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The cost-effectiveness of systematic home visits by nurses of frail elderly primary care patients and caregivers of demented patients
ISRCTN ISRCTN05358495
DOI 10.1186/ISRCTN05358495
ClinicalTrials.gov identifier
EudraCT number
Public title The cost-effectiveness of systematic home visits by nurses of frail elderly primary care patients and caregivers of demented patients
Scientific title
Acronym PIKO - Preventieve Interventie bij Kwetsbare Ouderen (Preventive Intervention for Frail Older persons)
Serial number at source N/A
Study hypothesis 1. To evaluate the cost-effectiveness of systematic home visits by nurses to frail elderly primary care patients.
Lay summary
Ethics approval The Ethical Committee of the VU medical center approved the study.
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Frailty, Dementia
Participants - inclusion criteria 1. Frail elderly as defined by:
1.1. Aged 75+ years persons living at home who score in the worst quartile of at least two of six COOP-charts are considered frail
1.2. Persons at high risk on the 7-minute screen and below the threshold of the Mini-Mental State Examination (MMSE) (less than 24)
2. Caregivers of demented persons (under 1.2.)
Participants - exclusion criteria Does not comply with the above inclusion criteria
Anticipated start date 01/07/2002
Anticipated end date 30/04/2007
Status of trial Completed
Patient information material
Target number of participants 1100
Interventions Trained community nurses visit patients at home, assess the care needs with the Resident Assessment Instrument - Home Care (RAI-HC), a multidimensional geriatric assessment. Computerisation enables direct identification of problem areas. The nurses make and execute standardised care-plans, targeted at individual needs that comply with patient priorities. The nurses visit the patients at least five times during a year in order to execute and monitor the care-plan. Special attention is paid to caregivers of demented persons by family meetings.

Controls receive usual care.
Primary outcome measure(s) Health related quality of life as measured with the Short Form 36 (SF-36), and Quality Adjusted Life Years by health utilities based on Euroqol (EQ-5D), measured at baseline, 6 and 18 months.
Secondary outcome measure(s) 1. (Days until) institutionalization: hospital stay, placement in nursing home or home for the elderly are surveyed and crosschecked at institutes, measured at baseline, 6 and 18 months
2. Hospital admissions, measured at 18 months
3. (Days until) mortality as checked with the Primary Care Physicians (PCPs), measured at 18 months
4. Direct costs as measured by patient questionnaires with three-monthly recall periods. These self-report data are supplemented by data from the centralized regional pharmacy database (medication use), regional hospital check, and nursing home checks. In case patients are not able to fill out the forms themselves a close relative will be approached, measured at baseline, 6 and 18 months
Sources of funding 1. Vrije University Medical Centre (VUMC) (Netherlands) (ref: 2002/121)
2. The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 2200-114)
Trial website http://www.emgo.nl/research_prog/care/researchprojects_58.asp
Publications 1. 2005 design and pilot results in http://www.ncbi.nlm.nih.gov/pubmed/16150147
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20457579
Contact name Dr  Hein  van Hout
  Address VU University Medical Centre
EMGO-Institute
Van der Boechorststraat 7
  City/town Amsterdam
  Zip/Postcode 1081 BT
  Country Netherlands
  Tel +31 (0)20 4448199
  Fax +31 (0)20 4448361
  Email Hpj.vanhout@vumc.nl
Sponsor Vrije University Medical Centre (VUMC) (Netherlands)
  Address EMGO Institute
Van der Boechorststraat 7
  City/town Amsterdam
  Zip/Postcode 1081 BT
  Country Netherlands
  Sponsor website: http://www.vumc.nl/
Date applied 09/08/2004
Last edited 29/06/2010
Date ISRCTN assigned 25/01/2005
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