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Enrolling by invitation NCT06478745

Trajectories and Experiences of People With Multimorbidity in Spain (LOXO-MULTIPAP) Project: a Mixed Methods Study

— Observational Multimorbidity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Retrospective and prospective cohort, Focus group, semi-structured interviews and Photovoice, Systematic review.
Who it may be relevant to
Registry conditions: Multimorbidity. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Trajectories and Experiences of Patients With Multimorbidity in the National Health Service of Spain: a Mixed Methods Study (LOXO-MULTIPAP)

Overview

The overall objective of the study is to analyze the evolution of multimorbidity, its most relevant patterns and trajectories in the Spanish National Health System population, from 2012 to 2022, and to analyze the factors that determine it, as well as the experience of professionals and patients in navigating the health system and in shared decision making. Multimorbidity trajectories can help identify homogeneous groups of individuals with similar needs and prognoses, and help practitioners and health systems to personalize clinical interventions and preventive strategies. Capturing this dynamism is the only way to better understand the natural history of multimorbidity and shed light on hitherto unexplained findings.

Detailed description

* Design: Mixed-method study.

* Quantitative study: retrospective and prospective observational study. It integrates demographic and clinical information from electronic medical records and clinical-administrative databases. It involves the harmonisation of the cohorts of users of the public health system of the 7 participating regions. * Qualitative study with a phenomenological and ethnographic approach using focus group techniques, semi-structured interviews and Photovoice to find out the perspective of patients and professionals in shared decision-making. * Systematic literature review on the effectiveness of interventions on training, multimorbidity and polypharmacy in health professionals. * Analysis:

* Quantitative study: Cluster, network and trajectory analysis * Qualitative study: Thematic content analysis that will be triangulated among the members of the research team. Meanings will be interpreted and an explanatory framework will be created with the contributions of each type of informant.

Interventions

  • Other Retrospective and prospective cohort
    * Retrospective study: Population-based retrospective cohort study with RWD. Patients ≥60 years old with 2 or more chronic diseases diagnosed before 01/01/2012, users of the public health system of the participating Autonomous Communities, will be included. Those who have had no contact with primary care defined as contact in a medical or nursing consultation in the previous two years (2010-2012) will be excluded. * Prospective longitudinal observational open cohort study developed in the contex
  • Other Focus group, semi-structured interviews and Photovoice
    The participants will be people with multimorbidity over 60 years of age recruited from Primary Care centers in Spain. A theoretical sampling will be carried out. Data will be collected through video and audio recordings from a total of 16 focus groups and 20 interviews in 7 regions, and will finally be transcribed for a triangulated thematic analysis. Two groups will be carried out with participation-action research methodology - Photovoice.
  • Other Systematic review
    No patient recruitment required

Primary outcome measures

  • Multimorbidity [Time frame: Baseline]
  • Death [Time frame: Start date 31/12/2012, 1 year]
  • Drugs [Time frame: 1 year]
  • Use of service [Time frame: 1 year]
  • Morbidity [Time frame: Baseline/ 1 year]
  • Frailty [Time frame: Baseline/ 1 year]
Secondary outcome measures (4)
  • Adherence [Time frame: Baseline]
  • Social support [Time frame: Baseline]
  • Functioning and disability [Time frame: Baseline/ 1 year]
  • Health releated quality of life [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • 60 years or older
  • 2 or more chronic diseases

Exclusion criteria

\- Not having used the national health system in the last year

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Spain · 1 center
  • Isabel del Cura González — Madrid

Identifiers

NCT: NCT06478745 · 20230033 · PI22/00768 Isabel del Cura · PI22/01651 Francisca Leiva · PI22/00701 Antonio Gimeno · PI22/01684 Bernardino Oliva · PI22/01398 Concepción Violan · PI22/01665 Rafael Rotaeche

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗