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

NCT ID: NCT06852716

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-02-01

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.

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Health education based on BCW theory

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

Routine health education

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuanjiao Yan

OTHER

Sponsor Role: lead

Responsible Party

Yuanjiao Yan

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Heming Wang

Role: PRINCIPAL_INVESTIGATOR

Xiamen Third Hospital

Locations

Xiamen Third Hospital

Xiamen, Fujian, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

LL202203

Identifier Type: -

Identifier Source: org_study_id