Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea

Sleep Apnea, Obstructive Clinical Trial

— PIMA1-JO-PR  

Official title:

Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea With an Intervention Based on Stratification and Personalization of Care Plans: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04691479
• Other study ID #: PIMA1-3450
• Secondary ID: 3450
• Status: Completed
• Phase: N/A
• Start date: March 10, 2018
• Est. completion date: November 20, 2018

Study information

• Verified date: December 2020
• Source: Air Liquide Healthcare Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The aim of this trial was to determine adherence to CPAP and health- related outcomes in patients with OSA via a comprehensive and multidisciplinary program based on stratification and individualized care plans, including the motivational interview.

A multicentre, randomized controlled trial (RCT) design was used. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: November 20, 2018
• Est. primary completion date: September 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Motivational Interview (MI) & Adherence Follow-Up
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 D30-D60-D90-D180 depending of the care plan, through the channel that belong for each care plan
• Adherence Follow-Up
The nurse takes the compliance of the CPAP device, and ask to the patient if he had some problems.

Locations

Country	Name	City	State
Spain	David Rudilla	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Air Liquide Healthcare Spain	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital Universitari Joan XXIII de Tarragona.

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Rudilla D, Galiana L, Landete P, Zamora E, Vergara I, Oliver A, Román A, Ancochea J. Development and Validation of the OSA-CPAP Perceived Competence Evaluation Interview. Arch Bronconeumol. 2020 Sep 15. pii: S0300-2896(20)30258-1. doi: 10.1016/j.arbres.2020.07.023. [Epub ahead of print] English, Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence (changes)	Number of hours of use of CPAP per night	Day 90, Day 180
Primary	Somnolence (changes)	Residual sleepiness after use of CPAP. Epworth Sleepiness Scale. Minimum score: 0; Maximum: 24. Higher scores=worse outcome	Day 1, Day 90, Day 180
Primary	Perceived Competence (changes)	Self-Efficacy in the CPAP treatment. Perceived Competence Evaluation Questionnaire. Minimum score: 0; Maximum score 13. Higher score= Better outcome.	Day 1, Day 90, Day 180
Secondary	Quality of Life (Changes)	Well-Being of the patient related to sleep apnea. Analogical Well-Being in Sleep Apnea Scale. Mininum score: 0; Maximum score: 10. Higher score= better outcome.	Day 1, Day 90, Day 180
Secondary	Mood (Changes)	Emotional status related to sleep apnea. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.	Day 1, Day 90, Day 180
Secondary	Activities (Changes)	Improving general activity after use CPAP. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.	Day 1, Day 90, Day 180
Secondary	Social Relations (Changes)	Improving general social relations after use CPAP. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.	Day 1, Day 90, Day 180