Ireland
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Enrolling by invitation Observational

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

NCT06478745 · tracked via the Priya Life Science Spain tracker
Sponsor
Gerencia de Atención Primaria, Madrid
Phase
Observational
Started
2024-06-30
Last updated
2024-07-03

Condition(s) studied

Multimorbidity

Investigational drug(s) / intervention(s)

Retrospective and prospective cohortFocus group, semi-structured interviews and PhotovoiceSystematic review

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 context of the MULTIPAP and LOXO studies.Patients over 65 years of age with multimorbidity (3 or more chronic pathologies) and polypharmacy (5 or more drugs taken during at least the last 3 months before inclusion in the study) under follow-up from primary care in Madrid, Aragon and Andalusia.

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.

Systematic review: No patient recruitment required

Study summary

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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: * 60 years or older * 2 or more chronic diseases Exclusion criteria: \- Not having used the national health system in the last year

Primary outcome measure(s)

  • Multimorbidity — Baseline
    Presence of two or more diagnoses of any of the 60 diseases categorised by the Swedish National Study of Ageing and Care (SNAC-K20) (It is a classification, not a scale)
  • Death — Start date 31/12/2012, 1 year
    Death and abandonment: the occurrence of this event will be measured, regardless of the cause
  • Drugs — 1 year
    300 ATC Swedish National Study of Ageing and Care (SNAC-K20) 8It is a classification, not a scale)
  • Use of service — 1 year
    Primary Care medical/nursing visits, emergencies, referrals, admissions
  • Morbidity — Baseline/ 1 year
    Defined with ICD-10, laboratory defined in the Swedish National Study of Ageing and Care (SNAC-K20). It is a classification, not a scale
  • Frailty — Baseline/ 1 year
    EFRAIL (It consists of 5 dichotomous questions. Scoring from 0 to 5. Interpretation: * Probable frailty: 3 to 5 points. * Probable pre-fragility: 1 to 2 points. * No fragility or robustness: 0 points)

Trial sites (1)

FacilityCityRegionStatus
Isabel del Cura González Madrid Spain

More Gerencia de Atención Primaria, Madrid trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06478745 on ClinicalTrials.gov ↗ ← All trials in Spain