MedTrace Logo

Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea

NCT04691479 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2020-12-31

No results posted yet for this study

Summary

A multicentre, randomized controlled trial (RCT) design.The control group followed the usual treatment, while the intervention group (PIMA) followed the treatment with an adapted and flexible care plan depending on socio-demographic, clinical and psychological variables. The treatment plan includes different channels (home, telephone, care center), a continuous evaluation, 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

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 D30-D60-D90-D180 depending of the care plan, through the channel that belong for each care plan

BEHAVIORAL

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 Universitari Joan XXIII de Tarragona.

    collaborator OTHER

  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    collaborator OTHER

  • Air Liquide Healthcare Spain

    lead INDUSTRY

Principal Investigators

  • Pedro Landete, PhD · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-10
Primary Completion
2018-09-11
Completion
2018-11-20

Countries

  • Spain

Study Locations

More Related Trials

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 NCT04691479 on ClinicalTrials.gov