Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Behavioral: Motivational Interview (MI) & Adherence Follow-Up
* Behavioral: Adherence Follow-Up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PIMAGroup<br>Educational and training program using motivational interview technical. Stratification labels: to determine the personalized intervention plan are obtained from two types of variables: personal and modulation variables. For psychological variables the Perceived Competence Evaluation Questionnaire validated in Adherence to CPAP in OSA (CEPCA) is used. Drowsiness is obtained through the administration of the Epworth Somnolence Test, and the apnoea-hypopnea index is taken from the patient's clinical history. Segmentation: With the psychological and clinical variables, in this first visit, predictive information is obtained on how the patient's adherence will be: high adherence, moderate adherence or low adherence. Taking this information into account, the care plan will start considering how the patient is and their situation with respect to adherence. Depending on their evolution, the care plan is adapted. For patients with low adherence, telemonitoring is used. | Behavioral: Motivational Interview (MI) & Adherence Follow-Up<br>* 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<br>|
| Experimental: Control<br>The patients followed the standard of care, which consists of starting therapy in the hospital, where the nurse performed training in the use of CPAP equipment, mask adjustment, and safety and maintenance instructions. For follow-up, the patient was always referred to the Hospital, with a frequency established by the Spanish Society of Pulmonology and Thoracic Surgery (Day 30, Day 90 and Day 180). The follow-up procedure consisted of reviewing the CPAP hour meter and resolving any incidents that may have arisen, with the necessary corrective actions (change of mask, positive reinforcement, and explanation of specific aspects). | Behavioral: Adherence Follow-Up<br>* The nurse takes the compliance of the CPAP device, and ask to the patient if he had some problems.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence (changes) | Number of hours of use of CPAP per night | Day 90, Day 180 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPAP, Sleep Apnea, Adherence, Quality of Life