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Completed

NCT Number: NCT04691479

Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

David Rudilla

Madrid, 28020, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interview (MI) & Adherence Follow-Up

Behavioral
  • 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

Behavioral

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

Primary outcomes

  1. Adherence (changes)

    Time frame: Day 90, Day 180

    Number of hours of use of CPAP per night

  2. Somnolence (changes)

    Time frame: Day 1, Day 90, Day 180

    Residual sleepiness after use of CPAP. Epworth Sleepiness Scale. Minimum score: 0; Maximum: 24. Higher scores=worse outcome

  3. Perceived Competence (changes)

    Time frame: Day 1, Day 90, Day 180

    Self-Efficacy in the CPAP treatment. Perceived Competence Evaluation Questionnaire. Minimum score: 0; Maximum score 13. Higher score= Better outcome.

Secondary outcomes

  1. Quality of Life (Changes)

    Time frame: Day 1, Day 90, Day 180

    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.

  2. Mood (Changes)

    Time frame: Day 1, Day 90, Day 180

    Emotional status related to sleep apnea. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.

  3. Activities (Changes)

    Time frame: Day 1, Day 90, Day 180

    Improving general activity after use CPAP. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.

  4. Social Relations (Changes)

    Time frame: Day 1, Day 90, Day 180

    Improving general social relations after use CPAP. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.

Sponsors and collaborators

Lead sponsor

Air Liquide Healthcare Spain

Industry

Collaborators

  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
  • Hospital Universitari Joan XXIII de Tarragona.

Registry information

Official study 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

Acronym: PIMA1-JO-PR

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 31, 2020
Registry last updated
Dec 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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