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

Piloto Study of an Individualized Plan for Improving Adherence to Portable Oxygen Therapy in Patients With Respiratory Pathology

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.

Study Overview

• Status: Completed
• Conditions: COPD; Dyspnea; ILD
• Intervention / Treatment: Behavioral: Educational and Training with counselling

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28020
    • David Rudilla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence - Changes	Number of hours of use of oxygen concentrator / day	Day 1 and Day 90
Dyspnea - Changes	Level of dyspnea, measured with the mMRC scale. Minimum score: 0, Maximum score: 4. A high score implies a worse outcome.	Day 1 and Day 90
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.	Day 1 and Day 90
Emotional State - Changes	Mood, measured with a 3 level likert item . Minimum score: 0, Maximum score: 2. A high score implies a better outcome.	Day 1 and Day 90
Activities	Level of activity. measured with a 3 level likert item . Minimum score: 0, Maximum score: 2. A high score implies a better outcome.	Day 1 and Day 90
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.	Day 1 and Day 90

Collaborators and Investigators

• Sponsor: Air Liquide Healthcare Spain
• Collaborators: Hospital Sant Joan de Deu
• Investigators: Principal Investigator: David Rudilla, PhD, Air Liquide Healthcare

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): April 26, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (ACTUAL): December 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: PIMAOX-CEI 20/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No