Background and rationale. Although the literature suggests that caregivers have different needs at various stages of the patient's illness, to date, most studies have focused only on the needs of care...
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\| Sample Size \| The quality of validation studies requires the enrollment of about 4-10 patients per questionnaire item, with a minimum of 100 subjects to ensure the stability of the variance-covariance matrix. Based on this, for our study, administration to about 300 caregivers (about 25 subjects for each of the 13 participating centers) is considered adequate, assuming a data loss and/or compilation error rate of about 15%. Thus, the final sample available for analysis is about 255 subjects for the detection of needs and the study of the questionnaire's reliability and validity. \| \| Study Duration \| 3 years \| \| Study Phases \| 1) Recruitment of family members of patients hospitalized in the Neurorehabilitation Units of the participating ICS Maugeri SPA SB Institutes. (Patients with neurological diseases, recruited within 10 days from the start of hospitalization. Recruitment will take place directly in the wards, through verbal request and after explaining the purposes, halfway through the hospitalization period.) 2) Upon patient admission to the ward and in any case within the first 10 days of admission, administration of the Informational Needs Detection Questionnaire (QBI-R). 3) At patient discharge (within 7 days from the discharge date), the Informational Needs Assessment Questionnaire (QBI-V) will be provided to assess the degree of satisfaction with which informational needs have been met. \| \| Statistical Methods \| A descriptive analysis of the data collected through the questionnaires will be performed, as well as a validation study of the questionnaire. The measures derived from the questionnaires will be summarized with the mean and standard deviation or, where more appropriate, by the median and interquartile range. The factorial structure of the questionnaire will be explored, and internal consistency will be assessed by calculating item-total correlations and Cronbach's alpha coefficient. Test-retest reliability will be tested on a reduced sample of caregivers (50 subjects) evaluated at T0 and T1 using Spearman's non-parametric correlation coefficients. Furthermore, the reproducibility of the total and scale scores will be tested using intraclass correlation coefficients (ICC). Concurrent validity of the scale will also be assessed by comparison with the CNA for the QBI-R part and with the SAT-16 for the QBI-V. Finally, FSQ scores will be correlated with measures of anxiety, depression, and caregiver burden. Statistical analyses will be conducted using the Stata 11 statistical package (STATA Corp. LLC).
Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn moreWings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
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