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| Name | Class |
|---|---|
| Colgate Palmolive | INDUSTRY |
| KleinLife | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control: Standard of Care | No Intervention | Regular dental care under the standard clinic operation | |
| Intervention 1: Group-based oral health education | Experimental | Group based oral health education |
|
| Intervention 2: Individual-based oral health education | Experimental | Individual-based motivational interviewing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Health Education | Behavioral | Group-based oral health education vs Individual-based oral health education using motivational interviewing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oral Health Related Quality of Life (OHIP-14; Slade, 1997) | The oral health related quality of life scale is a 14-item measurement of individuals' perceptions of the social impact of oral conditions on their well-being. This scale evaluates the consequences of oral conditions across dimensions of functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Items are rated on a 5- point Likert type scale ranging from 0 (never) to 4 (very often), regarding how frequently impact has been experienced. The total score ranges from 0 to 56; higher OHIP-14 scores indicate greater impact, hence poorer oral-health-related quality of life. | change from baseline to 12 months |
| Change in Oral Health Self Efficacy (Modified Version of Finlayson, 2007). | Oral health self efficacy uses a 6 item scale and is a measurement of how confident seniors feel about their ability to perform oral hygiene tasks (1) under a lot of stress; (2) being depressed; (3) feeling anxious; (4) feeling that they were too busy; (5) being tired or; (6) being worried about other things in their life. The four response options range from 'very confident' to 'not at all confident'. The possible score range is 0 to 24,with high scores indicating high self-efficacy. | change from baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oral Health Knowledge (Khanagar, 2014) | Oral health knowledge measurement of the seniors pre and post intervention will be conducted using a list of 15 knowledge statements to which subjects had to report agreement wit the statement (yes), disagreement (no) or don't know. The frequency numbers provided in the results table correspond to correct responses for each individual item. | change from baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MARISOL TELLEZ, PhD | Associate Professor Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple Univerity Kornberg School of Dentistry | Philadelphia | Pennsylvania | 19140 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control: Standard of Care | Regular dental care under the standard clinic operation |
| FG001 | Intervention 1: Group-based Oral Health Education | Group based oral health education Oral Health Education: Group based oral health education vs Individual motivational interviewing |
| FG002 | Intervention 2:Individual-based Oral Health Education Using MI | Individual-based motivational interviewing Oral Health Education: Group based oral health education vs Individual motivational interviewing |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Regular dental care under the standard clinic operation |
| BG001 | Intervention 1 | Group based oral health education Oral Health Education: Group based oral health education vs Individual motivational interviewing |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Oral Health Related Quality of Life (OHIP-14; Slade, 1997) | The oral health related quality of life scale is a 14-item measurement of individuals' perceptions of the social impact of oral conditions on their well-being. This scale evaluates the consequences of oral conditions across dimensions of functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Items are rated on a 5- point Likert type scale ranging from 0 (never) to 4 (very often), regarding how frequently impact has been experienced. The total score ranges from 0 to 56; higher OHIP-14 scores indicate greater impact, hence poorer oral-health-related quality of life. | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 12 months |
|
No adverse event data were collected.
No adverse event data were collected.Nature of intervention tested would not generate mortality outcomes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Regular dental care under the standard clinic operation | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marisol Tellez Merchan | Kornber School of Dentistry | 2177071773 | marisol@temple.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2017 | Mar 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006267 | Health Education, Dental |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| BG002 | Intervention 2 | Individual-based motivational interviewing Oral Health Education: Group based oral health education vs Individual motivational interviewing |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Oral Health Related Quality of Life | The oral health related quality of life scale is a 14-item measurement of individuals' perceptions of the social impact of oral conditions on their well-being. Items are rated on a 5- point Likert type scale ranging from 0 (never) to 4 (very often), regarding how frequently impact has been experienced. The total score ranges from 0 to 56; higher OHIP-14 scores indicate greater impact, hence poorer oral-health-related quality of life. | Mean | Standard Deviation | units on a scale |
|
| Self Efficacy | Oral health self efficacy uses a 6 item scale and is a measurement of how confident seniors feel about their ability to perform oral hygiene tasks (1) under a lot of stress; (2) being depressed; (3) feeling anxious; (4) feeling that they were too busy; (5) being tired or; (6) being worried about other things in their life. The four response options range from 'very confident' to 'not at all confident'. The possible score range is 0 to 24,with high scores indicating high self-efficacy. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Intervention 1 | Group based oral health education Oral Health Education: Group based oral health education vs Individual motivational interviewing |
| OG002 | Intervention 2 | Individual-based motivational interviewing Oral Health Education: Group based oral health education vs Individual motivational interviewing |
|
|
|
| Primary | Change in Oral Health Self Efficacy (Modified Version of Finlayson, 2007). | Oral health self efficacy uses a 6 item scale and is a measurement of how confident seniors feel about their ability to perform oral hygiene tasks (1) under a lot of stress; (2) being depressed; (3) feeling anxious; (4) feeling that they were too busy; (5) being tired or; (6) being worried about other things in their life. The four response options range from 'very confident' to 'not at all confident'. The possible score range is 0 to 24,with high scores indicating high self-efficacy. | Posted | Mean | Standard Deviation | score on a scale | change from baseline to 12 months |
|
|
|
| Secondary | Change in Oral Health Knowledge (Khanagar, 2014) | Oral health knowledge measurement of the seniors pre and post intervention will be conducted using a list of 15 knowledge statements to which subjects had to report agreement wit the statement (yes), disagreement (no) or don't know. The frequency numbers provided in the results table correspond to correct responses for each individual item. | Posted | Count of Participants | Participants | change from baseline to 12 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Intervention 1 | Group based oral health education Oral Health Education: Group based oral health education vs Individual motivational interviewing | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Intervention 2 | Individual-based motivational interviewing Oral Health Education: Group based oral health education vs Individual motivational interviewing | 0 | 0 | 0 | 0 | 0 | 0 |
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| D011636 | Public Health Dentistry |
| D004778 | Environment and Public Health |
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| You can chew just as well with dentures as with |
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| Older adults with dry mouth get more cavities |
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| The most common cause of dry mouth is medication |
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| It is normal for people to have pain and sores in |
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| Individuals who do not cooperate for daily mouth c |
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| Name Box Insert Function Dental check-ups are as i |
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| People can lose their teeth if they remain dirty |
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| As people get old they naturally lose their teeth |
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| Dentures that don't fit well can cause oral cancer |
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| Dentures should be removed for few hours every day |
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| People with no teeth need to be seen by dentist |
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| Mouth rinsing is a good alternative to daily tooth |
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| Older adults with teeth need to use fluorides |
|