PHARMACEUTICAL CARE OF ADOLESCENTS WITH DIABETES MELLITUS TYPE 1: THE DIADEMA STUDY, A RANDOMIZED CONTROLLED TRIAL

2015 ◽  
Vol 101 (1) ◽  
pp. e1.67-e1
Author(s):  
Emina Obarčanin ◽  
Manfred Krueger ◽  
Petra Mueller ◽  
Verena Nemitz ◽  
Holger Schwender ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Pharmaceutical Care ◽  
Intervention Group ◽  
Well Being ◽  
Diabetes Mellitus Type ◽  
Control Group ◽  
Randomized Controlled ◽  
Phone Calls ◽  
The Impact

BackgroundAdolescents with type 1 diabetes mellitus (T1DM) often show low adherence to complex insulin regimens, leading to poor glycemic control. The benefit of pharmaceutical care in adults with diabetes mellitus type 2 (T2DM) has been widely explored; however, evidence in adolescents with T1DM remains scarce.ObjectiveTo evaluate the impact of pharmaceutical care in adolescents with T1DM provided by a multidisciplinary team on multiple important clinical outcomes.SettingAt the outpatient Helios Paediatric Clinic and at the 12 regular community pharmacies of the study patients with 14 pharmacists in the Krefeld area, Germany, and at the University Pediatric Clinic with one pharmacist on-site in Sarajevo, Bosnia-Herzegovina.MethodsA randomized, controlled, prospective, multicenter study in 68 adolescents with T1DM. The intervention group received monthly structured pharmaceutical care delivered by pharmacists plus supplementary phone calls for 6 months. The control group received usual diabetic care. Data were collected at baseline and after 3 and 6 months. In addition, HbA1c was measured after 12 months.Main outcome measures The between-group difference in the change from baseline in glycosylated hemoglobin (HbA1c), the number of severe hypoglycemic events in both groups, and patient well-being in the intervention group.ResultsThe improvement from baseline in HbA1c was significantly greater in the intervention group than in the control group after 6 months (change from baseline −0.54 vs. +0.32%, p=0.0075), even after adjustment for country-specific variables (p=0.0078). However, the effect was more pronounced after only 3 months (−1.09 vs. +0.23%, p=0.00002). There was no significant between-group difference in the number of severe hypoglycemia events. After 6 months, the well-being according to the WHO-5 index in the intervention group increased significantly from 52.8% to 63.3%. After 12 months the mean total HbA1c remained significantly reduced in the intervention compared to the control group (8.6% vs. 9.5%, p=0.0184).ConclusionThe improved outcomes seen in this study provide new evidence that pharmaceutical care adds value to the management of T1DM in adolescents. However, the optimal methods of achieving sustained long-term improvements in this specific patient population require further study.

scholarly journals A Phase 1 Randomized Controlled Trial of an At-Home Positive Psychology Intervention for Individuals with Multiple Sclerosis

2020 ◽  
Author(s):  
Melanie E. Freedman ◽  
Brian C. Healy ◽  
Jeff C. Huffman ◽  
Tanuja Chitnis ◽  
Howard L. Weiner ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Positive Psychology ◽  
Controlled Trial ◽  
Phase 1 ◽  
Intervention Group ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
Phone Calls ◽  
At Home

Abstract Background: Positive psychology (PP) uses targeted activities to increase the frequency and intensity of positive feelings and may improve overall well-being in medically ill populations. In this pilot study, we examined the feasibility, acceptability and potential impact of a five-week, telephone-delivered, PP intervention for individuals with multiple sclerosis (MS). Methods: Participants were randomized 1:1 to a five-week at-home PP intervention or waitlist control condition. Participants engaged in weekly phone calls with a study trainer and completed one PP exercise, such as recalling a past success, each week. Feasibility was determined by the number of sessions completed, and acceptability was assessed by weekly post-exercise participant ratings (0–10) of ease and utility. Efficacy was explored by examining between-group differences in changes from baseline on psychological variables, health-related quality of life (HRQOL), and self-reported functional activities at five and ten weeks. Results: Thirty patients enrolled in the study. Ninety-three percent of participants (n = 28) completed all exercises. Ease scores ranged from 7.7–8.7 and utility scores ranged from 8.2–8.7. The PP intervention was associated with significantly greater increases (P < .05) in positive affect, optimism, state and trait anxiety, general health, and resilience in the intervention group compared to the control group. Approximately half of the PP participants maintained ≥ 50% of the improvement at 10 weeks. Conclusions: This five-week, telephone-based PP intervention was feasible and acceptable to individuals with MS. Larger randomized controlled trials are warranted to further investigate the utility of this intervention to improve well-being and other health outcomes in MS.

scholarly journals Awakening Compassion in Managers—a New Emotional Skills Intervention to Improve Managerial Compassion

2020 ◽  
Author(s):  
Miia Paakkanen ◽  
Frank Martela ◽  
Jari Hakanen ◽  
Lotta Uusitalo ◽  
Anne Pessi
Keyword(s):  
Leadership Behaviors ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Control Group ◽  
Organizational Research ◽  
Emotional Skills ◽  
Randomized Controlled ◽  
Post Test ◽  
The Impact

Abstract Compassion is in high demand within organizational research, with important implications for leadership, well-being, and productivity. However, thus far only meditation-based interventions have been implemented to increase compassion in organizations. Our aim was to explore whether compassion could be increased among managers through improving their emotional skills. We implemented a quasi-randomized controlled trial with pre-test and post-test design of a new emotional skills cultivation training among managers, measuring the treatment group (N = 68), the control group (N = 90), and their followers (N = 85 and N = 72). Compared to the control group, the managers exhibited significantly increased sense of emotional skills, with some evidence for an improved sense of compassion. We also found that emotional skills mediated the impact of participating in the intervention group and compassion. Additionally, servant leadership behaviors in the intervention group improved following the intervention. These results demonstrate that instead of being something innate, compassion is a skill that can be increased through training emotional skills, with observable benefits for the organization.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 3097
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

scholarly journals Assessing the impact of the European resilience curriculum in preschool, early and late primary school children

2021 ◽  
pp. 014303432110250
Author(s):  
Celeste Simões ◽  
Anabela C. Santos ◽  
Paula Lebre ◽  
João R. Daniel ◽  
Cátia Branquinho ◽  
...  
Keyword(s):  
Mental Health ◽  
Intervention Group ◽  
Well Being ◽  
Primary School Children ◽  
Control Group ◽  
Physical And Mental Health ◽  
Quasi Experimental ◽  
Mental Health Difficulties ◽  
Prosocial Behaviours ◽  
The Impact

Resilience is an individual’s ability to adapt successfully to and persevere during and after significant challenges. Resilience programmes based on a socioemotional learning approach have been associated with an increase in protextive factors (e.g., prosocial competencies), improvements in physical and mental health, and a decrease in internalised and externalised symptoms. The present study aimed to evaluate the impact of the RESCUR curriculum implemented in Portuguese schools on students’ academic, behavioural, and socioemotional outcomes, based on child and teacher reports. Participants included 1,084 children (53.2% male) aged 3-15 ( M = 7.24, SD = 2.31). A quasi-experimental study compared outcomes for an experimental intervention group (AIG) with a waiting list control group (WG). The results showed the RESCUR programme decreased mental health difficulties while increasing both prosocial behaviours and well-being. In addition, academic performance increased for those in preschool after implementation. Both teachers and children consistently reported positive behavioural changes in resilience-related competencies after implementing RESCUR. Our findings contribute to the recent research on the potential of RESCUR to address key socioemotional competencies and improve relevant protextive factors. Study limitations and future recommendations are addressed.

scholarly journals Influence of physical activity on periodontal health in patients with type 2 diabetes mellitus. A blinded, randomized, controlled trial

2021 ◽  
Author(s):  
K. Wernicke ◽  
J. Grischke ◽  
M. Stiesch ◽  
S. Zeissler ◽  
K. Krüger ◽  
...  
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Periodontal Health ◽  
Randomized Controlled ◽  
Hba1c Levels

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.

scholarly journals Impact of ELKa, the Electronic Device for Prandial Insulin Dose Calculation, on Metabolic Control in Children and Adolescents with Type 1 Diabetes Mellitus: A Randomized Controlled Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-9 ◽  
Author(s):  
Agnieszka Kowalska ◽  
Katarzyna Piechowiak ◽  
Anna Ramotowska ◽  
Agnieszka Szypowska
Keyword(s):  
Diabetes Mellitus ◽  
Type 1 Diabetes ◽  
Type 1 Diabetes Mellitus ◽  
Metabolic Control ◽  
Electronic Device ◽  
Intervention Group ◽  
Insulin Dosage ◽  
Control Group ◽  
Prandial Insulin

Background. The ELKa system is composed of computer software, with a database of nutrients, and a dedicated USB kitchen scale. It was designed to automatize the everyday calculations of food exchanges and prandial insulin doses. Aim. To investigate the influence of the ELKa on metabolic control in children with type 1 diabetes mellitus (T1DM). Methods. A randomized, parallel, open-label clinical trial involved 106 patients aged <18 years with T1DM, HbA1C≤10%, undergoing intensive insulin therapy, allocated to the intervention group, who used the ELKa (n=53), or the control group (n=53), who used conventional calculation methods. Results. After the 26-week follow-up, the intention-to-treat analysis showed no differences to all endpoints. In per protocol analysis, 22/53 (41.5%) patients reporting ELKa usage for >50% of meals achieved lower HbA1C levels (P=0.002), lower basal insulin amounts (P=0.049), and lower intrasubject standard deviation of blood glucose levels (P=0.023) in comparison with the control. Moreover, in the intervention group, significant reduction of HbA1C level, by 0.55% point (P=0.002), was noted. No intergroup differences were found in the hypoglycemic episodes, BMI-SDS, bolus insulin dosage, and total daily insulin dosage. Conclusions. The ELKa system improves metabolic control in children with T1DM under regular usage. The trial is registered at ClinicalTrials.gov, number NCT02194517.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic some family physicians were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psycho-social support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received &lsquo;care as usual&rsquo;. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW in-terventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

Supporting Children Who Experience Domestic Violence: Evaluating the Child Witness to Domestic Violence Program

2021 ◽  
pp. 088626052110358
Author(s):  
Erin C. Schubert
Keyword(s):  
Domestic Violence ◽  
Intervention Group ◽  
Well Being ◽  
The United States ◽  
Control Group ◽  
Child Witness ◽  
Negative Consequences ◽  
Emotional Symptoms ◽  
Child Gender ◽  
The Impact

Impacting 1 in 4 children in the United States, childhood exposure to domestic violence predicts myriad negative sequelae. Intervening post exposure is critical to help children and their protective parent heal and avoid long-term negative consequences. Children aged 2-17 and their mothers who were victims of domestic violence participated in a 12-week group program delivered by domestic violence agency staff that provides psychoeducation on the impact of trauma and domestic violence and aims to improve parent and child well-being. The impact of the Child Witness to Domestic Violence (CWDV) program was tested in an intervention group ( n = 69 children, 33 mothers) who participated in CWDV and control group ( n = 80 children, 39 mothers) consisting of children whose mothers received adult-focused domestic violence services but were not enrolled in CWDV or other child-focused services. Multiple regression analyses controlling for child gender, child age, mother’s age, and the outcome of interest at time 1 found that participation in CWDV program significantly predicted better child functioning as indicated by less hyperactivity ( B = –.85, p = .06), fewer negative emotional symptoms ( B = –1.14, p = .01), and fewer total behavioral difficulties ( B = –2.48, p = .02) as well as higher maternal hope ( B = .57, p = .03). These data provide promising evidence of the impact of a brief, replicable group intervention that promotes healing and well-being among children and parents exposed to domestic violence. Limitations include a quasi-experimental design and reliance on maternal report.

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