Clinical trial NCT06103799: Application of Information-Motivation-Behavioral Model-based Continuity of Care on the Peri-implantitis Recovery in Diabetic Implant Overdenture Patients
Official title: Application of Information-Motivation-Behavioral Model-based Continuity of Care on the Peri-implantitis Recovery in Diabetic Implant Overdenture Patients: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Resorption
Diabetes
Lead sponsor: The Dental Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The information-motivation-behavioral skills (IMB) model, first proposed by Fisher, is composed of three elements-information, motivation, and behavioral skills-and is aimed at transferring patients' behavior into a positive direction, including self-behavior management ability, medication compliance and so on. For diabetic patients with poor adherence, the IMB model of care can be considered.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators recruited 32 diabetic IOD patients with a total of 110 problematic implants who had completed the treatment for peri-implantitis between January 2021 and March 2023 as research subjects. The patients were randomly assigned to the control group or the experimental group using the random number table. The control group received routine postoperative medical advice, whereas the experimental group was given an IMB model-based continuity of care.

Detailed description: Continuity of care involves a series of actions designed to ensure that patients undergoing a transfer from different health care settings (e.g., from hospital to home) or within the same setting (e.g., different units in the hospital) receive different levels of collaborative and continuous care, including discharge planning, referrals, and continuous follow-up and guidance after the patient returns home . It encompasses the roles of both provider and receiver. Patients who actively participate will receive more substantial treatment. Additionally, a retrospective cohort study has shown that continuity of care is associated with lower risk of cardiovascular disease risk among individuals with type 2 diabetes. Another prospective cohort has shown that the application of continuity of care in the dental field enhances oral anticancer therapy adherence.

The information-motivation-behavioral skills (IMB) model, first proposed by Fisher, is composed of three elements-information, motivation, and behavioral skills-and is aimed at transferring patients' behavior into a positive direction, including self-behavior management ability, medication compliance and so on. For diabetic patients with poor adherence, the IMB model of care can be considered.

This model may be particularly useful in diabetic IOD patients since they are more prone to peri-implantitis than patients with other types of implant restorations or non-diabetic patients. However, the efficacy of the combination of the IMB model and continuity of care in improving healing, bone resorption, disease management and control, and quality of life in the specific population group of diabetic IOD patients remains unclear. To this end, the current study was aimed at investigating whether this model of care can help achieve better clinical outcomes and improve patient satisfaction with the services provided, thereby obtaining data to serve as a reference and scientific basis for the improvement of intervention plans.

Eligibility criteria: Inclusion Criteria:

The inclusion criteria in this study were as follows:

1. IOD patients who had type 2 diabetes with peri-implantitis in at least one implant,
2. patients with clear consciousness and good communicative competence,
3. patients who could take good care of themselves and were proficient in using mobile communication and internet devices
4. patients who agreed to participate in our study.

Exclusion Criteria:

Patients with any of the following were excluded from our study:

1. type 1 diabetes and other particular types of diabetes,
2. severe cognitive dysfunction or psychiatric disorders, and
3. inability to use mobile electronic devices.

Primary outcomes:
measure: Peri-implant bone resorption
timeFrame: 1-2years
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 1-2years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Stomatologic Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: