NCT05724043

Brief Summary

Poor oral health is common in care-dependent older adults, and healthcare professionals report numerous barriers when it comes to provision of oral care for elderly patients. Frequently reported barriers are lack of oral health knowledge/skills and care resistant behaviors (CRB) in patients suffering from dementia. Other barriers include lack of adequate oral care routines and satisfactory systems for documentation of issues related to oral health, a high workload and unclear responsibilities. To overcome these barriers, an easy-to-use digital tool named SmartJournal has been developed to assist health personnel in preserving the older patient's oral health. SmartJournal has three components: one for documentation of oral hygiene routines, one for monthly oral health assessment and one for e-learning (a digital knowledge base with information on geriatric oral health and handling of CRB). The objectives of the present study are to assess: 1) the effectiveness of SmartJournal in enhancing nursing home caregivers' capability, opportunity, motivation and routines related to oral care, 2) whether SmartJournal usage may result in improved oral health for nursing home residents and 3) whether SmartJournal usage may result in changes in documentation of oral health related issues in patient journals. A cluster randomized controlled trial (C-RCT) will be employed to assess effects of SmartJournal usage as specified in the study objectives. Nursing homes located in Rogaland, Norway, will be recruited and randomly assigned to an intervention- and a control group. The intervention group will be provided with tablets containing SmartJournal, while the control group will continue with existing oral care routines. The intervention will last for 12 weeks. Measurements will be performed in both groups at baseline, immediately post-intervention (3 months) and at follow-up (9 months) and include: 1) a survey assessing caregivers' capability, opportunity, motivation and routines related to oral care, 2) oral examinations in residents using mucosal-plaque score (MPS) as a primary outcome variable for assessing oral health status, and 3) examination of patient journals to assess the frequency and quality of reported oral health related issues. We hypothesize that SmartJournal usage will have a positive effect as measured by favorable changes in study variable scores.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
322

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2024

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

January 10, 2023

Last Update Submit

August 4, 2025

Conditions

Oral Health

Keywords

Oral healthCare-dependent elderlyNursing homeNursing staffInterventionDigital tool

Outcome Measures

Primary Outcomes (1)

  • Mucosal-plaque index (MPS)

    The primary outcome measure is MPS. MPS is comprised of a four-point plaque score (PS) and a four-point mucosal score (MS). PS = 1: no visible plaque, PS = 2: plaque is barely visible, PS = 3: moderate amount of plaque, PS = 4: large amount of plaque almost covering the whole surface of teeth. MS = 1: normal mucosa, MS = 2: mild inflammation, MS = 3: medium inflammation, MS = 4: strong inflammation. For both scores, if in doubt between 1 and 2, dental personnel are instructed to score 1. If in doubt between 3 and 4, they are instructed to score 4. The index is designed to evaluate oral health and oral hygiene in groups of individuals. This makes it a suitable index to be used when conditions are not optimal to assess the patient's oral health. In a nursing home setting, dental personnel have limited equipment and poor light compared to an ordinary dental clinic setting. Therefore, using an index designed to be applied outside a dental clinic setting is feasible in this research.

    Change in MPS from baseline at 3 months and 9 at months.

Secondary Outcomes (1)

  • Survey data

    Change in variable scores for capability, opportunity, motivation and routines (measured in questionnaire) from baseline at 3 months and at 9 months.

Other Outcomes (1)

  • Patient journals

    For oral health related documentation: change in frequency and content from baseline at 3 months and at 9 months. For sociodemographics, medical conditions and prescribed medication: measurement at baseline only.

Study Arms (2)

SmartJournal

EXPERIMENTAL

Nursing homes in the intervention group will receive the SmartJournal intervention. They will be provided with toolboxes including tablets with SmartJournal installed, antibacterial touchscreen wipes, flashlights for monthly oral inspections, instruction video, instruction book and SmartJournal information posters. They will also receive oral hygiene equipment packages including toothbrushes for permanent teeth and prosthetic devices, dental floss, interdental brushes, toothpaste and inspection mirrors. Training, follow-up and technical support for SmartJournal usage will be provided by project staff employed at the Oral Health Centre of Expertise Rogaland. The intervention will last for 12 weeks.

Device: SmartJournal

Control group

NO INTERVENTION

Nursing homes in the control group will also receive oral hygiene equipment packages but will, in contrast to the intervention group, continue with existing oral care routines.

Interventions

SmartJournalDEVICE

SmartJournal is a tablet application with three modules: Module 1 offers a system for simple check-box registration of daily oral hygiene routines. This module also includes an open text field where the caregiver can give a brief description of strategies used if the patient shows resistant behaviors. Module 2 offers a system for monitoring the patient's oral health through monthly check-ups. This module is an image-based, interactive learning- and assessment tool. Upon completion of the monthly oral health assessment health personnel receive a summary report with suggestions for tailored preventive and/or curative measures to be initiated. Module 3 offers an easily accessible knowledge base which includes information on geriatric oral health, standard equipment and procedures for daily oral hygiene routines for patients with various care needs. It also includes scientifically documented strategies that may be used to approach patients with dementia refusing oral care assistance.

SmartJournal

Eligibility Criteria

Age60 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nursing homes:
  • Located in Rogaland county, Norway
  • Long-term facilities
  • Residents (patients):
  • Long-term residents (i.e., residents with the nursing home as their permanent address)
  • Residents with and without dementia, who can undergo oral examination
  • Nursing staff:
  • All types of nursing staff (nurses, auxiliary nurses, students)
  • Full- and parttime staff

You may not qualify if:

  • Nursing homes:
  • Specialized nursing homes (e.g., psychiatry, substance abuse)
  • Short-term facilities (e.g., rehabilitation, respite care)
  • Nursing homes already following a specific protocol for oral care and/or participate in other comprehensive interventions
  • Residents (patients):
  • Short-term residents
  • Critically ill and terminal patients receiving palliative care
  • Nursing staff:
  • Staff with purely administrative tasks (e.g., heads of institutions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oral Health Centre of Expertise Rogaland, Norway

Stavanger, 4016, Norway

Location

Related Publications (2)

  • Karamehmedovic E, Myhren LE, Jensen KHM, Rodakowska EJ, Astrom AN, Melbye EL. Evaluating the role of the smartjournal digital intervention in improving oral hygiene among nursing home residents: a cluster randomised trial. BMC Oral Health. 2025 Oct 10;25(1):1589. doi: 10.1186/s12903-025-06994-0.

    PMID: 41073970DERIVED

  • Melbye EL, Bull VH, Hidle KS. Assessment of the SmartJournal Intervention for Improved Oral Care in Nursing Homes: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2023 Oct 6;12:e46926. doi: 10.2196/46926.

    PMID: 37801358DERIVED

Study Officials

  • Elisabeth Lind Melbye, PhD

    Oral Health Centre of Expertise Rogaland, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants will not receive information about who is included in the intervention- and control group, respectively. They will only receive information that is relevant for their participation. The chosen study design (C-RCT) facilitates this masking by reducing the possibility of contamination between the groups.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A pragmatic cluster randomized controlled trial (C-RCT) will be employed to assess effects of SmartJournal usage as specified in the study objectives. Nursing homes located in Rogaland, Norway, will be recruited and randomly assigned to an intervention group and a control group. Nursing homes in the intervention group will be provided with tablets containing SmartJournal and receive training and follow-up throughout the intervention period. Nursing homes in the control group will continue with existing oral care routines. The intervention will last for 12 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2023

First Posted

February 13, 2023

Study Start

March 1, 2023

Primary Completion

June 5, 2024

Study Completion

July 3, 2024

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

IPD from this study will not be shared with researchers outside the project group. This is emphasized in the information- and consent form that will be handed out to potential participants before data collection.

Locations

NO(1)