MultimorbidityLOXONCT06478745
Trajectories and Experiences of People With Multimorbidity in Spain (LOXO-MULTIPAP) Project: a Mixed Methods Study
An observational study of Multimorbidity, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Multimorbidity
- What is being tested?
- Retrospective and prospective cohort, Focus group, semi-structured interviews and Photovoice and Systematic review
- How many people
- 3,239,950 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2024to 1 Jul 2027
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 60 years or older
- 2 or more chronic diseases
Who cannot join
- Not having used the national health system in the last year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Trajectories and Experiences of Patients With Multimorbidity in the National Health Service of Spain: a Mixed Methods Study (LOXO-MULTIPAP)
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.
- Conditions
- Multimorbidity
- Being tested
- Retrospective and prospective cohort, Focus group, semi-structured interviews and Photovoice, Systematic review
- Keywords
- Multimorbidity, Primary Health Care, Trajectories, Mixed-methods, Patterns, Qualitative study, Discussion group, Semi-structured interviews, Photovoice, Shared decision-making, Cluster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective and prospective cohortOther
- 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 PhotovoiceOther
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 reviewOther
No patient recruitment required
| Study group | Role | What they receive |
|---|---|---|
| Quantitative Aim | Ambispective longitudinal observational study Receives: Other: Retrospective and prospective cohort | |
| Qualitative Aim | Focus group, semi-structured interviews and Photovoice Receives: 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. Receives: Other: Systematic review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Death
Death and abandonment: the occurrence of this event will be measured, regardless of the cause
Measured: Start date 31/12/2012, 1 year
Drugs
300 ATC Swedish National Study of Ageing and Care (SNAC-K20) 8It is a classification, not a scale)
Measured: 1 year
Use of service
Primary Care medical/nursing visits, emergencies, referrals, admissions
Measured: 1 year
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
Measured: Baseline/ 1 year
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)
Measured: Baseline/ 1 year
Secondary outcomes (4)
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)
Measured: Baseline
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)
Measured: Baseline
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)
Measured: Baseline/ 1 year
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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start30 Jun 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 3,239,950 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Madrid
- Sponsor type
- Other government
- 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
- Principal investigator, Isabel Del Cura-Gonzalez, Gerencia de Atención Primaria, Madrid
- Investigators
- Isabel del Cura González, PhD,MD, Study director, Gerencia Asistencial de Atención Primaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478745
- Sponsor's protocol ID
- 20230033
- Other IDs
- 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
- Acronym
- LOXO
- Status last verified
- Jul 2024
- First submitted
- 17 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trajectories and Experiences of Patients With Multimorbidity in the National Health Service of Spain: a Mixed Methods Study (LOXO-MULTIPAP)
- ClinicalTrials.gov ID
- NCT06478745
- Acronym / sponsor ID
- LOXO / 20230033
- Conditions
- Multimorbidity
- Keywords
- Multimorbidity, Primary Health Care, Trajectories, Mixed-methods, Patterns, Qualitative study, Discussion group, Semi-structured interviews
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,239,950 participants (estimated)
- Lead sponsor
- Gerencia de Atención Primaria, MadridOther government
- 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
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quantitative Aim | – | Other: Retrospective and prospective cohortAmbispective longitudinal observational study |
| Qualitative Aim | – | Other: Focus group, semi-structured interviews and PhotovoiceFocus group, semi-structured interviews and Photovoice |
| Systematic Review Aim | – | Other: Systematic reviewSystematic literature review on the effectiveness of interventions on training, multimorbidity and polypharmacy in health professionals. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 60 years or older
- 2 or more chronic diseases
Key exclusion criteria (1 listed)
- Not having used the national health system in the last year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Quantitative Aim |
| Focus group, semi-structured interviews and PhotovoiceThe 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 | Qualitative Aim |
| Systematic reviewNo patient recruitment required | Other | Systematic Review Aim |
Primary outcome
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)
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
Drugs
Time frame: 1 year
300 ATC Swedish National Study of Ageing and Care (SNAC-K20) 8It is a classification, not a scale)
Use of service
Time frame: 1 year
Primary Care medical/nursing visits, emergencies, referrals, admissions
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
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)
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Multimorbidity
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Preoperative Multimorbidity and Functional Recovery After Total Knee Arthroplasty
Knee Osteoarthritis, Multimorbidity
Active, not recruiting
Optimizing Prescribing Decisions for Hospitalized Older Adults With Chronic Conditions
Prescribing Decisions, Diabetes
RecruitingObservational study
How Complexity and Multiple Illnesses Affect Hospitalized Patients' Health: A Multicenter Study
Multimorbidities
Not yet recruiting
Cardiovascular Disease Multimorbidity
Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabel del Cura González, PhD,MD study director
Gerencia Asistencial de Atención Primaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multimorbidity, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multimorbidity (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.