Chronic Obstructive Pulmonary Disease (COPD)COPD、MCINCT06852716
A Study of in Elderly Patients With COPD on Long-term Home Oxygen Therapy Combined With MCI
A study testing Health education based on BCW theory and Routine health education in people with Chronic Obstructive Pulmonary Disease (COPD), run by Yuanjiao Yan at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Health education based on BCW theory and Routine health education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Health education based on BCW theory, Routine health education
- Keywords
- health education
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education based on BCW theoryOther
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 educationOther
(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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Routine health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: First and third months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Jun 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuanjiao Yan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuanjiao Yan, Fujian Provincial Hospital
- Investigators
- Heming Wang, Principal investigator, Xiamen Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852716
- Sponsor's protocol ID
- LL202203
- Acronym
- COPD、MCI
- Status last verified
- Mar 2025
- First submitted
- 18 Feb 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06852716
- Acronym / sponsor ID
- COPD、MCI / LL202203
- Keywords
- health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yuanjiao YanUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health education based on BCW theory | Experimental | Other: Health education based on BCW theoryIt 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 |
| Routine health education | Active comparator | 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 ;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health education based on BCW theoryThe 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. | Other | Health education based on BCW theory |
| 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 |
Primary outcome
The execution of LTHOT
Time frame: First and third months
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.
LTHOT Health Beliefs
Time frame: First and third months
.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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heming Wang principal investigator
Xiamen Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education based on BCW theory and Routine health education in people with Chronic Obstructive Pulmonary Disease (COPD), run by Yuanjiao Yan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The execution of LTHOT (time frame: First and third months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.