Plain English Summary
Not provided at time of registration
Trial website
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 examiners 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
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
-
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.