scholarly journals An open trial pilot study examining a remote patient monitoring system for pediatric obesity: Design and Methods (Preprint)

2021 ◽  
Author(s):  
Crystal Lim

BACKGROUND Pediatric obesity is a critical public health issue in the US. There is a significant need to augment care in multidisciplinary pediatric obesity clinics with innovative evidence-based technology to improve weight status and health outcomes for children needing specialty pediatric obesity treatment. OBJECTIVE This manuscript describes the design and methods of an open trial pilot study to examine a remote patient monitoring system (RPMS) for children, 8 to 17 years of age, receiving treatment in a multidisciplinary pediatric obesity clinic. METHODS Participants will include 45 youth with obesity and their parents. Families will receive standard care in the clinic and the RPMS for three months. The RPMS consists of a tablet, weight scale, and pedometer. The system provides daily educational content and encourages daily use of the pedometer and weekly weigh-ins. Children and parents will complete baseline, post-treatment (Month 3), and follow-up assessments (Month 6). The main aim of the study is to examine feasibility and satisfaction with the RPMS, as well as assess initial effectiveness. RESULTS We hypothesize high feasibility and satisfaction, with rates over 75% and that after the treatment children will exhibit improved weight status, blood pressure, glucose, A1c, dietary intake, physical activity, health-related quality of life, and self-efficacy compared to pre-treatment and parents will report improved child health-related quality of life and home-food environment. These gains are expected to persist at follow-up. CONCLUSIONS This study is novel in that it is the first to design, implement, and examine a RPMS in a pediatric obesity clinic. If the RPMS is feasible, effective, and easily accessible for diverse and underserved families it may prove to be a practical, acceptable, and cost-effective weight management treatment for youth seeking treatment for severe obesity, which has important implications for the future of pediatric obesity treatments. CLINICALTRIAL Clinicaltrials.gov Identifier: NCT04029597

2015 ◽  
Vol 172 (5) ◽  
pp. 619-626 ◽  
Author(s):  
Marcus Quinkler ◽  
Roy Miodini Nilsen ◽  
Kathrin Zopf ◽  
Manfred Ventz ◽  
Marianne Øksnes

ObjectivePatients with adrenal insufficiency (AI) have impaired health-related quality of life (HRQoL), which is thought to be in part due to unphysiological glucocorticoid replacement therapy. The aim was to compare once-daily hydrocortisone (HC) dual-release tablet (modified-release) with conventional HC therapy regarding clinical data and HRQoL.Design and methodsWe conducted an open, prospective trial at one endocrine center. There were 15 of 26 patients with primary AI, nine of 18 patients with secondary AI, and six congenital adrenal hyperplasia patients switched to modified-release HC therapy by their own decision. We evaluated clinical outcome and disease-specific HRQoL by using AddiQoL questionnaire at baseline and at follow-up (median 202 days (85–498)).ResultsPatients on modified-release HC (n=30) showed significant decreases in BMI (26.0±0.75–25.6±0.71, P for change=0.006) and HbA1c (6.04±0.29–5.86±0.28, P for change=0.005), whereas patients remaining on conventional HC (n=20) showed no change in these parameters (P for interaction=0.029 and 0.017 respectively). No significant change in AddiQoL score were found in the modified-release HC group (83.8 baseline and 84.9 at follow-up; P for change=0.629). In the conventional HC group, there was a significant decrease in scores (84.0 baseline and 80.9 at follow-up; P for change=0.016), with a between-treatment P for interaction of 0.066. The fatigue subscore of AddiQoL showed the same pattern with a significant decrease (P for change=0.024) in patients on conventional HC therapy (P for interaction=0.116).ConclusionsModified-release HC decreases BMI and HbA1c compared with conventional HC treatment. In addition, it seems to stabilize HRQoL over time.


Author(s):  
Georgina E. Sellyn ◽  
Alan R. Tang ◽  
Shilin Zhao ◽  
Madeleine Sherburn ◽  
Rachel Pellegrino ◽  
...  

OBJECTIVEThe authors’ previously published work validated the Chiari Health Index for Pediatrics (CHIP), a new instrument for measuring health-related quality of life (HRQOL) for pediatric Chiari malformation type I (CM-I) patients. In this study, the authors further evaluated the CHIP to assess HRQOL changes over time and correlate changes in HRQOL to changes in symptomatology and radiological factors in CM-I patients who undergo surgical intervention. Strong HRQOL evaluation instruments are currently lacking for pediatric CM-I patients, creating the need for a standardized HRQOL instrument for this patient population. This study serves as the first analysis of the CHIP instrument’s effectiveness in measuring short-term HRQOL changes in pediatric CM-I patients and can be a useful tool in future CM-I HRQOL studies.METHODSThe authors evaluated prospectively collected CHIP scores and clinical factors of surgical intervention in patients younger than 18 years. To be included, patients completed a baseline CHIP captured during the preoperative visit, and at least 1 follow-up CHIP administered postoperatively. CHIP has 2 domains (physical and psychosocial) comprising 4 components, the 3 physical components of pain frequency, pain severity, and nonpain symptoms, and a single psychosocial component. Each CHIP category is scored on a scale, with 0 indicating absent and 1 indicating present, with higher scores indicating better HRQOL. Wilcoxon paired tests, Spearman correlations, and linear regression models were used to evaluate and correlate HRQOL, symptomatology, and radiographic factors.RESULTSSixty-three patients made up the analysis cohort (92% Caucasian, 52% female, mean age 11.8 years, average follow-up time 15.4 months). Dural augmentation was performed in 92% of patients. Of the 63 patients, 48 reported preoperative symptoms and 42 had a preoperative syrinx. From baseline, overall CHIP scores significantly improved over time (from 0.71 to 0.78, p < 0.001). Significant improvement in CHIP scores was seen in patients presenting at baseline with neck/back pain (p = 0.015) and headaches (p < 0.001) and in patients with extremity numbness trending at p = 0.064. Patients with syringomyelia were found to have improvement in CHIP scores over time (0.75 to 0.82, p < 0.001), as well as significant improvement in all 4 components. Additionally, improved CHIP scores were found to be significantly associated with age in patients with cervical (p = 0.009) or thoracic (p = 0.011) syrinxes.CONCLUSIONSThe study data show that the CHIP is an effective instrument for measuring HRQOL over time. Additionally, the CHIP was found to be significantly correlated to changes in symptomatology, a finding indicating that this instrument is a clinically valuable tool for the management of CM-I.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Nina Tusa ◽  
Hannu Kautiainen ◽  
Pia Elfving ◽  
Sanna Sinikallio ◽  
Pekka Mäntyselkä

Abstract Backround Chronic diseases and multimorbidity are common in the ageing population and affect the health related quality of life. Health care resources are limited and the continuity of care has to be assured. Therefore it is essential to find demonstrable tools for best treatment practices for patients with chronic diseases. Our aim was to study the influence of a participatory patient care plan on the health-related quality of life and disease specific outcomes related to diabetes, ischemic heart disease and hypertension. Methods The data of the present study were based on the Participatory Patient Care Planning in Primary Care. A total of 605 patients were recruited in the Siilinjärvi Health Center in the years 2017–2018 from those patients who were followed up due to the treatment of hypertension, ischemic heart disease or diabetes. Patients were randomized into usual care and intervention groups. The intervention consisted of a participatory patient care plan, which was formulated in collaboration with the patient and the nurse and the physician during the first health care visit. Health-related quality of life with the 15D instrument and the disease-specific outcomes of body mass index (BMI), low density lipoprotein cholesterol (LDL-C), hemoglobin A1c (HbA1C) and blood pressure were assessed at the baseline and after a one-year follow-up. Results A total of 587 patients with a mean age of 69 years were followed for 12 months. In the intervention group there were 289 patients (54% women) and in the usual care group there were 298 patients (50% women). During the follow-up there were no significant changes between the groups in health-related quality and disease-specific outcomes. Conclusions During the 12-month follow-up, no significant differences between the intervention and the usual care groups were detected, as the intervention and the usual care groups were already in good therapeutic equilibrium at the baseline. Trial registration ClinicalTrials.gov Identifier: NCT02992431. Registered 14/12/2016


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