Multicare cohort study - patterns of multi-morbidity in primary health care
| ISRCTN | ISRCTN89818205 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89818205 |
| Secondary identifying numbers | 01ET0725-31; 01ET1006A-K |
- Submission date
- 27/09/2011
- Registration date
- 09/11/2011
- Last edited
- 21/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
Multimorbidity is defined as the presence of two or more chronic (long-term) medical conditions in one patient. In this study we aim to identify clusters of combinations of diseases (multi-morbidity patterns) in the elderly population and to determine their frequency and severity. We will investigate the development of these clusters over time, how they interact, and the consequences for the patient's quality of life.
Who can participate?
Patients aged 65 to 85 with at least three chronic conditions, randomly selected from the participating GP surgeries
What does the study involve?
Information about the patients' chronic conditions is collected using GP interviews and chart reviews. Additional data is collected in patient interviews using standard questionnaires and tests.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Eight study centers distributed across Germany (Bonn, Düsseldorf, Frankfurt/Main, Hamburg, Jena, Leipzig, Mannheim and Munich)
When is the study starting and how long is it expected to run for?
July 2008 to December 2013
Who is funding the study?
Federal Ministry of Education and Research (Germany)
Who is the main contact?
Prof. Hendrik van den Bussche
Contact information
Scientific
University Medical Center Hamburg-Eppendorf
Department of Primary Medical Care
Martinistr. 52
Hamburg
20246
Germany
Study information
| Study design | Multicentre prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Patterns of multi-morbidity in primary health care: a multicentre, prospective, observational cohort study |
| Study hypothesis | 1. Identify clusters of combinations of diseases/disorders (multi-morbidity patterns) in the elderly general practice population and to determine their frequency and severity in relation to each other 2. Investigate the development of these clusters over time, especially with regard to the internal interaction between the diseases within the cluster (addition, synergism, buffer, protection) 3. Analyse the relationship of mental and somatic disorders in these patterns 4. Identify prognostic variables for the course of specific multi-morbidity patterns 5. Investigate the somatic, psychological and social consequences of multi-morbidity (patterns) for the patient's quality of life and functional status 6. Describe the utilisation of health care resources and the costs of care of multi-morbidity (patterns) |
| Ethics approval(s) | Ethics Committee of the Medical Association of Hamburg, 14/02/2008; amended 26/11/2008, ref: 2881 |
| Condition | Multimorbidity |
| Intervention | The patients will be recruited from GP surgeries in 8 study centers distributed across Germany (Bonn, Düsseldorf, Frankfurt/Main, Hamburg, Jena, Leipzig, Mannheim and Munich). The morbidity of the patients will be registered via chart reviews, GP interviews and patient interviews in a standardized assessment of 46 diagnosis groups including duration and severity. The other data will be collected in comprehensive patient interviews. It is projected to perform a total of 9 waves of data collection by means of both GP and patient interviews. Each wave will take 15 months to be accomplished. |
| Intervention type | Other |
| Primary outcome measure | 1. The variables under study belong to four groups: 1.1. Morbidity (GP and patient-reported) 1.2. Functional status 1.3. Resources/risk factors 1.4. Socio-demographic data 2. The domain of functional status includes: 2.1. Activities and instrumental activities of daily living 2.2. Motor skills 2.3. Senses (i.e. hearing and vision) 2.4. Cognition 2.5. Pain 2.6. Health-related quality of life 3. Resources include: 3.1. Physical activity 3.2. Balanced nutrition 3.3. Social support 3.4. General self-efficacy 3.5. Utilization of medical services 3.6. Quality of medical care according to the Chronic Care Model. 4. Risk factors include: 4.1. Physical inactivity 4.2. Malnutrition 4.3. Alcohol abuse 4.4. Smoking 4.5. Body mass index 4.6. Waist-to-hip-ratio 5. Socio-demographic variables include: 5.1. Age 5.2. Gender 5.3. Migrant status 5.4. Marital status 5.5. Living conditions 5.6. Household size 5.7. Education 5.8. Former occupation 5.9. Income 5.10. Wealth |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/07/2008 |
| Overall study end date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 3050 |
| Participant inclusion criteria | Patients were randomly selected from general practitioner (GP) charts and were included if they: 1. Were born between 01 July 1923 and 30 June 1943 2. Have consulted their GP within the last completed quarter (i.e. 3 month period) 3. Have at least 3 chronic conditions out of a list of 29 diagnosis groups |
| Participant exclusion criteria | 1. Insufficient ability to consent (e.g. dementia) 2. Insufficient ability to participate in interviews (e.g. blindness, deafness) 3. Poorly known to the GP because of accidental consultation 4. Residence in a nursing home 5. Insufficient ability to speak and read German 6. Severe illness probably lethal within three months 7. Participation in other studies at the time of recruitment |
| Recruitment start date | 01/07/2008 |
| Recruitment end date | 30/09/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
20246
Germany
Sponsor information
Government
Hannoversche Straße 28-30
Berlin
10115
Germany
"ROR" |
https://ror.org/04pz7b180 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in high-impact peer reviewed journals |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available because data are owned by the MultiCare consortium and the authors of publications are not allowed to share them with third parties. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/08/2009 | Yes | No | |
| Results article | results | 03/04/2012 | Yes | No | |
| Results article | results | 01/02/2013 | Yes | No | |
| Results article | results | 15/06/2013 | Yes | No | |
| Results article | results | 24/06/2013 | Yes | No | |
| Results article | results | 03/01/2014 | Yes | No | |
| Results article | results | 01/03/2014 | Yes | No | |
| Results article | results | 17/03/2014 | Yes | No | |
| Results article | results | 01/04/2014 | Yes | No | |
| Results article | results | 08/04/2014 | Yes | No | |
| Results article | results | 18/07/2014 | Yes | No | |
| Results article | results | 07/08/2014 | Yes | No | |
| Results article | results | 01/10/2014 | Yes | No | |
| Results article | results | 07/02/2015 | Yes | No | |
| Results article | results | 01/10/2015 | Yes | No | |
| Results article | results | 06/06/2016 | Yes | No | |
| Results article | 17/09/2021 | 21/09/2021 | Yes | No |
Editorial Notes
21/09/2021: Publication reference added.
19/10/2017: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2019 to 30/09/2009.
2. The overall trial end date was changed from 30/06/2019 to 31/12/2013.
3. IPD sharing statement added.
18/10/2017: Publication references added.
14/03/2016: Plain English summary added.
