Condition category
Not Applicable
Date applied
30/07/2004
Date assigned
21/09/2004
Last edited
01/09/2009
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 Erik VanRossum

ORCID ID

Contact details

P.O.Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 388 2367
Erik.Vanrossum@epid.unimaas.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2200.0115

Study information

Scientific title

Acronym

Study hypothesis

Preventive home visits to elderly people by public health nurses aim to maintain or improve the functional status of elderly and reduce the use of institutional care services. A number of trials that investigated the effects of home visits show positive results, but others do not. The outcomes can depend on differences in characteristics of the intervention programme, but also on the selection of the target population. A risk group approach seems promising, but further evidence is needed. We decided to carry out a study to investigate the effects in a population of elderly with (perceived) poor health rather than the general population. Also, we test whether nurses who are qualified at a lower professional level (home nurses instead of public health nurses) are able to obtain convincing effects. The results of this study will contribute to the discussion on effective public health strategies for the aged.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Self-reported (perceived) health problems

Intervention

The intervention consists of (at least) 8 systematic home visits over an 18 months period. Experienced home nurses from the local home care organisation carry out the visits. The control group receives usual care.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The outcome measures cover 2 domains: health status and service use. In addition a cost effectiveness analysis will be conducted.
The primary health related outcome measures are: self-rated health, functional status, quality of life and changes in self-reported problems.
The use of services relates to the frequency and duration of care from the following services: domestic and community nursing care, GP, physiotherapy, day care in institutional care settings, hospital outpatient clinics, hospital, nursing home, home for the elderly, use of aids and modifications to the home. The primary outcomes for service use are specialist medical care and hospital (re-) admission.

Secondary outcome measures

Secondary health related outcome measures: information will be obtained, among other things, on health complaints, medication use, and loneliness and mental health. The
municipality will supply mortality data over the entire research period.

Overall trial start date

01/05/2002

Overall trial end date

30/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Elderly (70-84 years) living in the community with self-reported poor health status

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

330

Participant exclusion criteria

Those who already receive home nursing care

Recruitment start date

01/05/2002

Recruitment end date

30/11/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

P.O.Box 616
Maastricht
6200 MD
Netherlands

Sponsor information

Organisation

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

Sponsor details

Laan van Nieuw Oost Indië 334
P.O. Box 93245
The Hague
2509 AE
Netherlands
+31 (0)70 349 5111
bloemers@zonmw.nl

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (ZonMw), 2200.0115

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

2004 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15601473
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18375878

Publication citations

  1. Protocol

    Nicolaides-Bouman A, van Rossum E, Kempen GI, Knipschild P, Effects of home visits by home nurses to elderly people with health problems: design of a randomised clinical trial in the Netherlands [ISRCTN92017183]., BMC Health Serv Res, 2004, 4, 1, 35, doi: 10.1186/1472-6963-4-35.

  2. Results

    Bouman A, van Rossum E, Evers S, Ambergen T, Kempen G, Knipschild P, Effects on health care use and associated cost of a home visiting program for older people with poor health status: a randomized clinical trial in the Netherlands., J. Gerontol. A Biol. Sci. Med. Sci., 2008, 63, 3, 291-297.

Additional files

Editorial Notes