ClinicalTrials.gg
Enrolling by invitationNCT06478745LOXOUpdated Jul 3, 2024

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

An observational study in Multimorbidity, sponsored by Gerencia de Atención Primaria, Madrid. Enrolling by invitation at 1 site in Spain. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Gerencia de Atención Primaria, Madrid · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
3,239,950
Ages
60 Years and older
Sex
All
01

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.

Read the 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.
02

Conditions studied

  • Multimorbidity

Keywords

  • Multimorbidity
  • Primary Health Care
  • Trajectories
  • Mixed-methods
  • Patterns
  • Qualitative study
  • Discussion group
  • Semi-structured interviews
  • Photovoice
  • Shared decision-making
  • Cluster
03

In context

Lead sponsor

Gerencia de Atención Primaria, Madrid is the lead sponsor of 29 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patientes aged 60 years or older with 2 or more chronic diseases diagnosed before 2012-01-01. Population registered at Primary Health Centres in Spain.

Sampling Method: Not Applicable

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 60 years or older
  • 2 or more chronic diseases

Exclusion criteria

Exclusion criteria:

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

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
3,239,950 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • Quantitative Aim

    Ambispective longitudinal observational study

    Other: Retrospective and prospective cohort

  • Qualitative Aim

    Focus group, semi-structured interviews and Photovoice

    Other: Focus group, semi-structured interviews and Photovoice

  • Systematic Review Aim

    Systematic literature review on the effectiveness of interventions on training, multimorbidity and polypharmacy in health professionals.

    Other: Systematic review

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.

  • OtherSystematic review

    No patient recruitment required

06

What researchers measure

Primary outcomes

  1. Multimorbidity

    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)

    Time frame: Baseline

  2. Death

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

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

  3. Drugs

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

    Time frame: 1 year

  4. Use of service

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

    Time frame: 1 year

  5. Morbidity

    Defined with ICD-10, laboratory defined in the Swedish National Study of Ageing and Care (SNAC-K20). It is a classification, not a scale

    Time frame: Baseline/ 1 year

  6. Frailty

    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)

    Time frame: Baseline/ 1 year

Secondary outcomes

  1. Adherence

    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)

    Time frame: Baseline

  2. Social support

    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)

    Time frame: Baseline

  3. Functioning and disability

    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)

    Time frame: Baseline/ 1 year

  4. Health releated quality of life

    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)

    Time frame: Baseline

Other outcomes

  1. Age

    Years

    Time frame: Baseline

  2. Sex

    Male/Female

    Time frame: Baseline

  3. Country

    Country of origin

    Time frame: Baseline

  4. Deprivation Index

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

    Time frame: Baseline

07

Study locations

1 site
  • Isabel del Cura González
    Madrid, 28035, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2024; primary completion for Jul 2025, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 17, 2024
First posted
Jun 27, 2024
StartEst.
Jun 30, 2024
Primary completionEst.
Jul 1, 2025
CompletionEst.
Jul 1, 2027
Last update
Jul 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06478745
Lead sponsor
Gerencia de Atención Primaria, Madrid
Collaborators
PI. Bernardino Oliva. Instituto Investigación Sanitaria Illes Balears, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, PI Antonio Gimeno. Instituto de Investigación Sanitaria Aragón., PI. Rafael Rotaeche. Instituto Investigación Bioguipuzcoa. Osakidetza, PI. Francisca Leiva. Instituto de Investigacion Biomedica de Malaga., CI. Julian Librero. Navarra Biomed. Servicio Navarro de Salud, Fundación Investigacion en Innovacion Biomédica en Atención Primaria FIIBAP, Instituto de Investigación Sanitaria Gregorio Marañón
Responsible party
Isabel Del Cura-Gonzalez (Principal - Coordinator researcher, Gerencia de Atención Primaria, Madrid) — Principal investigator
First posted
Jun 27, 2024
Start date
Jun 30, 2024 (estimated)
Primary completion
Jul 1, 2025 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Jul 3, 2024

Study contacts

Isabel del Cura González, PhD,MD
study director · Gerencia Asistencial de Atención Primaria

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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