Plain English Summary
Not provided at time of registration
Trial website
http://www.emgo.nl/research_prog/care/researchprojects_58.asp
Contact information
Type
Scientific
Primary contact
Dr Hein van Hout
ORCID ID
Contact details
VU University Medical Centre
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 4448199
Hpj.vanhout@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PIKO - Preventieve Interventie bij Kwetsbare Ouderen (Preventive Intervention for Frail Older persons)
Study hypothesis
1. To evaluate the cost-effectiveness of systematic home visits by nurses to frail elderly primary care patients.
Ethics approval
The Ethical Committee of the VU medical center approved the study.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Condition
Frailty, Dementia
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
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
Overall trial start date
01/07/2002
Overall trial end date
30/04/2007
Reason abandoned
Eligibility
Participant 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.)
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
1100
Participant exclusion criteria
Does not comply with the above inclusion criteria
Recruitment start date
01/07/2002
Recruitment end date
30/04/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Centre
Amsterdam
1081 BT
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (Netherlands)
Sponsor details
EMGO Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Vrije University Medical Centre (VUMC) (Netherlands) (ref: 2002/121)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 2200-114)
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. 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
Publication citations
-
Design and pilot results
van Hout HP, Nijpels G, van Marwijk HW, Jansen AP, Van't Veer PJ, Tybout W, Stalman WA, Design and pilot results of a single blind randomized controlled trial of systematic demand-led home visits by nurses to frail elderly persons in primary care [ISRCTN05358495]., BMC Geriatr, 2005, 5, 11, doi: 10.1186/1471-2318-5-11.
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Results
van Hout HP, Jansen AP, van Marwijk HW, Pronk M, Frijters DF, Nijpels G, Prevention of adverse health trajectories in a vulnerable elderly population through nurse home visits: a randomized controlled trial [ISRCTN05358495]., J. Gerontol. A Biol. Sci. Med. Sci., 2010, 65, 7, 734-742, doi: 10.1093/gerona/glq037.