Oral Health Education Interventions Among Seniors

NCT ID: NCT03301714

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-15
• Study Completion Date: 2019-02-28

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.

Conditions

Quality of Life; Self Efficacy; Knowledge

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control: Standard of Care

Regular dental care under the standard clinic operation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention 1: Group-based oral health education

Group based oral health education

Group Type: EXPERIMENTAL

Oral Health Education

Intervention Type: BEHAVIORAL

Group-based oral health education vs Individual-based oral health education using motivational interviewing

Intervention 2: Individual-based oral health education

Individual-based motivational interviewing

Group Type: EXPERIMENTAL

Oral Health Education

Intervention Type: BEHAVIORAL

Group-based oral health education vs Individual-based oral health education using motivational interviewing

Interventions

Oral Health Education

Group-based oral health education vs Individual-based oral health education using motivational interviewing

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: collaborator

KleinLife

OTHER

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MARISOL TELLEZ, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor Temple University

Locations

Temple Univerity Kornberg School of Dentistry

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TempleU

Identifier Type: -

Identifier Source: org_study_id