Trial document





This trial has been registered retrospectively.
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  DRKS00005136

Trial Description

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Title

Longitudinal Urban Cohort Ageing Study, Subproject 1: Ageing of the longitudinal cohort in the metropolitan region of Hamburg

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Trial Acronym

LUCAS, SP 1: Longitudinal Cohort

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URL of the Trial

http://www.albertinen.de/krankenhaeuser/geriatrische_klinik/leistungsspektrum/lucas/teilprojekt1

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Brief Summary in Lay Language

In coming decades, Germany will experience a significant increase in both the number and proportion of old and oldest old people in the population. However, little is known about the normal ageing process and its health protection because medical assumptions about the ageing process and age-related functional decline mostly result from observations in hospitals and nursing homes and do not represent the majority of community-dwelling elderly people in industrialised countries. To better understand the normal ageing process, changes in health status of the same persons have been observed and analysed over the length of 12 years including health reserves and behaviour, healthy and disability free live expectancy, loss of functional skills, need of nursing care (Pflegestufe), nursing home admission and mortality. Therefore, 3,326 independently living community-dwelling elderly (60+ years) without nursing care according to the German long-term care insurance (Pflegeversicherung I-III) and without cognitive impairment were recruited in 21 general practices in Hamburg in 2000. Information about pre-clinical markers for healthy ageing vs. the development of functional decline, has been collected in a periodic survey process at baseline, 1 year, 7 year, 9 year and 11 year follow up (28.350 person years). Aim: Obtaining epidemiological data using periodic assessments of key parameters (a) to describe individual ageing trajectories in a metropolitan setting; (b) to find determinants of healthy ageing; (c) to assess long-term effects of specific health promotion interventions; (d) to produce results for health care planning for different target groups of elderly persons (robust to disabled); (e) to set up a framework for embedded studies to investigate various hypotheses in specific subgroups of the longitudinal cohort of elderly persons (e.g. RCT No. ISRCTN 28458424 concerning health promotion in old age during wave 1).

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Brief Summary in Scientific Language

Background: In coming decades, Germany will experience a significant increase in both the number and proportion of old and oldest old people in the population. However, little is known about the normal ageing process and its health protection because medical assumptions about the ageing process and age-related functional decline mostly result from observations in hospitals and nursing homes and do not represent the majority of community-dwelling elderly people in industrialised countries.
Purpose: To better understand the normal ageing process, changes in health status of the same persons have been observed and analysed over the length of 12 years including health reserves and behaviour, healthy and disability free live expectancy, loss of functional skills, need of nursing care (Pflegestufe), nursing home admission and mortality. Therefore, 3,326 independently living community-dwelling elderly (60+ years) without nursing care according to the German long-term care insurance (Pflegeversicherung I-III) and without cognitive impairment were recruited in 21 general practices in Hamburg in 2000 to carry out the study “Active health promotion in old age” (2000-2005). This study was the basis for the re-recruitment of the cohort (LUCAS cohort) for further periodic surveys to collect information about pre-clinical markers for healthy ageing versus the development of functional decline also at 7, 9 and 11 year follow up (28.350 person years).
Aim: Obtaining epidemiological data using periodic assessments of key parameters
(1) to describe individual ageing trajectories in a metropolitan setting, documenting changes in functional status, the onset of frailty, disability, need of care and mortality;
(2) to find determinants of healthy ageing;
(3) to assess long-term effects of specific health promotion interventions;
(4) to produce results for health care planning for fit, pre-frail, frail and disabled elderly persons;
(5) to set up a framework for embedded studies to investigate various hypotheses in specific subgroups of elderly (e.g. RCT No. ISRCTN 28458424 concerning health promotion in old age during wave 1).
Hypothesis: (A) Individual health developments can only be tracked by studying no single medical condition but by focussing on the natural course of ageing in the same individuals quantifying simultaneously behaviour, co-morbidity, functional competence and their changes. (B) A cohort study of older persons (60-100 Jahre) is feasible and can maintain a good participation rate over twelve years, even when extensive self-reported health data are collected repeatedly through self-filled questionnaires (BMBF funding 01ET0708 + 01ET1002A).

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Organizational Data

  •   DRKS00005136
  •   2013/07/09
  •   [---]*
  •   yes
  •   Approved
  •   PV2856, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

  •   U1111-1139-5309 
  •   01ET0708 + 01ET1002A  (BMBF-Fördernummer)
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Health Condition or Problem studied

  •   ICF Carrying out daily routine (d230)
  •   R54 -  Senility
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Interventions/Observational Groups

  •   Persons 60 years and older have been asked with a questionnaire concerning ageing in periodic intervals (1-, 7-, 9-, 11-year follow-up).
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Mortality after 7, 9, 11 years using data from the Central Registry Office Hamburg (Fachamt Einwohnerwesen).
Disability after 7, 9, 11 years using data from the Medical Insurance
Company (Medizinischer Dienst der Krankenversicherung Nord)

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Secondary Outcome

Functional decline after 7, 9, 11 years with geriatric questionnaire.
Frailty after 7, 9, 11 years with geriatric questionnaire.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2007/11/22
  •   3326
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   60   Years
  •   no maximum age
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Additional Inclusion Criteria

Year 2000: patients 60 + years in participating general practices (GP) in Hamburg. Year 2007 (re-recruitment for 7 year follow-up): all participants in the cohort from 2000 who were still alive (=LUCAS longitudinal cohort).

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Exclusion Criteria

Study start in 2000:
• patients needing help in basic activities of daily life,
• patients obtaining nursing care according to the German long-term care insurance (Pflegeversicherung I-III),
• patients with cognitive impairment,
• patients with terminal disease and/or
• patients unable to understand German.

Exclusion criteria LUCAS start (2007):
• lost to follow-up or not willing to continue participation.

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Addresses

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    • Albertinen-Haus, Zentrum für Geriatrie und Gerontologie, Wissenschaftliche Einrichtung an der Universität Hamburg
    • Mr.  Professor Dr. med.  Wolfgang  von Renteln-Kruse 
    • Sellhopsweg 18-22
    • 22459  Hamburg
    • Germany
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    • Albertinen-Haus, Zentrum für Geriatrie und Gerontologie, Forschungsabteilung Wissenschaftliche Einrichtung an der Universität Hamburg
    • Ms.  Dr. rer. nat.  Ulrike  Dapp 
    • Sellhopsweg 18-22
    • 22459  Hamburg
    • Germany
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    • Albertinen-Haus, Zentrum für Geriatrie und Gerontologie, Forschungsabteilung Wissenschaftliche Einrichtung an der Universität Hamburg
    • Ms.  Claudia  Leonhardt 
    • Sellhopsweg 18-22
    • 22459  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.