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Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea (PIMA1-JO-PR)

Primary Purpose

Sleep Apnea, Obstructive

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Motivational Interview (MI) & Adherence Follow-Up
Adherence Follow-Up
Sponsored by
Air Liquide Healthcare Spain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring CPAP, Sleep Apnea, Adherence, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • David Rudilla

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PIMAGroup

Control

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Adherence (changes)
Number of hours of use of CPAP per night
Somnolence (changes)
Residual sleepiness after use of CPAP. Epworth Sleepiness Scale. Minimum score: 0; Maximum: 24. Higher scores=worse outcome
Perceived Competence (changes)
Self-Efficacy in the CPAP treatment. Perceived Competence Evaluation Questionnaire. Minimum score: 0; Maximum score 13. Higher score= Better outcome.

Secondary Outcome Measures

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.
Mood (Changes)
Emotional status related to sleep apnea. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.
Activities (Changes)
Improving general activity after use CPAP. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.
Social Relations (Changes)
Improving general social relations after use CPAP. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.

Full Information

First Posted
December 21, 2020
Last Updated
December 29, 2020
Sponsor
Air Liquide Healthcare Spain
Collaborators
Hospital Universitari Joan XXIII de Tarragona., Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
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1. Study Identification

Unique Protocol Identification Number
NCT04691479
Brief Title
Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea
Acronym
PIMA1-JO-PR
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 10, 2018 (Actual)
Primary Completion Date
September 11, 2018 (Actual)
Study Completion Date
November 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Air Liquide Healthcare Spain
Collaborators
Hospital Universitari Joan XXIII de Tarragona., Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
CPAP, Sleep Apnea, Adherence, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
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.
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PIMAGroup
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Experimental
Arm 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 Type
Behavioral
Intervention Name(s)
Motivational Interview (MI) & Adherence Follow-Up
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Adherence Follow-Up
Intervention Description
The nurse takes the compliance of the CPAP device, and ask to the patient if he had some problems.
Primary Outcome Measure Information:
Title
Adherence (changes)
Description
Number of hours of use of CPAP per night
Time Frame
Day 90, Day 180
Title
Somnolence (changes)
Description
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
Title
Perceived Competence (changes)
Description
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
Secondary Outcome Measure Information:
Title
Quality of Life (Changes)
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.
Time Frame
Day 1, Day 90, Day 180
Title
Mood (Changes)
Description
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
Title
Activities (Changes)
Description
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
Title
Social Relations (Changes)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Landete, PhD
Organizational Affiliation
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Official's Role
Principal Investigator
Facility Information:
Facility Name
David Rudilla
City
Madrid
ZIP/Postal Code
28020
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Publication of results in two phases: National Congress in Portugal Publication in Research Journal
IPD Sharing 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.
IPD Sharing Access Criteria
Researchers and reviewers

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Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea

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