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

      , PhD 1 , 2 , , , PhD 2 , , DPH 3 , , MSc, MD 1
      (Reviewer), (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      oral health, elderly, oral hygiene, prevention, clinical trial, crossover design

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          Low-income older adults 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 are typically administered in institutional rather than community settings. Furthermore, multiple simultaneous interventions at different levels in the locations where people live and work are likely to have more impact and sustainability than single interventions in clinical settings.


          This paper outlines a protocol for conducting a bilingual 5-year community-based trial of a bilevel intervention that addresses community norms, beliefs, intentions, and practices to improve oral health hygiene of vulnerable older adults living in publicly subsidized housing. The intervention utilizes (1) a face-to-face counseling approach (adapted motivational interviewing [AMI]) and (2) resident-run oral health campaigns in study buildings.


          The study’s modified fractional factorial crossover design randomizes 6 matched buildings into 2 conditions: AMI followed by campaign (AB) and campaign followed by AMI (BA). The total intervention cycle is approximately 18 months in duration. The design compares the 2 interventions alone (T0-T1), and in different sequences (T1-T2), using a self-reported survey and clinical assessment to measure Plaque Score (PS) and Gingival Index (GI) as outcomes. A final timepoint (T3), 6 months post T2, assesses sustainability of each sequence. The intervention is based on the Fishbein integrated model that includes both individual and contextual modifiers, norms and social influence, beliefs, attitudes, efficacy, and intention 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. They are tailored through the AMI and targeted to building populations through the peer-facilitated oral health campaigns. The sample size is 360, 180 in each condition, with an attrition rate of 25%. The study is funded by National Institute of Dental and Craniofacial Research (NIDCR) and has been reviewed by University of Connecticut and NIDCR institutional review boards and NIDCR’s clinical trials review procedures.


          When compared against each other, the face-to-face intervention is expected to have greater positive effects on clinical outcomes and oral health quality of life through the mediators. When sequences are compared, the results may be similar but affected by different mediators. The arm consisting of the BA is expected to have better sustainability. The protocol’s unique features include the comparative effectiveness crossover design; the introduction of new emotion-based mediators; the balancing of fidelity, tailoring, and targeting; and resident engagement in the intervention.


          If successful, the evaluated interventions can be scaled up for implementation in other low-income congregate living and recreational settings with older adult collectives.

          Trial Registration

          ClinicalTrials.gov NCT02419144; https://clinicaltrials.gov/ct2/show/NCT02419144

          International Registered Report Identifier (IRRID)


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          Most cited references54

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          Assessing self-maintenance: activities of daily living, mobility, and instrumental activities of daily living.

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          The aging of the population of the United States and a concern for the well-being of older people have hastened the emergence of measures of functional health. Among these, measures of basic activities of daily living, mobility, and instrumental activities of daily living have been particularly useful and are now widely available. Many are defined in similar terms and are built into available comprehensive instruments. Although studies of reliability and validity continue to be needed, especially of predictive validity, there is documented evidence that these measures of self-maintaining function can be reliably used in clinical evaluations as well as in program evaluations and in planning. Current scientific evidence indicates that evaluation by these measures helps to identify problems that require treatment or care. Such evaluation also produces useful information about prognosis and is important in monitoring the health and illness of elderly people.
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            The development of measures for assessing oral health status is essential to the evolution and maturation of a scientific knowledge base in geriatric dentistry. The literature suggests a high prevalence of dental diseases in older adults, yet valid and reliable instruments to assess the impact of oral diseases on older individuals or populations are lacking. This paper describes the rationale for and the development of the Geriatric Oral Health Assessment Index (GOHAI), a self-reported measure designed to assess the oral health problems of older adults. Following a review of the literature and consultation with health care providers and patients, a pilot instrument was developed. The GOHAI was initially tested on a convenience sample of 87 older adults. A revised instrument was then administered to a sample of 1755 Medicare recipients in Los Angeles County. The GOHAI demonstrated a high level of internal consistency and reliability as measured by a Cronbach's alpha of 0.79. Associations of the GOHAI with a single-item rating of dental health and with clinical and sociodemographic supported the construct validity of the index. Having fewer teeth, wearing a removable denture and perceiving the need for dental treatment were significantly related to a worse (lower) GOHAI score. Respondents who were white, well educated, and with a higher annual household income were more likely to have a high GOHAI score, indicating fewer dental problems. Additional applications of the GOHAI are necessary to further evaluate the instrument's validity and reliability, and to establish population norms of oral health in older adult populations as measured by the GOHAI.
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                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                December 2019
                18 December 2019
                : 8
                : 12
                : e14555
                [1 ] Institute for Community Research Hartford, CT United States
                [2 ] University of Connecticut School of Dental Medicine Farmington, CT United States
                [3 ] Department of Public Health Sciences University of Connecticut School of Medicine Farmington, CT United States
                Author notes
                Corresponding Author: Jean Schensul Jean.schensul@ 123456icrweb.org
                Author information
                ©Jean Schensul, Susan Reisine, James Grady, Jianghong Li. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.12.2019.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 1 May 2019
                : 24 September 2019
                : 3 October 2019
                : 3 October 2019

                oral health,elderly,oral hygiene,prevention,clinical trial,crossover design


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