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

Not Applicable

Completed

• Conditions: COPD; ILD; Dyspnea
• Interventions: Behavioral: Educational and Training with counselling

• Registration Number: NCT04691336
• Lead Sponsor: Air Liquide Healthcare Spain

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.

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2019-04-26
• Study Completion: 2019-09-30
• Status Verified: 2020-12
• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2020-12-30
• Last Update Submitted: 2020-12-30
• Study First Posted: 2020-12-31
• Last Update Posted: 2020-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PIMAGroup	Educational and Training with counselling	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.

Primary Outcome Measures

Name	Time	Method
Adherence - Changes	Day 1 and Day 90	Number of hours of use of oxygen concentrator / day
Quality of Life - Changes	Day 1 and Day 90	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	Day 1 and Day 90	Mood, measured with a 3 level likert item . Minimum score: 0, Maximum score: 2. A high score implies a better outcome.
Activities	Day 1 and Day 90	Level of activity. measured with a 3 level likert item . Minimum score: 0, Maximum score: 2. A high score implies a better outcome.
Dyspnea - Changes	Day 1 and Day 90	Level of dyspnea, measured with the mMRC scale. Minimum score: 0, Maximum score: 4. A high score implies a worse outcome.
Social Relations	Day 1 and Day 90	Level of social activity. measured with a 3 level likert item . Minimum score: 0, Maximum score: 2. A high score implies a better outcome.

Trial Locations

Locations (1)

David Rudilla; 🇪🇸 Madrid, Spain