Conectar
by Mila Pacheco, Pedro Sá, Gláucia Santos, Ney Boa-Sorte, Kilma Domingues, Larissa Assis, Marina Silva, Ana Oliveira, Daniel Santos, Jamile Ferreira, Rosemeire Fernandes, Flora Fortes, Raquel Rocha, Genoile Santana
AimsEvaluate the impact of an intervention program in non-adherent patients with ulcerative colitis.
MethodsParallel controlled randomized clinical trial (1:1), approved by the ethics committee (No. 3.068.511/2018) and registered at The Brazilian Clinical Trials Registry (No. RBR-79dn4k). Non-adherent ulcerative colitis patients according to the Morisky-Green-Levine-test were included. Recruitment began in August 2019 until August 2020, with 6-month follow-up. All participants received standard usual care, and additionally the intervention group received educational (video, educational leaflet, verbal guidance) and behavioral interventions (therapeutic scheme, motivational and reminder type short message services). Researchers were blinded for allocation prior to data collection at Visits 1 and 2 (0 and 6 months). Primary outcome: 180-day adherence rate, with relative risk 95%CI. Secondary outcome: 180-day quality of life according to SF-36 domains, using Student’s t test. Variables with p Results
Forty-six and 49 participants were allocated in control and intervention groups, respectively. Two were excluded due to intervention refusal, and 4 and 6 were lost to follow-up in control and intervention groups. There was no post-intervention adherence rate difference, even after adjustment for type of non-adherence (unintentional/both/intentional) as confounder, or if considered as adherent the intervention group participants lost in follow-up. Interventions promoted better quality of life scores even after multivariate analysis for “Pain”, when adjusted for ulcerative colitis severity, sex, and marital status (β = 18.352, p = 0.004), “Vitality”, when adjusted for ulcerative colitis severity (β = 10.568, p = 0.015) and “Emotional Aspects”, when adjusted for disease severity, income, and education (β = 24.907, p = 0.041).
ConclusionsThe intervention program was not able to produce a significant medication adherence rate difference between comparative groups, however, there was a significant improvement in quality of life. Study limitations may include: sample size calculated to identify differences of 30%, leading to a possible insufficient power; non blinded participants, exposing the results to the risk of performance bias; outcomes based on self-reported data.
This study aimed to evaluate the effectiveness, safety and costs of FreeStyle Libre (FSL) glucose monitoring system for children and adolescents with type 1 diabetes mellitus (T1DM) in Spain.
Prospective, multicentre pre-post study.
Thirteen Spanish public hospitals recruited patients from January 2019 to March 2020, with a 12-month follow-up.
156 patients were included.
Primary: glycated haemoglobin (HbA1c) change. Secondary: severe hypoglycaemic events (self-reported and clinical records), quality of life, diabetes treatment knowledge, treatment satisfaction, adverse events, adherence, sensor usage time and scans. Healthcare resource utilisation was assessed for cost analysis from the National Health System perspective, incorporating direct healthcare costs. Data analysis used mixed regression models with repeated measures. The intervention’s total cost was estimated by multiplying health resource usage with unit costs.
In the whole sample, HbA1c increased significantly (0.32%; 95% CI 0.10% to 0.55%). In the subgroup with baseline HbA1c≥7.5% (n=88), there was a significant reduction at 3 months (–0.46%; 95% CI –0.69% to –0.23%), 6 months (–0.49%; 95% CI –0.73% to –0.25%) and 12 months (–0.43%; 95% CI –0.68% to –0.19%). Well-controlled patients had a significant 12-month worsening (0.32%; 95% CI 0.18% to 0.47%). Self-reported severe hypoglycaemia significantly decreased compared with the previous year for the whole sample (–0.37; 95% CI –0.62 to –0.11). Quality of life and diabetes treatment knowledge showed no significant differences, but satisfaction increased. Adolescents had lower sensor usage time and scans than children. Reduction in HbA1c was significantly associated with device adherence. No serious adverse effects were observed. Data suggest that use of FSL could reduce healthcare resource use (strips and lancets) and costs related to productivity loss.
The use of FSL in young patients with T1DM was associated with a significant reduction in severe hypoglycaemia, and improved HbA1c levels were seen in patients with poor baseline control. Findings suggest cost savings and productivity gains for caregivers. Causal evidence is limited due to the study design. Further research is needed to confirm results and assess risks, especially for patients with lower baseline HbA1c.
La forma en la que recibimos una noticia, una enfermedad, el modo de rechazarla hasta llegar a aceptarla y aprender a vivir con ella, nos refleja y ayuda a entender la conducta más humana. Conocer sus emociones, los altibajos e incluso los cambios de opinión por inseguridades que se reflejan durante el proceso de la enfermedad y su tratamiento. Este relato nos aportará esa valoración más integral de la persona desde que recibe la noticia, como la toma y la asimila, para al final relatarnos su experiencia vivida. Es un relato biográfico con un diseño basado en la Fenomenología, analizando el contenido expuesto desde la narración de Esther, mi paciente.
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