MultimorbidityNCT02609516
Impact of Socioeconomic Inequalities in Transition Between Health, Multimorbidity and Death Amongst Older People
An observational study of Multimorbidity, run by University College, London at 1 site in United Kingdom.
Trial summary
Life expectancy at age 65 in the most deprived fifth of the English population was about 4 years shorter than of the most affluent fifth in 2010. The inverse gradient between mortality and social position is well established. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multimorbidity
- What is being tested?
- This is not an intervention study
- How many people
- 1,300,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients included in the CALIBER dataset.
Who may be able to join
- Registered with a participating practice that has agreed to data linkage
- Registered with an 'up to standard' participating general practice for at least 1 year
- Aged 45 and over on Jan 1st 2001 or who turn 45 between 1st Jan 2001 and 25th March 2010, irrespective of initial health status.
Who cannot join
- Patients with a record unlinked to deprivation due to missing or incomplete postcode of residence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What is the Impact of Socioeconomic Inequalities in the Rates of Transition Between Health, Multimorbidity and Death Amongst Older People in England?
Life expectancy at age 65 in the most deprived fifth of the English population was about 4 years shorter than of the most affluent fifth in 2010. The inverse gradient between mortality and social position is well established. But how disease patterns and multimorbidity (having two or more long term conditions at the same time) impact on differential mortality rates is inconclusive: is it because disadvantaged groups acquire more or more lethal combinations of, diseases over their life course; or, simply, become ill at ages younger than more affluent groups?
Read the detailed description
The association between social inequality and cause-specific mortality and single disease morbidity has been studied extensively. However, it remains unclear whether having two or more chronic diseases concurrently (or 'multimorbidity') plays a role in contributing to the inequalities gap in survival. This is particularly relevant given an ageing population and the trend of a widening in the life expectancy gap across several European countries.
Multimorbidity incidence increases rapidly with age. Estimates of the prevalence of multimorbidity in older people range from 55% to 98%, mainly due to the selection of diseases included, population coverage (hospital, community) and data source (self-reported surveys or clinical records). However, across all studies there is a clear and consistent pattern of higher prevalence rates at older ages, with multimorbidity.
Many aspects of the patient health trajectory remain under-explored. Patient case-mixes are likely to vary across socioeconomic groups, alongside a host of prognostic factors, including the clustering of multiple risk factors, age of onset, and disease presentation, progression and management in the presence of multiple health conditions.
- Conditions
- Multimorbidity
- Being tested
- This is not an intervention study
- Keywords
- Multimorbidity, Health inequalities, Ageing, Mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is not an intervention studyOther
This study is based on the retrospective analysis of linked electronic health records.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Patients without any of the pre-specified chronic diseases Receives: Other: This is not an intervention study | |
| Multimorbid | Patients having any two or more of the pre-specified chronic diseases Receives: Other: This is not an intervention study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yearly multimorbidity incidence rate
Numerator: Of patients with either 0 or 1 chronic diseases as on 1st Jan of the year, all those who become multimorbid by 31st Dec of the year.
Denominator: patient years at risk of patients with either 0 or 1 chronic diseases as on 1st Jan of the year
Measured: 10 years
Yearly multimorbidity prevalence
Numerator: all those with 2 or more listed diseases on 1st July of the year. Denominator: All eligible patients on 1st July of the year, irrespective of disease status on that date.
Measured: 10 years
Yearly all-cause mortality rates
Numerator: number of deaths until 31st Dec of the year amongst the patients included in the denominator.
Denominator: Person years at risk of patients with 0,1,2 or more diseases on 1st Jan of the year.
Measured: 10 years
Overall life expectancy
Incident rates of transitions between no disease, 1 disease, 2+ diseases, and death.
Measured: 10 years
Health state-specific life expectancies
Incident rates of transitions between four health states - no disease, 1 disease, 2+ diseases, and death.
Measured: 10 years
Secondary outcomes (1)
Yearly non-accidental mortality rates
As outcome 3 but excluding accidental deaths from the numerator
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionJan 2017 (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.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,300,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds
- Responsible party
- Principal investigator, Harry Hemingway, University College, London
- Investigators
- Madhavi Bajekal, PhD, Study director, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609516
- Sponsor's protocol ID
- 14_179
- Status last verified
- Nov 2015
- First submitted
- 17 Nov 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Impact of Socioeconomic Inequalities in the Rates of Transition Between Health, Multimorbidity and Death Amongst Older People in England?
- ClinicalTrials.gov ID
- NCT02609516
- Acronym / sponsor ID
- 14_179
- Conditions
- Multimorbidity
- Keywords
- Multimorbidity, Health inequalities, Ageing, Mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300,000 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University of Leeds
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jan 2017 (estimated)
- First posted
- 20 Nov 2015 (estimated)
- 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.
Life expectancy at age 65 in the most deprived fifth of the English population was about 4 years shorter than of the most affluent fifth in 2010. The inverse gradient between mortality and social position is well established. But how disease patterns and multimorbidity (having two or more long term conditions at the same time) impact on differential mortality rates is inconclusive: is it because disadvantaged groups acquire more or more lethal combinations of, diseases over their life course; or, simply, become ill at ages younger than more affluent groups?
Detailed description
The association between social inequality and cause-specific mortality and single disease morbidity has been studied extensively. However, it remains unclear whether having two or more chronic diseases concurrently (or 'multimorbidity') plays a role in contributing to the inequalities gap in survival. This is particularly relevant given an ageing population and the trend of a widening in the life expectancy gap across several European countries.
Multimorbidity incidence increases rapidly with age. Estimates of the prevalence of multimorbidity in older people range from 55% to 98%, mainly due to the selection of diseases included, population coverage (hospital, community) and data source (self-reported surveys or clinical records). However, across all studies there is a clear and consistent pattern of higher prevalence rates at older ages, with multimorbidity.
Many aspects of the patient health trajectory remain under-explored. Patient case-mixes are likely to vary across socioeconomic groups, alongside a host of prognostic factors, including the clustering of multiple risk factors, age of onset, and disease presentation, progression and management in the presence of multiple health conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Other: This is not an intervention studyPatients without any of the pre-specified chronic diseases |
| Multimorbid | – | Other: This is not an intervention studyPatients having any two or more of the pre-specified chronic diseases |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included in the CALIBER dataset.
Key inclusion criteria (3 listed)
- Registered with a participating practice that has agreed to data linkage
- Registered with an 'up to standard' participating general practice for at least 1 year
- Aged 45 and over on Jan 1st 2001 or who turn 45 between 1st Jan 2001 and 25th March 2010, irrespective of initial health status.
Key exclusion criteria (1 listed)
- Patients with a record unlinked to deprivation due to missing or incomplete postcode of residence.
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 |
|---|---|---|
| This is not an intervention studyThis study is based on the retrospective analysis of linked electronic health records. | Other | Healthy, Multimorbid |
Primary outcome
Yearly multimorbidity incidence rate
Time frame: 10 years
Numerator: Of patients with either 0 or 1 chronic diseases as on 1st Jan of the year, all those who become multimorbid by 31st Dec of the year. Denominator: patient years at risk of patients with either 0 or 1 chronic diseases as on 1st Jan of the year
Yearly multimorbidity prevalence
Time frame: 10 years
Numerator: all those with 2 or more listed diseases on 1st July of the year. Denominator: All eligible patients on 1st July of the year, irrespective of disease status on that date.
Yearly all-cause mortality rates
Time frame: 10 years
Numerator: number of deaths until 31st Dec of the year amongst the patients included in the denominator. Denominator: Person years at risk of patients with 0,1,2 or more diseases on 1st Jan of the year.
Overall life expectancy
Time frame: 10 years
Incident rates of transitions between no disease, 1 disease, 2+ diseases, and death.
Health state-specific life expectancies
Time frame: 10 years
Incident rates of transitions between four health states - no disease, 1 disease, 2+ diseases, and death.
1 secondary outcome
Yearly non-accidental mortality rates
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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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. This study is not recruiting at the moment.
Madhavi Bajekal, PhD study director
University College, London
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 University College, London at 1 site in United Kingdom.
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 3 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: status not confirmed, as of the sponsor's last update on 20 Nov 2015. 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 United Kingdom. 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?
Results are not available in the source record.
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?
Yearly multimorbidity incidence rate (time frame: 10 years). The study lists 5 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 20 Nov 2015.