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

NCT04691336 | Completed DMC

• 1 other identifier: PIMAOX-CEI 20/04
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; ILD; Dyspnea

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

PIMAGroup

EXPERIMENTAL

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

Educational and Training with counselling BEHAVIORAL

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

PIMAGroup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Air Liquide Healthcare Spain: lead
• Hospital Sant Joan de Deu: collaborator

Study Sites (1)

David Rudilla

Madrid, 28020, Spain

Location

Related Publications (2)

• 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

  BACKGROUND

• 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.

  PMID: 26062752 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Counseling

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• David Rudilla, PhD

  Air Liquide Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: December 31, 2020
• Study Start: March 1, 2019
• Primary Completion: April 26, 2019
• Study Completion: September 30, 2019
• Last Updated: December 31, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: 36 months after the publication of the work in a research journal
• Access Criteria: Researchers who want to replicate the study

Locations

ES (1)