المؤلفون: Helmer, Stefanie M., Rogge, Alizé A., Fischer, Felix, Pach, Daniel, Horneber, Markus, Roll, Stephanie, Witt, Claudia M.

المصدر: Trials; 1/29/2019, Vol. 20 Issue 1, p1-12, 12p, 2 Diagrams, 2 Charts

مصطلحات موضوعية: BLENDED learning, ONCOLOGISTS, INTEGRATIVE medicine, ALTERNATIVE medicine, PHYSICIAN-patient relations

مستخلص: Background: Many cancer patients are interested in complementary and integrative medicine during and after regular cancer treatment. Given the high number of users it is important that physicians and patients engage in a dialog about useful complementary and integrative medicine therapies during cancer treatment. In a prospective, multi-center, cluster-randomized evaluation study we will develop, implement and evaluate a training program for oncology physicians advising their patients on complementary and integrative medicine. The main objective of the study is to evaluate whether training physicians in a blended-learning approach (e-learning + skills-training workshop) in providing advice to their cancer patients on complementary and integrative medicine, in addition to handing out an information leaflet about reputable websites, has different effects on the outcomes of patients, physicians, and their interaction level, compared to only giving out the information leaflet.Methods/design: Forty-eight oncology physicians will be included into a cluster-randomized trial to either participate or not in the blended-learning training. Physicians will then advise 10 cancer patients each, resulting in 480 patients participating in the trial. The blended learning consists of nine units of up to 45 min of e-learning and 18 units of up to 45 min of on-site skills-training workshop focusing. Outcomes will be measured on the physician, patient, and physician-patient-interaction level.Discussion: A blended-learning program for oncology physicians to advise their cancer patients in a systematic way and a reasonable time frame on complementary and integrative medicine will be evaluated in depth in a large cluster-randomized trial.Trial Registration: German Clinical Trials Register, ID: DRKS00012704 . Registered on 28 August 2017. [ABSTRACT FROM AUTHOR]

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المؤلفون: Wang, Yanshang, Guo, Dan, Wang, Ming, Hu, Mingzheng, Zhu, Dawei, Yu, Qianqian, Li, Zhansheng, Zhang, Xiaoyi, Ding, Ruoxi, Zhao, Miaomiao, He, Ping

المصدر: Trials; 8/22/2023, Vol. 24 Issue 1, p1-19, 19p, 3 Diagrams, 2 Charts, 1 Graph

مصطلحات موضوعية: CLUSTER randomized controlled trials, INTEGRATIVE medicine, MEDICAL personnel, PEOPLE with diabetes, MENTAL depression

مصطلحات جغرافية: CHINA

مستخلص: Background: Managing the multimorbidity of diabetes and depression remains a clinical challenge for patients and healthcare professionals due to the fragmented healthcare delivery system. To effectively cope with multimorbidity, there is an urgent need for the health system to transform into people-centered integrated care (PCIC) system globally. Therefore, this paper describes the protocol of community-based integrated care for patients with diabetes and depression (CIC-PDD) project, an integrated and shared-care intervention project. Methods/design: CIC-PDD project is conducted in two phases, namely "care model development" and "implementation and evaluation." In the first phase, CIC-PDD model was designed and developed based on the four criteria of collaborative care model (CCM) and was subsequently adjusted to align with the context of China. The second phase entails a pragmatic, two-arm, cluster randomized controlled implementation trial, accompanied by parallel mixed-methods process evaluation and cost-effectiveness analysis. Discussion: We anticipate CIC-PDD project will facilitate the development and innovation of PCIC model and related theories worldwide, particularly in low- and middle-income countries (LMICs). In addition, CIC-PDD project will contribute to the exploration of primary health care (PHC) in addressing the multimorbidity of physical and mental health issues. Trial registration: ClinicalTrials.gov registration ChiCTR2200065608 (China Clinical Trials Registry https://www.chictr.org.cn). Registered on November 9, 2022. [ABSTRACT FROM AUTHOR]

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المؤلفون: Xie, Fengjiao, Wen, Shuang, Deng, Aiwen, Chen, Jianhao, Xiong, Ribo

المصدر: Trials; 5/8/2023, Vol. 24 Issue 1, p1-11, 11p, 1 Chart, 1 Graph

مصطلحات موضوعية: FRAIL elderly, CLUSTER randomized controlled trials, INTEGRATIVE medicine, CHRONIC care model, RESEARCH protocols, CHINA studies

مصطلحات جغرافية: CHINA

مستخلص: Background: While community-based eldercare has proven to be effective in qualitative studies, there is limited evidence on the effectiveness of this geriatric care model in rural communities where caring for older people is traditionally the responsibility of family members, but a formal long-term care was recently introduced in China. CIE is a rural community-embedded intervention using multidisciplinary team, to provide evidenced-based integrated care services for frail older people including social care services and allied primary healthcare and community-based rehabilitation services. Methods: CIE is a prospective stepped-wedge cluster randomized trial conducted at 5 community eldercare centers in rural China. The multifaceted CIE intervention, guided by chronic care model and integrated care model, consists of five components: comprehensive geriatric assessment, individualized care planning, community-based rehabilitation, interdisciplinary case management, and care coordination. The intervention is rolled out in a staggered manner in these clusters of centers at an interval of 1 month. The primary outcomes include functional status, quality of life, and social support. Process evaluation will also be conducted. Generalized linear mixed model is employed for binary outcomes. Discussion: This study is expected to provide important new evidence on clinical effectiveness and implementation process of an integrated care model for frail older people. The CIE model is also unique as the first registered trial implementing a community-based eldercare model using multidisciplinary team to promote individualized social care services integrated with primary healthcare and community-based rehabilitation services for frail older people in rural China, where formal long-term care was recently introduced. Trial registration {2a}: China Clinical Trials Register (http://www.chictr.org.cn/historyversionpub.aspx?regno=ChiCTR2200060326). May 28th, 2022. [ABSTRACT FROM AUTHOR]

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المؤلفون: Bruhn, Maja, Laugesen, Henriette, Kromann-Larsen, Matilde, Trevino, Cathrine Selnes, Eplov, Lene, Hjorthøj, Carsten, Carlsson, Jessica

المصدر: Trials; 10/8/2022, Vol. 23 Issue 1, p1-14, 14p, 2 Diagrams, 1 Chart

مصطلحات موضوعية: MENTAL health services, REFUGEE services, INTEGRATIVE medicine, RANDOMIZED controlled trials, PHYSICIANS, DIALECTICAL behavior therapy

مستخلص: Background: The complexity of past trauma and ongoing post-migration stressors challenges the existing mental health treatment for trauma-affected refugees. Therefore, interventions are needed to accommodate these complex challenges in mental health treatment. This study examines the effect of an add-on integrated care intervention compared to treatment as usual (TAU) for trauma-affected refugees in a randomised controlled trial (RCT).Methods: The study is carried out at a Danish outpatient clinic and will include 197 treatment-seeking refugees with post-traumatic stress disorder (PTSD) who are unemployed and affiliated with municipal employment services. Mental health TAU comprises 10 sessions with a medical doctor (pharmacological treatment and psychoeducation) and 16-20 sessions with a psychologist (manual-based cognitive behavioural therapy) for a period of 8 to 12 months. The add-on intervention strengthens coordination between mental health treatment and employment interventions with three cross-sectoral collaborative meetings during the mental health treatment. The integrated care intervention draws attention to the bidirectional impact of mental health problems and post-migration stressors and focuses on cross-sectoral shared plans. The primary outcome is functioning, measured by WHODAS 2.0, the interviewer-administered 12-item version, with secondary outcomes measuring quality of life, mental health symptoms, and post-migration stressors.Discussion: The RCT is novel in intervention design for trauma-affected refugees and will bring forward new perspectives and knowledge of integrated care interventions for trauma-affected refugees. The integrated care intervention is expected to reduce post-migration stressors that negatively affect the treatment of trauma-related mental health problems, thereby improving preconditions for enhanced treatment outcomes. The intervention builds on existing practices in the Danish healthcare and employment sectors, which ensures high scalability and sustainability for future practices.Trial Registration: ClinicalTrials.gov Identifier: NCT04244864 , registered 28 January 2020.Protocol Version: 17 September 2022, version 2. [ABSTRACT FROM AUTHOR]

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المؤلفون: McBain, Ryan K., Mwale, Owen, Ruderman, Todd, Kayira, Waste, Connolly, Emilia, Chalamanda, Mark, Kachimanga, Chiyembekezo, Khongo, Brown David, Wilson, Jesse, Wroe, Emily, Raviola, Giuseppe, Smith, Stephanie, Coleman, Sarah, Kelly, Ksakrad, Houde, Amruta, Tebeka, Mahlet G., Watson, Samuel, Kulisewa, Kazione, Udedi, Michael, Wagner, Glenn

المصدر: Trials; 9/16/2021, Vol. 22 Issue 1, p1-14, 14p, 3 Diagrams, 2 Charts

مصطلحات موضوعية: CLUSTER randomized controlled trials, SYSTOLIC blood pressure, MENTAL depression, RESEARCH protocols, INTEGRATIVE medicine, HEALTH facilities, VIRAL load

مصطلحات جغرافية: MALAWI, SUB-Saharan Africa

مستخلص: Background: Malawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease-including HIV/AIDS. Additionally, depression is a leading cause of disability in the country but largely remains undiagnosed and untreated. The lack of cost-effective, scalable solutions is a fundamental barrier to expanding depression treatment. Against this backdrop, one major success has been the scale-up of a network of more than 700 HIV clinics, with over half a million patients enrolled in antiretroviral therapy (ART). As a chronic care system with dedicated human resources and infrastructure, this presents a strategic platform for integrating depression care and responds to a robust evidence base outlining the bi-directionality of depression and HIV outcomes.Methods: We will evaluate a stepped model of depression care that combines group-based Problem Management Plus (group PM+) with antidepressant therapy (ADT) for 420 adults with moderate/severe depression in Neno District, Malawi, as measured by the Patient Health Questionnaire-9 (PHQ-9) and Mini-International Neuropsychiatric Interview (MINI). Roll-out will follow a stepped-wedge cluster randomized design in which 14 health facilities are randomized to implement the model in five steps over a 15-month period. Primary outcomes (depression symptoms, functional impairment, and overall health) and secondary outcomes (e.g., HIV: viral load, ART adherence; diabetes: A1C levels, treatment adherence; hypertension: systolic blood pressure, treatment adherence) will be measured every 3 months through 12-month follow-up. We will also evaluate the model's cost-effectiveness, quantified as an incremental cost-effectiveness ratio (ICER) compared to baseline chronic care services in the absence of the intervention model.Discussion: This study will conduct a stepped-wedge cluster randomized trial to compare the effects of an evidence-based depression care model versus usual care on depression symptom remediation as well as physical health outcomes for chronic care conditions. If determined to be cost-effective, this study will provide a model for integrating depression care into HIV clinics in additional districts of Malawi and other low-resource settings with high HIV prevalence.Trial Registration: ClinicalTrials.gov NCT04777006 . Registered on 1 March, 2021. [ABSTRACT FROM AUTHOR]

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المؤلفون: Lee, Mi-Joo, Yun, Young-Ju, Yu, Sun-ae, Shin, Yong-Beom, Kim, Soo-Yeon, Han, Jun-hee

المصدر: Trials; 8/17/2020, Vol. 21 Issue 1, pN.PAG-N.PAG, 1p, 2 Charts, 2 Graphs

مصطلحات موضوعية: CHILDREN with cerebral palsy, MEDICAL rehabilitation, INTEGRATIVE medicine, RANDOMIZED controlled trials, PEOPLE with cerebral palsy, GOAL Attainment Scaling

مصطلحات جغرافية: SOUTH Korea

مستخلص: Background: Traditional Korean medicine (TKM) has been employed for the treatment of children with cerebral palsy in Korea; however, the addition of TKM to usual rehabilitation (UR) treatment is hindered by insufficient evidence of clinical improvement with TKM in patients with cerebral palsy. In this study, we will evaluate the effectiveness and safety of integrative medicine rehabilitation (IMR) for cerebral palsy through a randomized controlled clinical study.Methods: Eighty children (2-6 years old) diagnosed with cerebral palsy will be recruited and randomly divided into groups A and B. Patients in group A will receive IMR with UR, while those in group B will receive only UR during weeks 1-12 of the study. IMR includes acupuncture treatment (head and limb acupuncture) three times a week and the administration of herbal medicine (Yukgunza-tang and Yukmijihwang-tang extracts) twice a day in parallel with UR. Evaluations will be conducted at the beginning of the study and at 12 and 24 weeks (follow-up). The primary outcome is the Gross Motor Function Measure-88 score, and the secondary outcomes are the scores for the Goal Attainment Scale, Korean Bayley Scales of Infant Development III, and the Pediatric Quality of Life Inventory, and adverse events.Discussion: This will be the first pragmatic randomized controlled trial to evaluate the efficacy and safety of IMR in children with cerebral palsy in Korea. The results will help to demonstrate if IMR is an effective therapeutic approach for cerebral palsy.Trial Registration: Ministry of Food and Drug Safety 31361 ( http://www.mfds.go.kr ). Registered on 29 June 2017. Clinical Research Information Service KCT0002620 ( https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=9819 ). Registered on 29 December 2017. [ABSTRACT FROM AUTHOR]

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المؤلفون: Tamminga, Sietske J., Hoving, Jan L., Frings-Dresen, Monique H. W., de Boer, Angela G. E. M.

المصدر: Trials; 9/15/2016, Vol. 17, p1-10, 10p, 1 Diagram, 1 Chart

مصطلحات موضوعية: CANCER patients, RETURN to work programs, EMPLOYMENT reentry, HEALTH care intervention (Social services), INTEGRATIVE medicine, RANDOMIZED controlled trials, EMPLOYMENT, TUMORS & psychology, COMPARATIVE studies, COST effectiveness, EXPERIMENTAL design, RESEARCH methodology, MEDICAL care costs, MEDICAL cooperation, NURSES, QUALITY of life, RESEARCH, SICK leave, TELEMEDICINE, TIME, TUMORS, WORK capacity evaluation, PILOT projects, OCCUPATIONAL roles, EVALUATION research, TREATMENT effectiveness, ECONOMICS

مصطلحات جغرافية: NETHERLANDS

مستخلص: Background: Although the importance of work for patients with cancer is nowadays more acknowledged both in the literature as well as in cancer survivorship care, effective interventions targeting the return to work of these patients are still scarce. Therefore, we developed a nurse-led, stepped-care, e-health intervention aimed at enhancing the return to work of patients with cancer. The objective of this study is to describe the content of the intervention and the study design used to evaluate the feasibility and (cost) effectiveness of the intervention.Methods: We designed a multi-centre randomised controlled trial with a follow-up of 12 months. Patients who have paid employment at the time of diagnosis, are on sick leave and are between 18-62 years old will be eligible to participate. After patients have signed the informed consent form and filled in the baseline questionnaire, they are randomly allocated to either the nurse-led, stepped-care, e-health intervention called Cancer@Work, or care as usual. The primary outcome is sustainable return to work. Secondary outcomes are sick leave days, work ability, work functioning, quality of life, quality of working life and time from initial sick leave to full return to work without extensive need for recovery. The feasibility of the Cancer@Work intervention and direct and indirect costs will be determined. Outcomes will be assessed by questionnaires at 3, 6, 9 and 12 months of follow-up.Discussion: The results of this study will provide new insights into the feasibility and (cost) effectiveness of Cancer@Work, a nurse-led, stepped-care, e-health intervention for cancer patients aimed at enhancing their return to work. If proven effective, the intention is to implement the Cancer@Work intervention in usual psycho-oncological care.Trial Registration: NTR (Netherlands Trial Registry): NTR5190 . Registered on 18 June 2015. [ABSTRACT FROM AUTHOR]

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المؤلفون: Qiu, Ruijin, Zhong, Changming, Wan, Siqi, Zhang, Yao, Wei, Xuxu, Li, Min, Hu, Jiayuan, Chen, Shiqi, Zhao, Chen, Chen, Zhao, Chen, Jing, Shang, Hongcai

المصدر: Trials; 3/28/2022, Vol. 23 Issue 1, p1-9, 9p, 1 Diagram, 3 Charts

مستخلص: Background: Integrative medicine is commonly used in China. Researchers prefer to report efficacy outcomes rather than safety outcomes in clinical trials; thus, evidence regarding safety in integrative medicine is unclear. Developing a core outcome set (COS) for safety outcomes is necessary. In this study, a representative example of the methodology for developing COS to assess safety outcomes of cardiovascular diseases in clinical trials investigating integrated medicine will be developed.Methods and Analysis: Safety information will be extracted from package inserts and through systematic reviews of treatments for cardiovascular diseases (including angina pectoris, myocardial infarction, heart failure, arrhythmia, and hypertension) to develop an extensive list of safety outcomes, which will then be categorized according to whether subjective or objective outcomes. Questionnaires for clinician-reported safety outcomes and patient-reported safety outcomes will be developed. Two rounds of the Delphi survey will then be conducted for different stakeholders (traditional Chinese medicine clinicians and researchers in cardiovascular diseases, Western medicine clinicians and researchers in cardiovascular diseases, integrated medicine clinicians and researchers of cardiovascular diseases, pharmacologists, methodologists of evidence-based medicine, and patients). After round 2 of the Delphi analysis, a face-to-face consensus meeting will be held to determine the final COS for assessing safety outcomes in cardiovascular diseases.Discussion: A COS for safety outcomes in cardiovascular diseases may improve the consistency of reporting results and will help identify potential bias of selective reporting in the future.Trial Registration: This study was registered in the Core Outcome Measures in Effectiveness Trials database as study 1564 . [ABSTRACT FROM AUTHOR]

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المؤلفون: Kuang, Zhuoran, Li, Xiaoyan, Cai, Jianxiong, Chen, Yaolong, Qiu, Xiaoyuan, Ni, Xiaojia, Evidence-based Traditional and Integrative Medicine Working Group for Public Health Emergency

المصدر: Trials; 4/7/2021, Vol. 22 Issue 1, p1-3, 3p, 2 Diagrams

مصطلحات موضوعية: HEALTH surveys, CHINESE medicine, COVID-19, RECORDING & registration, SARS disease, H1N1 influenza

مستخلص: An amendment to this paper has been published and can be accessed via the original article. [ABSTRACT FROM AUTHOR]

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المؤلفون: Kuang, Zhuoran, Li, Xiaoyan, Cai, Jianxiong, Chen, Yaolong, Qiu, Xiaoyuan, Ni, Xiaojia, Evidence-based Traditional and Integrative Medicine Working Group for Public Health Emergency

المصدر: Trials; 3/5/2021, Vol. 22 Issue 1, p1-11, 11p, 1 Diagram, 4 Charts

مصطلحات موضوعية: CHINESE medicine, HEALTH surveys, COVID-19, CLINICAL trial registries, EMERGENCY medical services communication systems, H1N1 influenza

مستخلص: Objective: To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS.Method: We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes.Results: A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s).Conclusion: Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data. [ABSTRACT FROM AUTHOR]

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