Condition category
Not Applicable
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
28/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M. Boorsma

ORCID ID

Contact details

Westfriese Zorggroep de Omring
Verpleeghuis Lindendael
Koepoortsweg 35
Hoorn
1624 AB
Netherlands
ma.boorsma@wxs.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR544

Study information

Scientific title

Acronym

Pikov

Study hypothesis

Transmural integrated care is effective on quality of life, functional health and disability.

Ethics approval

Received from local medical ethics committee

Study design

Multicentre randomised open label active controlled crossover group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Activities of daily living (ADL) disabled, chronic disorder

Intervention

TIC is operationalised in three sequential elements:
1. An in home multidimensional assessment is carried out by trained staff of the patient's functional health and care needs with the resident assessment instrument (RAI)
2. The assessment outcomes are discussed in a multidisciplinary consultation (MC). The MC presents individualised care plans to manage or treat modifiable disabilities and risk factors.
3. Consultation by a nursing home physician and psychologist is offered to the frailest residents at risk for nursing home admission (according to the RAI)

The control subjects receive care as usual.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Quality adjusted life years
2. Functional health
3. Disability
4. Cost effectiveness

Secondary outcome measures

1. Admission to hospital and nursing home
2. Mortality
3. Patients care satisfaction

Overall trial start date

01/01/2006

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Persons who have at least one chronic disorder and are ADL-disabled.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

166

Participant exclusion criteria

Terminally ill

Recruitment start date

01/01/2006

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Westfriese Zorggroep de Omring
Hoorn
1624 AB
Netherlands

Sponsor information

Organisation

West Fresian Area Care Group (Westfriese Zorggroep de Omring) (Netherlands)

Sponsor details

Lindendael Nursing Home (Verpleeghuis Lindendael)
Koepoortsweg 35
Hoorn
1624 AB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

VU University Medical Centre (VUMC) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Funder name

West Fresian Area Care Group (Westfriese Zorggroep de Omring) (Netherlands)

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. 2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18606020
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21708967
3. 2012 cost-effectiveness analysis in http://www.ncbi.nlm.nih.gov/pubmed/22655047

Publication citations

  1. Protocol

    Boorsma M, van Hout HP, Frijters DH, Ribbe MW, Nijpels G, The cost-effectiveness of a new disease management model for frail elderly living in homes for the elderly, design of a cluster randomized controlled clinical trial., BMC Health Serv Res, 2008, 8, 143, doi: 10.1186/1472-6963-8-143.

  2. Boorsma M, Frijters DH, Knol DL, Ribbe ME, Nijpels G, van Hout HP, Effects of multidisciplinary integrated care on quality of care in residential care facilities for elderly people: a cluster randomized trial., CMAJ, 2011, 183, 11, E724-32, doi: 10.1503/cmaj.101498.

  3. MacNeil Vroomen JL, Boorsma M, Bosmans JE, Frijters DH, Nijpels G, van Hout HP, Is it time for a change? A cost-effectiveness analysis comparing a multidisciplinary integrated care model for residential homes to usual care., PLoS ONE, 2012, 7, 5, e37444, doi: 10.1371/journal.pone.0037444.

Additional files

Editorial Notes