Condition category
Not Applicable
Date applied
31/01/2013
Date assigned
27/02/2013
Last edited
20/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In our study, ethnic community health workers will act as liaison between elderly immigrants and local health care and social welfare services to make sure that treatment and care is more accessible for elderly immigrants. The aim is to find our how well this approach works. When we have evidence that this works well, the community health worker function can be further integrated into the existing local health care and welfare system.

Who can participate?
Elderly people aged 55 years and over, living independently (alone or with others), born in Turkey, Morocco, Moluccan Islands or a descendant of Moluccan immigrants born in the Netherlands and who lived in one of the Moluccan camps.

What does the study involve?
Our study aims to recruit 194 elderly immigrants. They will be randomly allocated to one of two groups: 97 to the intervention group and 97 to the control group. Participants in the intervention group are invited by community health workers to participate in the intervention programme that consists of four steps. (1) Participants participate in home visits conducted by community health workers in order to examine their health problems, barriers to health care and social welfare services and needs for adequate care. (2) Participants participate in problem focused working groups organized by community health workers to discuss commonly shared problems based on the home visits.(3) Participants co-operate with community health workers and providers of health care and social welfare services in finding solutions, creating and conducting improvement programmes (concrete initiatives necessary for providing care and social welfare services that meet the participants' health and social welfare needs). (4) Participants are involved in the implementation of the improvements programmes in the community. Participants are invited to face to face interviews at two points in time: a baseline interview within two weeks after the home visit by the community health worker and a follow-up interview 18 months after the baseline interview. Participants in the control group do not receive the visit of community health workers.

What are the possible benefits and risks of participating?
Our study can contribute to the improvement of care for elderly immigrants by developing culturally sensitive care in which elderly people actively participate. No risks are involved for elderly participants.

Where is the study run from?
Our study has been set up by the University Medical Center Utrecht. We are carrying out the study in three (semi) urban residential areas in the Netherlands which all have a community of immigrants (Turks, Moroccans and Moluccans).

When is the study starting and how long is it expected to run for?
The recruitment started in October 2011. The study will be expected to be completed in December 2013.

Who is funding the study?
ZonMw, the Netherlands Organization for Health Research and Development.

Who is the main contact?
Professor Niek de Wit
N.J.dewit@umcutrecht.nl

Trial website

http://www.stem-nuzo.nl/

Contact information

Type

Scientific

Primary contact

Prof Niek de Wit

ORCID ID

Contact details

UMC Utrecht
div. Julius Centrum
Correspondence Str. 6.131
PO Box 85500
3508 GA Utrecht
The Netherlands
Utrecht
3508 GA
Netherlands
+31(0)88 75 682 47
N.J.dewit@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11-138/C

Study information

Scientific title

Culturally sensitive care for elderly immigrants through ethnic community health workers: development and effect study of a community-based intervention programme in the Netherlands

Acronym

VOICE

Study hypothesis

We developed an intervention programme in which ethnic community health workers act as liaisons between elderly immigrants and local health care and social welfare services. In this study we evaluate the effectiveness and the implementation of this intervention programme. We expect to find an increase in use of health care and social welfare facilities consumption, increase in perceived quality of life and decrease in reported number of functional limitations of elderly immigrants in the Netherlands.

Ethics approval

We submitted our study protocol to the Medical Ethics Committee of the University Medical Center Utrecht (UMCU) if this study falls under the Medical Research Involving Human Subjects Act (WMO). The committee judged that our study does not meet the WMO criteria and therefore is not subject to the WMO.

Study design

Quasi experiment with a pre-post test design with an intervention group and control group in three (semi) urban residential areas

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Use of health care and social welfare facilities

Intervention

Our study aims to recruit 194 elderly immigrants (97 for the invention group and 97 for the control group). The intervention group consists of Turks, Moroccans and Moluccans recruited by community health workers at three (semi) urban residential areas in the Netherlands. Controls are a matched group comparable in size and composition and live outside the three intervention sites. To assess the effectiveness of the intervention, the intervention group is compared with a group where no community health workers are introduced (no community health worker involvement is provided to controls). Data are collected at two points in time: a baseline assessment and a follow-up assessment 18 months after baseline assessment. The assessments are structured face-to-face
interviews in the preferred language of the respondent (Dutch, Turkish, Malay, Moroccan-Arabic or Moroccan-Berber) performed by trained interviewers with a similar ethnic background as the participants.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Use of health care and social welfare facilities is measured by self-reported care consumption at baseline and 18 months after baseline.

Secondary outcome measures

1. Perceived quality of life and is measured using the Short Form-12 (SF-12) and the EQ-5D+C.
2. Functional limitations are measured using the Katz-15.
Secondary outcomes are measured at baseline and 18 months after baseline.

Overall trial start date

01/10/2011

Overall trial end date

01/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 55 years and over
2. Living independently (alone or with others)
3. Born in Turkey, Morocco, Moluccan Islands or descendant of Moluccan immigrants born in the Netherlands and lived in one of the Moluccan 'camps'

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

We need a total of 194 elderly people

Participant exclusion criteria

Elderly people using care for severe psychiatric disorders are excluded from the study

Recruitment start date

01/10/2011

Recruitment end date

01/12/2013

Locations

Countries of recruitment

Netherlands

Trial participating centre

UMC Utrecht, div. Julius Centrum
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

The National Care for the Elderly Programme - ZonMw (Netherlands)

Sponsor details

The Netherlands Organisation for Health Research and Development
Laan van Nieuw Oost Indië 334
2593 CE The Hague
P.O. Box 93245
The Hague
2509 AE
Netherlands
+31 (0)70 349 51 11
Duijn@zonmw.nl

Sponsor type

Research organisation

Website

http://www.nationaalprogrammaouderenzorg.nl

Funders

Funder type

Research organisation

Funder name

This study is funded by a grant from ZonMW, the Netherlands Organization for Health Research and

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Development

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

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23497392

Publication citations

  1. Protocol

    Verhagen I, Ros WJ, Steunenberg B, de Wit NJ, Culturally sensitive care for elderly immigrants through ethnic community health workers: design and development of a community based intervention programme in the Netherlands., BMC Public Health, 2013, 13, 227, doi: 10.1186/1471-2458-13-227.

Additional files

Editorial Notes