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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06478745
Acronym
LOXO
Enrollment
3239950
Registered
2024-06-27
Start date
2024-06-30
Completion date
2027-07-01
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multimorbidity

Keywords

Multimorbidity, Primary Health Care, Trajectories, Mixed-methods, Patterns, Qualitative study, Discussion group, Semi-structured interviews, Photovoice, Shared decision-making, Cluster

Brief 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.

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

OTHERRetrospective 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.

OTHERFocus 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.

No patient recruitment required

Sponsors

PI. Bernardino Oliva. Instituto Investigación Sanitaria Illes Balears
CollaboratorUNKNOWN
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
CollaboratorOTHER
PI Antonio Gimeno. Instituto de Investigación Sanitaria Aragón.
CollaboratorUNKNOWN
PI. Rafael Rotaeche. Instituto Investigación Bioguipuzcoa. Osakidetza
CollaboratorUNKNOWN
PI. Francisca Leiva. Instituto de Investigacion Biomedica de Malaga.
CollaboratorUNKNOWN
CI. Julian Librero. Navarra Biomed. Servicio Navarro de Salud
CollaboratorUNKNOWN
Fundación Investigacion en Innovacion Biomédica en Atención Primaria FIIBAP
CollaboratorUNKNOWN
Instituto de Investigación Sanitaria Gregorio Marañón
CollaboratorOTHER
Gerencia de Atención Primaria, Madrid
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Use of service1 yearPrimary Care medical/nursing visits, emergencies, referrals, admissions
Drugs1 year300 ATC Swedish National Study of Ageing and Care (SNAC-K20) 8It is a classification, not a scale)
MultimorbidityBaselinePresence 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)
DeathStart date 31/12/2012, 1 yearDeath and abandonment: the occurrence of this event will be measured, regardless of the cause
FrailtyBaseline/ 1 yearEFRAIL (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)
MorbidityBaseline/ 1 yearDefined with ICD-10, laboratory defined in the Swedish National Study of Ageing and Care (SNAC-K20). It is a classification, not a scale

Secondary

MeasureTime frameDescription
Health releated quality of lifeBaselineEuroqol 5D-5L (It consists of 2 parts - The EQ-5D descriptive system and the Visual Analog Scale (VAS). Scale (VAS). In the VAS the individual scores his or her health between two extremes, 0 and 100, the worst and the best state of health imaginable. imaginable)
AdherenceBaselineMorisky-Green (Patients who answer NO to all four questions are considered compliant with treatment and those who answer YES to one or more are considered non-compliant)
Social supportBaselineDukes-Unk-11(This questionnaire consists of 11 items and a Likert-type response scale. The score range is between 11 and 55 points. A score equal to or greater than 32 indicates normal support, while a score of less than 32 indicates low perceived social support)
Functioning and disabilityBaseline/ 1 yearWHODAS (It is composed of 36 items that evaluate the following 6 dimensions. The overall score runs a scale from 0 to 100, with higher values indicating greater disability)

Other

MeasureTime frameDescription
AgeBaselineYears
Deprivation IndexBaselineMEDEA (Values from 1 to 5. Higher values indicate a more unfavorable socioeconomic situation)
CountryBaselineCountry of origin
SexBaselineMale/Female

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026