Welcome
Support Centre
22 July 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Multicare cohort study - patterns of multi-morbidity in primary health care
ISRCTN ISRCTN89818205
DOI 10.1186/ISRCTN89818205
ClinicalTrials.gov identifier
EudraCT number
Public title Multicare cohort study - patterns of multi-morbidity in primary health care
Scientific title Patterns of multi-morbidity in primary health care: a multicentre, prospective, observational cohort study
Acronym N/A
Serial number at source 01ET0725-31; 01ET1006A-K
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 patientís quality of life and functional status
6. Describe the utilisation of health care resources and the costs of care of multi-morbidity (patterns)
Lay summary Not provided at time of registration
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
Countries of recruitment Germany
Disease/condition/study domain Multimorbidity
Participants - 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
Participants - 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
Anticipated start date 01/07/2008
Anticipated end date 30/06/2019
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 3050
Interventions 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.
Primary outcome measure(s) 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 measure(s) No secondary outcome measures
Sources of funding German Federal Ministry of Education and Research (Germany) refs: 01ET0725-31 & 01ET1006A-K)
Trial website
Publications 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
Contact name Prof  Hendrik  van den Bussche
  Address University Medical Center Hamburg-Eppendorf
Department of Primary Medical Care
Martinistr. 52
  City/town Hamburg
  Zip/Postcode 20246
  Country Germany
Sponsor German Federal Ministry of Education and Research (Germany)
  Address Hannoversche Straße 28-30
  City/town Berlin
  Zip/Postcode 10115
  Country Germany
Date applied 27/09/2011
Last edited 14/04/2014
Date ISRCTN assigned 09/11/2011
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.