PIMA - Individualized Adherence Improvement Plan (PIMAGASOXMED)

• ClinicalTrials.gov Identifier: NCT04650061
• Recruitment Status: Recruiting
• First Posted: December 2, 2020
• Last Update Posted: December 2, 2020
• Sponsor: Air Liquide Healthcare Spain
• Collaborators: Hospital Sao Joao; Hospital Pedro Hispano
• Information provided by (Responsible Party): Air Liquide Healthcare Spain

Study Description

Brief Summary:

Continuous positive airway pressure (CPAP) is the first-line treatment for sleep apnoea/hypopnoea syndrome (OSA). The aim of this study is to know the results in adherence to CPAP and health related outcomes in patients with OSA through a comprehensive and multidisciplinary program based on stratification and individualized care plans, including the motivational interview.

Methods: A multicenter randomized controlled trial (RCT) is designed. The control group will follow the usual treatment, while the intervention group (PIMA) will follow the treatment according to the stratification label based on a comprehensive assessment. This label determines a personalized treatment plan for each patient, which includes different channels (home, telephone, care center) and the use of the motivational interview in each of the interventions with the patient. The main outcome was adherence. Secondary outcomes were quality of life, emotional state, activities, social relationships, perceived competence and motivation.

Condition or disease	Intervention/treatment	Phase
Sleep Apnea, Obstructive	Behavioral: Motivational Interview (MI) & Adherence Follow-Up; Device: Adherence Follow-Up	Not Applicable

Detailed Description:

The subjects enrolled in the study are required to have a diagnosis of OSA confirmed by sleep studies with polygraphy (PS) and / or polysomnography(PSG). Prior to enrolment in the study, all patients are informed in detail about the study and signed the consent form to participate. A randomisation process will follow using a random number generator in Statistical Package for the Social Sciences (SPSS) to systematically assign patients to one group or another, with allocation concealment. Responsible for randomization are prescribers.

The control group intervention. The patients will follow the standard of care, which consists of starting therapy in the home, where the nurse perform training in the use of CPAP equipment, mask adjustment, and safety and maintenance instructions. For follow-up, the patient is always visited at home or telephone, with a frequency established by the Portuguese Society of Sleep(Day 7, Day 21 and Day 180). The follow-up procedure consists of reviewing the CPAP hour meter and resolving any incidents that may have arisen, with the necessary corrective actions (change of mask, positive reinforcement, explanation of specific aspects).

The intervention group 'PIMA' (Personalized Adherence Improvement Plan, based on the Spanish acronym), starts the treatment with the educational and training program called MEntA (Motivational Interview for Adherence). MEntA intervention consists of one session lasting approximately 60 minutes, which is divided into two blocks: educational activity and training activity. In the first block, nurse explains the concepts of sleep apnoea and the symptoms, while a patient shows the CPAP treatment and how to optimize this to the fullest. This block is reinforced with documentation in hard copy and digital format. The second block on training activity was based on working with the treatment, equipment, safety, hygiene and advice. MEntA uses the MI to the treatment of OSA with CPAP. In fact, the nurse uses MI not only at the beginning of therapy, but also in every contact that the patient has with the patient throughout the treatment (subsequent follow-up visits, phone calls, etc). For the PIMA group, the nurse was specifically trained to give this intervention to patients, including a training session with a clinical psychologist.

After the educational and training program, the nurse performs the stratification process to know a series of patient characteristics that will allow identifying the best care plan to obtain the best results in adherence and quality of life. The stratification labels that determine the personalized intervention plan are obtained from two types of variables: personal and modulation variables.With the psychological and clinical variables, in this first visit, "predictive" information is obtained on how the patient's adherence will be: high adherence, moderate adherence or low adherence. Taking this information into account, the care plan will start considering how the patient is and their situation with respect to adherence. Low or moderate adherence relative face plans are more intensive than high adherence relative care plans. In follow-up visits (whose frequency depends on the level of adherence), psychological and clinical variables are reviewed and the patient's adherence is added. Depending on their evolution, the care plan is adapted. For patients with low adherence, telemonitoring is used with hours of compliance, the Apnea-hypoanea index(AHI) and air leak.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: A multi-centre randomized, controlled trial (RCT)
• Masking: Single (Participant)
• Masking Description: The patient is informed that he participates in a study to test the efficacy of different care plans, but he is not informed if he belongs to the experimental or to the control group (standard of care)
• Primary Purpose: Treatment
• Official Title: Study on an Individualized Plan to Improve Patient Compliance to Therapy, Based on Stratification and Use of Telemonitoring for Sleep Apnea With CPAP
• Actual Study Start Date: October 1, 2020
• Estimated Primary Completion Date: January 14, 2021
• Estimated Study Completion Date: June 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: PIMA Group; MEntA: Educational & Training Program; Stratification: Identification of Personal Variables (Age, Level of study, Work status, preference of care attention, digital behaviour); Adherence evaluation: Evaluation of Perceived Competence, Quality of Life, Mood, Activities, Social relations and Social Support; Identification of Care plan and Schedule next visits; Follow-up D21-D90-D120-D180 depending of the care plan, through the channel that belong for each care plan	Behavioral: Motivational Interview (MI) & Adherence Follow-Up; With MI, the key goal is to empower the patient to commit to follow CPAP therapy, while providing empathic support, in a positive atmosphere, and without prejudice. The nurse does not directly advocate for behavior change (i.e. use CPAP as prescribed), but asks key questions to help the patient explore their feelings about the change, weighs the pros and cons of such change, and allows the patient to realize the discrepancy between the current risk (that is, not using CPAP as directed) and the benefits with good adherence.
Active Comparator: Control; Training program; Schedule next visits; Follow-up D21-D90-D120-D180 using the same process: visit at home or phone.	Device: Adherence Follow-Up; The nurse takes the compliance of the CPAP device, and ask to the patient if he had some problems.

Outcome Measures

Primary Outcome Measures :

1. Change in adherence in the first 6 months of treatment [ Time Frame: Day 21, Day 90, Day 120, Day 180 ]
   Number of hours using CPAP per night
2. Change in somnolence in the first 6 months of treatment [ Time Frame: Day 21, Day 90, Day 120, Day 180 ]
   Residual sleepiness after use of CPAP. Epworth Test
3. Change in perceived competence in the first 6 months of treatment [ Time Frame: Day 21, Day 90, Day 120, Day 180 ]
   Self-Efficacy in the CPAP treatment. Perceived Competence Evaluation Questionnaire
4. Change in Apnea-hypoanea index in the first 6 months of treatment [ Time Frame: Day 21, Day 90, Day 120, Day 180 ]
   Number of apneas-hypoapneas per night
5. Change in Air Leaks in the first 6 months of treatment [ Time Frame: Day 21, Day 90, Day 120, Day 180 ]
   Fly away through the suitcase adaptation of the mask. Measured in liters / per minute

Secondary Outcome Measures :

1. Change in Quality of Life in the first 6 months of treatment [ Time Frame: Day 21, Day 90, Day 120, Day 180 ]
   Well-Being of the patient related to sleep apnea. Analogical Well-Being in Sleep Apnea Scale
2. Change in Mood in the first 6 months of treatment [ Time Frame: Day 21, Day 90, Day 120, Day 180 ]
   Emotional status related to sleep apnea. Ad hoc question
3. Change in Activities in the first 6 months of treatment [ Time Frame: Day 21, Day 90, Day 120, Day 180 ]
   Improving general activity after use CPAP. Ad hoc question
4. Change in Social Relationships in the first 6 months of treatment [ Time Frame: Day 21, Day 90, Day 120, Day 180 ]
   Improving general social relations after use CPAP. Ad hoc question

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Older than 18 years, diagnosis of OSA confirmed by sleep studies with polygraphy (PS) and / or polysomnography (PSG)

Exclusion Criteria:

• subjects with obesity-related hypoventilation, severe COPD (chronic obstructive pulmonary disease) , cognitive disorders and those unable to understand the consent to participate

Contacts and Locations

Contacts

Contact: David Rudilla, PhD; +34667126630; david.rudilla@airliquide.com

Contact: Antonio Denis Ferreira; +(351) 96240 62 00; antoniod.ferreira@airliquide.com

Locations

Portugal

Antonio Ferreira; Recruiting

Avintes, Portugal, 4430-820

Contact: David Rudilla, PhD +34667126630 david.rudilla@airliquide.com

Contact: Antonio Ferreira +(351) 96240 62 00 antoniod.ferreira@airliquide.com

Sponsors and Collaborators

Air Liquide Healthcare Spain

Hospital Sao Joao

Hospital Pedro Hispano

Investigators

• Principal Investigator: David Rudilla, PhD; Air Liquide Healthcare Spain

More Information

• Responsible Party: Air Liquide Healthcare Spain
• ClinicalTrials.gov Identifier: NCT04650061
• Other Study ID Numbers: 88/CE/JAS
• First Posted: December 2, 2020
• Last Update Posted: December 2, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Plan Description

Publication of results in two phases:

• National Congress in Portugal
• Publication in Research Journal

• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: Q3 - 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases