Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia
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|ClinicalTrials.gov Identifier: NCT04390750|
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : April 4, 2022
|Condition or disease||Intervention/treatment||Phase|
|Mild Dementia||Behavioral: Care Partner-Assisted Intervention||Not Applicable|
Dyads that each consist of an individual with mild dementia and his/her care partner will be enrolled at two sites, Duke University in Durham, North Carolina and New York University in New York, New York. This is an unblinded, randomized trial to assess the acceptability and effectiveness of the oral health intervention among individuals with mild dementia (MD). The study will utilize qualitative and quantitative methods to learn about the oral health outcomes in individuals with mild dementia.
The study lasts 6 months. The first three months is the active intervention phase in which coaching and educational modules are delivered. The second three months is the maintenance period in which no coaching or educational modules are presented to participants. As a team, the study coordinator, the oral health evaluator (a dental hygienist), and the interventionist will conduct three visits with the participants and their care partners; baseline, 3-month (end of the active intervention phase), and 6-month (end of three-month maintenance phase).
The intervention protocol will include three groups; two treatment groups and one control group. All participants will receive oral health education material at the baseline visit. Treatment Group 1 and Treatment Group 2 will be given a smart electronic toothbrush. Only Treatment Group 2 will receive the in-home and telephone coaching throughout the duration of the study and will be instructed to record daily brushing habits. The coaching sessions include individualized instruction on oral hygiene technique, cueing strategy development, or oral hygiene monitoring and coaching. Treatment Group 1 and the Control Group will not receive the coaching sessions.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||3 Groups - 2 Treatment Groups, 1 Control Group|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Care Partner Assisted Intervention to Improve Oral Health of Individuals With Mild Dementia|
|Actual Study Start Date :||October 22, 2021|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
No Intervention: Treatment Group 1
Treatment Group 1 will receive a standard educational booklet, a clinical oral health evaluation and a smart electronic toothbrush with no instruction on oral hygiene technique. The study coordinator will download the toothbrush data for data collection. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided. The hygienist will provide basic instruction on proper use of the smart electronic toothbrush.
Experimental: Treatment Group 2
Treatment Group 2 will receive a standard educational booklet, a smart electronic toothbrush, a clinical oral health evaluation with tailored instruction on oral hygiene technique and care partner coaching. The study coordinator will download the toothbrush data for data collection. The dental hygienist and interventionist will work together to fulfill the following intervention components: tailored instruction and coaching.
Behavioral: Care Partner-Assisted Intervention
Tailored teaching and coaching
No Intervention: Control Group
The Control group will receive a standard educational booklet and a clinical oral health evaluation with no instruction on oral hygiene technique. The dental hygienist will observe the participant's normal toothbrushing technique, interdental cleaning procedures and the cleaning of partial dentures. No instruction is provided.
- Plaque Index [ Time Frame: 6 months ]
- Gingival Index [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390750
|Contact: Shahrzad Siamdoust, MPHfirstname.lastname@example.org|
|United States, New York|
|New York City (Participants Homes)||Recruiting|
|New York, New York, United States, 10010|
|Contact: Shahrzad Siamdoust, MPH 212-992-5966 email@example.com|
|Principal Investigator: Bei Wu, PhD|
|United States, North Carolina|
|North Carolina (Participants Homes)||Recruiting|
|Durham, North Carolina, United States, 27708|
|Contact: Cappye Mott, BA firstname.lastname@example.org|
|Principal Investigator: Brenda Plassman, PhD|
|Principal Investigator:||Bei Wu, PhD||New York University|