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PIMA - Individualized Adherence Improvement Plan

NCT04650061 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-12-02

No results posted yet for this study

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

Interventions

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.

DEVICE

Adherence Follow-Up

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

Sponsors & Collaborators

  • Hospital Sao Joao

    collaborator OTHER

  • Hospital Pedro Hispano

    collaborator OTHER

  • Air Liquide Healthcare Spain

    lead INDUSTRY

Principal Investigators

  • David Rudilla, PhD · Air Liquide Healthcare Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-01-14
Completion
2021-06-30

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04650061 on ClinicalTrials.gov