Quality of Life, Self Efficacy, Knowledge
Conditions
Keywords
motivational interviewing, elderly, oral health
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.
Interventions
BEHAVIORALOral Health Education
Group-based oral health education vs Individual-based oral health education using motivational interviewing
Sponsors
Colgate Palmolive
KleinLife
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oral Health Related Quality of Life (OHIP-14; Slade, 1997) | change from baseline to 12 months | 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 in Oral Health Self Efficacy (Modified Version of Finlayson, 2007). | change from baseline to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oral Health Knowledge (Khanagar, 2014) | change from baseline to 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Regular dental care under the standard clinic operation | 60 |
| Intervention 1 Group based oral health education
Oral Health Education: Group based oral health education vs Individual motivational interviewing | 60 |
| Intervention 2 Individual-based motivational interviewing
Oral Health Education: Group based oral health education vs Individual motivational interviewing | 60 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not receive allocated intervention | 0 | 2 | 3 |
| Overall Study | Lost to Follow-up | 10 | 4 | 4 |
Baseline characteristics
| Characteristic | Intervention 1 | Intervention 2 | Control | Total |
|---|---|---|---|---|
| Age, Continuous | 69.5 years STANDARD_DEVIATION 9.1 | 69.5 years STANDARD_DEVIATION 10.7 | 70.8 years STANDARD_DEVIATION 9.5 | 69.9 years STANDARD_DEVIATION 9.8 |
| Oral Health Related Quality of Life | 14.5 units on a scale STANDARD_DEVIATION 13.4 | 16.3 units on a scale STANDARD_DEVIATION 13.1 | 11.1 units on a scale STANDARD_DEVIATION 10.5 | 13.9 units on a scale STANDARD_DEVIATION 12.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 6 Participants | 5 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 13 Participants | 11 Participants | 40 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) White | 41 Participants | 39 Participants | 41 Participants | 121 Participants |
| Self Efficacy | 23.5 units on a scale STANDARD_DEVIATION 6.7 | 23.4 units on a scale STANDARD_DEVIATION 7.4 | 25.6 units on a scale STANDARD_DEVIATION 6.5 | 24.2 units on a scale STANDARD_DEVIATION 6.9 |
| Sex: Female, Male Female | 34 Participants | 37 Participants | 41 Participants | 112 Participants |
| Sex: Female, Male Male | 26 Participants | 23 Participants | 19 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: change from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Oral Health Related Quality of Life (OHIP-14; Slade, 1997) | 16.8 score on a scale | Standard Deviation 11.4 |
| Intervention 1 | Change in Oral Health Related Quality of Life (OHIP-14; Slade, 1997) | 12.4 score on a scale | Standard Deviation 11.2 |
| Intervention 2 | Change in Oral Health Related Quality of Life (OHIP-14; Slade, 1997) | 10.5 score on a scale | Standard Deviation 10.5 |
p-value: 0Regression, Linear
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.
Time frame: change from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Oral Health Self Efficacy (Modified Version of Finlayson, 2007). | 23.5 score on a scale | Standard Deviation 6.6 |
| Intervention 1 | Change in Oral Health Self Efficacy (Modified Version of Finlayson, 2007). | 24.5 score on a scale | Standard Deviation 7.5 |
| Intervention 2 | Change in Oral Health Self Efficacy (Modified Version of Finlayson, 2007). | 27.6 score on a scale | Standard Deviation 5.9 |
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.
Time frame: change from baseline to 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Change in Oral Health Knowledge (Khanagar, 2014) | Dentures that don't fit well can cause oral cancer | 12 Participants |
| Control | Change in Oral Health Knowledge (Khanagar, 2014) | It is normal for people to have pain and sores in | 7 Participants |
| Control | Change in Oral Health Knowledge (Khanagar, 2014) | Mouth rinsing is a good alternative to daily tooth | 12 Participants |
| Control | Change in Oral Health Knowledge (Khanagar, 2014) | As people get old they naturally lose their teeth | 19 Participants |
| Control | Change in Oral Health Knowledge (Khanagar, 2014) | Individuals who do not cooperate for daily mouth c | 5 Participants |
| Control | Change in Oral Health Knowledge (Khanagar, 2014) | You can chew just as well with dentures as with | 15 Participants |
| Control | Change in Oral Health Knowledge (Khanagar, 2014) | People can lose their teeth if they remain dirty | 48 Participants |
| Control | Change in Oral Health Knowledge (Khanagar, 2014) | Name Box Insert Function Dental check-ups are as i | 52 Participants |
| Control | Change in Oral Health Knowledge (Khanagar, 2014) | Older adults with teeth need to use fluorides | 35 Participants |
| Control | Change in Oral Health Knowledge (Khanagar, 2014) | People with no teeth need to be seen by dentist | 41 Participants |
| Control | Change in Oral Health Knowledge (Khanagar, 2014) | Older adults with dry mouth get more cavities | 29 Participants |
| Control | Change in Oral Health Knowledge (Khanagar, 2014) | health of mouth directly related to body.. | 48 Participants |
| Control | Change in Oral Health Knowledge (Khanagar, 2014) | Dentures should be removed for few hours every day | 26 Participants |
| Control | Change in Oral Health Knowledge (Khanagar, 2014) | The most common cause of dry mouth is medication | 31 Participants |
| Control | Change in Oral Health Knowledge (Khanagar, 2014) | When gums bleed during brushing.... | 9 Participants |
| Intervention 1 | Change in Oral Health Knowledge (Khanagar, 2014) | Dentures should be removed for few hours every day | 26 Participants |
| Intervention 1 | Change in Oral Health Knowledge (Khanagar, 2014) | When gums bleed during brushing.... | 11 Participants |
| Intervention 1 | Change in Oral Health Knowledge (Khanagar, 2014) | health of mouth directly related to body.. | 43 Participants |
| Intervention 1 | Change in Oral Health Knowledge (Khanagar, 2014) | You can chew just as well with dentures as with | 19 Participants |
| Intervention 1 | Change in Oral Health Knowledge (Khanagar, 2014) | Older adults with dry mouth get more cavities | 18 Participants |
| Intervention 1 | Change in Oral Health Knowledge (Khanagar, 2014) | The most common cause of dry mouth is medication | 33 Participants |
| Intervention 1 | Change in Oral Health Knowledge (Khanagar, 2014) | It is normal for people to have pain and sores in | 10 Participants |
| Intervention 1 | Change in Oral Health Knowledge (Khanagar, 2014) | Individuals who do not cooperate for daily mouth c | 7 Participants |
| Intervention 1 | Change in Oral Health Knowledge (Khanagar, 2014) | Name Box Insert Function Dental check-ups are as i | 54 Participants |
| Intervention 1 | Change in Oral Health Knowledge (Khanagar, 2014) | People can lose their teeth if they remain dirty | 45 Participants |
| Intervention 1 | Change in Oral Health Knowledge (Khanagar, 2014) | As people get old they naturally lose their teeth | 23 Participants |
| Intervention 1 | Change in Oral Health Knowledge (Khanagar, 2014) | Dentures that don't fit well can cause oral cancer | 10 Participants |
| Intervention 1 | Change in Oral Health Knowledge (Khanagar, 2014) | People with no teeth need to be seen by dentist | 35 Participants |
| Intervention 1 | Change in Oral Health Knowledge (Khanagar, 2014) | Mouth rinsing is a good alternative to daily tooth | 21 Participants |
| Intervention 1 | Change in Oral Health Knowledge (Khanagar, 2014) | Older adults with teeth need to use fluorides | 38 Participants |
| Intervention 2 | Change in Oral Health Knowledge (Khanagar, 2014) | As people get old they naturally lose their teeth | 23 Participants |
| Intervention 2 | Change in Oral Health Knowledge (Khanagar, 2014) | The most common cause of dry mouth is medication | 27 Participants |
| Intervention 2 | Change in Oral Health Knowledge (Khanagar, 2014) | Dentures that don't fit well can cause oral cancer | 16 Participants |
| Intervention 2 | Change in Oral Health Knowledge (Khanagar, 2014) | Older adults with dry mouth get more cavities | 18 Participants |
| Intervention 2 | Change in Oral Health Knowledge (Khanagar, 2014) | Mouth rinsing is a good alternative to daily tooth | 20 Participants |
| Intervention 2 | Change in Oral Health Knowledge (Khanagar, 2014) | Dentures should be removed for few hours every day | 27 Participants |
| Intervention 2 | Change in Oral Health Knowledge (Khanagar, 2014) | You can chew just as well with dentures as with | 16 Participants |
| Intervention 2 | Change in Oral Health Knowledge (Khanagar, 2014) | When gums bleed during brushing.... | 12 Participants |
| Intervention 2 | Change in Oral Health Knowledge (Khanagar, 2014) | People with no teeth need to be seen by dentist | 39 Participants |
| Intervention 2 | Change in Oral Health Knowledge (Khanagar, 2014) | Name Box Insert Function Dental check-ups are as i | 52 Participants |
| Intervention 2 | Change in Oral Health Knowledge (Khanagar, 2014) | Individuals who do not cooperate for daily mouth c | 5 Participants |
| Intervention 2 | Change in Oral Health Knowledge (Khanagar, 2014) | health of mouth directly related to body.. | 46 Participants |
| Intervention 2 | Change in Oral Health Knowledge (Khanagar, 2014) | People can lose their teeth if they remain dirty | 48 Participants |
| Intervention 2 | Change in Oral Health Knowledge (Khanagar, 2014) | It is normal for people to have pain and sores in | 8 Participants |
| Intervention 2 | Change in Oral Health Knowledge (Khanagar, 2014) | Older adults with teeth need to use fluorides | 31 Participants |