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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
129
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
The nurse takes the compliance of the CPAP device, and ask to the patient if he had some problems.
David Rudilla
Madrid, Spain
Adherence (changes)
Number of hours of use of CPAP per night
Time frame: Day 90, Day 180
Somnolence (changes)
Residual sleepiness after use of CPAP. Epworth Sleepiness Scale. Minimum score: 0; Maximum: 24. Higher scores=worse outcome
Time frame: Day 1, Day 90, Day 180
Perceived Competence (changes)
Self-Efficacy in the CPAP treatment. Perceived Competence Evaluation Questionnaire. Minimum score: 0; Maximum score 13. Higher score= Better outcome.
Time frame: Day 1, Day 90, Day 180
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.
Time frame: Day 1, Day 90, Day 180
Mood (Changes)
Emotional status related to sleep apnea. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.
Time frame: Day 1, Day 90, Day 180
Activities (Changes)
Improving general activity after use CPAP. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.
Time frame: Day 1, Day 90, Day 180
Social Relations (Changes)
Improving general social relations after use CPAP. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.
Time frame: Day 1, Day 90, Day 180
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