NCT05343962: OUTCOMES

Health Indicators and Patient Reported Outcomes. Identification of Significative Items Aimed at Improving Health Care Procceses.

Status unknown Last updated 27 April 2022

What this trial tests

trial in Parkinson Disease in 250 participants. Status unknown.

Timeline

1 March 2022

Primary endpoint
1 July 2023

31 December 2023

Quick facts

Lead sponsor	Instituto de Biomecanica de Valencia
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	250
Start date	1 March 2022
Primary completion	1 July 2023
Estimated completion	31 December 2023
Sites	1 location across Spain

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →
• Diabetes Mellitus — all drugs for Diabetes Mellitus →
• COVID-19 — all drugs for COVID-19 →
• Chronic Obstructive Pulmonary Disease (COPD) — all drugs for Chronic Obstructive Pulmonary Disease (COPD) →

Sponsor

Instituto de Biomecanica de Valencia

Who can join

18 and older, any sex, with Parkinson Disease or Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.