Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Hygiene in Assisted Living

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03892200
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : May 15, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
This project will modify a program that reduces pneumonia among nursing home residents with dementia, so that it is appropriate for assisted living residents with dementia. The program provides daily mouth care to reduce bacteria in the mouth that lead to aspiration pneumonia. The project will develop methods that can be taught to assisted living providers by community dental hygienists, and that are ready for evaluation in a pragmatic trial of AL residents with dementia and the staff who provide their care.

Condition or disease Intervention/treatment Phase
Aging Long-Term Care Behavioral: Daily Mouth Care Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adapting an Evidence-Based Program That Improves Oral Hygiene and Health for Assisted Living Residents With Dementia
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Daily Mouth Care
The intervention being tested is a standardized educational and skill-building program for use in assisted living communities, which highlights that mouth care is infection control (e.g., can reduce pneumonia); includes techniques and products to clean and protect the teeth, tongue, gums, and dentures (e.g., the jiggle-sweep approach to remove plaque, use of an interdental brush instead of floss); provides strategies for care provision in special situations (e.g., broken teeth); and includes a toolkit of dementia-sensitive approaches for people who are resistant (e.g., refuse to open the mouth). It also includes information about potential dental emergencies and issues that merit assessment.
Behavioral: Daily Mouth Care
Nursing assistants will be trained to provide daily mouth care to all residents in nursing homes. Mouth care supplies will also be provided to intervention assisted living communities.

No Intervention: Standard Mouth Care
Assisted living communities will continue to provide standard mouth care to all residents. Assisted living staff will not receive training or supplies in the control condition.



Primary Outcome Measures :
  1. Change in Plaque Index Score for Long-Term Care (PI-LTC) over time [ Time Frame: Baseline and 8 months ]
    The Plaque Index for Long-Term Care (PI-LTC) is a modification of the Simplified Oral Hygiene Index. It is derived by separately scoring the buccal and lingual surfaces of six sextants in the mouth (left, front, and right regions of the upper and lower jaw), resulting in 12 separate observations for residents with a full set of teeth; sextants not containing teeth do not receive a score. Within each sextant, the tooth surface with the worst plaque is scratched using an explorer and assigned a score (0=no plaque or stain present; 1=soft plaque covering not more than one third of the tooth surface or presence of extrinsic stains without other plaque regardless of surface area covered; 2=soft plaque covering between one third and two thirds of the tooth surface; or 3=soft plaque covering more than two thirds of the exposed tooth surface). PI-LTC scores range from 0-3 and are the average sextant score. Lower scores are better.

  2. Change in Gingival Index Score for Long-Term Care (GI-LTC) over time [ Time Frame: Baseline and 8 months ]
    The Gingival Index for Long-Term Care (GI-LTC) is a modification of the Gingival Index. Within each sextant, the most inflamed gingival surface is identified, swept using an explorer, and assigned a score (0=no inflammation; 1=mild inflammation, slight change in color, little change in texture; 2=moderate inflammation, glazing, redness, edema, and/or hypertrophy; or 3=severe inflammation, marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration). Overall GI-LTC scores range from 0-3 and are the average sextant score. Buccal and lingual surfaces scores also are calculated. Lower scores are better.

  3. Change in Denture Plaque Index Score (DPI) over time [ Time Frame: Baseline and 8 months ]
    The Denture Plaque Index (DPI) is scored by removing the denture, placing it in a bath of disclosing solution for 30 seconds, rinsing it under lukewarm water for 15 seconds, and assigning a score to each of four quadrants (upper and lower, and lingual and buccal) as follows: 0=no plaque, 1=light plaque (1-25% of area covered), 2=moderate plaque (26-50% of area covered), 3=heavy plaque (51-75% of area covered), or 4=very heavy plaque (76 100% of area covered). DPI is reported as the mean score of all quadrants and lower scores are better.


Secondary Outcome Measures :
  1. Incidence of pneumonia over time [ Time Frame: Collected monthly during eight-month study period ]
    The total number of diagnosed cases of pneumonia

  2. Incidence of hospitalizations over time [ Time Frame: Collected monthly during eight-month study period ]
    The total number of hospitalizations

  3. Staff self-efficacy to provide mouth care [ Time Frame: Baseline and 8 months ]
    The measure will be administered to all nursing assistants in the intervention sites at baseline and 8 months, and to all nursing assistants in the control sites at 8 months (to avoid a possible Hawthorne effect from pre-administration). In the intervention sites, the 8-month measure will include a retrospective pre-test that asks respondents to reflect on their initial self-efficacy after having learned what they might not have known that they did not know previously. The self efficacy measure has 35 categories, scored 1 (strongly disagree) to 4 (strongly agree). An increase in post-score shows higher self-efficacy to provide mouth care.

  4. Dental hygienists self-efficacy to train nursing assistants [ Time Frame: Baseline and 8 months ]
    The measure will be administered to all dental hygienists in the study at baseline and 8 months. The 8-month measure will include a retrospective pre-test that asks respondents to reflect on their initial self-efficacy after having learned what they might not have known that they did not know previously. The self efficacy measure has 35 categories, scored 1 (strongly disagree) to 4 (strongly agree). An increase in post-score shows higher self-efficacy to train nursing assistants.

  5. Average number of days mouth care was performed [ Time Frame: Collected during the eight month study period ]
    Daily mouth care will be documented on a simple log developed for the MCWB pilot study, on which the nursing assistant will record daily, for each resident, whether mouth care occurred. If mouth care did not occur, a reason is documented.

  6. Acceptability of the intervention (AIM) Feasibility of Intervention Measure (FIM) [ Time Frame: Baseline and 8 months ]
    The AIM is a four-item measure of implementation outcomes that is an indicator of implementation success. This measure will be administered to assisted living staff to determine the extent to which they believe the intervention and implementation strategy (e.g., training, coaching) is acceptable. The AIM has four items rated on a five-point Likert scale. Higher scores show more acceptability of the intervention.

  7. Intervention Appropriateness Measure (IAM) [ Time Frame: Baseline and 8 months ]
    The IAM is a four-item measure of implementation outcomes that is an indicator of implementation success. This measure will be administered to assisted living staff to determine the extent to which they believe the intervention and implementation strategy (e.g., training, coaching) is appropriate. The IAM has four items rated on a five-point Likert scale. Higher scores show more appropriateness of the intervention.

  8. Feasibility of Intervention Measure (FIM) [ Time Frame: Baseline and 8 months ]
    The FIM is a four-item measure of implementation outcomes that is an indicator of implementation success. This measure will be administered to assisted living staff to determine the extent to which they believe the intervention and implementation strategy (e.g., training, coaching) is feasible. The FIM has four items rated on a five-point Likert scale. Higher scores show more feasibility of the intervention.

  9. Texas Christian University Workshop Evaluation (WEVAL) [ Time Frame: Baseline ]
    The Texas Christian University Workshop Evaluation (WEVAL) 22-item Likert measure assesses utilization (e.g., "you used similar materials in the past with little success"), resources (e.g., "you have enough staff to implement the procedures"), training (e.g., "you would attend follow-up training"), and support (e.g., "your director would support and encourage use"). Lower scores mean less barriers to implementation.

  10. Texas Christian University Workshop Assessment Follow-up (WAFU) [ Time Frame: 4 months ]
    The Texas Christian University Workshop Assessment Follow-Up (WAFU) is a 14-item Likert measure with subscales related to training satisfaction (e.g., "do you expect to use these materials") and implementation barriers. Eight barriers are provided, related to resources (e.g., "lack of time") and procedures (e.g., "doesn't fit my style"); other barriers are queried. The form will be modified so the wording is consistent with MCWB, and to solicit suggestions as to how to overcome the barriers, as well as what facilitated implementation. Lower scores mean less barriers to implementation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Assisted living staff

Inclusion Criteria:

  • Are 18 years of age or older
  • Able to read and speak English fluently

Exclusion Criteria:

  • Do not provide direct care to residents in participating assisted living community

Family members

Inclusion Criteria:

  • Are 18 years of age or older
  • Able to read and speak English fluently

Exclusion Criteria:

  • Family member (resident) did not receive mouth care from AL staff

Public health dental hygienists

Inclusion Criteria:

  • Are 18 years of age or older
  • Able to read and speak English fluently

Exclusion Criteria:

  • Not employed by the NC DHHS Oral Health Section (Criteria to be a public health dental hygienist include five years practice experience and CPR and emergency medical training.)

Residents

Inclusion Criteria:

  • Are 18 years of age or older
  • Have teeth or have and use a denture
  • Have a diagnosis of dementia

Exclusion Criteria:

  • Requires antibiotic prophylaxis prior to oral hygiene examination
  • Currently on hospice or tube-feeding
  • Expected to die or be discharged in the next six months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892200


Contacts
Layout table for location contacts
Contact: Kimberly T Ward, BA 919-843-7811 kimberly_ward@unc.edu

Locations
Layout table for location information
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Sheryl Zimmerman, PhD    919-966-7173    sheryl_zimmerman@unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Sheryl Zimmerman, PhD University of North Carolina, Chapel Hill
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03892200    
Other Study ID Numbers: 18-2795
R01AG061966 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial will be shared after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Deidentified individual data that supports the results will be shared beginning 3 months and ending 5 years following article publication.
Access Criteria: An investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Mouth Care