Clinical trial NCT06852716: A Study of in Elderly Patients With COPD on Long-term Home Oxygen Therapy Combined With MCI
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: health education
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: The execution of LTHOT
timeFrame: First and third months
measure: LTHOT Health Beliefs
timeFrame: First and third months
Secondary outcomes:
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Xiamen Third Hospital
state: Fujian
Study officials:
affiliation: Xiamen Third Hospital
name: Heming Wang
role: PRINCIPAL_INVESTIGATOR
References: