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Sleep Apnea, ObstructivePIMA1-JO-PRNCT04691479

Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea

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 Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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
129 participants
Where
1 siteSpain
Study dates
10 Mar 2018to 20 Nov 2018
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.

Spain1 site

  • David Rudilla

    Madrid, 28020

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Motivational Interview (MI) & Adherence Follow-Up, Adherence Follow-Up
Keywords
CPAP, Sleep Apnea, Adherence, Quality of Life
Medical subject headings
Sleep Apnea, Obstructive, Sleep Apnea Syndromes

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

    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

  • Adherence Follow-UpBehavioural

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

Study groups in NCT04691479
Study groupRoleWhat they receive
PIMAGroupExperimental1. 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.
Receives: Behavioral: Motivational Interview (MI) & Adherence Follow-Up
ControlExperimentalThe 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).
Receives: Behavioral: Adherence Follow-Up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence (changes)

    Number of hours of use of CPAP per night

    Measured: Day 90, Day 180

  2. Somnolence (changes)

    Residual sleepiness after use of CPAP. Epworth Sleepiness Scale. Minimum score: 0; Maximum: 24. Higher scores=worse outcome

    Measured: Day 1, Day 90, Day 180

  3. Perceived Competence (changes)

    Self-Efficacy in the CPAP treatment. Perceived Competence Evaluation Questionnaire. Minimum score: 0; Maximum score 13. Higher score= Better outcome.

    Measured: Day 1, Day 90, Day 180

Secondary outcomes (4)

  1. 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.

    Measured: Day 1, Day 90, Day 180

  2. Mood (Changes)

    Emotional status related to sleep apnea. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.

    Measured: Day 1, Day 90, Day 180

  3. Activities (Changes)

    Improving general activity after use CPAP. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.

    Measured: Day 1, Day 90, Day 180

  4. Social Relations (Changes)

    Improving general social relations after use CPAP. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.

    Measured: Day 1, Day 90, 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 posted31 Dec 2020
  2. Study start10 Mar 2018
  3. Primary completion11 Sep 2018
  4. Study completion20 Nov 2018

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
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04691479
Sponsor's protocol ID
PIMA1-3450
Other IDs
3450
Acronym
PIMA1-JO-PR
Status last verified
Dec 2020
First submitted
21 Dec 2020
Last updated
31 Dec 2020
Results posted
No
Data monitoring committee
Yes
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 Spain.

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 2 inclusion and 3 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: finished, as of the sponsor's last update on 31 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 Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence (changes) (time frame: Day 90, Day 180). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04691479.

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 31 Dec 2020.

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