Sleep Apnea, Obstructive
Conditions
Keywords
CPAP, Sleep Apnea, Adherence, Quality of Life
Brief 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.
Detailed 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.
Interventions
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
BEHAVIORALAdherence Follow-Up
The nurse takes the compliance of the CPAP device, and ask to the patient if he had some problems.
Sponsors
Hospital Universitari Joan XXIII de Tarragona.
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Air Liquide Healthcare Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
After confirming their participation in the study, the patient was randomly assigned to one group or another, receiving the treatment as established in the protocol according to group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence (changes) | Day 90, Day 180 | Number of hours of use of CPAP per night |
| Somnolence (changes) | Day 1, Day 90, Day 180 | Residual sleepiness after use of CPAP. Epworth Sleepiness Scale. Minimum score: 0; Maximum: 24. Higher scores=worse outcome |
| Perceived Competence (changes) | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (Changes) | 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. |
| Social Relations (Changes) | 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. |
| Mood (Changes) | 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. |
| Activities (Changes) | 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. |
Countries
Spain
Outcome results
None listed