Sleep Apnea, ObstructivePIMAGASOXMEDNCT04650061
PIMA - Individualized Adherence Improvement Plan
A study testing Motivational Interview (MI) & Adherence Follow-Up and Adherence Follow-Up in people with Sleep Apnea, Obstructive, run by Air Liquide Healthcare Spain at 1 site in Portugal.
Trial summary
Continuous positive airway pressure (CPAP) is the first-line treatment for sleep apnoea/hypopnoea syndrome (OSA). The aim of this study is to know the results in adherence to CPAP and health related outcomes in patients with OSA through a comprehensive and multidisciplinary program based on stratification and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Motivational Interview (MI) & Adherence Follow-Up and Adherence Follow-Up
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years, diagnosis of OSA confirmed by sleep studies with polygraphy (PS) and / or polysomnography (PSG)
Who cannot join
- subjects with obesity-related hypoventilation, severe COPD (chronic obstructive pulmonary disease) , cognitive disorders and those unable to understand the consent to participate
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Antonio Ferreira
Avintes, 4430-820
David Rudilla, PhD, +34667126630, david.rudilla@airliquide.com
Antonio Ferreira, +(351) 96240 62 00, antoniod.ferreira@airliquide.com
About this study
Official title: Study on an Individualized Plan to Improve Patient Compliance to Therapy, Based on Stratification and Use of Telemonitoring for Sleep Apnea With CPAP
Continuous positive airway pressure (CPAP) is the first-line treatment for sleep apnoea/hypopnoea syndrome (OSA). The aim of this study is to know the results in adherence to CPAP and health related outcomes in patients with OSA through a comprehensive and multidisciplinary program based on stratification and individualized care plans, including the motivational interview.
Methods: A multicenter randomized controlled trial (RCT) is designed. The control group will follow the usual treatment, while the intervention group (PIMA) will follow the treatment according to the stratification label based on a comprehensive assessment. This label determines a personalized treatment plan for each patient, which includes different channels (home, telephone, care center) 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.
Read the detailed description
The subjects enrolled in the study are required to have a diagnosis of OSA confirmed by sleep studies with polygraphy (PS) and / or polysomnography(PSG). Prior to enrolment in the study, all patients are informed in detail about the study and signed the consent form to participate. A randomisation process will follow using a random number generator in Statistical Package for the Social Sciences (SPSS) to systematically assign patients to one group or another, with allocation concealment. Responsible for randomization are prescribers.
The control group intervention. The patients will follow the standard of care, which consists of starting therapy in the home, where the nurse perform training in the use of CPAP equipment, mask adjustment, and safety and maintenance instructions. For follow-up, the patient is always visited at home or telephone, with a frequency established by the Portuguese Society of Sleep(Day 7, Day 21 and Day 180). The follow-up procedure consists of reviewing the CPAP hour meter and resolving any incidents that may have arisen, with the necessary corrective actions (change of mask, positive reinforcement, explanation of specific aspects).
The intervention group 'PIMA' (Personalized Adherence Improvement Plan, based on the Spanish acronym), starts the treatment with the educational and training program called MEntA (Motivational Interview for Adherence). MEntA intervention consists of one session lasting approximately 60 minutes, which is divided into two blocks: educational activity and training activity. In the first block, nurse explains the concepts of sleep apnoea and the symptoms, while a patient shows the CPAP treatment and how to optimize this to the fullest. This block is reinforced with documentation in hard copy and digital format. The second block on training activity was based on working with the treatment, equipment, safety, hygiene and advice. MEntA uses the MI to the treatment of OSA with CPAP. In fact, the nurse uses MI not only at the beginning of therapy, but also in every contact that the patient has with the patient throughout the treatment (subsequent follow-up visits, phone calls, etc). For the PIMA group, the nurse was specifically trained to give this intervention to patients, including a training session with a clinical psychologist.
After the educational and training program, the nurse performs the stratification process to know a series of patient characteristics that will allow identifying the best care plan to obtain the best results in adherence and quality of life. The stratification labels that determine the personalized intervention plan are obtained from two types of variables: personal and modulation variables.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. Low or moderate adherence relative face plans are more intensive than high adherence relative care plans. In follow-up visits (whose frequency depends on the level of adherence), psychological and clinical variables are reviewed and the patient's adherence is added. Depending on their evolution, the care plan is adapted. For patients with low adherence, telemonitoring is used with hours of compliance, the Apnea-hypoanea index(AHI) and air leak.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Motivational Interview (MI) & Adherence Follow-Up, Adherence Follow-Up
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interview (MI) & Adherence Follow-UpBehavioural
With MI, the key goal is to empower the patient to commit to follow CPAP therapy, while providing empathic support, in a positive atmosphere, and without prejudice. The nurse does not directly advocate for behavior change (i.e. use CPAP as prescribed), but asks key questions to help the patient explore their feelings about the change, weighs the pros and cons of such change, and allows the patient to realize the discrepancy between the current risk (that is, not using CPAP as directed) and the benefits with good adherence.
Adherence Follow-UpDevice
The nurse takes the compliance of the CPAP device, and ask to the patient if he had some problems.
| Study group | Role | What they receive |
|---|---|---|
| PIMA Group | Experimental | 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 D21-D90-D120-D180 depending of the care plan, through the channel that belong for each care plan Receives: Behavioral: Motivational Interview (MI) & Adherence Follow-Up |
| Control | Active comparator | 1. Training program
2. Schedule next visits
3. Follow-up D21-D90-D120-D180 using the same process: visit at home or phone. Receives: Device: Adherence Follow-Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adherence in the first 6 months of treatment
Number of hours using CPAP per night
Measured: Day 21, Day 90, Day 120, Day 180
Change in somnolence in the first 6 months of treatment
Residual sleepiness after use of CPAP. Epworth Test
Measured: Day 21, Day 90, Day 120, Day 180
Change in perceived competence in the first 6 months of treatment
Self-Efficacy in the CPAP treatment. Perceived Competence Evaluation Questionnaire
Measured: Day 21, Day 90, Day 120, Day 180
Change in Apnea-hypoanea index in the first 6 months of treatment
Number of apneas-hypoapneas per night
Measured: Day 21, Day 90, Day 120, Day 180
Change in Air Leaks in the first 6 months of treatment
Fly away through the suitcase adaptation of the mask. Measured in liters / per minute
Measured: Day 21, Day 90, Day 120, Day 180
Secondary outcomes (4)
Change in Quality of Life in the first 6 months of treatment
Well-Being of the patient related to sleep apnea. Analogical Well-Being in Sleep Apnea Scale
Measured: Day 21, Day 90, Day 120, Day 180
Change in Mood in the first 6 months of treatment
Emotional status related to sleep apnea. Ad hoc question
Measured: Day 21, Day 90, Day 120, Day 180
Change in Activities in the first 6 months of treatment
Improving general activity after use CPAP. Ad hoc question
Measured: Day 21, Day 90, Day 120, Day 180
Change in Social Relationships in the first 6 months of treatment
Improving general social relations after use CPAP. Ad hoc question
Measured: Day 21, Day 90, Day 120, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Oct 2020
- Primary completion14 Jan 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A multi-centre randomized, controlled trial (RCT)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Liquide Healthcare Spain
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Sao Joao, Hospital Pedro Hispano
- Responsible party
- Sponsor
- Investigators
- David Rudilla, PhD, Principal investigator, Air Liquide Healthcare Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650061
- Sponsor's protocol ID
- 88/CE/JAS
- Acronym
- PIMAGASOXMED
- Status last verified
- Dec 2020
- First submitted
- 24 Nov 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication of results in two phases: * National Congress in Portugal * Publication in Research Journal
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on an Individualized Plan to Improve Patient Compliance to Therapy, Based on Stratification and Use of Telemonitoring for Sleep Apnea With CPAP
- ClinicalTrials.gov ID
- NCT04650061
- Acronym / sponsor ID
- PIMAGASOXMED / 88/CE/JAS
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Air Liquide Healthcare SpainIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Sao Joao, Hospital Pedro Hispano
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 14 Jan 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Continuous positive airway pressure (CPAP) is the first-line treatment for sleep apnoea/hypopnoea syndrome (OSA). The aim of this study is to know the results in adherence to CPAP and health related outcomes in patients with OSA through a comprehensive and multidisciplinary program based on stratification and individualized care plans, including the motivational interview.
Methods: A multicenter randomized controlled trial (RCT) is designed. The control group will follow the usual treatment, while the intervention group (PIMA) will follow the treatment according to the stratification label based on a comprehensive assessment. This label determines a personalized treatment plan for each patient, which includes different channels (home, telephone, care center) 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 subjects enrolled in the study are required to have a diagnosis of OSA confirmed by sleep studies with polygraphy (PS) and / or polysomnography(PSG). Prior to enrolment in the study, all patients are informed in detail about the study and signed the consent form to participate. A randomisation process will follow using a random number generator in Statistical Package for the Social Sciences (SPSS) to systematically assign patients to one group or another, with allocation concealment. Responsible for randomization are prescribers.
The control group intervention. The patients will follow the standard of care, which consists of starting therapy in the home, where the nurse perform training in the use of CPAP equipment, mask adjustment, and safety and maintenance instructions. For follow-up, the patient is always visited at home or telephone, with a frequency established by the Portuguese Society of Sleep(Day 7, Day 21 and Day 180). The follow-up procedure consists of reviewing the CPAP hour meter and resolving any incidents that may have arisen, with the necessary corrective actions (change of mask, positive reinforcement, explanation of specific aspects).
The intervention group 'PIMA' (Personalized Adherence Improvement Plan, based on the Spanish acronym), starts the treatment with the educational and training program called MEntA (Motivational Interview for Adherence). MEntA intervention consists of one session lasting approximately 60 minutes, which is divided into two blocks: educational activity and training activity. In the first block, nurse explains the concepts of sleep apnoea and the symptoms, while a patient shows the CPAP treatment and how to optimize this to the fullest. This block is reinforced with documentation in hard copy and digital format. The second block on training activity was based on working with the treatment, equipment, safety, hygiene and advice. MEntA uses the MI to the treatment of OSA with CPAP. In fact, the nurse uses MI not only at the beginning of therapy, but also in every contact that the patient has with the patient throughout the treatment (subsequent follow-up visits, phone calls, etc). For the PIMA group, the nurse was specifically trained to give this intervention to patients, including a training session with a clinical psychologist.
After the educational and training program, the nurse performs the stratification process to know a series of patient characteristics that will allow identifying the best care plan to obtain the best results in adherence and quality of life. The stratification labels that determine the personalized intervention plan are obtained from two types of variables: personal and modulation variables.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. Low or moderate adherence relative face plans are more intensive than high adherence relative care plans. In follow-up visits (whose frequency depends on the level of adherence), psychological and clinical variables are reviewed and the patient's adherence is added. Depending on their evolution, the care plan is adapted. For patients with low adherence, telemonitoring is used with hours of compliance, the Apnea-hypoanea index(AHI) and air leak.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A multi-centre randomized, controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| PIMA Group | Experimental | Behavioral: Motivational Interview (MI) & Adherence Follow-Up1. 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 D21-D90-D120-D180 depending of the care plan, through the channel that belong for each care plan |
| Control | Active comparator | Device: Adherence Follow-Up1. Training program 2. Schedule next visits 3. Follow-up D21-D90-D120-D180 using the same process: visit at home or phone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Older than 18 years, diagnosis of OSA confirmed by sleep studies with polygraphy (PS) and / or polysomnography (PSG)
Key exclusion criteria (1 listed)
- subjects with obesity-related hypoventilation, severe COPD (chronic obstructive pulmonary disease) , cognitive disorders and those unable to understand the consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interview (MI) & Adherence Follow-UpWith MI, the key goal is to empower the patient to commit to follow CPAP therapy, while providing empathic support, in a positive atmosphere, and without prejudice. The nurse does not directly advocate for behavior change (i.e. use CPAP as prescribed), but asks key questions to help the patient explore their feelings about the change, weighs the pros and cons of such change, and allows the patient to realize the discrepancy between the current risk (that is, not using CPAP as directed) and the benefits with good adherence. | Behavioural | PIMA Group |
| Adherence Follow-UpThe nurse takes the compliance of the CPAP device, and ask to the patient if he had some problems. | Device | Control |
Primary outcome
Change in adherence in the first 6 months of treatment
Time frame: Day 21, Day 90, Day 120, Day 180
Number of hours using CPAP per night
Change in somnolence in the first 6 months of treatment
Time frame: Day 21, Day 90, Day 120, Day 180
Residual sleepiness after use of CPAP. Epworth Test
Change in perceived competence in the first 6 months of treatment
Time frame: Day 21, Day 90, Day 120, Day 180
Self-Efficacy in the CPAP treatment. Perceived Competence Evaluation Questionnaire
Change in Apnea-hypoanea index in the first 6 months of treatment
Time frame: Day 21, Day 90, Day 120, Day 180
Number of apneas-hypoapneas per night
Change in Air Leaks in the first 6 months of treatment
Time frame: Day 21, Day 90, Day 120, Day 180
Fly away through the suitcase adaptation of the mask. Measured in liters / per minute
4 secondary outcomes
Change in Quality of Life in the first 6 months of treatment
Time frame: Day 21, Day 90, Day 120, Day 180
Change in Mood in the first 6 months of treatment
Time frame: Day 21, Day 90, Day 120, Day 180
Change in Activities in the first 6 months of treatment
Time frame: Day 21, Day 90, Day 120, Day 180
Change in Social Relationships in the first 6 months of treatment
Time frame: Day 21, Day 90, Day 120, Day 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Individual participant dataSharing planned: Yes. Publication of results in two phases: * National Congress in Portugal * Publication in Research Journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Rudilla, PhD principal investigator
Air Liquide Healthcare Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interview (MI) & Adherence Follow-Up and Adherence Follow-Up in people with Sleep Apnea, Obstructive, run by Air Liquide Healthcare Spain at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Rudilla, PhD (+34667126630, david.rudilla@airliquide.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in adherence in the first 6 months of treatment (time frame: Day 21, Day 90, Day 120, Day 180). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020; AzTrials last refreshed its copy on 27 Oct 2026.