Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hendrik van den Bussche

ORCID ID

Contact details

University Medical Center Hamburg-Eppendorf
Department of Primary Medical Care
Martinistr. 52
Hamburg
20246
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01ET0725-31; 01ET1006A-K

Study information

Scientific title

Patterns of multi-morbidity in primary health care: a multicentre, prospective, observational cohort study

Acronym

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

Ethics Committee of the Medical Association of Hamburg, 14 February 2008; amended 26 November 2008, ref: 2881

Study design

Multicentre prospective observational cohort study

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/07/2008

Overall trial end date

30/06/2019

Reason abandoned

Eligibility

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 type

Patient

Age group

Senior

Gender

Both

Target number of participants

3050

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

30/06/2019

Locations

Countries of recruitment

Germany

Trial participating centre

University Medical Center Hamburg-Eppendorf
Hamburg
20246
Germany

Sponsor information

Organisation

German Federal Ministry of Education and Research (Germany)

Sponsor details

Hannoversche Straße 28-30
Berlin
10115
Germany

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

German Federal Ministry of Education and Research (Germany) refs: 01ET0725-31 & 01ET1006A-K)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19671164
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22471952
3. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23257152
4. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23768192
5. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23826124
6. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24387712
7. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24580758
8. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24638040

Publication citations

  1. Protocol

    Schäfer I, Hansen H, Schön G, Maier W, Höfels S, Altiner A, Fuchs A, Gerlach FM, Petersen JJ, Gensichen J, Schulz S, Riedel-Heller S, Luppa M, Weyerer S, Werle J, Bickel H, Barth K, König HH, Rudolph A, Wiese B, Prokein J, Bullinger M, von dem Knesebeck O, Eisele M, Kaduszkiewicz H, Wegscheider K, van den Bussche H, The German MultiCare-study: Patterns of multimorbidity in primary health care - protocol of a prospective cohort study., BMC Health Serv Res, 2009, 9, 145, doi: 10.1186/1472-6963-9-145.

  2. Results

    Schäfer I, Hansen H, Schön G, Höfels S, Altiner A, Dahlhaus A, Gensichen J, Riedel-Heller S, Weyerer S, Blank WA, König HH, von dem Knesebeck O, Wegscheider K, Scherer M, van den Bussche H, Wiese B, The influence of age, gender and socio-economic status on multimorbidity patterns in primary care. First results from the multicare cohort study., BMC Health Serv Res, 2012, 12, 89, doi: 10.1186/1472-6963-12-89.

  3. Results

    van den Bussche H, Schäfer I, Wiese B, Dahlhaus A, Fuchs A, Gensichen J, Höfels S, Hansen H, Leicht H, Koller D, Luppa M, Nützel A, Werle J, Scherer M, Wegscheider K, Glaeske G, Schön G, A comparative study demonstrated that prevalence figures on multimorbidity require cautious interpretation when drawn from a single database., J Clin Epidemiol, 2013, 66, 2, 209-217, doi: 10.1016/j.jclinepi.2012.07.019.

  4. Results

    König HH, Leicht H, Bickel H, Fuchs A, Gensichen J, Maier W, Mergenthal K, Riedel-Heller S, Schäfer I, Schön G, Weyerer S, Wiese B, Bussche Hv, Scherer M, Eckardt M, , Effects of multiple chronic conditions on health care costs: an analysis based on an advanced tree-based regression model., BMC Health Serv Res, 2013, 13, 219, doi: 10.1186/1472-6963-13-219.

  5. Results

    Brettschneider C, Leicht H, Bickel H, Dahlhaus A, Fuchs A, Gensichen J, Maier W, Riedel-Heller S, Schäfer I, Schön G, Weyerer S, Wiese B, van den Bussche H, Scherer M, König HH, , Altiner A, Bickel H, Blank W, Brettschneider C, Bullinger M, van den Bussche H, Dahlhaus A, Ehreke L, Freitag M, Fuchs A, Gensichen J, Gerlach F, Hansen H, Heinrich S, Höfels S, von dem Knesebeck O, König HH, Krause N, Leicht H, Luppa M, Maier W, Mayer M, Mellert C, Nützel A, Paschke T, Petersen J, Prokein J, Riedel-Heller S, Romberg HP, Schäfer I, Scherer M, Schön G, Steinmann S, Schulz S, Wegscheider K, Weckbecker K, Werle J, Weyerer S, Wiese B, Zieger M, , Relative impact of multimorbid chronic conditions on health-related quality of life--results from the MultiCare Cohort Study., PLoS ONE, 2013, 8, 6, e66742, doi: 10.1371/journal.pone.0066742.

  6. Results

    Nützel A, Dahlhaus A, Fuchs A, Gensichen J, König HH, Riedel-Heller S, Maier W, Schäfer I, Schön G, Weyerer S, Wiese B, Scherer M, van den Bussche H, Bickel H, Self-rated health in multimorbid older general practice patients: a cross-sectional study in Germany., BMC Fam Pract, 2014, 15, 1, doi: 10.1186/1471-2296-15-1.

  7. Results

    Hansen H, Schäfer I, Schön G, Riedel-Heller S, Gensichen J, Weyerer S, Petersen JJ, König HH, Bickel H, Fuchs A, Höfels S, Wiese B, Wegscheider K, van den Bussche H, Scherer M, Agreement between self-reported and general practitioner-reported chronic conditions among multimorbid patients in primary care - results of the MultiCare Cohort Study., BMC Fam Pract, 2014, 15, 39, doi: 10.1186/1471-2296-15-39.

  8. Results

    Bock JO, Luppa M, Brettschneider C, Riedel-Heller S, Bickel H, Fuchs A, Gensichen J, Maier W, Mergenthal K, Schäfer I, Schön G, Weyerer S, Wiese B, van den Bussche H, Scherer M, König HH, Impact of depression on health care utilization and costs among multimorbid patients--from the MultiCare Cohort Study., PLoS ONE, 2014, 9, 3, e91973, doi: 10.1371/journal.pone.0091973.

Editorial Notes