## Protocol Section
### Identification Module
**NCT ID:** NCT04691479

**Acronym:** PIMA1-JO-PR

**Brief Title:** Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea

**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

#### Organization Study ID Info
**ID:** PIMA1-3450
#### Organization
**Class:** INDUSTRY
**Full Name:** Air Liquide Healthcare Spain
#### Secondary ID Infos
**Domain:** Ethics Committee for Clinical Research
**ID:** 3450
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2018-11-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-12-31

**Type:** ACTUAL

**Last Update Submit Date:** 2020-12-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-09-11

**Type:** ACTUAL

#### Start Date
**Date:** 2018-03-10

**Type:** ACTUAL

**Status Verified Date:** 2020-12

#### Study First Post Date
**Date:** 2020-12-31
**Type:** ACTUAL
**Study First Submit Date:** 2020-12-21
**Study First Submit QC Date:** 2020-12-29
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Hospital Universitari Joan XXIII de Tarragona.

**Class:** OTHER

**Name:** Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Air Liquide Healthcare Spain

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Sleep Apnea, Obstructive

**Keywords:**

- CPAP

- Sleep Apnea

- Adherence

- Quality of Life

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**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.

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 129

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 1. Educational and training program using motivational interview technical.
2. 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.
3. 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.
4. 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.

**Intervention Names:**

- Behavioral: Motivational Interview (MI) & Adherence Follow-Up

**Label:** PIMAGroup

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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).

**Intervention Names:**

- Behavioral: Adherence Follow-Up

**Label:** Control

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- PIMAGroup

**Description:** 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

**Name:** Motivational Interview (MI) & Adherence Follow-Up

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Control

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

**Name:** Adherence Follow-Up

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Number of hours of use of CPAP per night

**Measure:** Adherence (changes)

**Time Frame:** Day 90, Day 180

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

**Measure:** Somnolence (changes)

**Time Frame:** Day 1, Day 90, Day 180

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

**Measure:** Perceived Competence (changes)

**Time Frame:** Day 1, Day 90, Day 180

#### Secondary Outcomes

**Description:** 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.

**Measure:** Quality of Life (Changes)

**Time Frame:** Day 1, Day 90, Day 180

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

**Measure:** Mood (Changes)

**Time Frame:** Day 1, Day 90, Day 180

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

**Measure:** Activities (Changes)

**Time Frame:** Day 1, Day 90, Day 180

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

**Measure:** Social Relations (Changes)

**Time Frame:** Day 1, Day 90, Day 180

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Madrid

**Country:** Spain

**Facility:** David Rudilla

**Zip:** 28020

#### Overall Officials

**Official 1:**

**Affiliation:** Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

**Name:** Pedro Landete, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Researchers and reviewers

**Description:** Publication of results in two phases:

* National Congress in Portugal
* Publication in Research Journal

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

**IPD Sharing:** YES

**Time Frame:** At the moment we are presenting the results in a journal for publication. The data may be requested from any of the researchers, and may be consulted online, the data being 100% anomized. Data accessibility will be in the next 36 months after publication.

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-02-14

- Filename: Prot_SAP_ICF_000.pdf

- Has ICF: True

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

- Size: 736145

- Type Abbrev: Prot_SAP_ICF

- Upload Date: 2020-12-29T07:45

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000012818

- Term: Signs and Symptoms, Respiratory

- ID: D000020919

- Term: Sleep Disorders, Intrinsic

- ID: D000020920

- Term: Dyssomnias

- ID: D000012893

- Term: Sleep Wake Disorders

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M4361

- Name: Apnea

- Relevance: HIGH

- As Found: Apnea

- ID: M15694

- Name: Sleep Apnea Syndromes

- Relevance: HIGH

- As Found: Sleep Apnea

- ID: M22010

- Name: Sleep Apnea, Obstructive

- Relevance: HIGH

- As Found: Sleep Apnea, Obstructive

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15623

- Name: Signs and Symptoms, Respiratory

- Relevance: LOW

- As Found: Unknown

- ID: M22242

- Name: Parasomnias

- Relevance: LOW

- As Found: Unknown

- ID: M22654

- Name: Sleep Disorders, Intrinsic

- Relevance: LOW

- As Found: Unknown

- ID: M22655

- Name: Dyssomnias

- Relevance: LOW

- As Found: Unknown

- ID: M15696

- Name: Sleep Wake Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: HIGH

- As Found: Quality of Life

### Condition Browse Module - Meshes

- ID: D000001049

- Term: Apnea

- ID: D000012891

- Term: Sleep Apnea Syndromes

- ID: D000020181

- Term: Sleep Apnea, Obstructive

### Misc Info Module

- Version Holder: 2024-05-24
