The cost-effectiveness of systematic home visits by nurses of frail elderly primary care patients and caregivers of demented patients

ISRCTN	ISRCTN05358495
DOI	https://doi.org/10.1186/ISRCTN05358495
Protocol serial number	N/A
Sponsor	Vrije University Medical Centre (VUMC) (Netherlands)
Funders	Vrije University Medical Centre (VUMC) (Netherlands) (ref: 2002/121), The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 2200-114)

Submission date: 09/08/2004
Registration date: 25/01/2005
Last edited: 15/08/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Hein van Hout
Scientific

VU University Medical Centre
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 4448199
Email	Hpj.vanhout@vumc.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	The cost-effectiveness of systematic home visits by nurses of frail elderly primary care patients and caregivers of demented patients
Study acronym	PIKO - Preventieve Interventie bij Kwetsbare Ouderen (Preventive Intervention for Frail Older persons)
Study objectives	1. To evaluate the cost-effectiveness of systematic home visits by nurses to frail elderly primary care patients.
Ethics approval(s)	The Ethical Committee of the VU medical center approved the study.
Health condition(s) or problem(s) studied	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
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.
Key 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
Completion date	30/04/2007

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	1100
Key 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.)
Key exclusion criteria	Does not comply with the above inclusion criteria
Date of first enrolment	01/07/2002
Date of final enrolment	30/04/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

VU University Medical Centre

Amsterdam
1081 BT
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	design and pilot results	08/09/2005		Yes	No
Results article	results	01/07/2010		Yes	No
Other publications	Correction to results article	14/08/2024	15/08/2024	Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

15/08/2024: Publication reference added.