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

Sponsor

Air Liquide Healthcare Spain (Industry)

Overall Status

Completed

CT.gov ID

NCT04691479

Collaborator

Hospital Universitari Joan XXIII de Tarragona. (Other), Fundación de Investigación Biomédica - Hospital Universitario de La Princesa (Other)

129

Enrollment

Location

Arms

8.4

Actual Duration (Months)

15.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive	Behavioral: Motivational Interview (MI) & Adherence Follow-Up Behavioral: Adherence Follow-Up	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

129 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 10, 2018

Actual Primary Completion Date :

Sep 11, 2018

Actual Study Completion Date :

Nov 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PIMAGroup 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 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
Experimental: Control 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 The nurse takes the compliance of the CPAP device, and ask to the patient if he had some problems.

Arm

Intervention/Treatment

Experimental: PIMAGroup

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

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

Experimental: Control

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	David Rudilla	Madrid		Spain	28020

Sponsors and Collaborators

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

Investigators

Principal Investigator: Pedro Landete, PhD, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study Documents (Full-Text)

Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Feb 14, 2018

More Information

Publications

None provided.

Responsible Party:

Air Liquide Healthcare Spain

ClinicalTrials.gov Identifier:

NCT04691479

Other Study ID Numbers:

PIMA1-3450
3450

First Posted:

Dec 31, 2020

Last Update Posted:

Dec 31, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Air Liquide Healthcare Spain

Additional relevant MeSH terms:

Apnea

Sleep Apnea Syndromes

Sleep Apnea, Obstructive

Study Results

No Results Posted as of Dec 31, 2020