Observational Study for the Identification of Relevant Variables Related to Health Status, Disability and Quality in Different Populations, Through the Analysis of Health Determinants and Paremeters Obtained by Means of Patient-reported Outcomes Questionnaires.
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Subjects with a medical diagnosis and currently cursing with Parkinson's Disease (PD)
研究概览
简要总结
The objective of this study is to identify key indicators in the follow-up of subjects with different pathologies related to both the person's environment, as well as the perception of their health and general quality of life and related to their disease. To this end, a cross-sectional observational study of qualitative data collection through questionnaires, mostly validated, has been proposed to try to identify these indicators.
Based on these questionnaires, the specific objectives of this study are as follows:
- Unify questionnaires
- Assess data quality
- Identify key indicators, through a factor analysis
- Design a second reduced version of the questionnaires collecting the key indicators and eliminating those items that are exclusive to each other.
In order to identify the key indicators, it will be necessary to measure at least 30 subjects from each pathological group, as well as a cohort of at least 100 subjects without pathologies in order to validate and contrast the results.
The subjects will be recruited through the own databases of participants in previous trials of the Institute of Biomechanics of Valencia, who have given written consent to be contacted in order to request their participation in any other study where their profile may fit. They will also be recruited and contacted through the collaborating associations (Parkinson Valencia Association, Valencian Diabetes Association, Consorci Hospital General Universitari de València, Arnau de Vilanova Valencia Hospital).
The surveys will be included in an online platform specialized in the realization of questionnaires. This data will be exported for further storage, management and analysis. All information will be anonymized for processing and analysis, and may be used under the terms and conditions dictated by the current legal framework.
To participate in the study, participants must accept the terms and conditions included in the first page of the survey embedded in the online platform, where the aspects related to the study methodology and the use of them data are exposed.
The statistical analysis will treat the data provided by the variables and how they are related to each other, testing differences according to the characteristics of the patient and clinical indicators. For that, non-parametric techniques such as the χ² test, the Kruskal-Wallis test and cluster analysis will be used.
详细描述
SCIENTIFIC JUSTIFICATION OF THE PROJECT Currently, the value-based (VBHC) approach to health promotes the incorporation of the patient's experience, environment, and characteristics into the clinical data used in decision-making, to improve the efficiency of treatments and improve patient satisfaction and adherence, putting them at the center of the intervention1.
Healthcare must be driven by a constant effort to deliver results that truly matter to patients. However, this is hampered by the scarcity of transparent and standardized outcome data. In addition, the lack of clarity regarding the definition of value has led to divergent approaches, the term "value" coexists to convey the humanistic principles that underpin health systems2, and to refer to cost reduction and overall efficiency of the process3. Philosophical value and cost containment are important, however, improving health outcomes is essential for value creation4.
One of the benchmarks in the incorporation of patient experience is the International consortium for health outcomes measurement (ICHOM), which has a set of standards ready for use5. The standards have been developed to allow doctors and scientists to document, report and compare the results related to different pathologies in a standardized way. Such international benchmarks improve understanding of the course of diseases and enable the identification of "best practices", producing better informed treatment decisions5.
Patients' perceptions of their health and experiences are key to patient-centered care [6], these experiences are based on Patient Rated Outcomes Measures (PROM) which are questionnaires that measure patients' views of their health status; and Patient Rated Experiences Measures (PREM) which are questionnaires that measure patients' perception of their experience while receiving care. The questionnaires are based on generic scales of health, quality of life and others specific to pathologies6. The datasets can be used for: research, quality improvement projects, clinical performance evaluation, audit and economic valuation.
When carrying out this type of studies, it is necessary to consider the limitations in the PROM and PREM questionnaires6, that sometimes are very focused on clinical and health issues, may have failures in interpretation when extrapolating variables of a social nature to the clinical environment, or refer to specific issues that do not influence or interest the person. Therefore, it is necessary to collect holistic information from different segments of the population according to different factors and individually (location, housing, family environment, occupation, medication status, emerging risks ...), to ensure that heterogeneous data are available from multiple sources7.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women older tan 18 years old with no chronic or acute conditions declared.
- •Having the ability to understand the information of the questionnaires to be completed.
- •Exclusion Criteria
- •Non-acceptance of the terms and conditions of the study. Rest of the participants Inclusion Criteria
- •Men and women older tan 18 years old with some of the following:
- •a medical diagnosis and currently cursing with Parkinson's Disease (PD)
- •a medical diagnosis and currently cursing with Diabetes Mellitus type I and II (DM I/II)
- •a medical diagnosis and currently cursing or who have cursed at some point in the past with SARS Covid-19 Infection (COVID-19)
- •a medical diagnosis and currently cursing with Chronic obstructive pulmonary disease (COPD).
- •a medical diagnosis and who have cursed at some point with Stroke, either ischemic or hemorrhagic (ST)
- •Having the ability to understand the information of the questionnaires to be completed or to have a support person who can help to complete them.
- •Exclusion Criteria
- •Non-acceptance of the terms and conditions of the study.
排除标准
- 未提供
结局指标
主要结局
Subjects with a medical diagnosis and currently cursing with Parkinson's Disease (PD)
时间窗: through study completion, an average of 1 year and a half
Custom-made questionnaire designed to collect relevant sociodemographic information of each subject, including: age, gender, height, weight, education, occupation, country of birth and residence, civil status, environment, physical activity, diet, drugs and alcohol consumption, pathological conditions, current/recent and past medical or psychological treatments, living conditions, family and social support.
Euroquol-5D (EQ-5D-5L). Spanish version.
时间窗: through study completion, an average of 1 year and a half
The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
PROMIS Scale v1.2 - Global Health9. Spanish version
时间窗: through study completion, an average of 1 year and a half
Health-Related Life or Perceived Health Quality Questionnaire. Patient Reported Outcome Measurement Information System (PROMIS) Global Health v1.2 short form is a 10-item instrument representing multiple domains. Scores are assigned for both Global Physical Health component and Global Mental Health component.
次要结局
- Problem Areas in Diabetes (PAID)13. Spanish version.(through study completion, an average of 1 year and a half)
- PHQ-9 (Patient Health Questionnaire-9). Spanish version.(through study completion, an average of 1 year and a half)
- The Self-administered Comorbidity Questionnaire (SCQ-9). Spanish version(through study completion, an average of 1 year and a half)
- PROMIS Social Isolation (v2.0, 4ª)16. Spanish version.(through study completion, an average of 1 year and a half)
- FLU-PRO. Spanish version.(through study completion, an average of 1 year and a half)
- Modified Medical Research Council (mMRC) scale of dyspnea. Spanish version.(through study completion, an average of 1 year and a half)
- COPD Assessment Test (CAT). Spanish version.(through study completion, an average of 1 year and a half)
- Patient-Reported Health Status questions as describe in the ICHOM Official Standard Set. Translated into spanish.(through study completion, an average of 1 year and a half)
- PROMIS-10_Q01. Spanish version.(through study completion, an average of 1 year and a half)
- Consumer Reports Effectiveness Scale (CREST- 4). Spanish version.(Cross-sectional)
- Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Spanish version.(through study completion, an average of 1 year and a half)
- Non-movement problems in Parkinson's (PD-NMS). Spanish version.(through study completion, an average of 1 year and a half)