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Intervention in emotional abilities for adolescents with type 1 diabetes mellitus in a hospital setting: a study protocol for a randomised controlled trial.

ABSTRACT: INTRODUCTION:Type 1 diabetes mellitus (T1DM) is one of the most frequent chronic endocrine diseases in the paediatric population. As a result, this disease has a strong impact on psychological well-being. In line with this, emotional factors play an important role in adaptation. The aim of the present study protocol is to design an emotional abilities programme to improve metabolic control assessed by haemoglobin A1c (HbA1c) samples. Specifically, this intervention will be focused on adaptive coping strategies to deal with unpleasant emotions associated with T1DM. The primary aim of this project is to assess whether the employment of this new psychological intervention improves the emotional abilities of adolescents with T1DM. METHODS AND ANALYSIS:Two focus groups will be carried out for the design and evaluation of the programme following the APEASE criteria (affordability, practicability, effectiveness, acceptability, side effects/safety and equity). Behavioural change will be based on the Behaviour Change Wheel. Sixty-two participants from 12 to 18 years of age will be recruited at a public hospital and randomised to either an intervention or a control group. The intervention group will receive an emotional abilities training programme. The control group will receive usual educational intervention. The primary outcomes are metabolic control and emotional abilities. The secondary outcomes include emotional distress control, positive and negative affect, healthy habits, and quality of life. Data will be collected at baseline, immediately postintervention, and at follow-up visits at 6 and 12 months. A feasibility analysis will be conducted. ETHICS AND DISSEMINATION:The study has been approved by the Ethics Committee of Universidad Loyola Andalucía. Results will be submitted for publication in peer-reviewed journals and disseminated across the scientific community. TRIAL REGISTRATION NUMBER:NCT03734367.

SUBMITTER: Ruiz-Aranda D

PROVIDER: S-EPMC6720468 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Intervention in emotional abilities for adolescents with type 1 diabetes mellitus in a hospital setting: a study protocol for a randomised controlled trial.

Ruiz-Aranda Desiree D Resurrección Davinia M DM Gutierrez-Colosia Mencia R MR Martinez-Brocca Maria Asuncion MA

BMJ open 20190827 8

<h4>Introduction</h4>Type 1 diabetes mellitus (T1DM) is one of the most frequent chronic endocrine diseases in the paediatric population. As a result, this disease has a strong impact on psychological well-being. In line with this, emotional factors play an important role in adaptation. The aim of the present study protocol is to design an emotional abilities programme to improve metabolic control assessed by haemoglobin A1c (HbA1c) samples. Specifically, this intervention will be focused on ada ...[more]

PMID: 31462466

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Project description:BackgroundThe evidence suggests that brief alcohol-focused interventions, directed at hazardous and harmful drinkers in non-specialist settings such as primary care are effective in reducing alcohol consumption. However, there is a need for further research in the hospital setting. This is a randomised controlled trial to investigate the effectiveness of a 10-minute brief intervention amongst 'at risk' drinkers admitted to general hospital wards. Unlike some previous trials, this trial is randomised, used blinded assessors, includes an intention-to-treat analysis, included female subjects and excluded people with alcohol dependence.MethodsA total of 250 'at risk' drinkers admitted to King's College Hospital were identified using the Alcohol Use Disorders Identification Test (AUDIT). Some 154 subjects entered the study and were randomly allocated to the control and intervention groups. Subjects in the control group received no advice about their drinking whilst subjects in the intervention group received 10 minutes of simple advice on reducing alcohol consumption. Recruitment took place between 1995 and 1997. The primary outcome was the AUDIT questionnaire at 12 months. Secondary outcomes were a previous week's Drinks Diary, questionnaires (General Health Questionnaire, Alcohol Problems Questionnaire and the Severity of Alcohol Dependence Questionnaire) and laboratory blood tests (gamma glutamyl transferase, mean cell volume and haemoglobin).ResultsAt 3-month and 12-month follow-up, all participants were included in the intention-to-treat analysis. At both time points there was no evidence of an intervention effect that could be attributed to the brief intervention. Both the intervention and control groups had an improved AUDIT score and reduced levels of alcohol consumption as measured by a subjective Drinks Diary at 3 months which was maintained at 12 months.ConclusionsThis study has added further evidence on brief interventions in the hospital setting. In contrast to the recent Cochrane review by McQueen et al., the results of this study do not support the effectiveness of a brief alcohol intervention in general hospital wards. However our study was underpowered and there were flaws in the statistical analyses, and these limitations temper the strength of our conclusions.

Project description:IntroductionGestational diabetes mellitus (GDM) is a glucose intolerance occurring in 3%-10% of pregnant women and being a risk factor for multiple maternal and fetal complications. The risk of perinatal complications is proportional to the level of maternal hyperglycaemia. Proper glycaemic control is therefore one of the key elements of GDM therapy. Until recently, determination of blood glucose concentration was performed using glucose meters, which involved multiple fingerpricks. Nowadays, due to the flash glucose monitoring (FGM) availability, it is possible to collect measurements at any time without routine puncturing. The aim of the presented study is to assess the impact of FGM on the efficacy of treatment in population of patients diagnosed with GDM.Methods and analysisThis is a prospective, randomised study, that will recruit 100 women at 24-28 weeks of gestation at the 1st Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland. Women diagnosed with GDM, who will meet the inclusion criteria, will be individually randomised to the FGM or self-monitoring of blood glucose groups. Further on, clinical and laboratory results of the mother and their newborns will be collected for analysis during the course of pregnancy. Primary outcome is mean glycaemia result in each group after 1 month analysis and percentage of results in the target glycaemic range. The secondary objectives will be to compare the two groups for maternal and neonatal outcomes in conjunction with long-term glycaemic control using blood glycated haemoglobin and fructosamine serum concentrations.Ethics and disseminationThe study is exempt from regional ethics review due to its nature of quality improvement in patient care. The study has been approved by the Bioethics Committee at the Medical University of Warsaw and the patient privacy protection boards governing over the recruitment sites. Results of the study will be presented in peer-reviewed journals and at conferences.Trial registration numberNCT04422821.

Project description:BackgroundSupporting self-management behaviours is recommended guidance for people with asthma. Preliminary work suggests that a brief, intensive, patient-centred intervention may be successful in supporting people with asthma to participate in life roles and activities they value. We seek to assess the feasibility of undertaking a cluster-randomised controlled trial (cRCT) of a brief, goal-setting intervention delivered in the context of an asthma review consultation.Methods/designA two armed, single-blinded, multi-centre, cluster-randomised controlled feasibility trial will be conducted in UK primary care. Randomisation will take place at the practice level. We aim to recruit a total of 80 primary care patients with active asthma from at least eight practices across two health boards in Scotland (10 patients per practice resulting in ~40 in each arm). Patients in the intervention arm will be asked to complete a novel goal-setting tool immediately prior to an asthma review consultation. This will be used to underpin a focussed discussion about their goals during the asthma review. A tailored management plan will then be negotiated to facilitate achieving their prioritised goals. Patients in the control arm will receive a usual care guideline-based review of asthma. Data on quality of life, asthma control and patient confidence will be collected from both arms at baseline and 3 and 6 months post-intervention. Data on health services resource use will be collected from all patient records 6 months pre- and post-intervention. Semi-structured interviews will be carried out with healthcare staff and a purposive sample of patients to elicit their views and experiences of the trial. The outcomes of interest in this feasibility trial are the ability to recruit patients and healthcare staff, the optimal method of delivering the intervention within routine clinical practice, and acceptability and perceived utility of the intervention among patients and staff.Trial registrationISRCTN18912042.

Project description:IntroductionAdolescent eating patterns are characterised by high consumption of unhealthy foods, which has resulted in an increasing prevalence of overweight and chronic diseases. It is crucial to promote healthy eating habits, and nutritional interventions based on the transtheoretical model have been found to be especially effective. Mobile health strategies also seem promising for adolescents. This study aims to outline a smartphone intervention via WhatsApp for adolescents to promote healthy eating consumption, better nutritional knowledge, self-efficacy in the adoption of healthy practices and progress through the stages of change.Methods and analysisThere will be three distinct groups in this randomised study: a general intervention group (GG), in which the participants will receive the same healthy eating messages, based on the Brazilian food guide; a tailored intervention group (TG), in which the participants will receive healthy eating messages based on their stage of change; and a control group (CG), in which participants will receive messages on a different theme. Possession of a smartphone, use of WhatsApp and being a senior student (16-19 years) from a public school of the Federal District of Brazil will be the study's inclusion criteria. Rural schools will be excluded. The sample size estimated is 390 individuals: 38 in the GG, 314 in the TG and 38 in the CG. The intervention will last 6 weeks, with a daily message sent to the students. We will investigate nutritional knowledge, self-efficacy in the adoption of healthy eating practices, food consumption and stages of change using preintervention and postintervention questionnaires. Memorisation of the messages will be also assessed.Ethics and disseminationThe study was approved by the University of Brasília, School of Health Sciences and Research Ethics Committee. At the end of the study, the participating schools will receive a printed report with the main results of the intervention.Trial registration numberRBR-5b9jk7.

Project description:BackgroundDiabetes is associated with premature morbidity and mortality from its many complications. There are limited data on the chronic complications of diabetes in children and adolescents in sub-Saharan Africa.ObjectiveThe study aims to determine the (1) burden and related factors of chronic systemic complications of diabetes, including diabetic and nondiabetic ocular conditions in children and adolescents, and (2) quality of life (QoL) of participants compared to healthy controls. This manuscript describes the study methodology.MethodsDemographic information, medical history, anthropometric measurements, and laboratory characteristics were collected, and the participants were screened for microvascular and macrovascular complications as well as nondiabetic ocular disease. QoL questionnaires were administered to participants, their caregivers, and controls. Participants were followed up annually up to 3 years to determine the natural history of and trends in these conditions. SPSS Version 25.0 will be used for data analysis. Continuous and categorical data will be presented as mean (SD) and as percentages (%), respectively. t tests and analysis of variance will be used to compare means, and chi-square tests will be used to compare categorical data. Correlation, regression, and logistic regression analyses will be employed to establish linear associations and causal associations as appropriate. Relative risk and odds ratios will be used to estimate risk. QoL outcomes in Ghanaian children and adolescents with diabetes mellitus compared with caregivers and healthy controls will be assessed using the Pediatric Quality of Life inventory. Significance will be set at α=.05.ResultsInstitutional approval from the Ethical and Protocol Review Committee of the University of Ghana Medical School was received on August 22, 2014 (Protocol Identification Number: MS-Et/M.12-P4.5/2013-2014). Funding for the project was received from the University of Ghana Research Fund (#UGRF/9/LMG-013/2015-2016) in March 2016. Patient recruitment, clinical examination, and data collection commenced in August 2016 and was completed in September 2019. A total of 58 children and adolescents with diabetes mellitus have been recruited. Blood samples were stored at -80 °C for analysis, which was completed at the end of July 2020. Data analysis is ongoing and will be completed by the end of December 2020. Investigators plan to submit the results for publication by the end of February 2021.ConclusionsThe prevalence, natural history, trends in diabetic complications and nondiabetic ocular disease, and QoL will be provided. Our data may inform policies and interventions to improve care given to children and adolescents with diabetes.International registered report identifier (irrid)DERR1-10.2196/21440.

Project description:A comprehensive approach, including social and emotional affectations, has been recently proposed as an important framework to understand Developmental Language Disorder (DLD). There is an increasing considerable interest in knowing how language and emotion are related, and as far as we know, the role of the emotional regulation (ER) of parents of children with and without DLD, and their impact on their children's ER is still unknown. The main aims of this study are to advance our knowledge of ER in school-age children and adolescents with and without DLD, to analyze the predictive value of expressive and receptive vocabulary on ER in school-age children and adolescents, and to explore parental ER and their effect on their children's and adolescents' ER. To cover all objectives, we carried out three studies. In the first and second study, expressive and receptive vocabulary were assessed in wave 1, and ER (Emotional Regulation Checklist -ERC- for children and Emotion Regulation Scale -DERS- for adolescents) was assessed in wave 2, 4 years later. Participants in the first study consisted of two groups of school-aged children (13 had DLD and 20 were typically developing children -TD). Participants in the second study consisted of two groups of adolescents (16 had DLD and 16 were TD adolescents). In the third study, the ER of 65 of the parents of the children and adolescents from study 1 were assessed during wave 2 via self-reporting the DERS questionnaire. Results showed no significant differences in ER between DLD and TD groups neither in middle childhood nor in adolescence. Concerning vocabulary and ER, expressive language predicted ER in school-age children but not in adolescents. Finally, parental ER explained their school-age children's ER, but this was not the case in adolescents. In conclusion, the present data indicated that expressive vocabulary has a fundamental role in ER, at least during primary school years, and adds new evidence of the impact of parents' ER upon their children's ER, encouraging educators and speech language pathologists to include parents' assessments in holistic evaluations and interventions for children with language and ER difficulties.

Dataset Information

Intervention in emotional abilities for adolescents with type 1 diabetes mellitus in a hospital setting: a study protocol for a randomised controlled trial.

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Intervention in emotional abilities for adolescents with type 1 diabetes mellitus in a hospital setting: a study protocol for a randomised controlled trial.

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