Impact of anxiety, depression and disease-related distress on long-term glycaemic variability among subjects with Type 1 diabetes mellitus.

BACKGROUND: Anxiety, depression, and disease-related distress are linked to worse overall glycaemic control, in terms of HbA1c. This study was aimed to evaluate whether traits of these emotional disorders are associated with long-term glycaemic variability in subjects with Type 1 diabetes. METHODS: Longitudinal retrospective study. Six-year HbA1c data (2014-2019) from 411 subjects with Type 1 diabetes who had participated in a previous study to design a diabetes-specific quality of life questionnaire in the year 2014 were included. Scores for Spanish versions of the Hospital Anxiety and Depression Scale (HADS) and Problem Areas in Diabetes (PAID) scale were obtained at baseline, along with sociodemographic and clinical data. Long-term glycaemic variability was measured as the coefficient of variation of HbA1c (HbA1c-CV). The association between HADS and PAID scores and HbA1c-CV was analysed with Spearman correlations and multiple regression models, both linear and additive, including other covariates (age, sex, diabetes duration time, type of treatment, baseline HbA1c, use of anxiolytic or antidepressant drugs, education level and employment status). RESULTS: Scores of depression, anxiety and distress were positively and significantly correlated to HbA1c-CV in univariate analyses. Multiple regression study demonstrated an independent association only for diabetes distress score (p < 0.001). Age, diabetes duration time, baseline HbA1c, education level and employment status were also significantly associated with HbA1c-CV. However, when subjects were analyzed separately in two age groups, distress scores were associated with HbA1c-CV only among those aged 25 years or older, while anxiety scores, but not distress, were associated with HbA1c-CV among those younger than 25 years. CONCLUSIONS: Psychological factors, particularly disease-related distress and anxiety, are associated with long-term glycaemic variability in subjects with Type 1 diabetes.

Cocreation of Massive Open Online Courses to Improve Digital Health Literacy in Diabetes: Pilot Mixed Methods Study.

BACKGROUND: Self-management education is a fundamental aspect in the health care of people with diabetes to develop the necessary skills for the improvement of health outcomes. Patients are required to have the competencies to manage electronic information resources-that is, an appropriate level of digital health literacy. The European project IC-Health aimed to improve digital health literacy among people with diabetes through the cocreation of massive open online courses (MOOCs). OBJECTIVE: We report the preliminary results obtained in 3 participating countries in the IC-Health project (Italy, Spain, and Sweden) regarding (1) experience of the participants during the cocreation process of MOOCs, (2) perceived changes in their digital health literacy level after using MOOCs, and (3) a preliminary assessment of the acceptability of MOOCs. METHODS: The cocreation of the MOOCs included focus groups with adults and adolescents with diabetes and the creation of independent communities of practice for type 1 diabetes and type 2 diabetes participants aimed to co-design the MOOCs. Quantitative measures of the acceptability of MOOCs, experience in the cocreation process, and increase in digital health literacy (dimensions of finding, understanding, and appraisal) were assessed. RESULTS: A total of 28 participants with diabetes participated in focus groups. Adults and adolescents agreed that the internet is a secondary source of health-related information. A total of 149 participants comprised the diabetes communities of practice. A total of 9 MOOCs were developed. Acceptability of the MOOCs and the cocreation experience were positively valued. There was a significant improvement in digital health literacy in both adults and adolescents after using MOOCs (P<.001). CONCLUSIONS: Although the results presented on self-perceived digital health literacy are preliminary and exploratory, this pilot study suggests that IC-Health MOOCs represent a promising tool for the medical care of diabetes, being able to help reduce the limitations associated with low digital health literacy and other communication barriers in the diabetes population.

Prehabilitation for Bariatric Surgery: A Randomized, Controlled Trial Protocol and Pilot Study.

Bariatric surgery is the most efficacious treatment for obesity, though it is not free from complications. Preoperative conditioning has proved beneficial in various clinical contexts, but the evidence is scarce on the role of prehabilitation in bariatric surgery. We describe the protocol and pilot study of a randomized (ratio 1:1), parallel, controlled trial assessing the effect of a physical conditioning and respiratory muscle training programme, added to a standard 8-week group intervention based on therapeutical education and cognitive-behavioural therapy, in patients awaiting bariatric surgery. The primary outcome is preoperative weight-loss. Secondary outcomes include associated comorbidity, eating behaviour, physical activity, quality of life, and short-term postoperative complications. A pilot sample of 15 participants has been randomized to the intervention or control groups and their baseline features and results are described. Only 5 patients completed the group programme and returned for assessment. Measures to improve adherence will be implemented and once the COVID-19 pandemic allows, the clinical trial will start. This is the first randomized, clinical trial assessing the effect of physical and respiratory prehabilitation, added to standard group education and cognitive-behavioural intervention in obese patients on the waiting list for bariatric surgery. Clinical Trial Registration: NCT0404636.

Motivational Interviewing and Self-Care in Type 1 Diabetes: A Randomized Controlled Clinical Trial Study Protocol.

Background: Type 1 diabetes is a disease with complex therapeutic recommendations that require day-to-day lifestyle changes. Motivational Interviewing is a communication tool that has proved effective in changing behaviors in people with addictions, obesity and type 2 diabetes. Our objective is to evaluate the effects of a Motivational Interviewing intervention in people with type 1 diabetes. Methods: Sixty-six patients with type 1 diabetes and hemoglobin A1c >= 8% have been included and randomly assigned (computer-generated sequence, sealed envelopes, ratio 1:1) either to the intervention or to the control group. In the intervention group, appointments every 4 months with the endocrinologist include Motivational Interviewing; in the control group, the appointments proceed as usual. Patients will be followed for 16 months. The primary outcome will be self-care behaviors, assessed by a validated questionnaire, the Diabetes Self-Care Inventory-Revised Version. Secondary outcomes include: HbA1c, motivation for self-care, self-efficacy, health-related quality of life, satisfaction with professional-patient relationship, and fulfillment of patients' own objectives. The practitioners receive training in Motivational Interviewing in order to help them promote adherence to self-care, encourage patient motivation and improve the doctor-patient relationship. The Motivational Interviewing intervention will be evaluated by two psychologists, blinded to the assigned treatment, through video recordings of the sessions and the administration of a purpose-built questionnaire, the EVEM 2.0 scale. Discussion: There is evidence that MI can improve self-care in type 2 diabetes. In this study, we aim to evaluate the effect of MI on self-care and HbA1c in people with type 1 diabetes. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03906786, identifier NCT03906786.

Identification of Psychological Factors Associated with Adherence to Self-Care Behaviors amongst Patients with Type 1 Diabetes.

PURPOSE: To explore the factors involved in adherence to self-care behaviors in patients with type 1 diabetes. MATERIALS AND METHODS: Patients with type 1 diabetes (age range: 14-71 years) were invited to participate at seven Spanish hospitals. They completed a dossier which recorded sociodemographic and clinical variables and also measured personality variables, emotional state, beliefs, and concerns regarding the illness, by means of questionnaires. RESULTS: A total of 428 patients with type 1 diabetes were included (58% women, age 36 (11.8) years, diabetes duration 18.3 (10.2) years, HbA1c 7.9 +/-1.3%). A total of 60.1% of patients found it difficult to follow the treatment recommendations for the care of their disease. The reasons given were mood (25.2%), lack of motivation (13.4%), work (12%), and economic difficulties (3.8%). Other personal reasons were reported by 5.7%. Motivation, training in diabetes management, importance the patient attributed to the disease, and self-efficacy were the variables that predicted adherence to self-care behaviors, together accounting for 32% of its variance. Anxiety and depression were highly prevalent in this study population (57.1% and 23.1%, respectively) and were associated with lower adherence. CONCLUSION: In the present study assessing patients with type 1 diabetes, motivation, training in diabetes management, beliefs regarding the disease, and self-efficacy were the main contributors to adherence to self-care behaviors. On the other hand, anxiety and depression were highly prevalent and associated with lower adherence. Thus, supplementing therapeutic education with strategies designed to raise levels of motivation, discussion of beliefs about the disease, and encouragement of self-efficacy might be a useful way to increase patient involvement in self-care.

Adaptation and cross-cultural validation of the Spanish version of the Thyroid-Related Quality-of-Life Patient-Reported Outcome questionnaire.

INTRODUCTION: The ThyPRO questionnaire is the most widely used tool for measuring quality of life in patients with benign thyroid diseases. The purpose of this study was to adapt and validate a Spanish translation of the ThyPRO and its abbreviated version (ThyPRO-39). MATERIAL AND METHODS: Adaptation to the Spanish language was performed using the forward-backward translation method, followed by a pretesting study on five representative patients. The final questionnaire (ThyPROes) was administered to 155 patients with thyroid disorders recruited in a tertiary Spanish hospital. Psychometric properties were evaluated by multitrait scaling and estimation of internal consistency reliability (Cronbach's alpha coefficient). Data from a previous sample of 902 Danish patients were used to analyze differential item functioning (DIF) between the Spanish and the original Danish versions of the questionnaire using ordinal logistic regression. RESULTS: Three of 85 items in ThyPROes and four of the 39 items in ThyPRO-39es lacked convergent validity, while lack of discriminant validity was found for in nine and 14 items of each version respectively. Cronbach's alpha was >0.7 for 12 of 13 scales in the ThyPRO and 10 of 12 scales in the ThyPRO-39es. Eight items in the ThyPROes were flagged with DIF (one with non-uniform DIF), as were two items in the ThyPRO-39es. DIF magnitude was small (explained variance in the item score <3%) in most cases, with a minor impact on scale scores. CONCLUSIONS: The Spanish versions of the ThyPRO and ThyPRO-39 show acceptable psychometric properties and good cross-lingual validity, and are suitable for use in clinical studies.

Preconception care in diabetes: Predisposing factors and barriers. / Control preconcepcional en la diabetes: factores predisponentes y barreras.

BACKGROUND AND OBJECTIVE: Preconception care has been shown to decrease the risk of pregnancy-related complications in women with diabetes, but many women do not plan their pregnancies. Our aim was to identify the associated factors and barriers related to involvement of these women in preconception care. MATERIAL AND METHODS: Fifty women with pregestational diabetes (28 with type 1 diabetes) and 50 non-diabetic pregnant women were consecutively enrolled at our hospital. They completed a questionnaire, and their medical histories were reviewed. RESULTS: All 33 patients with diabetes who received preconception care had a similar current age (34.3±5.3 years) and age at diagnosis (20.3±11.3) than those with no preconception care (n=17) (31.8±5.3 and 19.1±10.6 years respectively; P>.1), but were more frequently living with their partners (97% vs. 70.6%; P=.014), employed (69.7% vs. 29.4%; P=.047), and monitored by an endocrinologist (80.6% vs. 50%; P=.034), had more commonly had previous miscarriages (78.6% vs. 10%; P=.001), and knew the impact of diabetes on pregnancy (87.5% vs. 58.8%; P=.029). The frequency of preconceptional folic acid intake was similar in pregnant women with and without diabetes (23.8% vs. 32%; P>.1). CONCLUSIONS: Preconception care of diabetic patients is associated to living with a partner, being employed, knowing the risks of pregnancy-related complications, having previous miscarriages, and being monitored by an endocrinologist. Pregnancy planning is infrequent in both women with and without diabetes.

ViDa1: The Development and Validation of a New Questionnaire for Measuring Health-Related Quality of Life in Patients with Type 1 Diabetes.

This study describes the development of a new questionnaire to measure health-related quality of life (HRQoL) in patients with type 1 diabetes (the ViDa1 questionnaire) and provides information on its psychometric properties. For its development, open interviews with patients took place and topics relevant to patients' HRQoL were identified and items were generated. Qualitative analysis of items, expert review, and refinement of the questionnaire followed. A pilot study (N = 150) was conducted to explore the underlying structure of the 40-item ViDa1 questionnaire. A Principal Component Analysis (PCA) was performed and six of the items that did not load on any of the factors were eliminated. The results supported a four-dimensional structure for ViDa1, the dimensions being Interference of diabetes in everyday life, Self-care, Well-being, and Worry about the disease. Subsequently, the PCA was repeated in a larger sample (N = 578) with the reduced 34-item version of the questionnaire, and a Confirmatory Factor Analysis (CFA) was performed (N = 428). Overall fit indices obtained presented adequate values which supported the four-factor model initially proposed [([Formula: see text] 2601.93) (p < 0.001); Root Mean Square Error of Approximation = 0.060 (CI = 0.056 -0.064)]. As regards reliability, the four dimensions of the ViDa1 demonstrated good internal consistency, with Cronbach's alphas ranging between 0.71 and 0.86. Evidence of convergent-discriminant validity in the form of high correlations with another specific HRQoL questionnaire for diabetes and low correlations with other constructs such as self-efficacy, anxiety, and depression were presented. The ViDa1 also discriminated between different aspects of clinical interest such as type of insulin treatment, presence of chronic complications, and glycemic control, temporal stability, and sensitivity to change after an intervention. In conclusion, the ViDa1 questionnaire presents adequate psychometric properties and may represent a good alternative for the evaluation of HRQoL in type 1 diabetes.

Quality of life and type 1 diabetes: a study assessing patients' perceptions and self-management needs.

PURPOSE: The main objective of this study was to assess quality of life (QoL) and treatment satisfaction in a group of patients with type 1 diabetes (T1D) and explore their needs regarding and their perception of QoL living with diabetes. MATERIALS AND METHODS: Patients with type 1 diabetes attending the outpatient endocrinology clinics of a reference hospital were invited to participate in a cross-sectional study. Clinical and sociodemographic data were obtained (interview and clinical records), and diabetes-related QoL was assessed using a standardized questionnaire. In 67 participants, satisfaction with treatment was also assessed, and an open interview was performed, assessing the impact of diabetes, long-term worries, flexibility, restrictions, and self-perception of QoL. Descriptive statistical analysis, bivariate analysis, and multivariate analysis were performed in order to find factors associated with QoL. Interviews were analyzed and summarized questionwise. RESULTS: Mean patient age was 31.4±11.6 years, diabetes duration 14.2±9.3 years, and glycated hemoglobin (HbA1c) 8.5%±1.9% (69±20.8 mmol/mol International Federation of Clinical Chemistry [IFCC]). The questionnaires showed good average QoL scores (94.6+22.9) and treatment satisfaction scores (25.7±6.7). QoL worsened with increasing HbA1c, female sex, severity of complications, and lower education (r (2)=0.283, P<0.005). In the open interview, 68.5% of the patients reported that diabetes had changed their lives, 83.5% identified complications as their most important long-term concern, and 59.7% said that they needed more training to manage the disease. CONCLUSION: Poor glycemic control, lower education, complications, and female sex are associated with worse QoL. Semi-structured interviews identified aspects not included in the standardized questionnaires.

Design, construction, and implementation of an online platform for patients with type 1 diabetes: EncoDiab.

PURPOSE: The purpose of this study was to develop, build, and implement a virtual platform equipped with practical tools, relevant contents, and communication rooms, with the aim of facilitating patients' self-management of type 1 diabetes mellitus (T1DM). MATERIALS AND METHODS: The design of the platform was based on the suggestions of T1DM patients who were being managed at two reference hospitals. Patients' needs and preferences were identified in group discussion sessions. Before having access to the platform, patients underwent a baseline assessment, which included physical examination and the administration of validated questionnaires for evaluation of clinical background, quality of life, treatment satisfaction, and well-being. RESULTS: A total of 33 patients were included in the study; 54.5% of them were men, their median age was 34 (18-50) years, the median duration of diabetes was 15 (1-38) years, and the median A1C was 7.4% (6%-12.6%). Based on their suggestions and requests, the online platform EncoDiab was built and organized into four domains: a personal domain, two domains shared by the patients and the staff of each of the two participating hospitals, and one domain that was accessible to all participants. The platform included practical tools (a body mass index calculator, a carbohydrate counting tool, and an insulin-dose calculator), a library with relevant information (documents on prevention and treatment of acute complications, nutrition, exercise, etc), and a chat room. CONCLUSION: Although the study is still ongoing, our current results demonstrate the feasibility of building and implementing an online platform for helping T1DM patients in the self-management of their disease in the public health setting.