Trial Outcomes & Findings for Implementing a Participatory, Multi-level Intervention to Improve Asian American Health Study (NCT NCT03438045)

NCT ID: NCT03438045

Last Updated: 2021-08-13

Results Overview

Number of patients who agree or strongly agree with the statement that the CHW helped me to improve how I take care of my health, based on exit interviews administered via in-person paper questionnaire at the end of the outreach event (4 possible responses: strongly agree, agree, disagree, strongly disagree) used in the Sikh American Families Oral Health Promotion Program.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

up to 6 months

Results posted on

2021-08-13

Participant Flow

Five Chinese American community-based organizations have already volunteered to participate in this study: * Asian Americans for Equality. * Chinatown YMCA, a Branch of the YMCA of Greater New York. * Chinese American Planning Council. * Coalition for Asian American Children and Families. * Hamilton-Madison House. The three outreach centers for this study will be selected from among the affiliated outreach centers of these organizations.

No assignment to groups was part of this feasibility and acceptability study. All participants received the intervention.

Participant milestones

Participant milestones
Measure
Partnered Intervention
The aspects of the partnering package of evidence-based intervention strategies are: (1) written agreements of collaboration for dental screening, health promotion, and incentives; (2) culturally-tailored and language-specific adaptation of materials; (3) demonstrations with role-playing of proper brushing with fluoride toothpaste and flossing techniques; and (4) CHW follow-up with patients of oral health care receipt and dental hygiene behaviors. Additionally, bilingual (English and Mandarin Chinese) CHWs will receive additional training in oral health promotion demonstration, oral health services and programs available at local clinics and hospitals, information about dental and health insurance, and evidence-based oral health behaviors. Partnered intervention: CHWs will provide dental education and counseling, lead interactive demonstrations of brushing with fluoride toothpaste and flossing, and improve access to dental care through dental coverage enrollment and linkage to local dentists.
Overall Study
STARTED
75
Overall Study
COMPLETED
75
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Missing information for 1 participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Partnered Intervention
n=75 Participants
The aspects of the partnering package of evidence-based intervention strategies are: (1) written agreements of collaboration for dental screening, health promotion, and incentives; (2) culturally-tailored and language-specific adaptation of materials; (3) demonstrations with role-playing of proper brushing with fluoride toothpaste and flossing techniques; and (4) CHW follow-up with patients of oral health care receipt and dental hygiene behaviors. Additionally, bilingual (English and Mandarin Chinese) CHWs will receive additional training in oral health promotion demonstration, oral health services and programs available at local clinics and hospitals, information about dental and health insurance, and evidence-based oral health behaviors. Partnered intervention: CHWs will provide dental education and counseling, lead interactive demonstrations of brushing with fluoride toothpaste and flossing, and improve access to dental care through dental coverage enrollment and linkage to local dentists.
Age, Continuous
58.9 years
STANDARD_DEVIATION 19.3 • n=74 Participants • Missing information for 1 participant.
Sex: Female, Male
Female
62 Participants
n=74 Participants • Missing information for 1 participant.
Sex: Female, Male
Male
12 Participants
n=74 Participants • Missing information for 1 participant.
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=75 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
74 Participants
n=75 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=75 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=75 Participants
Race (NIH/OMB)
Asian
74 Participants
n=75 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=75 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=75 Participants
Race (NIH/OMB)
White
0 Participants
n=75 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=75 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=75 Participants
Region of Enrollment
United States
75 participants
n=75 Participants
Preferred language
Chinese
74 Participants
n=75 Participants
Preferred language
English
0 Participants
n=75 Participants
Preferred language
Missing
1 Participants
n=75 Participants

PRIMARY outcome

Timeframe: up to 6 months

Number of patients who agree or strongly agree with the statement that the CHW helped me to improve how I take care of my health, based on exit interviews administered via in-person paper questionnaire at the end of the outreach event (4 possible responses: strongly agree, agree, disagree, strongly disagree) used in the Sikh American Families Oral Health Promotion Program.

Outcome measures

Outcome measures
Measure
Partnered Intervention
n=72 Participants
The aspects of the partnering package of evidence-based intervention strategies are: (1) written agreements of collaboration for dental screening, health promotion, and incentives; (2) culturally-tailored and language-specific adaptation of materials; (3) demonstrations with role-playing of proper brushing with fluoride toothpaste and flossing techniques; and (4) CHW follow-up with patients of oral health care receipt and dental hygiene behaviors. Additionally, bilingual (English and Mandarin Chinese) CHWs will receive additional training in oral health promotion demonstration, oral health services and programs available at local clinics and hospitals, information about dental and health insurance, and evidence-based oral health behaviors. Partnered intervention: CHWs will provide dental education and counseling, lead interactive demonstrations of brushing with fluoride toothpaste and flossing, and improve access to dental care through dental coverage enrollment and linkage to local dentists.
Number of Patients Who Agree or Strongly Agree With the Statement, "The Community Health Worker (CHW) Helped me to Improve How I Take Care of my Health" Based on a 4-point Likert Scale.
Strongly agree
21 Participants
Number of Patients Who Agree or Strongly Agree With the Statement, "The Community Health Worker (CHW) Helped me to Improve How I Take Care of my Health" Based on a 4-point Likert Scale.
Agree
50 Participants
Number of Patients Who Agree or Strongly Agree With the Statement, "The Community Health Worker (CHW) Helped me to Improve How I Take Care of my Health" Based on a 4-point Likert Scale.
Disagree
1 Participants
Number of Patients Who Agree or Strongly Agree With the Statement, "The Community Health Worker (CHW) Helped me to Improve How I Take Care of my Health" Based on a 4-point Likert Scale.
Strongly disagree
0 Participants

SECONDARY outcome

Timeframe: up to 6 months

Number of patients who agree or strongly agree with the statement that the CHW answered my questions or concerns, based on exit interviews administered via in-person paper questionnaire at the end of the outreach event (4 possible responses: strongly agree, agree, disagree, strongly disagree) used in the Sikh American Families Oral Health Promotion Program.

Outcome measures

Outcome measures
Measure
Partnered Intervention
n=67 Participants
The aspects of the partnering package of evidence-based intervention strategies are: (1) written agreements of collaboration for dental screening, health promotion, and incentives; (2) culturally-tailored and language-specific adaptation of materials; (3) demonstrations with role-playing of proper brushing with fluoride toothpaste and flossing techniques; and (4) CHW follow-up with patients of oral health care receipt and dental hygiene behaviors. Additionally, bilingual (English and Mandarin Chinese) CHWs will receive additional training in oral health promotion demonstration, oral health services and programs available at local clinics and hospitals, information about dental and health insurance, and evidence-based oral health behaviors. Partnered intervention: CHWs will provide dental education and counseling, lead interactive demonstrations of brushing with fluoride toothpaste and flossing, and improve access to dental care through dental coverage enrollment and linkage to local dentists.
Number of Patients Who Agree or Strongly Agree With the Statement, "The Community Health Worker (CHW) Answered my Questions or Concerns" Based on a 4-point Likert Scale.
Strongly agree
16 Participants
Number of Patients Who Agree or Strongly Agree With the Statement, "The Community Health Worker (CHW) Answered my Questions or Concerns" Based on a 4-point Likert Scale.
Agree
50 Participants
Number of Patients Who Agree or Strongly Agree With the Statement, "The Community Health Worker (CHW) Answered my Questions or Concerns" Based on a 4-point Likert Scale.
Disagree
1 Participants
Number of Patients Who Agree or Strongly Agree With the Statement, "The Community Health Worker (CHW) Answered my Questions or Concerns" Based on a 4-point Likert Scale.
Strongly disagree
0 Participants

SECONDARY outcome

Timeframe: up to 6 months

Number of patients who agree or strongly agree with the statement that the information and topics were informative, based on exit interviews administered via in-person paper questionnaire at the end of the outreach event (4 possible responses: strongly agree, agree, disagree, strongly disagree) used in the Sikh American Families Oral Health Promotion Program.

Outcome measures

Outcome measures
Measure
Partnered Intervention
n=69 Participants
The aspects of the partnering package of evidence-based intervention strategies are: (1) written agreements of collaboration for dental screening, health promotion, and incentives; (2) culturally-tailored and language-specific adaptation of materials; (3) demonstrations with role-playing of proper brushing with fluoride toothpaste and flossing techniques; and (4) CHW follow-up with patients of oral health care receipt and dental hygiene behaviors. Additionally, bilingual (English and Mandarin Chinese) CHWs will receive additional training in oral health promotion demonstration, oral health services and programs available at local clinics and hospitals, information about dental and health insurance, and evidence-based oral health behaviors. Partnered intervention: CHWs will provide dental education and counseling, lead interactive demonstrations of brushing with fluoride toothpaste and flossing, and improve access to dental care through dental coverage enrollment and linkage to local dentists.
Number of Patients Who Agree or Strongly Agree With the Statement, "The Information and Topics Were Informative" Based on a 4-point Likert Scale.
Strongly agree
17 Participants
Number of Patients Who Agree or Strongly Agree With the Statement, "The Information and Topics Were Informative" Based on a 4-point Likert Scale.
Agree
52 Participants
Number of Patients Who Agree or Strongly Agree With the Statement, "The Information and Topics Were Informative" Based on a 4-point Likert Scale.
Disagree
0 Participants
Number of Patients Who Agree or Strongly Agree With the Statement, "The Information and Topics Were Informative" Based on a 4-point Likert Scale.
Strongly disagree
0 Participants

SECONDARY outcome

Timeframe: up to 6 months

Number of patients who agree or strongly agree with the statement that the in-person demonstrations were helpful in improving oral health, based on exit interviews administered via in-person paper questionnaire at the end of the outreach event (4 possible responses: strongly agree, agree, disagree, strongly disagree) used in the Sikh American Families Oral Health Promotion Program.

Outcome measures

Outcome measures
Measure
Partnered Intervention
n=69 Participants
The aspects of the partnering package of evidence-based intervention strategies are: (1) written agreements of collaboration for dental screening, health promotion, and incentives; (2) culturally-tailored and language-specific adaptation of materials; (3) demonstrations with role-playing of proper brushing with fluoride toothpaste and flossing techniques; and (4) CHW follow-up with patients of oral health care receipt and dental hygiene behaviors. Additionally, bilingual (English and Mandarin Chinese) CHWs will receive additional training in oral health promotion demonstration, oral health services and programs available at local clinics and hospitals, information about dental and health insurance, and evidence-based oral health behaviors. Partnered intervention: CHWs will provide dental education and counseling, lead interactive demonstrations of brushing with fluoride toothpaste and flossing, and improve access to dental care through dental coverage enrollment and linkage to local dentists.
Number of Patients Who Agree or Strongly Agree With the Statement, "The In-person Demonstrations Were Helpful in Improving Oral Health" Based on a 4-point Likert Scale.
Strongly agree
17 Participants
Number of Patients Who Agree or Strongly Agree With the Statement, "The In-person Demonstrations Were Helpful in Improving Oral Health" Based on a 4-point Likert Scale.
Agree
52 Participants
Number of Patients Who Agree or Strongly Agree With the Statement, "The In-person Demonstrations Were Helpful in Improving Oral Health" Based on a 4-point Likert Scale.
Disagree
0 Participants
Number of Patients Who Agree or Strongly Agree With the Statement, "The In-person Demonstrations Were Helpful in Improving Oral Health" Based on a 4-point Likert Scale.
Stronly disagree
0 Participants

Adverse Events

Partnered Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mary E. Northridge, PhD, MPH, Director of Dental Research

NYU Grossman School of Medicine

Phone: (347) 377-4342

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place