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Accepted for/Published in: JMIR Research Protocols

Date Submitted: May 1, 2019
Date Accepted: Oct 3, 2019

The final, peer-reviewed published version of this preprint can be found here:

Improving Oral Health in Older Adults and People With Disabilities: Protocol for a Community-Based Clinical Trial (Good Oral Health)

Schensul J, Reisine S, Grady J, Li J

Improving Oral Health in Older Adults and People With Disabilities: Protocol for a Community-Based Clinical Trial (Good Oral Health)

JMIR Res Protoc 2019;8(12):e14555

DOI: 10.2196/14555

PMID: 31850853

PMCID: 6939248

Good Oral Health: An innovative protocol for a community based clinical trial to improve oral health in older adults and people with disabilities.

  • Jean Schensul; 
  • Susan Reisine; 
  • James Grady; 
  • Jianghong Li

ABSTRACT

Background:

Low income older adults and people with disabilities of diverse backgrounds s experience disparities in oral health problems including caries and periodontal disease that can exacerbate already high levels of chronic and acute health problems. Behavioral interventions have been shown to improve oral health status, but they are administered in institutional settings, not targeted to community dwelling low income older adults and people with disabilities. Further, public health principles suggest that multiple interventions at different levels in the locations where people live and work are likely to have more impact and more sustainability than single interventions in clinical settings.

Objective:

This paper outlines a protocol for conducting a bilingual five year community based trial that utilizes a bilevel intervention to change community norms, beliefs intentions and practices, to improve oral health hygiene in publically subsidized housing for vulnerable older adults and people with disabilities. The intervention utilizes a face to face approach (AMI) that includes adapted motivational interviewing, and resident-run oral health campaigns in study buildings.

Methods:

The study’s modified fractional factorial crossover design randomizes six matched buildings into two conditions (AB, AMI followed by campaign) and BA (campaign followed by AMI). The design compares the two interventions alone (T0-T1), and in different sequences (T1-T2), using a self-report survey and clinical assessment to measure Plaque Score (PS) and Gingival Index (GI) as outcomes. A final timepoint (T3) assesses sustainability of each sequence. The intervention is based on Fishbein’s Integrated Model that includes both individual and contextual modifiers, norms and social influence, beliefs, attitudes and intentions as predictors of improvements in PS, GI and Oral Health Quality of Life. The cognitive and behavioral domains in the intervention constitute the mechanisms through which the intervention should have a positive effect. These domains are tailored to individuals through the AMI and to building populations through the peer developed and run oral health campaigns. The sample size is 360, 180 in each condition with an attrition rate of 25%. The study is funded by NIDCR and has been reviewed by University of Connecticut and NIDCR IRBs and NIDCR’s clinical trials internal and consultant review procedures.

Results:

When compared against each other the face to face intervention is expected to have greater positive effects on clinical outcomes and OHQOL through the mediators; when sequences are compared the results may be similar but affected by different mediators. The Campaign followed by AMI is expected to have better sustainability. The protocol’s unique features include the crossover design, the introduction of new emotion-based mediators, the balancing of fidelity and tailoring, and resident engagement in the intervention.

Conclusions:

If successful the evaluated interventions can be scaled up for implementation in other low income congregate living and recreational settings with older adult collectives. Clinical Trial: ClinicalTrials.gov Protocol Registration and Results System (PRS): Unique Protocol ID: 14-188-6


 Citation

Please cite as:

Schensul J, Reisine S, Grady J, Li J

Improving Oral Health in Older Adults and People With Disabilities: Protocol for a Community-Based Clinical Trial (Good Oral Health)

JMIR Res Protoc 2019;8(12):e14555

DOI: 10.2196/14555

PMID: 31850853

PMCID: 6939248

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