Condition category
Oral Health
Date applied
30/03/2010
Date assigned
07/04/2010
Last edited
10/11/2010
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.mondzorgonderzoek.nl

Contact information

Type

Scientific

Primary contact

Prof C. De Baat

ORCID ID

Contact details

Department of Oral Function and Prosthetic Dentistry
Radboud University Nijmegen Medical Centre
P.O. Box 9101
Nijmegen
6500 HB
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effectiveness of an oral hygiene based intervention to improve oral health of dependent elderly living in long-term care facilities in the Netherlands and Belgium: a cluster randomised controlled clinical trial

Acronym

ABRIM

Study hypothesis

Supervised implementation of the guideline "Oral health care in institutions providing long-term care to elderly people" is more effective than to non-supervised implementation.

Ethics approval

1. Ethics Committee of the Ghent University approved in June 2008 (ref: EC UZG 2008/440; B67020084505)
2. Ethics Committee of the Radboud Universtity of Nijmegen approved in November 2008 (ref: CMO NL2466.091.08)

Study design

Cluster randomised intervention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

Oral health

Intervention

The intervention consisted of supervised implementation of the guideline and derived protocols. Supervision was conducted by an external implementation supervisor (researcher). In the intervention group the oral health care will be given after oral health training sessions to the nurses and nurse-aides.

The derived protocols contained all assignments and forms for implementing oral health care as inextricable part of the daily care of the residents. Six assignments and three forms were assigned to the managing director and two assignments and two forms were concerning the executive care providers.

The intervention includes:
1. Initiating an oral health care team by appointing an oral health care project leader, wards' organising oral health care providers, a nursing home physician, and optionally a speech therapist or an occupational therapist. All team members are employees of the institution.
2. A PowerPoint presentation (1.5 hours) on the guideline, the derived protocols, and the supervising process in each institution of the intervention group at the start of the study, addressing the managing director or his/her substitute, the institution's ward heads and the appointed oral health care project leader. This presentation will be provided by the external implementation supervisor.
3. One teaching and 1 practical education session (2 hours each) at the start of the study addressing all wards' organising oral health care providers. The education will be provided by an experienced dental hygienist. The education deals with common oral diseases in elderly people, oral health assessment and management, as well as oral hygiene care and products. The wards' organising oral health care providers will be trained additional skills facilitating to educate executive care providers at ward level.
4. One practical education session (1.5 hour) for all executive care providers, 1 month after the start of the study. The education sessions will be provided at ward level by the wards' organising oral health care provider using a PowerPoint presentation prepared by the external implementation supervisor. All instructions for oral health care (e.g. tooth brushing) will be taught and demonstrated on site with residents per ward.
5. Monitoring the supervised implementation of the guideline will be carried out by the external implementation supervisor by consultations with the wards' organising oral health care providers of each institution of the intervention group at 6 and 18 weeks after the start of the study. The consultations will be guided by 10 open questions concerning the progress of the supervised implementation process (content and questionnaires SWOT-analysis), the target group (involvement of all residents and the residents' reflections), and the organisational aspects (time spent, reflections of the oral health care team members).

Residents in the control group contain the same 'profile' as the residents in the intervention group. In the control group oral health care will be given as usual.

In both arms of the trial an a-select sample of 30 residents in each LTC will be followed for a period of 6 months after the baseline oral hygiene assessment.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

An important outcome variable of the intervention is the oral hygiene score of the residents, assessing scores of denture and dental plaque. Denture plaque will be scored using Methylene Blue® disclosing solution according to Augsburger and Elahi (score range = 0 to 4). Dental plaque will be scored using the validated plaque index described by Silness and Löe (score range = 0 to 3). The assessment will be performed at a subset of the 6 so-called 'Ramfjörd teeth'. In absence of one of these teeth, the corresponding distal neighbour tooth will be assessed. Examiners are dentists and master dental students practically educated and calibrated on the diagnostic criteria. Prior to the study, 16 residents will be examined for determining the intra- and inter-examiners’ reliability. Detailed information on reliability will be determined comparing each examiner’s score with the scores of a golden standard.

Measured in January - June 2009 and again in August 2008 - January 2010. Focus group interviews were done only in the intervention arm, over a period of 6 months after the initial oral health care training session. Semi-structured interviews have been done within 3 months after the intervention period of 6 months (January 2010 - March 2010).

Secondary outcome measures

The process evaluation involves assessing the extent to which the intervention program is performed according to protocols, the nature of the oral care recommendations made to the participants, compliance with these recommendations, care providers judgements about the intervention program and oral care recommendations. Data on these topics will be collected using focus-groups. Semi-structured interviews will be held with the participating care providers and nursing home physicians during the intervention period in order to record their experiences and opinions on the guideline "Oral health care in institutions providing long-term care to elderly people" and derived protocols.

Overall trial start date

01/03/2009

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Institutions of long-term care:
1. Providing long-term care to 120 to 150 residents
2. Having wards with mainly somatic and psycho-geriatric residents, with 20 residents minimally
3. Netherlands: moderately or highly care dependent; Belgium: also providing care for minor dependent residents
4. Residents aged 70 - 100 years, men and women

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

360 residents in each country

Participant exclusion criteria

An institution will not be eligible for inclusion if any of the following exclusion criteria is applicable:
1. A guideline or protocol for oral health care is already in function
2. Extra education courses on oral health care for the executive care providers had been held during the last 24 months

Individuals:
1. Residents in coma
2. Terminally ill. Terminally ill is defined as death expected within six months.
3. In day-care or in short-term residency

Recruitment start date

01/03/2009

Recruitment end date

01/06/2010

Locations

Countries of recruitment

Belgium, Netherlands

Trial participating centre

Department of Oral Function and Prosthetic Dentistry
Nijmegen
6500 HB
Netherlands

Sponsor information

Organisation

De Open Ankh Foundation (Netherlands)

Sponsor details

Oude Tempellaan 1
Soesterberg
3769 JA
Netherlands

Sponsor type

Research organisation

Website

http://www.openankh.nl/

Funders

Funder type

Research organisation

Funder name

De Opbouw Foundation (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

De Open Ankh Foundation (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

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20598123

Publication citations

  1. Results

    van der Putten GJ, De Visschere L, Schols J, de Baat C, Vanobbergen J, Supervised versus non-supervised implementation of an oral health care guideline in (residential) care homes: a cluster randomized controlled clinical trial., BMC Oral Health, 2010, 10, 17, doi: 10.1186/1472-6831-10-17.

Additional files

Editorial Notes