Implementation of oral care in primary diabetes care in the Netherlands

• Register: ISRCTN
• Last refreshed on: 27 March 2023
• Main ID: ISRCTN10145611
• Date of registration: 01/02/2017
• Prospective Registration: No
• Primary sponsor: Academisch Centrum Tandheelkunde Amsterdam
• Public title: Implementation of oral care in primary diabetes care in the Netherlands
• Scientific title: Best practice model for interdisciplinary medicine in treating diabetes patients. The need for implementation of oral care
• Date of first enrolment: 01/03/2015
• Target sample size: 2400
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN10145611
• Study type: Interventional
• Study design: Multi-centre cluster randomized controlled trial (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Netherlands

Contacts

• Name: Martijn Verhulst

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged 18 years and over
2. Diabetes mellitus Type 2
3. Follows the standardized primary diabetes care protocol
4. Understands spoken and written Dutch

Exclusion criteria:
1. Don't understand spoken and written Dutch
2. Attend secondary diabetes care (i.e. internal medicine at the hospital)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus Type 2
Nutritional, Metabolic, Endocrine
Diabetes Mellitus Type 2

Intervention(s)

24 participating GP practices are randomly 24 participating GP practices are randomly allocated to either the control group or the intervention group, using the SNOSE (sequentially numbered, opaque, sealed envelopes) protocol.

Intervention group: Nurse practitioners at participating practices are were instructed to pay extra attention to oral health during their consultation hours, on top of their usual care. This consists of:
1. Informing the diabetes patients about the relationship between oral health and diabetes mellitus, and emphasizing it’s important to take care of their oral health.
2. Actively stimulating the patients to visit the dentist at least once/twice a year, using a standard referral letter. This referral letter also contained a return form, meant for the dentist. When the patient actually visited the dental office, the dentist would fill in this form and send it back to the GP practice.
3. Providing the patients with an introduction kit, containing (preventive) oral care products (e.g. oral rinse, tooth paste, interdental brushes etc.)

Control group: Nurse practitioners provide care as usual, without paying extra attention to oral health.

For all participants, the follow-up time is 12 months. Usually, a patient visits the GP/nurse practitioner every three months in the Dutch primary care, and these moments were used to continue motivating the participating patients to visit a dentist during the 12 months follow-up.

Primary Outcome(s)

1. Self-reported oral health, using a questionnaire based on large epidemiological studies from the United States, measured at baseline and 12 months
2. Oral health is assessed using an oral examination by a dentist at baseline and 12 months
3. Oral health related quality of life is assessed using the OHIP-14 questionnaire at baseline and 12 months
4. General quality of life is assessed using the SF-36 questionnaire at baseline and 12 months

Secondary Outcome(s)

Parameters of protocolization and optimalization:
1. Number of patients which are referred to a specialist by the dentist during the 12 months follow up. This is registered by the dentist on the return form that the patient received at baseline.
2. Number of patients which are seen by the dentist is measured by the number of return forms that the GP practices received during the 12 months follow-up
3. Number of patients which are treated by the dentist is registered on the return forms that the they received during the 12 months follow-up
4. Feasibility and effectiveness of our intervention protocol is assessed using a questionnaire related to the opinion of diabetes practitioners, measured as soon as they finished the follow-up period.

Change in general health as recorded by the diabetes practitioner:
1. Number and severity of diabetes-related complications is assessed through medical record review at baseline and 12 months
2. (Bio)markers of metabolic control of diabetes mellitus (Glucose, HbA1c, Lipids, etc..) is assessed through medical record review at baseline and 12 months
3. General characteristics (BMI, smoking habits, diet, etc..) is assessed through medical record review at baseline and 12 months
4. Medication use is assessed through medical record review at baseline and 12 months

Secondary ID(s)

14/585

Source(s) of Monetary Support

Sunstar Suisse SA

Ethics review

Status:
Approval date:
Contact:

The Medical Ethics Review Committee VU University Medical Center (registered with the OHRP as IRB00002991) discussed the application. On 29 January 2015, it was confirmed that the Medical Research Involving Human Subjects ACT (WMO) did not apply for this study, and an official approval of this study by the committee was not required.

Results

• Results available: Yes
• Date Completed: 31/12/2017