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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
  • Antonio Ferreira

    Avintes, 4430-820

    David Rudilla, PhD, +34667126630, david.rudilla@airliquide.com

    Antonio Ferreira, +(351) 96240 62 00, antoniod.ferreira@airliquide.com

    Recruiting

Other trials in Portugal

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.

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 groups in NCT04650061
Study groupRoleWhat they receive
PIMA GroupExperimental1. 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
ControlActive comparator1. 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted2 Dec 2020
  2. Study start1 Oct 2020
  3. Primary completion14 Jan 2021 (estimated)
  4. Study completion30 Jun 2021 (estimated)

Resources

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)
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

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.

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