PIMA - Individualized Adherence Improvement Plan

NCT04650061 | Unknown

• 1 other identifier: 88/CE/JAS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (5)

• Change in adherence in the first 6 months of treatment

  Number of hours using CPAP per night

  Day 21, Day 90, Day 120, Day 180

• Change in somnolence in the first 6 months of treatment

  Residual sleepiness after use of CPAP. Epworth Test

  Day 21, Day 90, Day 120, Day 180

• Change in perceived competence in the first 6 months of treatment

  Self-Efficacy in the CPAP treatment. Perceived Competence Evaluation Questionnaire

  Day 21, Day 90, Day 120, Day 180

• Change in Apnea-hypoanea index in the first 6 months of treatment

  Number of apneas-hypoapneas per night

  Day 21, Day 90, Day 120, Day 180

• Change in Air Leaks in the first 6 months of treatment

  Fly away through the suitcase adaptation of the mask. Measured in liters / per minute

  Day 21, Day 90, Day 120, Day 180

Secondary Outcomes (4)

• Change in Quality of Life in the first 6 months of treatment

  Day 21, Day 90, Day 120, Day 180

• Change in Mood in the first 6 months of treatment

  Day 21, Day 90, Day 120, Day 180

• Change in Activities in the first 6 months of treatment

  Day 21, Day 90, Day 120, Day 180

• Change in Social Relationships in the first 6 months of treatment

  Day 21, Day 90, Day 120, Day 180

Study Arms (2)

PIMA Group

EXPERIMENTAL

1. MEntA: Educational \& Training Program 2. Stratification: Identification of Personal Variables (Age, Level of study, Work status, preference of care attention, digital behaviour) 3. Adherence evaluation: Evaluation of Perceived Competence, Quality of Life, Mood, Activities, Social relations and Social Support 4. Identification of Care plan and Schedule next visits 5. 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

Control

ACTIVE COMPARATOR

1. Training program 2. Schedule next visits 3. Follow-up D21-D90-D120-D180 using the same process: visit at home or phone.

Device: Adherence Follow-Up

Interventions

Motivational Interview (MI) & Adherence Follow-Up BEHAVIORAL

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.

PIMA Group

Adherence Follow-Up DEVICE

The nurse takes the compliance of the CPAP device, and ask to the patient if he had some problems.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Air Liquide Healthcare Spain: lead
• Hospital Sao Joao: collaborator
• Hospital Pedro Hispano: collaborator

Study Sites (1)

Antonio Ferreira

Avintes, 4430-820, Portugal

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• David Rudilla, PhD

  Air Liquide Healthcare Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Rudilla, PhD

CONTACT

+34667126630; david.rudilla@airliquide.com

Antonio Denis Ferreira

CONTACT

+(351) 96240 62 00; antoniod.ferreira@airliquide.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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)
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multi-centre randomized, controlled trial (RCT)

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: October 1, 2020
• Primary Completion: January 14, 2021
• Study Completion: June 30, 2021
• Last Updated: December 2, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Q3 - 2021

Locations

PT (1)