Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea
NCT ID: NCT04691479
Last Updated: 2020-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
129 participants
INTERVENTIONAL
2018-03-10
2018-11-20
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PIMAGroup
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.
Motivational Interview (MI) & Adherence Follow-Up
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
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).
Adherence Follow-Up
The nurse takes the compliance of the CPAP device, and ask to the patient if he had some problems.
Interventions
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Motivational Interview (MI) & Adherence Follow-Up
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-Up
The nurse takes the compliance of the CPAP device, and ask to the patient if he had some problems.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of OSA confirmed by sleep studies with polygraphy (PS) and / or polysomnography (PSG)
Exclusion Criteria
* Severe COPD (chronic obstructive pulmonary disease)
* Cognitive disorders and those unable to understand the consent to participate
18 Years
ALL
No
Sponsors
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Hospital Universitari Joan XXIII de Tarragona.
OTHER
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
OTHER
Air Liquide Healthcare Spain
INDUSTRY
Responsible Party
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Principal Investigators
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Pedro Landete, PhD
Role: PRINCIPAL_INVESTIGATOR
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Locations
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David Rudilla
Madrid, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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3450
Identifier Type: REGISTRY
Identifier Source: secondary_id
PIMA1-3450
Identifier Type: -
Identifier Source: org_study_id