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

NCT05343962 | Unknown

• 1 other identifier: DPS_Outcomes
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Diabetes Mellitus; COVID-19; Chronic Obstructive Pulmonary Disease (COPD); Stroke

Keywords

Patient-Centered Outcomes Research; Pathological conditions; Health Status; Health Indicators

Outcome Measures

Primary Outcomes (3)

• Subjects with a medical diagnosis and currently cursing with Parkinson's Disease (PD)

  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.

  through study completion, an average of 1 year and a half

• Euroquol-5D (EQ-5D-5L). Spanish version.

  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.

  through study completion, an average of 1 year and a half

• PROMIS Scale v1.2 - Global Health9. Spanish version

  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.

  through study completion, an average of 1 year and a half

Secondary Outcomes (12)

• 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

• 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

Study Arms (6)

Parkinson's Disease (PD)

Subjects with a medical diagnosis and currently cursing with Parkinson's Disease (PD)

Diabetes Mellitus type I and II (DM I/II)

Subjects with a medical diagnosis and currently cursing or who have cursed at some point in the past with SARS Covid-19 Infection (COVID-19)

SARS Covid-19 Infection (COVID-19)

Subjects with a medical diagnosis and currently cursing or who have cursed at some point in the past with SARS Covid-19 Infection (COVID-19)

Chronic obstructive pulmonary disease (COPD)

Subjects with a medical diagnosis and currently cursing with Chronic obstructive pulmonary disease (COPD).

Stroke (ST)

Subjects with a medical diagnosis and who have cursed at some point with Stroke, either ischemic or hemorrhagic (ST)

Healthy population (HP)

Healthy population (HP). No chronic or acute conditions declared.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample. Contacted by the collaborators or by IBV itself.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Non-acceptance of the terms and conditions of the study.

Sponsors & Collaborators

• Instituto de Biomecanica de Valencia: lead
• Asociación Parkinson Valencia: collaborator
• Asociación Valenciana de Diabetes (https://www.avdiabetes.org/): collaborator
• Hospital General Universitario de Valencia: collaborator

Study Sites (1)

Instituto de Biomecánica de Valencia

Valencia, 46020, Spain

RECRUITING

Related Publications (21)

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• Welch G, Weinger K, Anderson B, Polonsky WH. Responsiveness of the Problem Areas In Diabetes (PAID) questionnaire. Diabet Med. 2003 Jan;20(1):69-72. doi: 10.1046/j.1464-5491.2003.00832.x.

  PMID: 12519323 BACKGROUND

• Kocalevent RD, Hinz A, Brahler E. Standardization of the depression screener patient health questionnaire (PHQ-9) in the general population. Gen Hosp Psychiatry. 2013 Sep-Oct;35(5):551-5. doi: 10.1016/j.genhosppsych.2013.04.006. Epub 2013 May 10.

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  PMID: 33454756 BACKGROUND

• Powers JH, Guerrero ML, Leidy NK, Fairchok MP, Rosenberg A, Hernandez A, Stringer S, Schofield C, Rodriguez-Zulueta P, Kim K, Danaher PJ, Ortega-Gallegos H, Bacci ED, Stepp N, Galindo-Fraga A, St Clair K, Rajnik M, McDonough EA, Ridore M, Arnold JC, Millar EV, Ruiz-Palacios GM. Development of the Flu-PRO: a patient-reported outcome (PRO) instrument to evaluate symptoms of influenza. BMC Infect Dis. 2016 Jan 5;16:1. doi: 10.1186/s12879-015-1330-0.

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• Medical Research Council. Committee on research into chronic bronchitis: instruction for use on the questionnaire on respiratory symptoms. Devon: W J Holman. 1966.

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• Salinas J, Sprinkhuizen SM, Ackerson T, Bernhardt J, Davie C, George MG, Gething S, Kelly AG, Lindsay P, Liu L, Martins SC, Morgan L, Norrving B, Ribbers GM, Silver FL, Smith EE, Williams LS, Schwamm LH. An International Standard Set of Patient-Centered Outcome Measures After Stroke. Stroke. 2016 Jan;47(1):180-6. doi: 10.1161/STROKEAHA.115.010898. Epub 2015 Nov 24.

  PMID: 26604251 BACKGROUND

• Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19.

  PMID: 19543809 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Diabetes Mellitus; COVID-19; Pulmonary Disease, Chronic Obstructive; Stroke

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Juan López Pascual, PhD, Leader Researcher

CONTACT

0034 678448128; juan.lopez@ibv.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 25, 2022
• Study Start: March 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 31, 2023
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)