Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05767190
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-22
First Post:
2022-05-12
Brief Title:
The MotivAir Study to Improve CPAP Adherence in OSAS Patients
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
The MotivAir Study a Randomized Controlled Trial of Motivational Interviewing-Based Intervention to Improve Adherence to CPAP in Patients With Obstructive Sleep Apnea Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MotivAir
Brief Summary:
This study aims to evaluate the effectiveness of the MotivAir program an intervention based on Motivational Interviewing MI principles and techniques - in enhancing adherence to Continuous Positive Airway Pressure CPAP therapy among patients with Obstructive Sleep Apnea Syndrome OSAS
Methods A multicenter randomized controlled trial RCT design with random allocation at the level of the individual will be conducted to compare the impact of the experimental program usual care plus MI with a control group receiving usual care only in improving selected clinical and psychological parameters in the patients
A minimum sample of 80 participants 40 patients per group will be recruited in each center according to the inclusion criteria After the initial screening participants will be randomly assigned to either the experimental group or the control condition The program will last 180 days and will be delivered by a trained nurse The impact of the MotivAir program on selected primary adherence to CPAP in terms of average hours of usage per night and the Apnea-Hypopnea Index AHI and secondary motivation perceived competence quality of life sleepiness as well as the emotional state daily life activities and quality of the social relationships of the person outcomes will be measured at baseline and after 1- 3- and 6-month from CPAP initiation
Methods A multicenter randomized controlled trial RCT design with random allocation at the level of the individual will be conducted to compare the impact of the experimental program usual care plus MI with a control group receiving usual care only in improving selected clinical and psychological parameters in the patients
A minimum sample of 80 participants 40 patients per group will be recruited in each center according to the inclusion criteria After the initial screening participants will be randomly assigned to either the experimental group or the control condition The program will last 180 days and will be delivered by a trained nurse The impact of the MotivAir program on selected primary adherence to CPAP in terms of average hours of usage per night and the Apnea-Hypopnea Index AHI and secondary motivation perceived competence quality of life sleepiness as well as the emotional state daily life activities and quality of the social relationships of the person outcomes will be measured at baseline and after 1- 3- and 6-month from CPAP initiation
Detailed Description:
Socio-demographic age level of studies presence of caregiver at home psychological motivation and perceived competence clinical variables somnolence and apnoea-hypopnea index and variables concerning the time the patient spends from home to the care center and the confidence in using electronic applications will be used to classify patients adherence to treatment as low moderate or high and to create a tailored motivational treatment plan for the subjects assigned to the experimental group Patients showing low adherence will receive a more intensive care plan than those recognized as highly compliant with CPAP use The results are patients with the a profile characterized by autonomy and mobility predisposition to remote-controlled follow-up patients with the b profile need for more intensity in follow-up or patients with the c profile more difficulties to move around and require more intensive treatment Profile d was applied to patients who were professional drivers as they require specific interventions based on their occupation see Rudilla et al 2021a
Participants assigned to the control group will receive a usual pulmonary rehabilitation program for patients with OSAS receiving CPAP therapy which is a standard technical training comprising information regarding the use maintenance and safety measures of the device plus a home inspection delivered by a technician who has the only task of doing maintenance to the machinery
In addition subjects in the MotivAir group will follow a telephone-based intervention - lasting approximately 45 minutes - based on MI principles and techniques delivered by a nurse For the specific purpose of the study the nurse will preliminarily receive 8 hours of MI training provided by two psychologists experts in the MI approach authors GR and GP During the training the nurse will learn about the collaborative evocative and client-centered spirit of MI and the characteristics that define each stage of change and will be instructed to apply the basic communication and listening skills of this approach open-ended questions affirmations reflective listening summarizing Then she will learn to reinforce and elicit change talk while also responding in ways that reduce counter-change talk and to roll with the patients inner resistance to change by affirming the patients autonomy and reflecting their resistant speech with empathy Next the issues of how and when to introduce the development of a change plan and enhance the individuals commitment to change will be addressed
The treatment plan will be implemented based on each patients level of adherence To low adherence score below 16 on the ESS and CEPCA questionnaires a more intensive telephone-based assistance day 1 8 16 30 90 120 180 from the end of the rehabilitation period will follow In the case of high adherence score greater than or equal to 16 on the ESS and CEPCA questionnaires phone encounters will be set on days 1 8 30 90 and 180 after treatment termination
At 1- 3- and 6-month follow-up adherence to the device will be assessed by automatedly recorded CPAP usage hoursnight and AHI Changes in the selected psychological variable will be also examined
Participants assigned to the control group will receive a usual pulmonary rehabilitation program for patients with OSAS receiving CPAP therapy which is a standard technical training comprising information regarding the use maintenance and safety measures of the device plus a home inspection delivered by a technician who has the only task of doing maintenance to the machinery
In addition subjects in the MotivAir group will follow a telephone-based intervention - lasting approximately 45 minutes - based on MI principles and techniques delivered by a nurse For the specific purpose of the study the nurse will preliminarily receive 8 hours of MI training provided by two psychologists experts in the MI approach authors GR and GP During the training the nurse will learn about the collaborative evocative and client-centered spirit of MI and the characteristics that define each stage of change and will be instructed to apply the basic communication and listening skills of this approach open-ended questions affirmations reflective listening summarizing Then she will learn to reinforce and elicit change talk while also responding in ways that reduce counter-change talk and to roll with the patients inner resistance to change by affirming the patients autonomy and reflecting their resistant speech with empathy Next the issues of how and when to introduce the development of a change plan and enhance the individuals commitment to change will be addressed
The treatment plan will be implemented based on each patients level of adherence To low adherence score below 16 on the ESS and CEPCA questionnaires a more intensive telephone-based assistance day 1 8 16 30 90 120 180 from the end of the rehabilitation period will follow In the case of high adherence score greater than or equal to 16 on the ESS and CEPCA questionnaires phone encounters will be set on days 1 8 30 90 and 180 after treatment termination
At 1- 3- and 6-month follow-up adherence to the device will be assessed by automatedly recorded CPAP usage hoursnight and AHI Changes in the selected psychological variable will be also examined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None