.S327934","DOIUrl":"https://doi.org/10.2147/OAJCT.S327934","url":null,"abstract":"Background: Cocaine use disorder is a worldwide problem. Presently, however, no adequate treatments exist. Gabapentin has been explored recently as an alternative for treating different substance use disorders, including cocaine. Methods: The aim of the present paper is to assess the effectiveness of gabapentin for treating cocaine use disorders. For this purpose, a systematic review of the literature was performed using the publication database, PubMed, with search limits from January 1, 1983 to February 28, 2018. The search terms used were combined as follows: “gabapentin” AND “cocaine”. Initially, 41 articles were identified, with additional 23 articles identified through reference exploration or web search. These 23 complementary articles relate mainly to the general description of gabapentin and discussion. After the analysis of the titles and abstracts, 18 references were removed, resulting in 46 articles for further analysis. Results and Discussion: Gabapentin is inadequate for treating cocaine dependence and relapse, and alleviating the subjective effects of cocaine. More research is necessary for exploring gabapentin alleviation of cocaine intoxication, and further investigation is required for confirming the gabapentin’s utility for treating cocaine addiction.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"13 1","pages":"45-60"},"PeriodicalIF":1.2,"publicationDate":"2021-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46645587","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Claudia Milena Garizábalo-Dávila, Alba Luz Rodríguez-Acelas, R. Mattiello, Wilson Cañón-Montañez
{"title":"Social Support Intervention for Self-Management of Type 2 Diabetes Mellitus: Study Protocol for a Randomized Controlled Trial","authors":"Claudia Milena Garizábalo-Dávila, Alba Luz Rodríguez-Acelas, R. Mattiello, Wilson Cañón-Montañez","doi":"10.2147/OAJCT.S314030","DOIUrl":"https://doi.org/10.2147/OAJCT.S314030","url":null,"abstract":"","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"1 1","pages":""},"PeriodicalIF":1.2,"publicationDate":"2021-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68413437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alison Majkut Klint, Jacob I. McPherson, Abhinav Tella, W. Vang, Srihari I Raju, Rebecca Windschitl, A. Ishani
Introduction: Burnout can have a negative impact on job satisfaction and productivity. Antecedents to burnout include workload, control, values, fairness, reward, community and job-person incongruency. Purpose: To better understand the impact of burnout in research staff, these seven antecedents to burnout were analyzed retrospectively within the call centers for the Diuretic Comparison Project. Methods: Two call centers were analyzed with respect to these antecedents to burnout. Consent rates and employee turnover of the two call centers were compared as a means of comparing productivity and job satisfaction, respectively. Results: An odds ratio of 0.13 (95% CI=[0.0164, 1.0853]) indicates that an employee at the Minneapolis call center had lower odds of leaving than an employee at the Canandaigua call center. The call center in Canandaigua had a consent rate of 2.7% (Figure 2). The consent rate for the same months of the following year in Minneapolis came out to 14.6%. Conclusion: A higher consent rate and lower turnover rate of the call center in Minneapolis could be a result of lower levels of burnout among callers. The confidence interval of the odds ratio calculated for turnover indicates that the result is not statistically significant. Due to the retrospective nature of the analysis, extraneous variables were not controlled for analyzing this data. The protocol of the Minneapolis call center appears to take into consideration the antecedents to burnout more than that of the Canandaigua call center. Further studies on burnout prevention methods for clinical research are needed. Research staff could benefit from strategies to help reduce burnout. Organizations should provide proper protocols and training concerning stress and burnout to improve the well-being of employees and, in turn, their productivity.
{"title":"Impacts of Research Staff Burnout for a National Large Scale Pragmatic Clinical Trial","authors":"Alison Majkut Klint, Jacob I. McPherson, Abhinav Tella, W. Vang, Srihari I Raju, Rebecca Windschitl, A. Ishani","doi":"10.2147/OAJCT.S312365","DOIUrl":"https://doi.org/10.2147/OAJCT.S312365","url":null,"abstract":"Introduction: Burnout can have a negative impact on job satisfaction and productivity. Antecedents to burnout include workload, control, values, fairness, reward, community and job-person incongruency. Purpose: To better understand the impact of burnout in research staff, these seven antecedents to burnout were analyzed retrospectively within the call centers for the Diuretic Comparison Project. Methods: Two call centers were analyzed with respect to these antecedents to burnout. Consent rates and employee turnover of the two call centers were compared as a means of comparing productivity and job satisfaction, respectively. Results: An odds ratio of 0.13 (95% CI=[0.0164, 1.0853]) indicates that an employee at the Minneapolis call center had lower odds of leaving than an employee at the Canandaigua call center. The call center in Canandaigua had a consent rate of 2.7% (Figure 2). The consent rate for the same months of the following year in Minneapolis came out to 14.6%. Conclusion: A higher consent rate and lower turnover rate of the call center in Minneapolis could be a result of lower levels of burnout among callers. The confidence interval of the odds ratio calculated for turnover indicates that the result is not statistically significant. Due to the retrospective nature of the analysis, extraneous variables were not controlled for analyzing this data. The protocol of the Minneapolis call center appears to take into consideration the antecedents to burnout more than that of the Canandaigua call center. Further studies on burnout prevention methods for clinical research are needed. Research staff could benefit from strategies to help reduce burnout. Organizations should provide proper protocols and training concerning stress and burnout to improve the well-being of employees and, in turn, their productivity.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2021-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48741420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Intensive Home Blood Pressure Lowering in Advanced Chronic Kidney Disease: A Pilot Randomized Controlled Trial Protocol","authors":"S. Bae, C. McCulloch, Raymond K. Hsu, E. Ku","doi":"10.2147/oajct.s311821","DOIUrl":"https://doi.org/10.2147/oajct.s311821","url":null,"abstract":"","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"1 1","pages":""},"PeriodicalIF":1.2,"publicationDate":"2021-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44784139","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
R. Shrivastava, Megha Vijay, Nathalie Maneby, R. Shrivastava
Background: Covid-19 infection is a multifactorial disease where the virus mainly enters through the nasal cavity, grows, triggers inflammation, and destroys nasal mucosa cells, allowing systemic virus entry and infection of other organs. When symptoms appear, the disease physiopathology is already established. The immune system tries to control the infection but if the infection persists, it gets tired, fatigued, stressed, and finally, there is burnout. Therefore, an effective treatment should be multi-targeted and should not focus only on one parameter. Minimizing virus concentration, reducing nasal mucosa inflammation, and keeping the nasal surface clean should lessen systemic infection and the probability of developing severe respiratory distress. We evaluated clinical efficacy and safety of an osmotic nasal surface cleaning, virus and cytokine trapping polymeric film, in early-stage Covid-19 positive symptomatic patients. Methods: A randomized, multicentric, observational study was performed to evaluate the efficacy and safety of the osmotic film in 213 patients, randomized in 2 equal arms, and confined for 14-days just after the RT-PCR+ test. Due to ethical reasons, all patients received symptomatic treatments (ST). In addition, the patients in Arm-1 received the test product (ST+TP, 2-3 sprays, 4-5 times/ day) for 14-days. Leicester Cough Questionnaire, Visual Analogue Scale, and Covid-19-associated symptoms such as fever, pain, taste, smell, and headache were evaluated daily. Home-confined patients were immediately hospitalized in case of aggravation of any life-threatening clinical sign. Results: Among 213 patients, 98 in the ST and 102 in the ST+TP group completed the study. Thirteen patients did not complete the study as 8 in the ST group and 5 in the ST+TP group were hospitalized during the study due to low blood oxygen levels or sudden health deterioration and were excluded from the study. In the remaining control standard treatment group (n=98), clinical signs sharply aggravated on day 1-2 followed by stabilisation between days 3-6 and progressive reduction thereafter. In the test product group (n=102), symptoms were stabilized just after the first application and improved progressively. Only 42/102 patients in the test product group presented nasal discharge or irritation due to the osmotic properties of the product. Conclusion: The continuous multi-target approach of detaching and neutralizing virus particles and pro-inflammatory cytokines from the nasal surface to minimize systemic virus exposure is a very logical and efficient approach to avoid Covid-19-induced systemic pathology.
{"title":"Clinical Efficacy of an Osmotic, Antiviral and Anti-Inflammatory Polymeric Nasal Film to Treat Covid-19 Early-Phase Respiratory Symptoms","authors":"R. Shrivastava, Megha Vijay, Nathalie Maneby, R. Shrivastava","doi":"10.2147/OAJCT.S307144","DOIUrl":"https://doi.org/10.2147/OAJCT.S307144","url":null,"abstract":"Background: Covid-19 infection is a multifactorial disease where the virus mainly enters through the nasal cavity, grows, triggers inflammation, and destroys nasal mucosa cells, allowing systemic virus entry and infection of other organs. When symptoms appear, the disease physiopathology is already established. The immune system tries to control the infection but if the infection persists, it gets tired, fatigued, stressed, and finally, there is burnout. Therefore, an effective treatment should be multi-targeted and should not focus only on one parameter. Minimizing virus concentration, reducing nasal mucosa inflammation, and keeping the nasal surface clean should lessen systemic infection and the probability of developing severe respiratory distress. We evaluated clinical efficacy and safety of an osmotic nasal surface cleaning, virus and cytokine trapping polymeric film, in early-stage Covid-19 positive symptomatic patients. Methods: A randomized, multicentric, observational study was performed to evaluate the efficacy and safety of the osmotic film in 213 patients, randomized in 2 equal arms, and confined for 14-days just after the RT-PCR+ test. Due to ethical reasons, all patients received symptomatic treatments (ST). In addition, the patients in Arm-1 received the test product (ST+TP, 2-3 sprays, 4-5 times/ day) for 14-days. Leicester Cough Questionnaire, Visual Analogue Scale, and Covid-19-associated symptoms such as fever, pain, taste, smell, and headache were evaluated daily. Home-confined patients were immediately hospitalized in case of aggravation of any life-threatening clinical sign. Results: Among 213 patients, 98 in the ST and 102 in the ST+TP group completed the study. Thirteen patients did not complete the study as 8 in the ST group and 5 in the ST+TP group were hospitalized during the study due to low blood oxygen levels or sudden health deterioration and were excluded from the study. In the remaining control standard treatment group (n=98), clinical signs sharply aggravated on day 1-2 followed by stabilisation between days 3-6 and progressive reduction thereafter. In the test product group (n=102), symptoms were stabilized just after the first application and improved progressively. Only 42/102 patients in the test product group presented nasal discharge or irritation due to the osmotic properties of the product. Conclusion: The continuous multi-target approach of detaching and neutralizing virus particles and pro-inflammatory cytokines from the nasal surface to minimize systemic virus exposure is a very logical and efficient approach to avoid Covid-19-induced systemic pathology.","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"13 1","pages":"11-20"},"PeriodicalIF":1.2,"publicationDate":"2021-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45582810","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Purpose: This study will aim to evaluate whether the provision of a structured nutrition education course to caregivers of children and adolescents with type 1 diabetes mellitus (T1DM) will help improve their children’s glycemic control, dietary intake, and diversity. Research Design and Methods: The study will be a cluster randomized controlled trial conducted at 10 health facilities with established T1DM clinics in Uganda. The facilities will include: Mulago National Referral Hospital, St. Francis Hospital, Lubaga Hospital, Mbale Regional Referral Hospital, Soroti Regional Referral Hospital, Holy innocents’ Hospital, Virika Hospital, Kagando Hospital, Nyakibale Hospital, and Wakiso Health Centre IV. The facilities will be randomized to control or intervention at a ratio of 1:1. A total of 100 caregiver-child pairs will be recruited. The participants in the control group will continue to receive routine medical care, while those in the intervention group will receive routine medical care and attend a structured group nutrition education course. The course will be delivered over 3 months, it will consist of a total of 8 face-to-face sessions lasting 45 minutes each. A two-member team of a diabetes specialist nurse and dietician will conduct the sessions. Each session will be conducted once a week and a question-and-answer session held every after 2 sessions. The primary outcome which is a change in glycated hemoglobin (HbA1c) and secondary outcomes (caregivers’ level of knowledge on general and diabetes-specific nutrition knowledge, children’s dietary diversity score, and children’s mean intake of energy, protein, and fat) will be assessed at baseline, 3, and 6 months. Intention-to-treat analysis will be conducted. Data will be reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement for cluster-randomized trials. The trial is registered with the Pan African Clinical Trials Registry (PACTR201902548129842).
{"title":"Effectiveness of a Structured Nutrition Education Course for Caregivers of Children and Adolescents with Type 1 Diabetes in Improving Glycemic and Dietary Outcomes: A Cluster-Randomized Controlled Trial Protocol","authors":"N. B. Ndahura, J. Munga, J. Kimiywe, E. Mupere","doi":"10.2147/OAJCT.S304290","DOIUrl":"https://doi.org/10.2147/OAJCT.S304290","url":null,"abstract":"Purpose: This study will aim to evaluate whether the provision of a structured nutrition education course to caregivers of children and adolescents with type 1 diabetes mellitus (T1DM) will help improve their children’s glycemic control, dietary intake, and diversity. Research Design and Methods: The study will be a cluster randomized controlled trial conducted at 10 health facilities with established T1DM clinics in Uganda. The facilities will include: Mulago National Referral Hospital, St. Francis Hospital, Lubaga Hospital, Mbale Regional Referral Hospital, Soroti Regional Referral Hospital, Holy innocents’ Hospital, Virika Hospital, Kagando Hospital, Nyakibale Hospital, and Wakiso Health Centre IV. The facilities will be randomized to control or intervention at a ratio of 1:1. A total of 100 caregiver-child pairs will be recruited. The participants in the control group will continue to receive routine medical care, while those in the intervention group will receive routine medical care and attend a structured group nutrition education course. The course will be delivered over 3 months, it will consist of a total of 8 face-to-face sessions lasting 45 minutes each. A two-member team of a diabetes specialist nurse and dietician will conduct the sessions. Each session will be conducted once a week and a question-and-answer session held every after 2 sessions. The primary outcome which is a change in glycated hemoglobin (HbA1c) and secondary outcomes (caregivers’ level of knowledge on general and diabetes-specific nutrition knowledge, children’s dietary diversity score, and children’s mean intake of energy, protein, and fat) will be assessed at baseline, 3, and 6 months. Intention-to-treat analysis will be conducted. Data will be reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement for cluster-randomized trials. The trial is registered with the Pan African Clinical Trials Registry (PACTR201902548129842).","PeriodicalId":19500,"journal":{"name":"Open Access Journal of Clinical Trials","volume":"Volume 13 1","pages":"1-10"},"PeriodicalIF":1.2,"publicationDate":"2021-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44859718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：