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

A Study of Behavioural Change in Elderly Patients With Chronic Obstructive Pulmonary Disease on Long-term Home Oxygen Therapy Combined With Mild Cognitive Impairment Impairment: a Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Other: Health education based on BCW theory; Other: Routine health education

Detailed Description

A 2-day uniform training was conducted by the researcher herself for the other interventionists prior to the implementation of the intervention, using a combination of PPT and other A combination of PowerPoint and other written materials was used to explain the intervention process, the content of the intervention, the method of group discussion, and common problems and solutions.

The intervention process, intervention content, group discussion methods, and common problems and solutions were explained using a combination of PPT and other written materials. In order to ensure the homogeneity of the intervention, scenarios were simulated through role-playing, and the effectiveness of the training was assessed and evaluated, with problems identified and corrected.

Problems were pointed out and corrected. Elderly patients with COPD combined with MCI who met the inclusion and exclusion criteria of LTHOT were divided into 2 groups.

The patients in the experimental group received the LTHOT health education programme for elderly COPD patients with MCI based on the BCW theory, and the patients in the control group received conventional health education.

The patients in the control group received routine health education. The study subjects were divided into 2 groups, 15-20 people in each group, and the intervention activities were carried out simultaneously in the 4 groups.

The content and period of the intervention were kept consistent, and equal attention was paid to each group. 30~40min each time, 2 times a month.

The contents of the two activities are the same, a total of 6 times, the researchers carry out activities at the time agreed with the research subjects in that month, and the research subjects The researchers will carry out the activities at the agreed time with the study subjects in the same month, and the study subjects can choose the time period to participate in the health education according to their own situation.

The intervention will be carried out in the form of in-home or online health education. Group lectures will be combined with individual counselling, and individual counselling will be provided after the lectures if there are any questions.

Intervention content: Implementation of the LTHOT health education programme for elderly patients with COPD combined with MCI based on the BCW theory.

It was based on a literature review by the researchers, with reference to the Chinese Expert Consensus on Diagnosis and Treatment of Acute Exacerbation of COPD(2022 Revision) the 2022 version of the Global Strategy for the Diagnosis, Treatment and Prevention of Chronic Obstructive Lung Disease (GOLD2022 report), and so on.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361000
      • Xiamen Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health education based on BCW theory; 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; 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.
Active Comparator: Routine health education; (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; (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yuanjiao Yan
• Investigators: Principal Investigator: Heming Wang, Xiamen Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: health education
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: LL202203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Research data and research-related materials will be available in a repository or online. After completion of the study, relevant data will be provided in the form of a URL or DOI.
• IPD Sharing Time Frame: After completion of the study,relevant data will be provided in the form of a URL or DOI
• IPD Sharing Access Criteria: Researchers whose proposed use of the data has been approved
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE

Drug and device information, study documents

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