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ISRCTN
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ISRCTN89818205
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ClinicalTrials.gov identifier
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Public title
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Multicare cohort study - patterns of multi-morbidity in primary health care
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Scientific title
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Patterns of multi-morbidity in primary health care: a multicentre, prospective, observational cohort study
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Acronym
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N/A
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Serial number at source
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01ET0725-31; 01ET1006A-K
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Study hypothesis
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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)
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Lay summary
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Not provided at time of registration
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Ethics approval
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Ethics Committee of the Medical Association of Hamburg, 14 February 2008; amended 26 November 2008, ref: 2881
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Study design
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Multicentre prospective observational cohort study
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Multimorbidity
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/07/2008
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Anticipated end date
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30/06/2019
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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3050
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Interventions
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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.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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German Federal Ministry of Education and Research (Germany) refs: 01ET0725-31 & 01ET1006A-K)
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Trial website
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Publications
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2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19671164
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Contact name
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Prof
Hendrik
van den Bussche
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Address
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University Medical Center Hamburg-Eppendorf
Department of Primary Medical Care
Martinistr. 52
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City/town
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Hamburg
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Zip/Postcode
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20246
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Country
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Germany
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Sponsor
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German Federal Ministry of Education and Research (Germany)
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Address
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Hannoversche Straße 28-30
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City/town
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Berlin
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Zip/Postcode
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10115
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Country
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Germany
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Date applied
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27/09/2011
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Last edited
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09/11/2011
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Date ISRCTN assigned
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09/11/2011
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