Condition category
Nervous System Diseases
Date applied
09/08/2004
Date assigned
25/01/2005
Last edited
29/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.vumc.nl/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes