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

Primary Purpose

COPD, ILD, Dyspnea

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Educational and Training with counselling
Sponsored by
Air Liquide Healthcare Spain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

  • David Rudilla

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PIMAGroup

Arm 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.

Outcomes

Primary Outcome Measures

Adherence - Changes
Number of hours of use of oxygen concentrator / day
Dyspnea - Changes
Level of dyspnea, measured with the mMRC scale. Minimum score: 0, Maximum score: 4. A high score implies a worse outcome.
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.
Emotional State - Changes
Mood, measured with a 3 level likert item . Minimum score: 0, Maximum score: 2. A high score implies a better outcome.
Activities
Level of activity. measured with a 3 level likert item . Minimum score: 0, Maximum score: 2. A high score implies a better outcome.
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.

Secondary Outcome Measures

Full Information

First Posted
December 28, 2020
Last Updated
December 30, 2020
Sponsor
Air Liquide Healthcare Spain
Collaborators
Hospital Sant Joan de Deu
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1. Study Identification

Unique Protocol Identification Number
NCT04691336
Brief Title
Individualized Plan for Improving Adherence to Portable Oxygen Therapy in Patients With Respiratory Pathology
Acronym
PIMAOX
Official Title
Piloto Study of an Individualized Plan for Improving Adherence to Portable Oxygen Therapy in Patients With Respiratory Pathology
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
April 26, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Liquide Healthcare Spain
Collaborators
Hospital Sant Joan de Deu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, ILD, Dyspnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PIMAGroup
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Educational and Training with counselling
Intervention Description
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
Primary Outcome Measure Information:
Title
Adherence - Changes
Description
Number of hours of use of oxygen concentrator / day
Time Frame
Day 1 and Day 90
Title
Dyspnea - Changes
Description
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
Title
Quality of Life - Changes
Description
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
Title
Emotional State - Changes
Description
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
Title
Activities
Description
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
Title
Social Relations
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Psychophysical inability to carry out questionnaires or refusal to answer them. Severe displacement problems.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Rudilla, PhD
Organizational Affiliation
Air Liquide Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
David Rudilla
City
Madrid
ZIP/Postal Code
28020
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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. Bibliometric impact. This project is expected to lead to world-class, high-impact publications.
IPD Sharing Time Frame
36 months after the publication of the work in a research journal
IPD Sharing Access Criteria
Researchers who want to replicate the study
Citations:
Citation
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
Results Reference
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PubMed Identifier
26062752
Citation
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.
Results Reference
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Individualized Plan for Improving Adherence to Portable Oxygen Therapy in Patients With Respiratory Pathology

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