Clinical trial NCT03301714: Oral Health Education Interventions Among Seniors
Official title: Oral Health Education Interventions and Its Association With Behavioral Outcomes: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Self Efficacy
Knowledge
Keywords: motivational interviewing
elderly
oral health
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Colgate Palmolive
name: KleinLife
First posted: 2017-10-04
Enrollment: 180
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study aims to assess the efficacy of an oral health education group based activity versus an individual based oral health education activity in terms of changes in oral health related quality of life (OHRQoL), self-efficacy and oral health knowledge.

Detailed description: Older adults have been described as one of the most underserved and vulnerable groups, who are at the highest risk for coronal and root caries, especially because more elderly adults are retaining their teeth. The Northeast Philadelphia KleinLife site is an important destination for the region's Jewish population comprising of at least 6500 seniors, and assisting more than 4500 seniors through food security programs. Recently, Temple University Kornberg School of Dentistry (TUKSoD) purchased the dental center at the facility to expand the services provided to these underserved population and improve their oral health. The study aims to assess the efficacy of an oral health education group based activity versus an individual based oral health education activity in terms of changes in oral health related quality of life (OHRQoL), self-efficacy and oral health knowledge. Methods: A non-probability sample of 190 senior members will be invited to participate in the trial. Potential subjects will be obtained in person through the ongoing flow of patients at TUKSoD Clinic at Kleinlife and the dental school. Seniors who consent to participate in the study will be randomly allocated to one of the 3 groups (Control: subjects will continue receiving regular dental care at the clinic, Intervention 1: subjects will continue receiving regular dental care at the clinic and be invited to participate in 2 group based education sessions during a 12 month period, and Intervention 2: subjects will continue receiving regular dental care at the clinic and be invited to participate in an individual-based education and prevention activity over a 18 month period. Randomization will be determined according to a predetermined random sequence, and neither the patient nor the research staff will be aware of the randomization outcome until after the patient has agreed to participate. The OHIP-14 will be used to assess OHRQoL, and self-efficacy scores will be the primary outcomes. Initially, we will assess the differences between the interventions and control using 2-sample t-tests. The main analysis will be based on linear mixed-effects models for repeated measures (using the OHIP 14 and self-efficacy scores as continuous outcome variables) to assess differences between intervention and control groups. Similar analyses will be conducted for secondary outcome measures Statistical significance will be set at p \< .05.

Eligibility criteria: Inclusion Criteria:

1. Must be 55 years old or older.
2. May be new, regular, emergency patients attending the TUKSoD clinic at Kleinlife or clinics at the Dental School or utilizing medical and social services at Kleinlife who have the intention to become patients of record at the dental clinic.
3. Must be able to speak and understand English.
4. Must be willing to provide consent to participate in the study for himself/herself.

Exclusion Criteria:

1. Subjects younger than 55 years old will be excluded from the study.
2. Subjects who do not provide consent for participation will be excluded from the study.
3. Subjects who do not speak and understand English

Primary outcomes:
measure: Change in Oral Health Related Quality of Life (OHIP-14; Slade, 1997)
timeFrame: change from baseline to 12 months
measure: Change in Oral Health Self Efficacy (Modified Version of Finlayson, 2007).
timeFrame: change from baseline to 12 months
Secondary outcomes:
measure: Change in Oral Health Knowledge (Khanagar, 2014)
timeFrame: change from baseline to 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple Univerity Kornberg School of Dentistry
state: Pennsylvania
Study officials:
affiliation: Associate Professor Temple University
name: MARISOL TELLEZ, PhD
role: PRINCIPAL_INVESTIGATOR
References: