scholarly journals Effects of the tailored activity program (TAP) on dementia-related symptoms, health events and caregiver wellbeing: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Laura N. Gitlin ◽  
Katherine Marx ◽  
Catherine Verrier Piersol ◽  
Nancy A. Hodgson ◽  
Jin Huang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Attention Control ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Activity Program ◽  
Health Related

Abstract Background People living with dementia (PLWD) and caregivers are adversely impacted by lack of meaningful activity leading to worse symptoms and impaired quality-of-life. There is a critical need to develop effective and well-tolerated treatments that mitigate clinical symptoms, engage PLWD and support caregiver wellbeing. We tested whether, compared to attention control, the Tailored Activity Program (TAP) reduced clinical symptoms and health-related events, and improved caregiver wellbeing, and if TAP activities were well-tolerated. Methods We conducted a single-blind randomized controlled trial among 250 dyads recruited from Baltimore-Washington DC (2012–2016) with a dementia diagnosis and clinically significant agitation/aggression. Dyads were randomized to TAP (n = 124) or attention control (n = 126), and interviewed at baseline, 3 (endpoint) and 6-months (follow-up) by interviewers masked to group allocation. TAP assessed PLWD abilities/interests, instructed caregivers in using prescribed activities, and provided dementia education and stress reduction techniques. Attention controls received disease education and home safety tips. Both groups had up to 8 home visits over 3-months. The primary outcome was frequency by severity scores for agitation/aggression subscales of Neuropsychiatric Inventory-Clinician using caregiver ratings. Secondary outcomes included number of instrumental (IADL) and activities of daily living (ADL) needing assistance, caregiver wellbeing, and confidence using activities. Health-related events (PLWD death, hospitalizations, caregiver hospitalization, depression) and perceived study benefits were captured over 6 months. PLWD tolerability of prescribed activities was examined. Results Of 250 dyads, most caregivers were female (81.2 %, n = 203), non-spouses (54.4 %, n = 136), white (59.2 %, n = 145) or African American (36.7 %, n = 90) with mean age = 65.4 (SD = 12.6). PLWD were mostly female (63.2 %, n = 158) with mean age = 81.4 (SD = 7.9), and mean MMSE = 14.3 (SD = 7.8). At 3-months, compared to controls, TAP conferred no benefit to agitation/aggression (p = 0.43, d = 0.11), but resulted in less IADL (p = 0.02, d=-0.33), and ADL (p = 0.04, d=-0.30) assistance, improved caregiver wellbeing (p = 0.01, d = 0.39), and confidence using activities (p = 0.02, d = 0.32). By 6-months, 15 PLWD in TAP had ≥ 1 health-related event versus 28 PLWD in control, demonstrating 48.8 % improvement in TAP (p = 0.03). TAP caregivers were more likely to perceive study benefits. Prescribed activities were well-tolerated. Conclusions Although TAP did not benefit agitation/aggression, it impacted important outcomes that matter to families warranting its use in dementia care. Clinical trial registration Clinicaltrials.gov # NCT01892579 at https://clinicaltrials.gov/; Date of clinical trial registration: 04/07/2013; Date first dyad enrolled: 15/11/2013.

Rest or 30-Min Walk as Exercise Intervention (RESTOREX) in Myasthenia Gravis: A Randomized Controlled Trial

2021 ◽  
pp. 1-7
Author(s):  
Usha K. Misra ◽  
Jayantee Kalita ◽  
Varun K. Singh ◽  
Aditya Kapoor ◽  
Abhilasha Tripathi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Myasthenia Gravis ◽  
Controlled Trial ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Secondary Endpoints

<b><i>Introduction:</i></b> There is a lack of evidence about the usefulness of exercise or rest in myasthenia gravis (MG). This study is aimed to evaluate the efficacy and safety of exercise or rest in MG. <b><i>Methods:</i></b> In a single-center open-labeled randomized controlled trial, the patients with mild to moderate MG were randomized to 30-min walk or rest in addition to the standard treatment. The primary endpoint was 50% improvement in the MG Quality of Life (MG-QOL15), and secondary endpoints were change in the Myasthenic Muscle Score (MMS), MG Activities of Daily Living (MGADL), grip strength, dose of acetylcholine esterase inhibitor and prednisone, 6-min walk test (6MWT), decrement in trapezius on the low-rate repetitive nerve stimulation test, and adverse events. The outcomes were defined at 3 months, by &#x3e;50% improvement in these outcome parameters. <b><i>Results:</i></b> Forty patients with MG were randomized to the exercise or rest arm. The 2 arms were matched for demographic and clinical parameters. The patients in the exercise arm had significantly better QOL evidenced by MG-QOL15 (<i>p =</i> 0.02). The secondary endpoints, distance covered in 6MWT (<i>p =</i> 0.007), were also better in the exercise arm without any adverse event. <b><i>Conclusion:</i></b> Regular exercise for 30 min in mild and moderate MG improves quality of life and walking distance compared to rest and is safe. <b><i>Clinical Trial Registration:</i></b> The clinical trial registration number is CTRI/2019/11/021869.

scholarly journals Approaches to cervical spine mobilization for neck pain: a pilot randomized controlled trial

2020 ◽  
Vol 28 (1) ◽  
Author(s):  
Claire Lagoutaris ◽  
Justin Sullivan ◽  
Michelle Hancock ◽  
Andrew M. Leaver
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Cervical Spine ◽  
Neck Pain ◽  
Controlled Trial ◽  
Trial Registration ◽  
Single Treatment ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Study design Pilot randomized controlled trial. Background Better understanding of the relative effectiveness of different approaches to cervical spine mobilization has been identified as a research priority in manual therapy practice. Two distinct approaches to the practice of mobilization have emerged in recent years, based on different reasoning models for selection of mobilization techniques. The objective of this pilot study was to assess feasibility aspects for a future randomized clinical trial by exploring short-term pain and disability outcomes after a single treatment with pragmatic versus prescriptive approaches to cervical mobilization for people with recent-onset neck pain at 48-h follow-up after randomization. Methods Twenty adults with a new episode of mechanical neck pain were randomly allocated to either pragmatic or prescriptive mobilization intervention groups. The pragmatic group received a single treatment of cervical mobilization with the technique, target segment, and grade selected by their treating therapist. The prescriptive group received a single treatment of standardized mobilization with techniques similar to a previous mobilization clinical trial. Feasibility outcomes were recruitment rates, randomization audit and completion of treatment and follow-up per protocol. The primary clinical outcome of interest was disability level measured at 48-h follow-up after randomization. Results Recruitment rates were approximately 2.5 participants per week and 100% of eligible participants were deemed suitable for treatment with cervical mobilization. There was sufficient variety in the range of pragmatic treatments selected and the data collection process imposed minimal burden on participants. Conclusions Our results provide supporting evidence for the feasibility of a future larger scale randomized clinical trial. Trial registration Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12616000446460). Registered 6th April 2016. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370448&isReview=true

scholarly journals TELERA—Asynchronous TELEmedicine for Patients With Rheumatoid Arthritis: Study Protocol for a Prospective, Multi-Center, Randomized Controlled Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Johanna Mucke ◽  
Johannes Knitza ◽  
Felix Muehlensiepen ◽  
Manuel Grahammer ◽  
Ramona Stenzel ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Medical App ◽  
Patient Reported ◽  
And Performance ◽  
Remote Care

Innovative strategies are needed to adequately assess and monitor disease activity of patients with rheumatoid arthritis (RA) in times of scarce appointments. The aim of the TELERA study is to evaluate the feasibility and performance of asynchronous telemedicine visits based on patient-generated data and patient's drug history. RA patients use a medical app, ABATON, that captures the results of a self-performed quick CRP-test, joint-count, and electronic patient-reported outcomes in between visits. This is a prospective, multi-center, randomized controlled trial performed in four German university centers. The estimated sample size is 120 patients. The main outcome is the agreement of rheumatologists' treatment decisions based on asynchronous telemedicine patient-generated data with traditional in-person rheumatology clinic-based decisions and with patient suggestions. The TELERA trial will provide evidence regarding the implementation of remote care in rheumatology.Clinical Trial Registration: This clinical trial was registered at German Registry for Clinical Trials (DRKS). http://www.drks.de/DRKS00016350, identifier: DRKS00024928.

scholarly journals Topical vancomycin for neurosurgery wound prophylaxis: an interim report of a randomized clinical trial on drug safety in a diverse neurosurgical population

2019 ◽  
Vol 131 (6) ◽  
pp. 1966-1973
Author(s):  
Ryan E. Radwanski ◽  
Brandon R. Christophe ◽  
Josephine U. Pucci ◽  
Moises A. Martinez ◽  
Michael Rothbaum ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
De Novo ◽  
Controlled Trial ◽  
Significant Risk ◽  
Standards Of Care ◽  
Systemic Absorption ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Neurosurgical Patients

OBJECTIVEPostoperative surgical site infections (SSIs) in neurosurgical patients carry a significant risk of increased morbidity and mortality. With SSIs accounting for approximately 20% of nosocomial infections and costing approximately $1.6 billion USD annually, there is a need for additional prophylaxis to improve current standards of care. Topical vancomycin is increasingly utilized in instrumented spinal and cardiothoracic procedures, where it has been shown to reduce the risk of SSIs. A randomized controlled trial assessing its efficacy in the general neurosurgical population is currently underway. Here, the authors report their initial impressions of topical vancomycin safety among patients enrolled during the 1st year of the trial.METHODSThis prospective, multicenter, patient-blinded, randomized controlled trial will enroll 2632 patients over 5 years. Here, the authors report the incidence of adverse events, the degree of systemic vancomycin absorption in treated patients, and pattern changes of antibiotic-resistant profiles of Staphylococcus aureus flora among patients enrolled during the 1st year.RESULTSThe topical vancomycin treatment group comprised 257 patients (514 total enrolled patients), of whom 2 exhibited weakly positive serum levels of vancomycin (> 3.0 mg/dl). S. aureus was detected preoperatively in the anterior nares of 35 (18.1%) patients and the skin near the surgical site of 9 (4.7%). Colonization in the nares remained for many patients (71.4%) through postoperative day 30. The authors found a significant association between preoperative S. aureus colonization and postoperative colonization. Seven methicillin-resistant isolates were detected among 6 different patients. Two isolates were detected preoperatively, and 5 were de novo postoperative colonization. No adverse responses to treatment have been reported to date.CONCLUSIONSThe authors’ data indicate that the use of topical vancomycin is safe with no significant adverse effects and minimal systemic absorption, and no development of vancomycin-resistant microorganisms.Clinical trial registration no.: NCT02284126 (clinicaltrials.gov)

scholarly journals An internet-based self-help intervention for people with psychological distress due to COVID-19: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Noemi Anja Brog ◽  
Julia Katharina Hegy ◽  
Thomas Berger ◽  
Hansjörg Znoj
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
The Self ◽  
Randomized Controlled ◽  
Self Help ◽  
Parallel Group ◽  
Related Quality ◽  
Health Related

Abstract Background The coronavirus-19 (COVID-19) has reached pandemic status and is affecting countries all over the world. The COVID-19 pandemic is accompanied by various stressors that require adjustment in everyday life and possibly changes in personal future prospects. While some individuals cope well with these challenges, some develop psychological distress including depressive symptoms, anxiety, or stress. Internet-based self-help interventions have proven to be effective in the treatment of various mental disorders such as depression and anxiety. Based on that, we developed an internet-based self-help program for individuals with psychological distress due to the situation surrounding the COVID-19 pandemic. The 3-week self-help program consists of 6 modules comprising texts, videos, figures, and exercises. Participants can request guidance within the self-help program (guidance on demand). The primary aim of this study is to evaluate the efficacy and feasibility of the self-help program compared to a waiting control condition. Methods The design is a parallel group randomized controlled trial. Participants are allocated to a 3-week self-help intervention plus care as usual or a 3-week waiting period with only care as usual. There are follow-ups after 6 weeks and 18 weeks. At least 80 participants with COVID-19 pandemic related psychological distress will be recruited. Primary outcome are depressive symptoms. Secondary outcomes include anxiety and chronic stress, suicidal experiences and behavior, health-related quality of life, generalized optimism and pessimism, embitterment, optimistic self-beliefs, emotion regulation skills, loneliness, resilience, and the satisfaction with and usability of the self-help program. Discussion To the best of our knowledge, this is one of the first studies investigating the efficacy of an internet-based self-help program for psychological distress due to the situation surrounding the COVID-19 pandemic. Thus, the results of this study may give further insight into the use of internet-based self-help programs in pandemic-related psychological distress. Trial registration ClinicalTrials.gov NCT04380909. Retrospectively registered on 8 May 2020.

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.

scholarly journals Japanese health and safety information for overseas visitors: protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mariko Nishikawa ◽  
Masaaki Yamanaka ◽  
Akira Shibanuma ◽  
Junko Kiriya ◽  
Masamine Jimba
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Safety Information ◽  
Intervention Group ◽  
Health And Safety ◽  
Trial Registration ◽  
Control Group ◽  
Internet Portal ◽  
Randomized Controlled

Abstract Background Before the COVID-19 pandemic occurred in January 2020, the number of overseas visitors to Japan had increased threefold over the last decade. To minimize the risk of health problems, visitors should be able to access information on the health care systems of the places they visit. Most short-term overseas visitors are young adults. Although they are not very likely to get sick from noncommunicable diseases, they are at high risk for injury and often experience stomach ailments, fever, or nausea when travelling. The objective of this study is to evaluate culturally and linguistically appropriate health information on preventive health behaviours and the health care system in Japan. We will examine the level of satisfaction of overseas visitors to Japan with health care-related educational materials using a five-minute digital game named Sa-Chan Japan. Methods Our study is a randomized controlled trial (RCT). We will assess both satisfaction and motivation before, during, and after the interventions and examine the changes over time. The intervention group will comprise overseas visitors who will view and answer questions in an animation named Sa-Chan Japan. The control group will comprise overseas visitors who will watch an English digital animation named Mari Info Japan. We will recruit 1002 participants through the Macromill Internet portal. We will contact overseas visitors who have either visited or wish to visit Japan from the United Kingdom, United States, and Australia. The participants will fill out a self-administered questionnaire online in the first quarter of 2021. We will determine the participants’ levels of satisfaction with the CSQ-8 (8-item Client Satisfaction Questionnaire). We will analyse the median score of the overseas visitors with both the Wilcoxon rank-sum and the Wilcoxon signed-rank tests. Our protocol of randomized controlled trials follows the SPIRIT guidelines. Discussion Our research will utilize unique digital education strategies in a game that promotes health and safety among overseas visitors to Japan. We believe the results of this study will be useful in overcoming the current challenges regarding pretravel health requirements for overseas visitors worldwide. Trial registration Version 1 of this trial was registered in the UMIN-CTR (University Hospital Medical Information Network Center Clinical Trials Registry), and the trial registration data are available on UMIN000042483, November 17, 2020.

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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