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CompletedNCT04691336PIMAOXUpdated Dec 31, 2020

Individualized Plan for Improving Adherence to Portable Oxygen Therapy in Patients With Respiratory Pathology

An interventional study of Educational and Training with counselling in COPD, ILD and Dyspnea, sponsored by Air Liquide Healthcare Spain. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-31.

Sponsored by Air Liquide Healthcare Spain · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Pilot study with patients with prescription of portable oxygen therapy, to test the impact on adherence of a patient-centered empowerment program, with contents on the nature of the respiratory pathology, the symptom of dyspnea, the benefits of the therapy, adjustment expectations and beliefs, as well as health habits.

Read the detailed description

All patients were summoned to the care center, being evaluated individually by a nurse, and based on the results, a care plan adapted to the specific needs and objectives was initiated. This care plan involved monitoring using different channels (face-to-face, telephone), with the main objective of monitoring the evolution of compliance, adherence and improving the quality of life of patients. The interventions that were carried out were educational and formative (using counseling communication skills), and technological (using monitoring tools in specific cases). The empowerment program was an educational session in which the nurse discussed content about dyspnea, the benefits of therapy, etc.

02

Conditions studied

  • COPD
  • ILD
  • Dyspnea

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients (over 18 years old) with prescription of portable oxygen therapy by the Pneumology Service of the Sant Joan de Dèu Hospital in Manresa.

Exclusion criteria

Exclusion Criteria:

  • Psychophysical inability to carry out questionnaires or refusal to answer them.
  • Severe displacement problems.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    PIMAGroup

    All patients were summoned to the care center, being evaluated individually by a nurse, and based on the results, a care plan adapted to the specific needs and objectives was initiated. This care plan involved monitoring using different channels (face-to-face, telephone), with the main objective of monitoring the evolution of compliance, adherence and improving the quality of life of patients. The interventions that were carried out were educational and formative (using counseling communication skills), and technological (using monitoring tools in specific cases). The empowerment program was an educational session in which the nurse discussed content about dyspnea, the benefits of therapy, etc.

    Behavioral: Educational and Training with counselling

Interventions

  • BehavioralEducational and Training with counselling

    The nurse conducts a structured interview that covers the following areas: information on respiratory attraction and the symptom of dyspnea, expectations and beliefs about oxygen therapy, use of oxygen therapy, healthy habits, social support. It also evaluates the patient's perception of oxygen therapy, and the level of dyspnea using the mMRC scale. After this, the nurse evaluates the current level of adherence, and if she considers that the patient needs a reinforcement session, she schedules a workshop with 3 other patients and their main caregivers. This workshop takes place 30 days after this interview. In other patients, depending on the level of adherence, a support call is made, and all patients are visited again at the center at 90 days, performing the same evaluation with a structured interview and the scales that were made on day 1

05

What researchers measure

Primary outcomes

  1. Adherence - Changes

    Number of hours of use of oxygen concentrator / day

    Time frame: Day 1 and Day 90

  2. Dyspnea - Changes

    Level of dyspnea, measured with the mMRC scale. Minimum score: 0, Maximum score: 4. A high score implies a worse outcome.

    Time frame: Day 1 and Day 90

  3. Quality of Life - Changes

    General well-being state, measured with a visual analog scale. Minimum score: 0, Maximum score: 10. A high score implies a better outcome.

    Time frame: Day 1 and Day 90

  4. Emotional State - Changes

    Mood, measured with a 3 level likert item . Minimum score: 0, Maximum score: 2. A high score implies a better outcome.

    Time frame: Day 1 and Day 90

  5. Activities

    Level of activity. measured with a 3 level likert item . Minimum score: 0, Maximum score: 2. A high score implies a better outcome.

    Time frame: Day 1 and Day 90

  6. Social Relations

    Level of social activity. measured with a 3 level likert item . Minimum score: 0, Maximum score: 2. A high score implies a better outcome.

    Time frame: Day 1 and Day 90

06

Study locations

1 site
  • David Rudilla
    Madrid, 28020, Spain
07

References and documents

Publications

  • Rudilla D, Valenzuela C, Beceiro MJ, Alonso T, Ancochea J. Fibrosis pulmonar idiopática y emociones. Una revisión sobre los aspectos psicológicos de la enfermedad. Rev Patol Respir. 2018; 21(2): 54-60
  • Rudilla D, Oliver A, Galiana L, Barreto P. A new measure of home care patients' dignity at the end of life: The Palliative Patients' Dignity Scale (PPDS). Palliat Support Care. 2016 Apr;14(2):99-108. doi: 10.1017/S1478951515000747. Epub 2015 Jun 11. PubMed 26062752 ↗

Individual participant data

Plan to share: Yes — 1. Clinical impact, assistance and / or technological development. This project has a great impact and clinical and technological significance. From the clinical point of view, the aim is to identify the patient in order to better serve him and ensure adherence to one of the treatments where it is more complex to achieve patient compliance. 2. Bibliometric impact. This project is expected to lead to world-class, high-impact publications.

08

Registry details

Key details

Study ID
NCT04691336
Lead sponsor
Air Liquide Healthcare Spain
Collaborators
Hospital Sant Joan de Deu
Responsible party
David Rudilla (Principal investigator, Air Liquide Healthcare Spain) — Principal investigator
First posted
Dec 31, 2020
Start date
Mar 1, 2019
Primary completion
Apr 26, 2019
Completion
Sep 30, 2019
Last update
Dec 31, 2020

Study contacts

David Rudilla, PhD
principal investigator · Air Liquide Healthcare

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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