Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-24 @ 5:01 PM
NCT ID:
NCT04390750
Brief Summary:
Care Partner Assisted Intervention to Improve Oral Health for Individuals with Mild Dementia is a randomized control trial (RCT) based in New York City and North Carolina. The intervention includes both a tailored oral care plan and a behavioral component using the Adaptive Leadership Framework for Chronic Illness that the team introduced to manage symptoms associated with chronic conditions, such as dementia. Objective 1 is to evaluate the efficacy of an intervention to improve oral hygiene clinical outcomes (i.e. plaque index and gingival index) by improving oral hygiene behavior (i.e., frequency and duration of toothbrushing) and oral health skills among individuals with mild dementia. Objective 2A is to determine whether effects of the intervention on oral hygiene behavioral outcomes, are mediated by the following variables from the care partners' perspective: 1) oral care self-efficacy; 2) care partner self-efficacy; 3) use of cueing methods; 4) and FOCUSED Communication. Objective 2B is to determine whether effects of the intervention on oral hygiene clinical outcomes, are mediated by the following variables from the care partner's perspective: 1) oral care self-efficacy; 2) care partner's self-efficacy; 3) use of cueing methods; 4) and FOCUSED Communication. Objective 3A is to determine whether effects of the intervention on oral hygiene clinical outcomes are mediated by oral hygiene behavioral outcomes. Objective 3B is to determine whether effects of the intervention on oral hygiene clinical outcomes are mediated by the care partner's factors, which then mediate the oral hygiene behavioral outcomes on oral hygiene clinical outcomes. This innovative care partner-assisted oral care behavior intervention will assist participants and care partners in implementing a cooperative oral hygiene care plan to prevent deterioration of oral health, which in turn, will help the targeted population maintain independence in completing daily activities and quality of life for an extended period of time.
Detailed Description:
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:
NCT04390750
Study Brief:
Protocol Section:
NCT04390750