Effectiveness of energy conservation management on fatigue and participation in multiple sclerosis: A randomized controlled trial

2017 ◽  
Vol 23 (11) ◽  
pp. 1527-1541 ◽  
Author(s):  
Lyan JM Blikman ◽  
Jetty van Meeteren ◽  
Jos WR Twisk ◽  
Fred AJ de Laat ◽  
Vincent de Groot ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Energy Conservation ◽  
Social Relations ◽  
Conservation Management ◽  
Controlled Trial ◽  
Outpatient Rehabilitation ◽  
Control Group ◽  
Intention To Treat ◽  
Unfavourable Effect ◽  
The Individual

Background: Fatigue is a frequently reported and disabling symptom in multiple sclerosis (MS). Objective: To investigate the effectiveness of an individual energy conservation management (ECM) intervention on fatigue and participation in persons with primary MS-related fatigue. Methods: A total of 86 severely fatigued and ambulatory adults with a definite diagnosis of MS were randomized in a single-blind, two-parallel-arm randomized clinical trial to the ECM group or the information-only control group in outpatient rehabilitation departments. Blinded assessments were carried out at baseline and at 8, 16, 26 and 52 weeks after randomization. Primary outcomes were fatigue (fatigue subscale of Checklist Individual Strength – CIS20r) and participation (Impact on Participation and Autonomy scale – IPA). Results: Modified intention-to-treat analysis was based on 76 randomized patients (ECM, n = 36; MS nurse, n=40). No significant ECM effects were found for fatigue (overall difference CIS20r between the groups = −0.81; 95% confidence interval (CI), −3.71 to 2.11) or for four out of five IPA domains. An overall unfavourable effect was found in the ECM group for the IPA domain social relations (difference between the groups = 0.19; 95% CI, 0.03 to 0.35). Conclusion: The individual ECM format used in this study did not reduce MS-related fatigue and restrictions in participation more than an information-only control condition.

scholarly journals Randomised controlled trial of a self-guided online fatigue intervention in multiple sclerosis

2018 ◽  
Vol 89 (9) ◽  
pp. 970-976 ◽  
Author(s):  
Jana Pöttgen ◽  
Rona Moss-Morris ◽  
Janina-Maria Wendebourg ◽  
Lena Feddersen ◽  
Stefanie Lau ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Controlled Trial ◽  
Treatment Options ◽  
Behavioural Therapy ◽  
Mean Difference ◽  
Control Group ◽  
Effective Treatment Option ◽  
Intention To Treat ◽  
Cost Effective Treatment ◽  
Treat Analysis

ObjectiveFatigue is a major disabling symptom in many chronic diseases including multiple sclerosis (MS), but treatment options are limited.Here, we tested the effectiveness of a self-guided , interactive, online fatigue management programme (ELEVIDA) based on principles of cognitive behavioural therapy (CBT) and related psychotherapeutic approaches (eg, mindfulness) for reducing fatigue in MS.MethodsPatients with MS and self-reported fatigue were recruited via the website of the German MS Society and assigned via an automated randomisation generator (1:1, no blocking or stratification) to a 12-week online intervention (ELEVIDA, n=139, 82% female, mean age 40.8, median patient determined disease steps (PDDS) 3.0) or a waitlist control group (n=136, 79% female, mean age 41.9, median PDDS 3.0). The primary outcome was the Chalder Fatigue Scale. Outcomes were assessed at baseline, at week 12 (postintervention) and at follow-up (week 24).ResultsCompared with the control group, significantly greater reductions in Chalder Fatigue Scale scores were seen in the ELEVIDA group at week 12 (primary endpoint, intention-to-treat analysis: between-group mean difference 2.74 points; 95% CI 1.16 to 4.32; p=0.0007; effect size d=0.53), with effects sustained at week 24 (intention-to-treat analysis: between-group mean difference 2.19 points; 95% CI 0.57 to 3.82; p=0.0080).ConclusionsOur trial provides evidence for the effectiveness of a self-guided , internet-based intervention to reduce fatigue in MS. Interventions such as ELEVIDA may be a suitable low barrier, cost-effective treatment option for MS fatigue.Trial registration numberISRCTN registry (number ISRCTN25692173).

scholarly journals Primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, DemStepCare

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Isabella Bablok ◽  
◽  
Harald Binder ◽  
Dominikus Stelzer ◽  
Klaus Kaier ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Dementia Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Care Model ◽  
Randomized Controlled ◽  
Individual Needs ◽  
Cluster Randomized ◽  
The Individual

Abstract Background Most people with dementia (PwD) are cared for at home, with general practitioners (GPs) playing a key part in the treatment. However, primary dementia care suffers from a number of shortcomings: Often, diagnoses are made too late and therapies by GPs do not follow the guidelines. In cases of acute crises, PwD are too often admitted to hospital with adverse effects on the further course of the disease. The aim of this study is to implement and evaluate a new GP-based, complex dementia care model, DemStepCare. DemStepCare aims to ensure demand-oriented, stepped care for PwD and their caregivers. Methods/design In a cluster randomized controlled trial, the care of PwD receiving a complex intervention, where the GP is supported by a multi-professional team, is compared to (slightly expanded) usual care. GPs are clustered by GP practice, with 120 GP practices participating in total. GP practices are randomized to an intervention or a control group. 800 PwD are to be included per group. Recruitment takes place in Rhineland-Palatinate, Germany. In addition, a second control group with at least 800 PwD will be formed using aggregated routine data from German health insurance companies. The intervention comprises the training of GPs, case management including repeated risk assessment of the patients’ care situation, the demand-oriented service of an outpatient clinic, an electronic case record, external medication analyses and a link to regional support services. The primary aims of the intervention are to positively influence the quality of life for PwD, to reduce the caregivers’ burden, and to reduce the days spent in hospital. Secondary endpoints address medication adequacy and GPs’ attitudes and sensitivity towards dementia, among others. Discussion The GP-based dementia care model DemStepCare is intended to combine a number of promising interventions to provide a complex, stepped intervention that follows the individual needs of PwD and their caregivers. Its effectiveness and feasibility will be assessed in a formative and a summative evaluation. Trial registration German Register of Clinical Trials (Deutsches Register Klinischer Studien, DRKS), DRKS00023560. Registered 13 November 2020 - Retrospectively registered. HTML&TRIAL_ID=DRKS00023560.

Do Nutrition Education Approaches With Preschoolers and Their Caregivers Influence Retention of Biofortified Orange-Fleshed Sweetpotato on Farms?: Evidence From Homa Bay County, Kenya

2021 ◽  
pp. 037957212110254
Author(s):  
Sylvester O. Ojwang ◽  
David J. Otieno ◽  
Julius J. Okello ◽  
Penina Muoki ◽  
Rose A. Nyikal
Keyword(s):  
Nutrition Education ◽  
Early Childhood Development ◽  
Controlled Trial ◽  
Text Messages ◽  
Sub Saharan Africa ◽  
Childhood Development ◽  
Control Group ◽  
Micronutrient Deficiencies ◽  
Household Level ◽  
Intention To Treat

Background: Biofortified staples have been promoted widely in sub-Saharan Africa to combat micronutrient deficiencies. Contemporary projects are increasingly using elementary schools to target households with these foods. Objective: This study assessed the effects of integrated nutrition education approaches, targeting preschoolers and their caregivers, on retention of orange-fleshed sweetpotato (OFSP) on farms in the second season after lapse of free vine dissemination initiatives. Methods: Rural farming households, with preschoolers and no prior engagement with OFSP, were targeted. A multistage sample of 431 preschooler–caregiver pairs was recruited for a cluster-randomized controlled trial. After issuing routine OFSP promotion activities, 15 village-level clusters of the pairs were randomized into 1 control group (3 villages) and 3 treatment arms (4 villages each) for the interventions. Baseline and follow-up household-level survey data were collected from the caregivers. The interventions included: (1) OFSP-branded exercise books, posters, and a poem to preschoolers only; (2) OFSP-oriented mobile phone-mediated text messages to caregivers only; and (3) both 1 and 2 provided to individual households concurrently. Interventions 1 and 2 were single-channeled, while 3 was multichanneled. We estimated the intention-to-treat (ITT) and treatment-on-the-treated (TOT) effects using a binary logit model and a special regressor method, respectively. Results: Only the multichanneled nutrition education approach had significant effects (ITT = 0.167, P = .001; TOT = .243, P = .007) on the caregivers’ likelihood to retain OFSP on their farms. Conclusions: The finding implies that multichanneled agriculture-nutrition education interventions through Early Childhood Development institutions can be effective in ensuring sustainable adoption of OFSP.

scholarly journals Study protocol: randomised controlled trial evaluating exercise therapy as a supplemental treatment strategy in early multiple sclerosis: the Early Multiple Sclerosis Exercise Study (EMSES)

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e043699
Author(s):  
Morten Riemenschneider ◽  
Lars G Hvid ◽  
Steffen Ringgaard ◽  
Mikkel K E Nygaard ◽  
Simon F Eskildsen ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Treatment Strategy ◽  
Controlled Trial ◽  
Treatment Strategies ◽  
Control Group ◽  
Disease Course ◽  
Disability Progression ◽  
Randomised Controlled

IntroductionIn the relapsing remitting type of multiple sclerosis (MS) reducing relapses and neurodegeneration is crucial in halting the long-term impact of the disease. Medical disease-modifying treatments have proven effective, especially when introduced early in the disease course. However, patients still experience disease activity and disability progression, and therefore, supplemental early treatment strategies are warranted. Exercise appear to be one of the most promising supplemental treatment strategies, but a somewhat overlooked ‘window of opportunity’ exist early in the disease course. The objective of this study is to investigate exercise as a supplementary treatment strategy early in the disease course of MS.Methods and analysisThe presented Early Multiple Sclerosis Exercise Study is a 48-week (plus 1-year follow-up) national multicentre single-blinded parallel group randomised controlled trial comparing two groups receiving usual care plus supervised high-intense exercise or plus health education (active control). Additionally, data will be compared with a population-based control group receiving usual care only obtained from the Danish MS Registry. The primary outcomes are annual relapse rate and MRI derived global brain atrophy. The secondary outcomes are disability progression, physical and cognitive function, MS-related symptoms, and exploratory MRI outcomes. All analyses will be performed as intention to treat.Ethics and disseminationThe study is approved by The Central Denmark Region Committees on Health Research Ethics (1-10-72-388-17) and registered at the Danish Data Protection Agency (2016-051-000001 (706)). All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences.Trial registration numberNCT03322761.

scholarly journals Effect of Inquiry-Based Stress Reduction (IBSR) Intervention on Well-Being, Resilience and Burnout of Teachers during the COVID-19 Pandemic

2021 ◽  
Vol 18 (7) ◽  
pp. 3689
Author(s):  
Tzofnat Zadok-Gurman ◽  
Ronit Jakobovich ◽  
Eti Dvash ◽  
Keren Zafrani ◽  
Benjamin Rolnik ◽  
...  
Keyword(s):  
Stress Reduction ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Stressful Events ◽  
Control Group ◽  
Subjective Well Being ◽  
Intention To Treat ◽  
School Year ◽  
Blended Intervention

Objective: The COVID-19 pandemic has had a major impact on teachers professional and personal lives. Our primary aim was to assess the effect of a blended Inquiry-Based Stress Reduction (IBSR), an emerging mindfulness and cognitive reframing intervention on teacher’s well-being. Our secondary aims were to assess the effect of IBSR on resilience, burnout, mindfulness, and stress among teachers during the COVID-19 pandemic. Methods: The study was a prospective controlled trial with an intervention group (N = 35) and a comparison control group (N = 32). The intervention took place in the Jerusalem District throughout the school year from November 2019 to May 2020. The sessions were conducted in blended learning that included traditional learning (face-to-face) and online learning. Data was analyzed on an intention-to-treat basis. Results: IBSR blended intervention enhanced the resilience and improved the subjective and psychological well-being of teachers in spite of the breakout of the COVID-19 pandemic and the first lockdown in Israel. Simultaneously the control group suffered from enhanced burnout levels and a decline in psychological and subjective well-being. Conclusions: Implementation of IBSR blended intervention during the school year may benefit teachers’ well-being and ability to flourish, even during stressful events such as the COVID-19 pandemic.

scholarly journals Effectiveness of Measures to Eradicate Staphylococcus aureus Carriage in Patients with Community-Associated Skin and Soft-Tissue Infections: A Randomized Trial

2011 ◽  
Vol 32 (9) ◽  
pp. 872-880 ◽  
Author(s):  
Stephanie A. Fritz ◽  
Bernard C. Camins ◽  
Kimberly A. Eisenstein ◽  
Joseph M. Fritz ◽  
Emma K. Epplin ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Soft Tissue ◽  
Controlled Trial ◽  
Control Group ◽  
Open Label ◽  
Intention To Treat ◽  
Intranasal Mupirocin ◽  
Mupirocin Ointment ◽  
Hygiene Education ◽  
To Receive

Background.Despite a paucity of evidence, decolonization measures are prescribed for outpatients with recurrent Staphylococcus aureus skin and soft-tissue infection (SSTI).Objective.Compare the effectiveness of 4 regimens for eradicating S. aureus carriage.Design.Open-label, randomized controlled trial. Colonization status and recurrent SSTI were ascertained at 1 and 4 months.Setting.Barnes-Jewish and St. Louis Children's Hospitals, St. Louis, Missouri, 2007–2009.Participants.Three hundred patients with community-onset SSTI and S. aureus colonization in the nares, axilla, or inguinal folds.Interventions.Participants were randomized to receive no therapeutic intervention (control subjects) or one of three 5-day regimens: 2% mupirocin ointment applied to the nares twice daily, intranasal mupirocin plus daily 4% chlorhexidine body washes, or intranasal mupirocin plus daily dilute bleach water baths.Results.Among 244 participants with 1-month colonization data, modified intention-to-treat analysis revealed S. aureus eradication in 38% of participants in the education only (control) group, 56% of those in the mupirocin group (P = .03 vs controls), 55% of those in the mupirocin and chlorhexidine group (P = .05), and 63% off those in the mupirocin and bleach group (P = .006). Of 229 participants with 4-month colonization data, eradication rates were 48% in the control group, 56% in the mupirocin only group (P = .40 vs controls), 54% in the mupirocin and chlorhexidine group (P = .51), and 71% in the mupirocin and bleach group (P = .02). At 1 and 4 months, recurrent SSTIs were reported by 20% and 36% of participants, respectively.Conclusions.An inexpensive regimen of dilute bleach baths, intranasal mupirocin, and hygiene education effectively eradicated S. aureus over a 4-month period. High rates of recurrent SSTI suggest that factors other than endogenous colonization are important determinants of infection.Trial Registration.ClinicalTrials.gov identifier: NCT00513799.

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

scholarly journals Title: Application of a physiotherapy protocol to women during the active phase of labour improves obstetric outcomes: a randomized clinical trial.

2021 ◽  
Author(s):  
LICIA SANTANA ◽  
Rubneide Gallo ◽  
Silvana Quintana ◽  
Geraldo Duarte ◽  
Cristine Homsi Ferreira ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Perinatal Outcomes ◽  
Active Phase ◽  
Labour Pain ◽  
Obstetric Outcomes ◽  
Control Group ◽  
Phase Duration ◽  
Intention To Treat ◽  
Reference Centre ◽  
Care Protocol

Objective: To evaluate the effectiveness of a non-pharmacological childbirth care protocol in women in the active phase of labour in improving obstetric and perinatal outcomes. Design: Randomized trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Setting: Reference Centre of Women’s Health of Ribeirão Preto–MATER, São Paulo, Brazil. Methods: Eighty low-risk primiparous women at the end of pregnancy and beginning of the active phase of labour were randomized to experimental group (EG) (n=40) or control group (CG) (n=40). Women in EG received four interventions: ambulation at 4 to 6 cm of cervical dilation; alternative maternal positions associated with TENS at 6 to 7 cm, and a warm shower bath at >7 cm. The CG received only routine obstetric. Main outcome measures: The length of the active phase of labour, the expulsive phase duration, and the prevalence of labour dystocia assessed by the partograph. Results: The parturients who received the sequential non-pharmacological protocol had a shorter length of the active phase of labour (CG=444 minutes; EG=373 minutes; p=0,02), presented rupture of membranes later in labour (CG=7cm; EG=8cm; p<0,01), requested pharmacological analgesia with more significant cervical dilatation (CG=5cm; EG=8cm; p<0,01) and had lower labour dystocia rates than the patients in the CG. Conclusion: The implementation of a sequential non-pharmacological protocol has the potential in decreased and delayed use of pharmacological analgesia, duration of the active phase of labour and dystocia rates. Keywords: length of labour, labour pain, dystocia, randomized controlled trial, non-pharmacological resources, pharmacological analgesia. Trial registration: NCT01601860 Link: https://clinicaltrials.gov/ct2/show/NCT01601860

scholarly journals A novel brief treatment for methamphetamine use disorders in South Africa: a randomised feasibility trial

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
K. Sorsdahl ◽  
D. J. Stein ◽  
S. Pasche ◽  
Y. Jacobs ◽  
R. Kader ◽  
...  
Keyword(s):  
South Africa ◽  
Controlled Trial ◽  
Adverse Outcomes ◽  
Feasibility Trial ◽  
Control Group ◽  
Brief Treatment ◽  
Middle Income ◽  
Methamphetamine Use ◽  
Intention To Treat

Abstract Background Effective brief treatments for methamphetamine use disorders (MAUD) are urgently needed to complement longer more intensive treatments in low and middle income countries, including South Africa. To address this gap, the purpose of this randomised feasibility trial was to determine the feasibility of delivering a six-session blended imaginal desensitisation, plus motivational interviewing (IDMI) intervention for adults with a MAUD. Methods We enrolled 60 adults with a MAUD and randomly assigned them 1:1 to the IDMI intervention delivered by clinical psychologists and a control group who we referred to usual care. Feasibility measures, such as rates of recruitment, consent to participate in the trial and retention, were calculated. Follow-up interviews were conducted at 6 weeks and 3 months post-enrollment. Results Over 9 months, 278 potential particiants initiated contact. Following initial screening 78 (28%) met inclusion criteria, and 60 (77%) were randomised. Thirteen of the 30 participants assigned to the treatment group completed the intervention. Both psychologists were highly adherent to the intervention, obtaining a fidelity rating of 91%. In total, 39 (65%) participants completed the 6-week follow-up and 40 (67%) completed the 3-month follow-up. The intervention shows potential effectiveness in the intention-to-treat analysis where frequency of methamphetamine use was significantly lower in the treatment than in the control group at both the 6 week and 3-month endpoints. No adverse outcomes were reported. Conclusions This feasibility trial suggests that the locally adapted IDMI intervention is an acceptable and safe intervention as a brief treatment for MAUD in South Africa. Modifications to the study design should be considered in a fully powered, definitive controlled trial to assess this potentially effective intervention. Trial registration The trial is registered with the Pan African Clinical Trials Registry (Trial ID: PACTR201310000589295)

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