A Study of in Elderly Patients With COPD on Long-term Home Oxygen Therapy Combined With MCI

NCT06852716 | Completed DMC

• 1 other identifier: LL202203
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn The effects of a health education programme based on BCW theory on elderly patients with chronic obstructive pulmonary disease and mild cognitive impairment The main questions it aims to answer are:Researchers will compare the effectiveness of this educational intervention with the conventional education group to see if the intervention programme can change patients' long-term home oxygen therapy adherence.The intervention phase lasts for 3 months, with sessions lasting 30 to 40 minutes, conducted twice a month. The content of both sessions is identical, resulting in a total of 6 sessions.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

health education

Outcome Measures

Primary Outcomes (2)

• The execution of LTHOT

  The execution of LTHOT was assessed using a self-designed Long-Term Home Oxygen Therapy Behavior Survey. Given that improper operational skills can affect the effectiveness of long-term home oxygen therapy, the survey primarily includes four dimensions: adherence to home oxygen therapy, cleaning and disinfection, safe oxygen use, and self-monitoring, with a total of 13 items. Each item has two response options: "Yes" and "No," where "Yes" indicates the behavior was performed, and "No" indicates it was not. A score of 1 is awarded for "Yes," and 0 for "No." The higher the total score, the better the patient's long-term home oxygen therapy behavior. The average daily oxygen use time was self-reported by the patient.The scores of the four dimensions were summed to obtain a total score, which was used to assess the implementation of long-term home oxygen therapy in patients.

  First and third months

• LTHOT Health Beliefs

  .The long-term home oxygen therapy health beliefs questionnaire designed by Yan Ying was used, with 4 dimensions and 26 items. 4 dimensions were: Perception of susceptibility to hypoxaemia，Perception of hypoxaemia severity，Perceived severity of hyepoxaemia.，Perceived benefits of long-term home oxygen therapy and Perceived barriers to long-term home oxygen therapy. According to the individual's perception of the health behavioural ability of long-term home oxygen therapy The scores were assessed according to the individual's knowledge of the health behavioural competence of long-term home oxygen therapy, with the total score ranging from 0 to 104, and the higher the score, the higher the score.

  First and third months

Study Arms (2)

Health education based on BCW theory

EXPERIMENTAL

It can be divided into intervention stage and follow-up stage. The intervention stage lasted for 3 months. The intervention measures in the intervention stage were as follows: stimulate the motivation to change (M), guide and motivate MCI patients to establish the health belief of insisting on long-term home oxygen therapy, and strengthen the importance and necessity of self-management; Training in behavioural change (C) Dissemination and presentation of knowledge manuals; Guide patients to correctly understand the definition, causes, clinical manifestations and hazards of COPD and MCI related diseases to improve their cognition and prevention awareness of the disease; Create a behavior change environment (O), provide a platform for patient communication, share and demonstrate home oxygen therapy skills, and improve long-term home oxygen therapy compliance. Follow-up stage: Relevant data were collected during outpatient visits or home visits to understand patients' LTHOT

Other: Health education based on BCW theory

Routine health education

ACTIVE COMPARATOR

(1) Give disease-related knowledge guidance according to nursing routine; (2) Guide patients and their families to standardize oxygen inhalation and ensure that patients correctly master oxygen inhalation operation methods; (3) Patiently answer patients' doubts about the disease, encourage patients to treat the disease with a positive attitude, and establish a good relationship of trust with patients and their families

Other: Routine health education

Interventions

Health education based on BCW theory OTHER

The intervention stage lasted for 3 months. The intervention measures in the intervention stage were as follows: stimulate the motivation to change (M), guide and motivate MCI patients to establish the health belief of insisting on long-term home oxygen therapy, and strengthen the importance and necessity of self-management; Training in behavioural change (C) Dissemination and presentation of knowledge manuals; Guide patients to correctly understand the definition, causes, clinical manifestations and hazards of COPD and MCI related diseases to improve their cognition and prevention awareness of the disease; Create a behavior change environment (O), provide a platform for patient communication, share and demonstrate home oxygen therapy skills, and improve long-term home oxygen therapy compliance. Along with the Visit stage: Collect relevant data during the patient's outpatient visit or home visit to understand the patient's long-term home oxygen therapy situation.

Health education based on BCW theory

Routine health education OTHER

(1) Give disease-related knowledge guidance according to nursing routine; (2) Guide patients and their families to standardize oxygen inhalation and ensure that patients correctly master oxygen inhalation operation methods; (3) Patiently answer patients' doubts about the disease, encourage patients to treat the disease with a positive attitude, and establish a good relationship of trust with patients and their families.

Routine health education

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 60 years old;
• Physician-diagnosed stable COPD based on the 2022 Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines ;
• SpO₂ \<88% or PaO₂ \<60 mmHg;
• Met diagnostic criteria for MCI , including subjective cognitive concerns;objective cognitive impairment in memory, executive function, attention, and/or language; preserved activities of daily living ; and absence of dementia ;
• Unimpaired Mandarin communication ability ;
• Voluntary participation in the study.

You may not qualify if:

• comorbid asthma or malignant lung cancer;
• long-term home oxygen therapy(≥15 hours/day);
• concurrent participation in similar trials;
• significant sensory impairments, such as vision or hearing loss ; history of psychiatric disorders or congenital intellectual disabilities; comatose state, presence of major diseases, or being in the terminal stage;
• presence of other neurological diseases that could cause cognitive impairment.

Sponsors & Collaborators

• Yuanjiao Yan: lead

Study Sites (1)

Xiamen Third Hospital

Xiamen, Fujian, 361000, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Health Education

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Heming Wang

  Xiamen Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 28, 2025
• Study Start: June 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: After completion of the study,relevant data will be provided in the form of a URL or DOI
• Access Criteria: Researchers whose proposed use of the data has been approved

Locations

CN (1)