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

COPD Clinical Trial

— PIMAOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04691336
• Other study ID #: PIMAOX-CEI 20/04
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: December 2020
• Source: Air Liquide Healthcare Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 30, 2019
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Dyspnea
• ILD

Intervention

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

Locations

Country	Name	City	State
Spain	David Rudilla	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Air Liquide Healthcare Spain	Hospital Sant Joan de Deu

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence - Changes	Number of hours of use of oxygen concentrator / day	Day 1 and Day 90
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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