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Enrolling by Invitation

NCT Number: NCT06478745

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

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.

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Key information

Conditions

Multimorbidity

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Isabel del Cura González

Madrid, 28035, Spain

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 60 years or older
  • 2 or more chronic diseases

Exclusion criteria

  • Not having used the national health system in the last year

Treatment and study plan

Retrospective and prospective cohort

Other
  • 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

Other

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

Other

No patient recruitment required

Primary outcomes

  1. Multimorbidity

    Time frame: 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)

  2. Death

    Time frame: Start date 31/12/2012, 1 year

    Death and abandonment: the occurrence of this event will be measured, regardless of the cause

  3. Drugs

    Time frame: 1 year

    300 ATC Swedish National Study of Ageing and Care (SNAC-K20) 8It is a classification, not a scale)

  4. Use of service

    Time frame: 1 year

    Primary Care medical/nursing visits, emergencies, referrals, admissions

  5. Morbidity

    Time frame: 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

  6. Frailty

    Time frame: 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)

Secondary outcomes

  1. Adherence

    Time frame: Baseline

    Morisky-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)

  2. Social support

    Time frame: Baseline

    Dukes-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)

  3. Functioning and disability

    Time frame: Baseline/ 1 year

    WHODAS (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)

  4. Health releated quality of life

    Time frame: Baseline

    Euroqol 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)

Other outcomes

  1. Age

    Time frame: Baseline

    Years

  2. Sex

    Time frame: Baseline

    Male/Female

  3. Country

    Time frame: Baseline

    Country of origin

  4. Deprivation Index

    Time frame: Baseline

    MEDEA (Values from 1 to 5. Higher values indicate a more unfavorable socioeconomic situation)

Sponsors and collaborators

Lead sponsor

Gerencia de Atención Primaria, Madrid

Other Gov

Collaborators

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

Registry information

Official study title

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

Acronym: LOXO

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Jun 27, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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