Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea

NCT04691479 | Completed DMC

• 2 other identifiers: PIMA1-34503450
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Keywords

CPAP; Sleep Apnea; Adherence; Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Quality of Life (Changes)

  Day 1, Day 90, Day 180

• Mood (Changes)

  Day 1, Day 90, Day 180

• Activities (Changes)

  Day 1, Day 90, Day 180

• Social Relations (Changes)

  Day 1, Day 90, Day 180

Study Arms (2)

PIMAGroup

EXPERIMENTAL

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.

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

Control

EXPERIMENTAL

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

Interventions

Motivational Interview (MI) & Adherence Follow-Up BEHAVIORAL

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

PIMAGroup

Adherence Follow-Up BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years
• Diagnosis of OSA confirmed by sleep studies with polygraphy (PS) and / or polysomnography (PSG)

You may not qualify if:

• Subjects with obesity-related hypoventilation
• Severe COPD (chronic obstructive pulmonary disease)
• Cognitive disorders and those unable to understand the consent to participate

Sponsors & Collaborators

• Air Liquide Healthcare Spain: lead
• Hospital Universitari Joan XXIII de Tarragona.: collaborator
• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: collaborator

Study Sites (1)

David Rudilla

Madrid, 28020, Spain

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Pedro Landete, PhD

  Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 31, 2020
• Study Start: March 10, 2018
• Primary Completion: September 11, 2018
• Study Completion: November 20, 2018
• Last Updated: December 31, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• Access Criteria: Researchers and reviewers

Locations

ES (1)